Hot PLR Content Marketing Christmas Island: September 2016

Wednesday, 28 September 2016

Trican

Trican may be available in the countries listed below.

Ingredient matches for Trican

Fluconazole

Fluconazole is reported as an ingredient of Trican in the following countries:

Israel

International Drug Name Search

Tenoxicam Bidiphar

Tenoxicam Bidiphar may be available in the countries listed below.

Ingredient matches for Tenoxicam Bidiphar

Tenoxicam

Tenoxicam is reported as an ingredient of Tenoxicam Bidiphar in the following countries:

Vietnam

International Drug Name Search

Ventolin Inhalation

Generic Name: albuterol (Inhalation route)

al-BUE-ter-ol

Commonly used brand name(s)

In the U.S.

Accuneb

ProAir HFA

Proventil

Proventil HFA

ReliOn Ventolin HFA

Ventolin

Ventolin HFA

In Canada

Alti-Salbutamol Inhalation Aerosol

Apo-Salvent

Salbutamol

Salbutamol Nebuamp

Salbutamol Respirator Solution

Ventolin Inhaler

Ventolin Nebules P.F.

Ventolin Respirator

Ventolin Rotacaps

Available Dosage Forms:

Aerosol Powder

Solution

Capsule

Powder

Therapeutic Class: Bronchodilator

Pharmacologic Class: Sympathomimetic

Uses For Ventolin

Albuterol is used to treat or prevent bronchospasm in patients with asthma, bronchitis, emphysema, and other lung diseases. This medicine is also used to prevent wheezing caused by exercise (exercise-induced bronchospasm).

Albuterol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, albuterol is used in certain patients with the following medical condition:

Hyperkalemia (too much potassium in the blood).

Before Using Ventolin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of albuterol inhalation aerosol (e.g., Proair® HFA) in children 4 years of age and older and albuterol inhalation solution (e.g., Accuneb®) in children 2 years of age and older. However, safety and efficacy have not been established for the aerosol in children younger than 4 years of age and for the solution in children younger than 2 years of age.

Geriatric

No information is available on the relationship of age to the effects of albuterol inhalation solution (e.g., Accuneb®) in geriatric patients.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of albuterol inhalation aerosol (e.g., Proair® HFA) in geriatric patients. However, elderly patients are more likely to have age-related heart or kidney problems, which may require caution and an adjustment in the dose for patients receiving albuterol.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Alprenolol

Arotinolol

Atenolol

Atomoxetine

Befunolol

Betaxolol

Bevantolol

Bisoprolol

Bopindolol

Brofaromine

Bucindolol

Bupranolol

Carteolol

Carvedilol

Celiprolol

Clorgyline

Dilevalol

Esmolol

Furazolidone

Iproniazid

Isocarboxazid

Labetalol

Landiolol

Lazabemide

Levobetaxolol

Levobunolol

Linezolid

Mepindolol

Metipranolol

Metoprolol

Moclobemide

Nadolol

Nebivolol

Nialamide

Nipradilol

Oxprenolol

Pargyline

Penbutolol

Phenelzine

Pindolol

Procarbazine

Propranolol

Rasagiline

Selegiline

Sotalol

Talinolol

Tertatolol

Timolol

Toloxatone

Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of albuterol

This section provides information on the proper use of a number of products that contain albuterol. It may not be specific to Ventolin. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine or any asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.

The albuterol inhalation solution (e.g., Accuneb®) should be used with a jet nebulizer that is connected to an air compressor with good air flow. The inhalation solution and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the inhalation solution in the nebulizer:

Use one container of solution or mix the exact amount of solution using the dropper provided for each dose.

Place the inhalation solution in the medicine reservoir or nebulizer cup on the machine.

Connect the nebulizer to the face mask or mouthpiece.

Use the face mask or mouthpiece to breathe in the medicine.

Use the nebulizer for about 5 to 15 minutes, or until the medicine in the nebulizer cup is gone.

Clean all the parts of the nebulizer after each use.

The albuterol inhalation aerosol (e.g., Proair® HFA) is used with a special inhaler that comes with patient instructions. Read the directions carefully before using this medicine. If you or your child do not understand the directions or are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check you or your child on a regular basis to make sure you are using it properly.

To use the aerosol inhaler:

The inhaler should be at room temperature before you use it.

Insert the metal canister firmly and fully into the clear end of the Proair® HFA mouthpiece. This mouthpiece should not be used with other inhaled medicines.

Remove the cap and look at the mouthpiece to make sure it is clean.

Shake the inhaler well and test spray it in the air 3 times before using it for the first time or if the inhaler has not been used for more than 2 weeks.

To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.

Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down once on the top of the canister.

Hold your breath for about 10 seconds, then breathe out slowly.

If you are supposed to use more than one puff, wait 1 minute before inhaling the second puff. Repeat these steps for the second puff, starting with shaking the inhaler.

When you have finished all of your doses, rinse your mouth with water and spit the water out.

Clean the inhaler mouthpiece at least once a week with warm running water for 30 seconds, and dry it completely.

If you need to use the inhaler before it is completely dry, shake off the excess water, replace the canister, and spray it 2 times in the air away from the face. Use your regular dose.

After using the inhaler, wash the mouthpiece again and dry it completely.

If the mouthpiece becomes blocked, washing it will help.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For inhalation aerosol dosage form (inhaler):
- For preventing bronchospasm:
  - Adults, teenagers, and children 4 years of age and older—Two puffs every 4 to 6 hours as needed.
  - Children younger than 4 years of age—Use and dose must be determined by your child's doctor.
- For preventing exercise-induced bronchospasm:
  - Adults, teenagers, and children 4 years of age and older—Two puffs taken 15 to 30 minutes before exercise.
  - Children younger than 4 years of age—Use and dose must be determined by your child's doctor.

For inhalation solution dosage form (used with a nebulizer):
- For preventing bronchospasm:
  - Adults and children older than 12 years of age—2.5 milligrams (mg) in the nebulizer 3 or 4 times per day as needed.
  - Children 2 to 12 years of age—0.63 to 1.25 mg in the nebulizer 3 or 4 times per day as needed.
  - Children younger than 2 years of age—Use and dose must be determined by your child's doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Ventolin

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine should not be used together with other inhaled medicines that are similar, such as isoproterenol (Isuprel®), levalbuterol (Xopenex™), metaproterenol (Alupent®), pirbuterol (Maxair®), or terbutaline (Brethaire®).

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using this medicine and check with your doctor right away if you or your child have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

Talk to your doctor or get medical help right away if:

Your symptoms do not improve or they become worse after using this medicine.

Your inhaler does not seem to be working as well as usual and you need to use it more often.

You or your child may also be taking an antiinflammatory medicine, such as a steroid (cortisone-like medicine), together with this medicine. Do not stop taking the antiinflammatory medicine, even if your asthma seems better, unless you are told to do so by your doctor.

Albuterol may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and check with your doctor right away if you or your child develop a skin rash, hives, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you or your child have more than one of the following symptoms: convulsions; decreased urine; dry mouth; increased thirst; irregular heartbeat; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in the hands, feet, or lips; shortness of breath; or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

Ventolin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Fast, irregular, pounding, or racing heartbeat or pulse

shakiness in the legs, arms, hands, or feet

trembling or shaking of the hands or feet

Less common

Abdominal or stomach pain

bladder pain

bloody or cloudy urine

chest discomfort

chest pain

cough or hoarseness

cough producing mucus

diarrhea

difficult or labored breathing

difficulty with swallowing

dizziness

feeling of warmth

fever or chills

frequent urge to urinate

hives

itching

loss of appetite

lower back or side pain

nausea

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the face, neck, arms, and occasionally, upper chest

runny nose

shortness of breath

skin rash

sore throat

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tightness in the chest

unusual tiredness or weakness

weakness

wheezing

Rare

Hives or welts

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

noisy breathing

redness of the skin

swelling of the mouth or throat

trouble breathing

Incidence not known

Agitation

anxiety

arm, back, or jaw pain

chest tightness or heaviness

confusion

convulsions

decreased urine

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

dry mouth

extra heartbeats

fainting

flushed, dry skin

fruit-like breath odor

hallucinations

headache

increased hunger

increased thirst

increased urination

irritability

lightheadedness

muscle pain or cramps

nervousness

nightmares

numbness or tingling in the hands, feet, or lips

pounding in the ears

rapid, deep breathing

restlessness

shakiness

slow or fast heartbeat

stomach cramps

sweating

unexplained weight loss

unusual feeling of excitement

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Body aches or pain

congestion

fever

runny nose

tender, swollen glands in the neck

trouble with swallowing

voice changes

Less common

Difficult, burning, or painful urination

earache

headache, severe and throbbing

muscle or bone pain

pain

redness of the skin

redness or swelling in the ear

redness, swelling, or soreness of the tongue

sleeplessness

sneezing

stuffy nose

swelling

tenderness

trouble in holding or releasing urine

trouble sleeping

unable to sleep

warmth on the skin

Rare

Sleepiness or unusual drowsiness

Incidence not known

Bad, unusual, or unpleasant (after) taste

change in taste

feeling of constant movement of self or surroundings

gagging

rough, scratchy sound to voice

sensation of spinning

tightness in the throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Ventolin Inhalation side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Ventolin Inhalation resources

Ventolin Inhalation Side Effects (in more detail)
Ventolin Inhalation Use in Pregnancy & Breastfeeding
Drug Images
Ventolin Inhalation Drug Interactions
Ventolin Inhalation Support Group
6 Reviews for Ventolin Inhalation - Add your own review/rating

Compare Ventolin Inhalation with other medications

Asthma, acute
Asthma, Maintenance
Bronchospasm Prophylaxis
COPD, Acute
COPD, Maintenance

Triazolam ABC

Triazolam ABC may be available in the countries listed below.

Ingredient matches for Triazolam ABC

Triazolam

Triazolam is reported as an ingredient of Triazolam ABC in the following countries:

Italy

International Drug Name Search

Trazodone-Sandoz

Trazodone-Sandoz may be available in the countries listed below.

Ingredient matches for Trazodone-Sandoz

Trazodone

Trazodone hydrochloride (a derivative of Trazodone) is reported as an ingredient of Trazodone-Sandoz in the following countries:

Luxembourg

International Drug Name Search

Transabon

Transabon may be available in the countries listed below.

Ingredient matches for Transabon

Tranexamic Acid

Tranexamic Acid is reported as an ingredient of Transabon in the following countries:

Japan

International Drug Name Search

Robitussin Night Cold

Generic Name: acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine (a SEET a MIN o fen, DEX troe meth OR fan, dox IL a meen, SOO doe e FED rin)

Brand Names: Alka-Seltzer Plus Night Time Cold Liquigel, All-Nite Multi-Symptom Cold/Flu Relief, Multi-Symptom Nighttime, NyCair, Nyquil Cold Medicine, NyQuil D, Nyquil Liquicap, Robitussin Night Cold, Theraflu Nighttime Severe Cold (pseudoephedrine)

What is Robitussin Night Cold (acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.

Doxylamine is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Dextromethorphan is a cough suppressant. It affects the cough reflex in the brain that triggers coughing.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine is used to treat headache, fever, body aches, cough, runny nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this medicine?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen, and can increase certain side effects of doxylamine. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking this medicine?

You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;

a blockage in your digestive tract (stomach or intestines);

kidney disease;

cough with mucus, or cough caused by emphysema or chronic bronchitis;

enlarged prostate or urination problems; or

if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

It is not known whether acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine may pass into breast milk and may harm a nursing baby. Antihistamines and decongestans may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

How should I take this medicine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking this medicine?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen, and can increase certain side effects of doxylamine. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

This medicine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

chest pain, rapid pulse;

fast, slow, or uneven heart rate;

severe dizziness or anxiety, feeling like you might pass out;

severe headache;

mood changes, confusion, hallucinations, severe nervousness;

tremor, seizure (convulsions);

fever, easy bruising or bleeding, unusual weakness;

urinating less than usual or not at all;

nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

Less serious side effects may include:

dizziness, drowsiness, mild headache;

dry mouth, nose, or throat;

constipation, diarrhea, mild nausea, upset stomach;

blurred vision;

feeling restless or irritable; or

sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect this medicine?

Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by doxylamine.

Ask a doctor or pharmacist if it is safe for you to use acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine if you are also using any of the following drugs:

leflunomide (Arava);

topiramate (Topamax);

zonisamide (Zonegran);

an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

an antidepressant;

birth control pills or hormone replacement therapy;

bladder or urinary medications;

blood pressure medication;

a bronchodilator;

cancer medicine;

cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

gout or arthritis medications (including gold injections);

HIV/AIDS medication;

medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;

medicines to treat psychiatric disorders;

an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

seizure medication.

This list is not complete and there may be other drugs that can affect acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine . Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Robitussin Night Cold resources

Robitussin Night Cold Side Effects (in more detail)
Robitussin Night Cold Use in Pregnancy & Breastfeeding
Robitussin Night Cold Drug Interactions
Robitussin Night Cold Support Group
3 Reviews for Robitussin Night Cold - Add your own review/rating

Compare Robitussin Night Cold with other medications

Cold Symptoms

Where can I get more information?

Your pharmacist can provide more information about acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine .

See also: Robitussin Night Cold side effects (in more detail)

Tuesday, 27 September 2016

Terbihexal

Terbihexal may be available in the countries listed below.

Ingredient matches for Terbihexal

Terbinafine

Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Terbihexal in the following countries:

Australia

Czech Republic

International Drug Name Search

Nu-Iron

In the US, Nu-Iron (iron polysaccharide systemic) is a member of the drug class iron products and is used to treat Iron Deficiency Anemia.

US matches:

Nu-Iron

Nu-Iron 150

Nu-Iron Plus

Ingredient matches for Nu-Iron

Polyferose

Polyferose is reported as an ingredient of Nu-Iron in the following countries:

United States

International Drug Name Search

Walavin

Walavin may be available in the countries listed below.

Ingredient matches for Walavin

Griseofulvin

Griseofulvin is reported as an ingredient of Walavin in the following countries:

India

International Drug Name Search

Cardura XL Extended-Release Tablets

Pronunciation: dox-AZ-oh-sin
Generic Name: Doxazosin
Brand Name: Cardura XL

Cardura XL Extended-Release Tablets are used for:

It may be used for treating symptoms of benign prostatic hyperplasia (BPH). Treating certain conditions as determined by your doctor.

Cardura XL Extended-Release Tablets are an alpha-blocker. It works by relaxing muscles in the prostate and bladder to improve the flow of urine.

Do NOT use Cardura XL Extended-Release Tablets if:

you are allergic to any ingredient of Cardura XL Extended-Release Tablets or to similar medicines (eg, prazosin, terazosin)

you have severe liver problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cardura XL Extended-Release Tablets:

Some medical conditions may interact with Cardura XL Extended-Release Tablets. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of prostate cancer, kidney or liver problems, or high or low blood pressure

if you have a history of stomach or bowel problems (eg, short bowel syndrome, narrowing, blockage, severe or chronic constipation)

if you have a history of heart problems (eg, heart failure, angina) or you have had a heart attack within the past 6 months

if you will be having eye surgery

Some MEDICINES MAY INTERACT with Cardura XL Extended-Release Tablets. Tell your health care provider if you are taking any of the following medicines.

Phosphodiesterase type 5 (PDE5) inhibitors (eg, sildenafil, vardenafil) because severe low blood pressure may occur

Anticholinergics (eg, benzotropine), clarithromycin, HIV protease inhibitors (eg, ritonavir), itraconazole, ketoconazole, nefazodone, telithromycin, or voriconazole because they may increase the risk of Cardura XL Extended-Release Tablets's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cardura XL Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cardura XL Extended-Release Tablets:

Use Cardura XL Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Cardura XL Extended-Release Tablets by mouth with breakfast.

Swallow Cardura XL Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.

Cardura XL Extended-Release Tablets works best if it is taken at the same time each day.

Continue to take Cardura XL Extended-Release Tablets even if you feel well. Do not miss any doses.

If you miss a dose of Cardura XL Extended-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cardura XL Extended-Release Tablets.

Important safety information:

Cardura XL Extended-Release Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Cardura XL Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Cardura XL Extended-Release Tablets may cause a sudden drop in blood pressure after the first dose. These effects will more likely occur after the first few doses or if your dose has increased, but can occur at any time while you are taking Cardura XL Extended-Release Tablets. If can also occur if you stop taking the medicine and then restart treatment.

Cardura XL Extended-Release Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

Before drinking alcohol, discuss it with your doctor. Alcohol may worsen dizziness and lightheadedness.

Cardura XL Extended-Release Tablets may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.

You may notice the tablet shell in your stool. This is normal and not a cause for concern.

Tell your doctor or dentist that you take Cardura XL Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery (including eye surgery).

Lab tests, including blood pressure, may be performed while you use Cardura XL Extended-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Cardura XL Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood pressure.

Cardura XL Extended-Release Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cardura XL Extended-Release Tablets while you are pregnant. It is not known if Cardura XL Extended-Release Tablets are found in breast milk. Do not breast-feed while taking Cardura XL Extended-Release Tablets.

Possible side effects of Cardura XL Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; headache; heartburn; lightheadedness; stomach upset; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or irregular heartbeat; painful or difficult urination; prolonged, painful erection; severe or prolonged dizziness or headache; shortness of breath; swelling of the hands, ankles, or feet; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Cardura XL side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe dizziness, drowsiness, or lightheadedness.

Proper storage of Cardura XL Extended-Release Tablets:

Store Cardura XL Extended-Release Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture and light. Do not store in the bathroom. Keep Cardura XL Extended-Release Tablets out of reach of children and away from pets.

General information:

If you have any questions about Cardura XL Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

Cardura XL Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

If using Cardura XL Extended-Release Tablets for an extended period of time, obtain refills before your supply runs out.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cardura XL Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Cardura XL resources

Cardura XL Side Effects (in more detail)
Cardura XL Use in Pregnancy & Breastfeeding
Cardura XL Drug Interactions
Cardura XL Support Group
1 Review for Cardura XL - Add your own review/rating

Compare Cardura XL with other medications

Benign Prostatic Hyperplasia

Phosphasal

Generic Name: hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate (Oral route)

hye-oh-SYE-a-meen SUL-fate, meth-EN-a-meen, METH-i-leen BLOO, FEN-il sal-I-si-late, SOE-dee-um FOS-fate, mono-BAY-sik

Commonly used brand name(s)

In the U.S.

Phosphasal

Urelle

Uretron D/S

Uribel

Urimar-T

UR N-C

Ustell

Uticap

Utira-C

Utrona-C

Available Dosage Forms:

Tablet

Capsule

Tablet, Enteric Coated

Tablet, Extended Release

Therapeutic Class: Urinary Antispasmodic

Pharmacologic Class: Hyoscyamine

Chemical Class: Salicylate, Non-Aspirin

Uses For Phosphasal

Urelle® is a combination of five medicines: hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate. It is used to relieve discomfort, swelling, pain, frequent urge to urinate, and cramps or spasms of the urinary tract caused by an infection or a diagnostic procedure.

Hyoscyamine is an antispasmodic drug, which relieves muscle cramps or spasms. Methenamine and methylene blue are antiseptic drugs, which help clear a urinary tract infection. Phenyl salicylate is a pain reliever. Sodium phosphate makes the urine more acidic, which helps methenamine work better.

This medicine is available only with your doctor's prescription.

Before Using Phosphasal

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Urelle® in children. However, use is not recommended in children 6 years of age and younger.

Geriatric

No information is available on the relationship of age to the effects of Urelle® in geriatric patients.

Breast Feeding

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amitriptyline

Amoxapine

Bupropion

Cisapride

Citalopram

Clomipramine

Desipramine

Desvenlafaxine

Doxepin

Duloxetine

Escitalopram

Fluoxetine

Fluvoxamine

Imipramine

Isocarboxazid

Linezolid

Maprotiline

Mesoridazine

Mirtazapine

Nortriptyline

Paroxetine

Phenelzine

Pimozide

Potassium

Protriptyline

Selegiline

Sertraline

Sparfloxacin

Thioridazine

Tranylcypromine

Trimipramine

Venlafaxine

Vilazodone

Alfuzosin

Amiodarone

Amitriptyline

Amoxapine

Apomorphine

Arsenic Trioxide

Asenapine

Astemizole

Azithromycin

Buspirone

Chloroquine

Chlorpromazine

Ciprofloxacin

Citalopram

Clarithromycin

Clomipramine

Clozapine

Crizotinib

Dasatinib

Desipramine

Disopyramide

Dofetilide

Dolasetron

Droperidol

Erythromycin

Flecainide

Fluconazole

Gatifloxacin

Gemifloxacin

Granisetron

Halofantrine

Haloperidol

Ibutilide

Iloperidone

Imipramine

Lapatinib

Levofloxacin

Lopinavir

Lumefantrine

Mefloquine

Methadone

Moxifloxacin

Nefazodone

Nilotinib

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Ondansetron

Paliperidone

Pazopanib

Perflutren Lipid Microsphere

Posaconazole

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Ranolazine

Salmeterol

Saquinavir

Solifenacin

Sorafenib

Sotalol

Sunitinib

Telavancin

Telithromycin

Terfenadine

Tetrabenazine

Trazodone

Trimipramine

Vandetanib

Vardenafil

Vemurafenib

Voriconazole

Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aluminum Carbonate, Basic

Aluminum Hydroxide

Aluminum Phosphate

Calcium Acetate

Calcium Carbonate

Calcium Citrate

Dihydroxyaluminum Aminoacetate

Dihydroxyaluminum Sodium Carbonate

Magaldrate

Magnesium Carbonate

Magnesium Hydroxide

Magnesium Oxide

Magnesium Trisilicate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use of hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate

This section provides information on the proper use of a number of products that contain hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate. It may not be specific to Phosphasal. Please read with care.

Take this medicine for the full time of treatment, even if you begin to feel better. Also, keep your appointments with your doctor for check-ups so that your doctor will be better able to tell you when to stop taking this medicine.

Drink extra fluids after you take this medicine so you will pass more urine.

Dosing

For oral dosage form (tablets):
- For treatment of symptoms of urinary tract infection or diagnostic procedure:
  - Adults—One tablet four times a day
  - Children 7 years of age and older—Use and dose must be determined by your doctor.
  - Children 6 years of age and younger—Use is not recommended.

Missed Dose

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Phosphasal

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If your or your child's symptoms do not improve or if they get worse, call your doctor.

Stop using this medicine and check with your doctor right away if you or your child have blurred vision, dizziness, or rapid pulse.

This medicine will make your urine to be colored blue. This is normal and is nothing to worry about.

This medicine will not cure a serious urinary tract infection and will only work to relieve symptoms as long as you continue to take it.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Phosphasal Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Blurred vision

dizziness

rapid pulse

Incidence not known

Blue-colored urine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tri-Adcortyl Cream

The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.

TRI-ADCORTYL CREAM

Your doctor has prescribed Tri-Adcortyl cream for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

REMEMBER: This medicine is for YOU. Only a doctor can prescribe it. Never give it to anyone else. It may harm them even if they have the same symptoms as you.

What Is In Tri-Adcortyl Cream?

This cream contains four active ingredients: triamcinolone acetonide which belongs to a group of medicines called steroids which are used to reduce inflammation, nystatin which is a member of a group of medicines called anti-fungal agents, neomycin and gramicidin which are antibiotics.

Each gram of Tri-Adcortyl contains 0.1% of triamcinolone acetonide, nystatin 100,000 units, neomycin 1625 units (0.25%) and gramicidin 0.025% and is supplied in tubes of 30g.

The other ingredients are: aluminium hydroxide, antifoam emulsion, benzyl alcohol, ethanol, ethylenediamine, hydrochloric acid, macrogol ether, perfume verley, polysorbate 60, propylene glycol, sorbitol, titanium dioxide, white soft paraffin, water.

Who Supplies This Cream?

Product Licence Holder:

E. R. Squibb & Sons Ltd

Uxbridge Business Park

Sanderson Road

Uxbridge

Middlesex

UB8 1DH

England

Tel:0800 7311736

Manufacturer:

Bristol-Myers Squibb SpA

Contrada Fontana Del Ceraso

03012 Anagni (Fr)

Italy

What is this medicine for ?

Tri-Adcortyl cream is prescribed for infected and inflammed skin conditions including eczema.

Before Using Your Medicine

Should you be using Tri-Adcortyl cream?

This cream has been prescribed to treat the skin problem that you showed your doctor. DO NOT use it on any other skin problems as it may make them worse.

DO NOT use Tri-Adcortyl cream if you have any of the following skin conditions:

Tuberculosis (TB) of the skin;

viral infections e.g. cold sores, herpes, chickenpox

acne

inflammation around the mouth (perioral dermatitis)

a condition called rosacea (flushed, red face)

Tri-Adcortyl cream should not be used:

inside the ears of patients with perforated eardrums (holes in eardrums)

for long periods of time

over large areas of the body

in the eyes

This cream should not be used if you have had an allergic reaction to any product containing the same ingredients as Tri-Adcortyl cream. If Tri-Adcortyl cream is to be used on the face, or on children, treatment should not be longer than 5 days and the treated area should not be covered with any airtight or waterproof plasters/dressings.

This medicine should not be used in children under one year of age.

What if I am pregnant or breast feeding ?

You should always tell your doctor if you are pregnant, planning to become pregnant or breast feeding and let him decide if it is wise for you to use this medicine.

Do you have problems with your ears or hearing?

Make sure that your doctor knows about any problems you have with your ears before you start using Tri-Adcortyl. Neomycin, which is one of the active ingredients, may be harmful to the ears, particularly if used in large amounts and for long periods of time.

Using Your Medicine

How should I apply Tri-Adcortyl cream?

This cream should be applied to the affected area two or occasionally three times daily. In the elderly this cream should be used sparingly and for short periods of time. If after 7 days little or no improvement occurs then tell your doctor.

If you are using this cream on burnt skin that has become infected or ulcerated skin, make sure you use a small amount of cream, as these skin conditions may make it easier for the active ingredients in the cream to pass through the skin into the blood stream and may increase the possibility of side-effects.

Are there special directions for children?

As children are more likely to get side effects, they should not normally be treated for longer than 5 days, unless your doctor has told you to to do so.

What if Tri-Adcortyl cream is swallowed?

If this cream is swallowed tell your doctor immediately or go to your nearest hospital casualty department.

What happens if you miss an application?

If you forget to use your cream, apply it as soon as possible. However, if it is nearly time for your next application skip the missed dose and continue as before.

What should you do if you put Tri-Adcortyl cream on areas of normal or healthy skin?

Remove the cream with a clean tissue and wash the area with plenty of water.

Undesirable Effects

Are there any unwanted effects of Tri-Adcortyl cream?

If absorbed into the bloodstream, the active ingredient neomycin can damage the ears or kidney. Check with your doctor if you notice any of the following side effects: blistering, burning, itching, peeling, dryness or other signs of skin irritation not present before using this cream.

If the cream is used for a long time additional side effects may occur. Check with your doctor as soon as possible if you notice any of these: acne or oily skin, increased facial hair growth, increased sweating, lightheadedness on standing, reddish purple lines on arms, face, legs, trunk or groin; thinning of skin with easy bruising or wounds that are slow to heal, rashes consisting of slightly raised rounded red patches. It may also cause changes in your body's sugar levels. If you have skin reaction tests, eg for allergies, the steroid contained in this cream may affect the result by reducing the reaction. If you notice any other unwanted effect tell your doctor or pharmacist.

Looking After Your Medicine

Do not use your medicine after the expiry date which you will find on both the Cream tube and carton.

Keep all your medicines out of reach and sight of children, preferably in a locked cupboard or medicine cabinet. Do not store Tri-Adcortyl cream above 25°C and avoid freezing.

If your doctor decides to stop the cream, ask your pharmacist to tell you what to do with any you have left.

DATE OF LAST REVISION June 2005

Monday, 26 September 2016

Trancopal Dolo

Trancopal Dolo may be available in the countries listed below.

Ingredient matches for Trancopal Dolo

Flupirtine

Flupirtine maleate (a derivative of Flupirtine) is reported as an ingredient of Trancopal Dolo in the following countries:

Germany

International Drug Name Search

Tanvimil Folico

Tanvimil Folico may be available in the countries listed below.

Ingredient matches for Tanvimil Folico

Folic Acid

Folic Acid is reported as an ingredient of Tanvimil Folico in the following countries:

Argentina

International Drug Name Search

Cognex

tacrine hydrochloride

Dosage Form: capsules

Cognex®

(Tacrine Hydrochloride Capsules)

Rx Only

Rev. 08/08

Description

Cognex® (tacrine hydrochloride) is a reversible cholinesterase inhibitor, known chemically as 1,2,3,4-tetrahydro-9-acridinamine monohydrochloride monohydrate. Tacrine hydrochloride is commonly referred to in the clinical and pharmacological literature as THA. It has an empirical formula of C13H14N2• HCl • H2O and a molecular weight of 252.74.

The molecular formula of tacrine hydrochloride is:

Tacrine hydrochloride is a white solid and is freely soluble in distilled water, 0.1N hydrochloric acid, acetate buffer (pH 4.0), phosphate buffer (pH 7.0 to 7.4), methanol, dimethylsulfoxide (DMSO), ethanol, and propylene glycol. The compound is sparingly soluble in linoleic acid and PEG 400.

Each capsule of Cognex® contains tacrine as the hydrochloride. Inactive ingredients are hydrous lactose, magnesium stearate, and microcrystalline cellulose. The hard gelatin capsules contain gelatin, NF; silicon dioxide, NF; sodium lauryl sulfate, NF; and the following dyes: 10 mg: D&C Yellow #10, FD&C Green #3, titanium dioxide; 20 mg: D&C Yellow #10, FD&C Blue #1, titanium dioxide; 30 mg: D&C Yellow #10, FD&C Blue #1, FD&C Red #40, titanium dioxide; 40 mg: D&C Yellow #10, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide.

Each 10-, 20-, 30-, and 40-mg Cognex® capsule for oral administration contains 12.75, 25.50, 38.25, and 51.00 mg of tacrine HCl, respectively.

Cognex - Clinical Pharmacology

Although widespread degeneration of multiple CNS neuronal systems eventually occurs, early pathological changes in Alzheimer's Disease involve, in a relatively selective manner, cholinergic neuronal pathways that project from the basal forebrain to the cerebral cortex and hippocampus. The resulting deficiency of cortical acetylcholine is believed to account for some of the clinical manifestations of mild to moderate dementia. Tacrine, an orally bioavailable, centrally active, reversible cholinesterase inhibitor, presumably acts by elevating acetylcholine concentrations in the cerebral cortex by slowing the degradation of acetylcholine released by still intact cholinergic neurons. If this theoretical mechanism of action is correct, tacrine's effects may lessen as the disease process advances and fewer cholinergic neurons remain functionally intact. There is no evidence that tacrine alters the course of the underlying dementing process.

Clinical Trial Data

The conclusion that Cognex® is an effective treatment for Alzheimer's Disease derives from two adequate and well controlled clinical investigations that evaluated tacrine's effects in patients with probable Alzheimer's disease of mild to moderate severity (NINCDS criteria, Mini-Mental State Examination (MMSE) of Folstein, Folstein and McHugh scores of 10 to 26).

In each study, outcomes during treatment with tacrine and placebo were assessed on two primary measures: (1) the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS cog) of Rosen, Mohs, and Davis and (2) a clinician's rated clinical global impression of change.

Study Endpoints

The ADAS cog is a multi-item test battery administered by a psychometrician that examines aspects of memory, attention, praxis, reason, and language. The worst possible score is 70. Elderly, normal adults may score as low as 0 or 1 unit, but individuals judged not to be demented can score higher. The mean score of patients entering each study was approximately 28 units (range 7 to 62). The ADAS cog score is reported to deteriorate at a rate of about 6 to 10 units per year for untreated patients at this stage of dementia.

The clinician's global assessments used in the two studies relied on a clinician's judgment about the overall clinical change observed in patients over the course of the study. Although the conditions for obtaining the clinical assessment differed in each study, the global assessment was rated on a 7-point scale in both studies. A rating of four (4) represents no change; lower ratings indicate improvement from baseline and higher ratings deterioration.

Twelve-Week Study

In one study of 12 weeks duration, patients were randomized to sequences that provided a comparison between placebo, 20, 40, and 80 mg/day by study's end. Statistically significant drug-placebo differences were detected on both primary outcome measures for the group titrated to 80 mg/day. Estimates of the size of the treatment effect varied between 2 and 4 ADAS cog units. The imprecision in these estimates reflects the fact that different analyses, conducted in attempts to account for the effects of the failure of a substantial fraction of the patients randomized to complete the full 12 weeks of the study, yielded different results.

The placebo-80 mg/day comparison also achieved statistical significance on the clinician's global impression of change (CGIC) with a 0.3 to 0.4 unit mean difference. The following diagram illustrates the percentages of patients falling into each global category at trial's end for the patients given placebo or 80 mg/day.

FIGURE 1. Percent of Patients in Each of the Seven Outcome Categories on the Clinician-Rated CGIC for Patients Completing 12 Weeks of Treatment (83% of patients randomized to placebo completed 12 weeks of treatment and are represented above; 56% of those randomized to the 80 mg/day Cognex® sequence completed 12 weeks)

Thirty-Week Study

The second study was 30 weeks long. Six hundred sixty-three patients were randomized to 4 treatment sequences (placebo and 3 drug groups) that called for the daily dose of tacrine to be increased at 6-week intervals, starting with a 40-mg/day dose. By study's end, a comparison between placebo, 80, 120, and 160 mg/day was possible. Patients in the 160 mg group received this dose for the final 12 weeks; the 120 mg group received that dose for 18 weeks.

The study showed statistically significant drug-placebo differences for the 80 and 120 mg/day groups at 18 weeks and for the 120 and 160 mg/day groups at 30 weeks on both a performance-based test of cognitive function (the ADAS cog) and a clinician's assessment of global change (Clinician Interview Based Impression: CIBI). Because many patients failed to complete 30 weeks on treatment, analyses that used each patient's last on-study value or retrieved patients' (see below) 30-week value, even if they were no longer in the study ("intent-to-treat” analysis) were also carried out. All analyses confirmed the effectiveness of tacrine, although the estimated mean treatment effect was different in each analysis.

Effects on ADAS Cog:

The results for the ADAS cog are shown in Figure 2 for the subset of patients actually completing the full 30 weeks of the study. They show that individual patients, whether assigned to tacrine or to placebo, had a wide range of responses. This variability in response is illustrated in the display that follows (Figure 2).

FIGURE 2. Cumulative Percent of Patients Completing 30 Weeks of Treatment Who Attained a Change in ADAS Cog Score From Baseline at Least as Large as the Value on the X Axis. The display is based on scores obtained from a subset of patients (ie, 64% of the 184 randomized to placebo and 27% of the 239 randomized to the 160 mg/daytreatment group).

Figure 2 presents the cumulative percentage (Y axis) of patients assigned to placebo or 160 mg/day who actually completed 30 weeks on treatment and who attained a change in ADAS cog score from baseline at least as large as the ADAS cog change score value given on the X axis. A negative change from baseline represents improvement; a positive change deterioration. Thus, in a display of this type, the curve for an effective treatment is shifted to the left of the curve for placebo. The frequency in each group of any response, e.g., an improvement of 7 ADAS cog units, can be found by plotting the change on the X axis, then reading upward along the Y axis. The variability of response is apparent from the fact that the distribution of responses under both treatment conditions range from large negative to large positive values. Nonetheless, the mean drug-placebo ADAS cog difference for the 30-week 160 mg/day completer patients is 4.8 units, a statistically significant difference.

Effects on CIBI:

The results on the CIBI are shown in Figure 3.

FIGURE 3. Percent of Patients in Each of the Seven Outcome Categories of the CIBI Among Those Completing 30 Weeks. The display is based on scores obtained from the same subset of patients as Figure 2.

Figure 3 is a histogram of the frequency distribution of CIBI scores attained by patients assigned to placebo or to the 160 mg/day tacrine dose group who actually completed the full 30 weeks of the study. The mean tacrine-placebo difference for this group of patients on the CIBI was 0.5 units and was statistically significant.

Expected Responses in Newly Treated Patients:

Although the results described clearly document tacrine's effectiveness, they are based on only a fraction of the patients initially randomized to tacrine, those who could tolerate tacrine and remain on treatment uninterrupted for the full 30 weeks. In considering the expected outcome in a group of patients newly started on tacrine, account must be taken both of the likelihood of staying on therapy and the responses in patients who do so.

Table 1 provides 3 different estimates of the proportion of patients assigned to treatment with tacrine at 160 mg a day or with placebo who attained a particular measure of improvement (ie, a 7 point improvement from baseline in ADAS cog score). The criterion has been chosen entirely for illustrative purposes.

Table 1. Proportion of Patients Attaining 7 Unit Improvement on the

ADAS Cog at the Week 30 Assessment

Treatment Group N Randomized	I N (%) of Those Randomized	II N (%) of Those Randomized	III N (%) of Those Randomized
Placebo (N = 184)	10/184 ( 5.4)	10/117 ( 8.5)	11/1431 ( 7.7)
160 mg/day (N = 239)	13/239 ( 5.4)	13/64 (20.3)	25/1722 (14.5)

1: 13 of the 143 were receiving tacrine when evaluated.

2: 41 of the 172 were not receiving tacrine when evaluated.

The first column of the table is based on all patients participating in the study. The proportion provides an estimate of the likelihood that a patient entering the study will (1) still be on his or her assigned treatment at week 30 and (2) will improve 7 or more ADAS cognitive points over his or her baseline score. The estimate of response derived in this manner is conservative because the rules under which the 30-week study was conducted required the withdrawal of patients with relatively low (>3 X ULN), asymptomatic, transaminase elevations. In actual clinical practice under the conditions of treatment recommended in the Dosage and Administration Section, a larger fraction of these patients would be able to remain on tacrine and the proportion of those improving 7 or more points on tacrine would be expected, therefore, to be increased (the third column illustrates this).

The second column of the table presents the proportion of 7 unit responders based on the number of patients who (1) were able to complete the full 30 weeks of the study and (2) attained an ADAS cognitive score at week 30 that was 7 or more points better than their baseline score. This analysis provides an optimistic estimate of tacrine's effects because it reflects experience gained only with the minority of patients who were able to remain on treatment to the study's end. The comparison between the proportions of placebo and 160 mg patients attaining a 7 or more point improvement is complicated further by the fact that a larger proportion of tacrine assigned patients withdrew prematurely.

The third column of the table presents the proportion of patients who had evaluations made at 30 weeks and had a 7-point or greater response. The analysis includes data from patients still on their assigned treatment at week 30 as well as patients who withdrew from the study prior to that time, but were retrieved for a week 30 evaluation. Because patients who withdrew prior to week 30 were permitted to receive tacrine under "open label” conditions, retrieved patients included in this analysis could be receiving either no treatment or treatment with tacrine. In this analysis, patients are considered under the treatment to which they were randomized, regardless of the treatment they were actually receiving at week 30. Thus, some placebo patients could have received tacrine and some tacrine patients could have been receiving no tacrine. Like the analysis based on percent randomized (column I), this analysis, therefore, tends to provide a conservative view of the expected effects of tacrine treatment.

Effects of Cognex® Over Time:

Figure 4 shows for each dose group the time course of change from baseline in ADAS cog scores for patients completing 30 weeks of treatment. There appears to be a persistent difference between groups, but all groups, after initial improvement, deteriorate with time.

FIGURE 4. ADAS Cog Change From Baseline Over Time for the Subset of Patients Completing 30 Weeks of Treatment. In all tacrine treatment groups dosing was initiated at 40 mg/day and increased in increments of 40 mg every 6 weeks until the target dose was achieved. Patient age, gender, and other baseline patient characteristics were not found to predict clinical outcome.

Clinical Pharmacokinetics (Absorption, Distribution, Metabolism, and Elimination)

Absorption:

Cognex® is rapidly absorbed after oral administration; maximal plasma concentrations occur within 1 to 2 hours. The rate and extent of tacrine absorption following administration of tacrine capsules and solution are virtually indistinguishable. Absolute bioavailability of tacrine is approximately 17 (SD ± 13) %. Food reduces tacrine bioavailability by approximately 30-40%; however, there is no food effect if tacrine is administered at least an hour before meals. The effect of achlorhydria on the absorption of tacrine is unknown.

Distribution:

Mean volume of distribution of tacrine is approximately 349 (SD ± 193) L. Tacrine is about 55% bound to plasma proteins. The extent and degree of tacrine's distribution within various body compartments has not been systematically studied. However, 336 hours after the administration of a single radiolabeled dose, approximately 25% of the radiolabel was not recovered in a mass balance study, suggesting the possibility that tacrine and/or one or more of its metabolites may be retained.

Metabolism:

Tacrine is extensively metabolized by the cytochrome P450 system to multiple metabolites, not all of which have been identified. The vast majority of radiolabeled species present in the plasma following a single dose of 14C radiolabeled tacrine are unidentified (ie, only 5% of radioactivity in plasma has been identified [tacrine and 3-hydroxylated metabolites; 1-, 2-, and 4-hydroxytacrine]).

Studies utilizing human liver preparations demonstrated that cytochrome P450 IA2 is the principal isozyme involved in tacrine metabolism. These findings are consistent with the observation that tacrine and/or one of its metabolites inhibits the metabolism of theophylline in humans (see PRECAUTIONS: Drug-Drug Interactions: theophylline). Results from a study utilizing quinidine to inhibit cytochrome P450 IID6 indicate that tacrine is not metabolized extensively by this enzyme system.

Following aromatic ring hydroxylation, tacrine's metabolites undergo glucuronidation. Whether tacrine and/or its metabolites undergo biliary excretion or entero-hepatic circulation is unknown.

Special Populations:

Age: Based on pooled pharmacokinetic studies (n = 192), there is no clinically relevant influence of age (50 to 84 years) on tacrine clearance. Gender: Average tacrine plasma concentrations are approximately 50% higher in females than in males. This is not explained by differences in body surface area or elimination half-life. The difference is probably due to higher systemic availability after oral dosing and may reflect the known lower activity of cytochrome P450 IA2 in women. Race: The effect of race on tacrine clearance has not been studied. Smoking: Mean plasma tacrine concentrations in current smokers are approximately one third the concentrations in nonsmokers. Cigarette smoking is known to induce cytochrome P450 IA2. Renal disease: Renal disease does not appear to affect the clearance of tacrine. Liver disease: Although studies in patients with liver disease have not been done, it is likely that functional hepatic impairment will reduce the clearance of tacrine and its metabolites.

Presystemic Clearance/Elimination/Excretion:

Tacrine undergoes presystemic clearance (ie, first pass metabolism). The extent of this first pass metabolism depends upon the dose of tacrine administered. Because the enzyme system involved can be saturated at relatively low doses, a larger fraction of a high dose of tacrine will escape first pass elimination than of a smaller dose. Thus, when a 40 mg daily dose is increased by 40 mg, the average plasma concentration will be increased by approximately 6 ng/mL. However, when a daily dose of 80 or 120 mg is increased by 40 mg, the increment in average plasma concentration is approximately 10 ng/mL.

Elimination of tacrine from the plasma, however, is not dose dependent (ie, the half-life is independent of dose or plasma concentration). The elimination half-life is approximately 2 to 4 hours. Following initiation of therapy or a change in daily dose, steady state tacrine plasma concentration should be attained within 24 to 36 hours.

Drug Interactions (See PRECAUTIONS)

Indications and Usage for Cognex

Cognex® (tacrine hydrochloride capsules) is indicated for the treatment of mild to moderate dementia of the Alzheimer's type.

Evidence of Cognex®'s effectiveness in the treatment of dementia of the Alzheimer's type derives from results of two adequate and well-controlled clinical investigations that compared tacrine and placebo on both a performance based measure of cognition and a clinician's global assessment of change. (See CLINICAL PHARMACOLOGY Section: Clinical Trial Data).

Contraindications

Cognex® is contraindicated in patients with known hypersensitivity to tacrine or acridine derivatives.

Cognex® is contraindicated in patients previously treated with Cognex® who developed treatment-associated jaundice; a serum bilirubin >3 mg/dL; and/or those exhibiting clinical signs or symptoms of hypersensitivity (eg, rash or fever) in association with ALT/SGPT elevations.

Warnings

Anesthesia

Cognex®, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia.

Cardiovascular Conditions

Because of its pharmacological action, Cognex® may have vagotonic effects on the sinoatrial and atrioventricular nodes possibly leading to bradycardia and/or heart block. These effects may be particularly harmful to patients with conduction abnormalities, bradyarrhythmias, or a sick sinus syndrome, but may also occur in patients without known preexisting cardiac disease.

Gastrointestinal Disease and Dysfunction

Cognex® is an inhibitor of cholinesterase and may be expected to increase gastric acid secretion due to increased cholinergic activity. Therefore, patients are at increased risk for developing ulcers. Those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) should be monitored closely for symptoms of active or occult gastrointestinal disease.

Cognex®, also as a predictable consequence of its pharmacological properties, can cause nausea, vomiting, and loose stools at recommended doses.

Liver Injury

Cognex® should be prescribed with care in patients with current evidence or history of abnormal liver function indicated by significant abnormalities in serum transaminase (ALT/SGPT; AST/SGOT), bilirubin, and gamma-glutamyl transpeptidase (GGT) levels (see PRECAUTIONS and DOSAGE AND ADMINISTRATION sections).

The use of tacrine in patients without a prior history of liver disease is commonly associated with serum aminotransferase elevations, some to levels ordinarily considered to indicate clinically important hepatic injury (see Table 2).

Experience gained in more than 12,000 patients who received tacrine in clinical studies and the treatment IND program indicates that if tacrine is promptly withdrawn following detection of these elevations, clinically evident signs and symptoms of liver injury are rare.

Long-term follow up of patients who experience transaminase elevations, however, is limited and it is impossible, therefore, to exclude, with certainty, the possibility of chronic sequelae.

Controlled Clinical Trials, Treatment IND and Post Marketing Experience:

Experience with tacrine in controlled trials and in a large, less closely monitored experience (a treatment IND) is summarized below:

Clinically evident liver toxicity: One of more than 12,000 patients exposed to tacrine in clinical studies and the treatment IND program had documented elevated bilirubin (5.3 X Upper Limit of Normal, ULN) and jaundice with transaminase levels (AST/SGOT) nearly 20 X ULN.

Rare cases of liver toxicity associated with jaundice, raised serum bilirubin, pyrexia, hepatitis and liver failure have been reported in post-marketing experience. Most of these cases have been reversible but some deaths have occurred. Since there was multiple pathology including infection, gallstones and carcinoma it was not possible to clearly establish the relationship to Cognex® treatment.

Blood chemistry signs of liver injury: Experience from the 30-week clinical study (described earlier) provides a representative estimate of the frequency of ALT/SGPT elevations expected for patients whose transaminase levels are monitored weekly and who receive Cognex® according to the recommended regimen for dose introduction and titration (Table 2). A dosing regimen employing a more rapid escalation of the daily dose of tacrine may be associated with more serious clinical events (see Monitoring of Liver function and the Management of the patient who develops transaminase elevations).

Table 2. Cumulative Incidence of ALT/SGPT Elevations

Based on Maximum Values with Weekly Monitoring During the 30-Week Study

[Number and (%) of Patients]

Maximum ALT	Males N = 229	Females N = 250	Total N = 479
Within Normal Limits	121 (53)	100 (40)	221 (46)
>ULN	108 (47)	150 (60)	258 (54)
>2 times ULN	77 (34)	104 (42)	181 (38)
>3 times ULN	58 (25)	81 (32)	139 (29)
>10 times ULN	12 (5)	19 (8)	31 (6)
>20 times ULN	3 (1)	6 (2)	9 (2)

Experience in 2446 patients who participated in all clinical trials, including the 30-week study, indicates approximately 50% of patients treated with Cognex® can be expected to have at least 1 ALT/SGPT level above ULN; approximately 25% of patients are likely to develop elevations >3 X ULN, and about 7% of patients may develop elevations >10 X ULN. Data collected from the treatment IND program were consistent with those obtained during clinical studies, and showed 3% of 5665 patients experiencing an ALT/SGPT elevation >10 X ULN.

In clinical trials where transaminases were monitored weekly, the median time to onset of the first ALT/SGPT elevation above ULN was approximately 6 weeks, with maximum ALT/SGPT occurring 1 week later, even in instances when Cognex® treatment was stopped. Under the conditions of forced slow upwards dose titration (increases of 40 mg a day every 6 weeks) employed in clinical studies, 95% of transaminase elevations >3 X ULN occurred within the first 18 weeks of Cognex® therapy, and 99% of the 10-fold elevations occurred by the 12th week and on not more than 80 mg; note, however, that for most patients ALT was monitored weekly and Cognex®was stopped when liver enzymes exceeded 3 X ULN. A total of 276 patients were monitored for ALT/SGPT levels every other week in two double-blind clinical studies, an open-label study, and amended treatment IND. The incidence, severity, time to onset, peak and recovery of ALT/SGPT levels were similar to weekly monitoring. With less frequent monitoring than every other week or the less stringent discontinuation criteria recommended below (see DOSAGE AND ADMINISTRATION), it is possible that marked elevations might be more common. It must also be appreciated that experience with prolonged exposure to the high dose (160 mg/day) is limited. In all cases, transaminase levels returned to within normal limits upon discontinuation of Cognex® treatment or following dosage reduction, usually within 4 to 6 weeks.

This relatively benign experience may be the consequence of careful laboratory monitoring that facilitated the discontinuation of patients early on after the onset of their transaminase elevations. Consequently, frequent monitoring of serum transaminase levels is recommended (see DOSAGE AND ADMINISTRATION, WARNINGS: Liver

Injury: Monitoring of Liver Function and the Management of the Patient Who Develops Transaminase Elevations and PRECAUTIONS: Laboratory Tests).

Liver biopsy experience: Liver biopsy results in 7 patients who received tacrine (1 in a Parke-Davis sponsored study and 6 in studies reported in the literature) revealed hepatocellular necrosis in 6 patients, and granulomatous changes in the seventh. In all cases, liver function tests returned to normal with no evidence of persisting hepatic dysfunction.

Experience with the rechallenge of patients with transaminase elevations following recovery: Two hundred and twelve patients among the 866 patients assigned to tacrine in the 12 and 30 week studies were withdrawn because they developed transaminase elevations >3 X ULN. One hundred and forty-five of these patients were subsequently rechallenged with weekly monitoring of ALT/SGPT. During their initial exposure to tacrine, 20 of these 145 had experienced initial elevations >10 times ULN, while the remainder had experienced elevations between 3 and 10 X ULN.

Upon rechallenge with an initial dose of 40 mg/day, only 48 (33%) of the 145 patients developed transaminase elevations greater than 3 X ULN. Of these patients, 44 had elevations that were between 3 and 10 X ULN and 4 had elevations that were > 10 X ULN.

The mean time to onset of elevations occurred earlier on rechallenge than on initial exposure (22 versus 48 days). Of the 145 patients rechallenged, 127 (88%) were able to continue Cognex® treatment, and 91 of these 127 patients titrated to doses higher than those associated with the initial transaminase elevation.

Predictors of the risk of transaminase elevations: The incidence of transaminase elevations is higher among females. There are no other known predictors of the risk of hepatocellular injury.

Monitoring of Liver function and the Management of the patient who develops transaminase elevations. (See also DOSAGE AND ADMINISTRATION and PRECAUTIONS: Laboratory Tests.)

Blood chemistries: Serum transaminase levels (specifically ALT/SGPT) should be monitored every other week from at least week 4 to week 16 following initiation of treatment, after which monitoring may be decreased to every 3 months. For patients who develop ALT/SGPT elevations greater than two times the upper limit of normal, the dose and monitoring regimen should be modified as described in Table 4 (see DOSAGE AND ADMINISTRATION).

A full monitoring sequence should be repeated in the event that a patient suspends treatment with tacrine for more than 4 weeks.

If ALT/SGPT elevations occur, the frequency of monitoring and the dose of Cognex® should be modified according to the table shown below in DOSAGE AND ADMINISTRATION.

Rechallenge: Patients with clinical jaundice confirmed by a significant elevation in total bilirubin (> 3 mg/dL) and/or those exhibiting clinical signs and/or symptoms of hypersensitivity (e.g. rash or fever) in association with ALT/SGPT elevations should immediately and permanently discontinue Cognex® and not be rechallenged.Other patients who are required to discontinue Cognex® treatment because of ALT/SGPT elevations may be rechallenged once ALT/SGPT levels return to within normal limits. (See DOSAGE AND ADMINISTRATION.)

Rechallenge of patients with ALT/SGPT elevations less than 10 X ULN has not resulted in serious liver injury. However, because experience in the rechallenge of patients who had elevations greater than 10 X ULN is limited, the risks associated with the rechallenge of these patients are not well characterized. Careful, frequent (weekly) monitoring of serum ALT/SGPT should be undertaken when rechallenging such patients.

If rechallenged, patients should be given an initial dose of 40 mg/day (10 mg QID) and ALT/SGPT levels monitored weekly. If, after 6 weeks on 40 mg/day, the patient is tolerating the dosage with no unacceptable elevations in ALT/SGPT, recommended dose-titration may be resumed. Weekly monitoring of the ALT/SGPT levels should continue for a total of 16 weeks after which monitoring may be decreased to monthly for 2 months and every 3 months thereafter.

Liver biopsy: Liver biopsy is not indicated in cases of uncomplicated transaminase elevation.

Genitourinary

Cholinomimetics may cause bladder outflow obstruction.

Neurological Conditions

Seizures: Cholinomimetics are believed to have some potential to cause generalized convulsions; seizure activity may, however, also be a manifestation of Alzheimer's disease.

Sudden worsening of the degree of cognitive impairment: Worsening of cognitive function has been reported following abrupt discontinuation of Cognex® or after a large reduction in total daily dose (80 mg/day or more).

Pulmonary Conditions

Because of its cholinomimetic action, Cognex® should be prescribed with care to patients with a history of asthma.

Precautions

General

Liver Injury:

see WARNINGS.

Hematology

An absolute neutrophil count (ANC) less than 500/µL occurred in 4 patients who received Cognex® during the course of clinical trials. Three of the 4 patients had concurrent medical conditions commonly associated with a low ANC; 2 of these patients remained on Cognex.® The fourth patient, who had a history of hypersensitivity (penicillin allergy), withdrew from the study as a result of a rash and also developed an ANC <500/µL, which returned to normal; this patient was not rechallenged and, therefore, the role played by Cognex® in this reaction is unknown.

Six patients had an absolute neutrophil count 1500/µL, associated with an elevation of ALT/SGPT.

The total clinical experience in more than 12,000 patients does not indicate a clear association between Cognex® treatment and serious white blood cell abnormalities.

Information for Patients and Caregivers

Patients and caregivers should be advised that the effect of Cognex® (brand of tacrine hydrochloride) therapy is thought to depend upon its administration at regular intervals, as directed.

The caregiver should be advised about the possibility of adverse effects. Two types should be distinguished: (1) those occurring in close temporal association with the initiation of treatment or an increase in dose (eg, nausea, vomiting, loose stools, diarrhea, etc) and (2) those with a delayed onset (eg, rash, jaundice, changes in the color of stool—black, very dark or light [ie, acholic]).

Patients and caregivers should be encouraged to inform the physician about the emergence of new events or any increase in the severity of existing adverse clinical events.

Caregivers should be advised that abrupt discontinuation of Cognex® or a large reduction in total daily dose (80 mg/day or more) may cause a decline in cognitive function and behavioral disturbances. Unsupervised increases in the dose of tacrine may also have serious consequences. Consequently, changes in dose should not be undertaken in the absence of direct instruction of a physician.

Laboratory Tests:(see WARNINGS: Liver Injury and DOSAGE AND ADMINISTRATION)

Serum transaminase levels (specifically ALT/SGPT) should be monitored in patients given Cognex® (see WARNINGS: Liver Injury).

Drug-Drug Interactions

Possible metabolic basis for interactions.

Tacrine is primarily eliminated by hepatic metabolism via cytochrome P450 drug metabolizing enzymes. Drug-drug interactions may occur when Cognex® is given concurrently with agents such as theophylline that undergo extensive metabolism via cytochrome P450 IA2.

Theophylline.

Coadministration of tacrine with theophylline increased theophylline elimination half-life and average plasma theophylline concentrations by approximately 2-fold. Therefore, monitoring of plasma theophylline concentrations and appropriate reduction of theophylline dose are recommended in patients receiving tacrine and theophylline concurrently. The effect of theophylline on tacrine pharmacokinetics has not been assessed.

Cimetidine.

Cimetidine increased the Cmax and AUC of tacrine by approximately 54% and 64%, respectively.

Anticholinergics.

Because of its mechanism of action, Cognex® has the potential to interfere with the activity of anticholinergic medications.

Cholinomimetics and Cholinesterase Inhibitors.

A synergistic effect is expected when Cognex® is given concurrently with succinylcholine (see WARNINGS), cholinesterase inhibitors, or cholinergic agonists such as bethanechol.

Fluvoxamine.

In a study of 13 healthy, male volunteers, a single 40 mg dose of tacrine added to fluvoxamine 100 mg/day administered at steady-state was associated with five- and eight-fold increases in tacrine Cmax and AUC, respectively, compared to the administration of tacrine alone. Five subjects experienced nausea, vomiting, sweating, and diarrhea following coadministration, consistent with the cholinergic effects of tacrine.

Other Interactions.

Rate and extent of tacrine absorption were not influenced by the coadministration of an antacid containing magnesium and aluminum. Tacrine had no major effect on digoxin or diazepam pharmacokinetics or the anticoagulant activity of warfarin.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Tacrine was mutagenic to bacteria in the Ames test. Unscheduled DNA synthesis was induced in rat and mouse hepatocytes in vitro. Results of cytogenetic (chromosomal aberration) studies were equivocal. Tacrine was not mutagenic in an in vitro mammalian mutation test. Overall, the results of these tests, along with the fact that tacrine belongs to a chemical class (acridines) containing some members which are animal carcinogens, suggest that tacrine may be carcinogenic.

Studies of the effects of tacrine on fertility have not been performed.

Pregnancy

Category C: Animal reproduction studies have not been conducted with tacrine. It is also not known whether Cognex® can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.

Nursing Mothers

It is not known whether this drug is excreted in human milk.

Pediatric Use

There are no adequate and well-controlled trials to document the safety and efficacy of tacrine in any dementing illness occurring in pediatric patients.

Adverse Reactions

Common Adverse Events Leading to Discontinuation

In clinical trials, approximately 17% of the 2706 patients who received Cognex® and 5% of the 1886 patients who received placebo withdrew permanently because of adverse events. It should be noted that some of the placebo-treated patients were exposed to Cognex® prior to receiving placebo due to the variety of study designs used, including crossover studies. Transaminase elevations were the most common reason for withdrawals during Cognex® treatment (8% of all Cognex®-treated patients, or 212 of 456 patients withdrawn). The controlled clinical trial protocols required that any patient with an ALT/SGPT elevation >3 X ULN be withdrawn, because of concern about potential hepatotoxicity. Apart from withdrawals due to transaminase elevations, 244 patients (9%) withdrew for adverse events while receiving Cognex®.

Other adverse events that most frequently led to the withdrawal of tacrine-treated patients in clinical trials were nausea and/or vomiting (1.5%), agitation (0.9%), rash (0.7%), anorexia (0.7%), and confusion (0.5%). These adverse events also most frequently led to the withdrawal of placebo-treated patients, although at lower frequencies (0.1% to 0.2%).

Most Frequent Adverse Clinical Events Seen in Association With the Use of Tacrine

The events identified here are those that occurred at an absolute incidence of at least 5% of patients treated with Cognex®, and at a rate at least 2-fold higher in patients treated with Cognex®than placebo.

The most common adverse events associated with the use of Cognex® were elevated transaminases, nausea and/or vomiting, diarrhea, dyspepsia, myalgia, anorexia, and ataxia. Of these events, nausea and/or vomiting, diarrhea, dyspepsia, and anorexia appeared to be dose-dependent.

Adverse Events Reported in Controlled Trials

Adverse Events Reported in Controlled Trials

The events cited in the tables below reflect experience gained under closely monitored conditions of clinical trials with a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.

Table 3 lists treatment-emergent signs and symptoms that occurred in at least 2% of patients with Alzheimer's disease in placebo-controlled trials and who received the recommended regimen for dose introduction and titration of Cognex® (see DOSAGE AND ADMINISTRATION).

Table 3. Adverse Events Occurring in at Least 2% of Patients Receiving Cognex®

at a Starting Dose of 40 mg/day with Titration in 40 mg/day Increments

Every 6 Weeks in Controlled Clinical Trials

[Number (%) of Patients]

BODY SYSTEM/Adverse Events	Cognex®N = 634	PlaceboN = 342
LABORATORY DEVIATIONS
Elevated Transaminasea	184 (29)	5 (2)
BODY AS A WHOLE
Headache	67 (11)	52 (15)
Fatigue	26 (4)	9 (3)
Chest Pain	24 (4)	18 (5)
Weight Decrease	21 (3)	4 (1)
Back Pain	15 (2)	14 (4)
Asthenia	15 (2)	7 (2)
DIGESTIVE SYSTEM
Nausea and/or Vomiting	178 (28)	29 (9)
Diarrhea	99 (16)	18 (5)
Dyspepsia	57 (9)	22 (6)
Anorexia	54 (9)	11 (3)
Abdominal Pain	48 (8)	24 (7)
Flatulence	22 (4)	5 (2)
Constipation	24 (4)	8 (2)
HEMIC AND LYMPHATIC SYSTEM
Purpura	15 (2)	8 (2)
MUSCULOSKELETAL SYSTEM
Myalgia	54 (9)	18 (5)
NERVOUS SYSTEM
Dizziness	73 (12)	39 (11)
Confusion	42 (7)	24 (7)
Ataxia	36 (6)	12 (4)
Insomnia	37 (6)	18 (5)
Somnolence	22 (4)	11 (3)
Tremor	14 (2)	2 (<1)
PSYCHOBIOLOGIC FUNCTION
Agitation	43 (7)	30 (9)
Depression	22 (4)	14 (4)
Thinking Abnormal	17 (3)	14 (4)
Anxiety	16 (3)	7 (2)
Hallucination	15 (2)	12 (4)
Hostility	15 (2)	5 (2)
RESPIRATORY SYSTEM
Rhinitis	51 (8)	22 (6)
Upper Respiratory Infection	18 (3)	11 (3)
Coughing	17 (3)	18 (5)
SKIN AND APPENDAGES
Rashb	46 (7)	18 (5)
Facial Flushing, Skin Flushing	16 (3)	3 (<1)
UROGENITAL SYSTEM
Urination Frequency	21 (3)	12 (4)
Urinary Tract Infection	21 (3)	20 (6)
Urinary Incontinence	16 (3)	9 (3)

a ALT or AST value of approximately 3 X ULN or greater or that resulted in a change in patient management. Patients were monitored weekly.

b Includes COSTART terms: rash, rash-erythematous, rash-maculopapular, urticaria, petechial rash, rash-vesiculobullous, and pruritus.

Other Adverse Events Observed During All Clinical Trials

Cognex® has been administered to 2706 individuals during clinical trials. A total of 1471 patients were treated for at least 3 months, 1137 for at least 6 months, and 773 for at least 1 year. Any untoward reactions that occurred during these trials were recorded as adverse events by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having similar types of events, the events were grouped into a smaller number of standardized categories using a modified COSTART dictionary. These categories are used in the listing below. The frequencies represent the proportion of the 2706 individuals exposed to Cognex® who experienced that event while receiving Cognex®. All adverse events are included except those already listed on the previous table and those COSTART terms too general to be informative. Events are further classified by body system categories and listed using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; and rare adverse events are those occurring in less than 1/1000 patients. These adverse events are not necessarily related to Cognex® treatment. Only rare adverse events deemed to be potentially important are included.

Body As a Whole:

Frequent: Chill, fever, malaise, peripheral edema. Infrequent: Face edema, dehydration, weight increase, cachexia, edema (generalized), lipoma. Rare: Heat exhaustion, sepsis, cholingeric crisis, death.

Cardiovascular System:

Frequent: Hypotension, hypertension. Infrequent: Heart failure, myocardial infarction, angina pectoris, cerebrovascular accident, transient ischemic attack, phlebitis, venous insufficiency, abdominal aortic aneurysm, atrial fibrillation or flutter, palpitation, tachycardia, bradycardia, pulmonary embolus, migraine, hypercholesterolemia. Rare: Heart arrest, premature atrial contractions, A-V block, bundle branch block.

Digestive System:

Infrequent: Glossitis, gingivitis, mouth or throat dry, stomatitis, increased salivation, dysphagia, esophagitis, gastritis, gastroenteritis, GI hemorrhage, stomach ulcer, hiatal hernia, hemorrhoids, stools bloody, diverticulitis, fecal impaction, fecal incontinence, hemorrhage (rectum), cholelithiasis, cholecystitis, increased appetite. Rare: Duodenal ulcer, bowel obstruction.

Endocrine System:

Infrequent: Diabetes. Rare: Hyperthyroid, hypothyroid.

Hemic and Lymphatic:

Infrequent: Anemia, lymphadenopathy. Rare: Leukopenia, thrombocytopenia, hemolysis, pancytopenia.

Musculoskeletal:

Frequent: Fracture, arthralgia, arthritis, hypertonia. Infrequent: Osteoporosis, tendinitis, bursitis, gout. Rare: Myopathy.

Nervous System:

Frequent: Convulsions, vertigo, syncope, hyperkinesia, paresthesia. Infrequent: Dreaming abnormal, dysarthria, aphasia, amnesia, wandering, twitching, hypesthesia, delirium, paralysis, bradykinesia, movement disorder, cogwheel rigidity, paresis, neuritis, hemiplegia, Parkinson's disease, neuropathy, extrapyramidal syndrome, reflexes decreased/absent. Rare: Tardive dyskinesia, dysesthesia, dystonia, encephalitis, coma, apraxia, oculogyric crisis, akathisia, oral facial dyskinesia, Bell's palsy, exacerbation of Parkinson's disease.

Psychobiologic Function:

Frequent: Nervousness. Infrequent: Apathy, increased libido, paranoia, neurosis. Rare: Suicidal, psychosis, hysteria.

Respiratory System:

Frequent: Pharyngitis, sinusitis, bronchitis, pneumonia, dyspnea. Infrequent: Epistaxis, chest congestion, asthma, hyperventilation, lower respiratory infection. Rare: Hemoptysis, lung edema, lung cancer, acute epiglottitis.

Skin and Appendages:

Frequent: Sweating increased. Infrequent: Acne, alopecia, dermatitis, eczema, skin dry, herpes zoster, psoriasis

Wednesday, 28 September 2016

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How should I take this medicine?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking this medicine?

This medicine side effects

What other drugs will affect this medicine?

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Tuesday, 27 September 2016

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Cardura XL Extended-Release Tablets are used for:

Do NOT use Cardura XL Extended-Release Tablets if:

Before using Cardura XL Extended-Release Tablets:

How to use Cardura XL Extended-Release Tablets:

Important safety information:

Possible side effects of Cardura XL Extended-Release Tablets:

If OVERDOSE is suspected:

General information:

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Commonly used brand name(s)

Uses For Phosphasal

Before Using Phosphasal

Allergies

Pediatric

Geriatric

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate

Dosing

Missed Dose

Storage

Precautions While Using Phosphasal

Phosphasal Side Effects

What Is In Tri-Adcortyl Cream?

Who Supplies This Cream?

Product Licence Holder:

Manufacturer:

What is this medicine for ?

Before Using Your Medicine

Should you be using Tri-Adcortyl cream?

What if I am pregnant or breast feeding ?

Do you have problems with your ears or hearing?

Using Your Medicine

How should I apply Tri-Adcortyl cream?

Are there special directions for children?

What if Tri-Adcortyl cream is swallowed?