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Saturday, 17 March 2012

Ampicillin Sodium

Generic Name: penicillin (Oral route, Injection route, Intravenous route, Intramuscular route)

Commonly used brand name(s)

In the U.S.

Amoxil

Bactocill

Bicillin L-A

Cloxapen

Crysticillin

Dynapen

Geocillin

Nafcil

Pfizerpen

Pipracil

Principen

Staphcillin

Ticar

Veetids

In Canada

Amoxil Pediatric

Ampicillin Sodium

Apo-Amoxi

Apo-Amoxi Sugar-Free

Apo-Cloxi

Apo-Pen-Vk

Gen-Amoxicillin

Med Amoxicillin

Nadopen V 200

Nadopen V 400

Novamoxin

Available Dosage Forms:

Powder for Suspension

Tablet

Tablet, Chewable

Tablet for Suspension

Tablet, Extended Release

Capsule

Powder for Solution

Suspension

Solution

Syrup

Uses For Ampicillin Sodium

Penicillins are used to treat infections caused by bacteria. They work by killing the bacteria or preventing their growth.

There are several different kinds of penicillins. Each is used to treat different kinds of infections. One kind of penicillin usually may not be used in place of another. In addition, penicillins are used to treat bacterial infections in many different parts of the body. They are sometimes given with other antibacterial medicines (antibiotics). Some of the penicillins may also be used for other problems as determined by your doctor. However, none of the penicillins will work for colds, flu, or other virus infections.

Penicillins are 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, penicillins are used in certain patients with the following medical conditions:

Chlamydia infections in pregnant women—Amoxicillin and ampicillin

Gas gangrene—Penicillin G

Helicobacter pylori-associated gastritis or peptic ulcer disease—Amoxicillin

Leptospirosis—Ampicillin and penicillin G

Lyme disease—Amoxicillin and penicillin V

Typhoid fever—Amoxicillin and ampicillin

Before Using Ampicillin Sodium

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Many penicillins have been used in children and, in effective doses, are not expected to cause different side effects or problems in children than they do in adults.

Some strengths of the chewable tablets of amoxicillin contain aspartame, which is changed by the body to phenylalanine, a substance that is harmful to patients with phenylketonuria.

Geriatric

Penicillins have been used in the elderly and have not been shown to cause different side effects or problems in older people than they do in younger adults.

Pregnancy

Penicillins have not been studied in pregnant women. However, penicillins have been widely used in pregnant women and have not been shown to cause birth defects or other problems in animal studies.

Breast Feeding

Penicillins pass into the breast milk. Even though only small amounts may pass into breast milk, allergic reactions, diarrhea, fungus infections, and skin rash may occur in nursing babies.

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 any of these medicines, 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 medicines in this class 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.

Cyclosporine

Methotrexate

Vecuronium

Venlafaxine

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 penicillin

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

Penicillins (except bacampicillin tablets, amoxicillin, penicillin V, pivampicillin, and pivmecillinam) are best taken with a full glass (8 ounces) of water on an empty stomach (either 1 hour before or 2 hours after meals) unless otherwise directed by your doctor.

For patients taking amoxicillin, penicillin V, pivampicillin, and pivmecillinam:

Amoxicillin, penicillin V, pivampicillin, and pivmecillinam may be taken on a full or empty stomach.

The liquid form of amoxicillin may also be taken by itself or mixed with formulas, milk, fruit juice, water, ginger ale, or other cold drinks. If mixed with other liquids, take immediately after mixing. Be sure to drink all the liquid to get the full dose of medicine.

For patients taking bacampicillin:

The liquid form of this medicine is best taken with a full glass (8 ounces) of water on an empty stomach (either 1 hour before or 2 hours after meals) unless otherwise directed by your doctor.

The tablet form of this medicine may be taken on a full or empty stomach.

For patients taking penicillin G by mouth:

Do not drink acidic fruit juices (for example, orange or grapefruit juice) or other acidic beverages within 1 hour of taking penicillin G since this may keep the medicine from working properly.

For patients taking the oral liquid form of penicillins:

This medicine is to be taken by mouth even if it comes in a dropper bottle. If this medicine does not come in a dropper bottle, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

Do not use after the expiration date on the label. The medicine may not work properly after that date. If you have any questions about this, check with your pharmacist.

For patients taking the chewable tablet form of amoxicillin:

Tablets should be chewed or crushed before they are swallowed.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you have a ”strep” infection, you should keep taking this medicine for at least 10 days. This is especially important in ”strep” infections. Serious heart problems could develop later if your infection is not cleared up completely. Also, if you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night . For example, if you are to take four doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

Make certain your health care professional knows if you are on a low-sodium (low-salt) diet. Some of these medicines contain enough sodium to cause problems in some people.

Dosing

The dose medicines in this class 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 these medicines. 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.

The number of tablets or teaspoonfuls of suspension 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 taking a penicillin.

For amoxicillin:
- For bacterial infections:
  - For oral dosage forms (capsules, oral suspension, tablets, and chewable tablets):
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—250 to 500 milligrams (mg) every eight hours or 500 to 875 mg every twelve hours, depending on the type and severity of the infection.
    - Neonates and infants up to 3 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 15 mg per kg (6.8 mg per pound) of body weight or less every twelve hours.
    - Infants 3 months of age and older and children weighing up to 40 kg (88 lbs.)—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.7 to 13.3 mg per kg (3 to 6 mg per pound) of body weight every eight hours or 12.5 to 22.5 mg per kg (5.7 to 10.2 mg per pound) of body weight every twelve hours.
      - For duodenal ulcers (associated with Helicobacter pylori bacterial infection):
        For oral dosage forms (capsules, oral suspension, tablets, and chewable tablets):
        Adults: 1000 mg twice a day every twelve hours for fourteen days, along with the two other medicines, clarithromycin and lansoprazole, as directed by your doctor.
        
        Teenagers and children: Use and dose must be determined by your doctor.
        For dual medicine therapy—
        Adults: 1000 mg three times a day every eight hours for fourteen days, along with the other medicine, lansoprazole, as directed by your doctor.
        
        Teenagers and children: Use and dose must be determined by your doctor.

For ampicillin:
- For bacterial infections:
  - For oral dosage forms (capsules and oral suspension):
    - Adults, teenagers, and children weighing more than 20 kilograms (kg) (44 pounds)—250 to 500 milligrams (mg) every six hours.
    - Infants and children weighing up to 20 kg (44 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight every six hours; or 16.7 to 33.3 mg per kg (7.6 to 15 mg per pound) of body weight every eight hours.
      - For injection dosage form:
        Adults, teenagers, and children weighing more than 20 kg (44 pounds)—250 to 500 mg, injected into a vein or muscle every three to six hours.
        
        Infants and children weighing up to 20 kg (44 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 12.5 mg per kg (5.7 mg per pound) of body weight, injected into a vein or muscle every six hours.

For bacampicillin:
- For bacterial infections:
  - For oral dosage forms (oral suspension and tablets):
    - Adults, teenagers, and children weighing more than 25 kilograms (kg) (55 pounds)—400 to 800 milligrams (mg) every twelve hours.
    - Children weighing up to 25 kg (55 pounds)—Bacampicillin tablets are not recommended for use in children weighing up to 25 kg (55 pounds). The dose of the oral suspension is based on body weight and must be determined by your doctor. The usual dose is 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight every twelve hours.

For carbenicillin:
- For bacterial infections:
  - For oral dosage form (tablets):
    - Adults and teenagers—500 milligrams (mg) to 1 gram every six hours.
    - Children—Dose must be determined by your doctor.
      - For injection dosage form:
        Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The usual dose is 50 to 83.3 mg per kilogram (kg) (22.8 to 37.9 mg per pound) of body weight, injected into a vein or muscle every four hours.
        
        Older infants and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 16.7 to 75 mg per kg (7.6 to 34 mg per pound) of body weight, injected into a vein or muscle every four to six hours.

For cloxacillin:
- For bacterial infections:
  - For oral dosage form (capsules and oral solution):
    - Adults, teenagers, and children weighing more than 20 kilograms (kg) (44 pounds)—250 to 500 milligrams (mg) every six hours.
    - Infants and children weighing up to 20 kg (44 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 to 12.5 mg per kg (2.8 to 5.7 mg per pound) of body weight every six hours.
      - For injection dosage form:
        Adults, teenagers, and children weighing more than 20 kg—250 to 500 mg, injected into a vein every six hours.
        
        Infants and children weighing up to 20 kg (44 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 to 12.5 mg per kg (2.8 to 5.7 mg per pound) of body weight, injected into a vein every six hours.

For dicloxacillin:
- For bacterial infections:
  - For oral dosage form (capsules and oral suspension):
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—125 to 250 milligrams (mg) every six hours.
    - Infants and children weighing up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 3.1 to 6.2 mg per kg (1.4 to 2.8 mg per pound) of body weight every six hours.

For flucloxacillin:
- For bacterial infections:
  - For oral dosage form (capsules and oral suspension):
    - Adults, teenagers, and children more than 12 years of age and weighing more than 40 kilograms (kg) (88 pounds)—250 to 500 milligrams (mg) every six hours.
    - Children less than 12 years of age and weighing up to 40 kg (88 pounds)—125 to 250 mg every six hours; or 6.25 to 12.5 mg per kg (2.8 to 5.7 mg per pound) of body weight every six hours.
    - Infants up to 6 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 mg per kg (2.8 mg per pound) of body weight every six hours.

For methicillin:
- For bacterial infections:
  - For injection dosage form:
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—1 gram injected into a muscle every four to six hours; or 1 gram injected into a vein every six hours.
    - Children weighing up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 25 milligrams (mg) per kg (11.4 mg per pound) of body weight, injected into a vein or muscle every six hours.

For mezlocillin:
- For bacterial infections:
  - For injection dosage form:
    - Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The usual dose is 33.3 to 87.5 milligrams (mg) per kilogram (kg) (15.1 to 39.8 mg per pound) of body weight, injected into a vein or muscle every four to six hours; or 3 to 4 grams every four to six hours.
    - Infants over 1 month of age and children up to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 50 mg per kg (22.7 mg per pound) of body weight, injected into a vein or muscle every four hours.

For nafcillin:
- For bacterial infections:
  - For oral dosage form (capsules and tablets):
    - Adults and teenagers—250 milligrams (mg) to 1 gram every four to six hours.
    - Older infants and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 to 12.5 mg per kilogram (kg) (2.8 to 5.7 mg per pound) of body weight every six hours.
    - Newborns—Dose is based on body weight and must be determined by your doctor. The usual dose is 10 mg per kg (4.5 mg per pound) of body weight every six to eight hours.
      - For injection dosage form:
        Adults and teenagers—500 mg to 2 grams injected into a vein or muscle every four to six hours.
        
        Infants and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 10 to 25 mg per kg (4.5 to 11.4 mg per pound) of body weight, injected into a muscle every twelve hours; or 10 to 40 mg per kg (4.5 to 18.2 mg per pound) of body weight, injected into a vein every four to eight hours.

For oxacillin:
- For bacterial infections:
  - For oral dosage form (capsules and oral solution):
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—500 milligrams (mg) to 1 gram every four to six hours.
    - Children weighing up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight every six hours.
      - For injection dosage form:
        Adults, teenagers, and children weighing more than 40 kg (88 pounds)—250 mg to 1 gram injected into a vein or muscle every four to six hours.
        
        Children weighing up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight, injected into a vein or muscle every four to six hours.
        
        Premature infants and newborns—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 mg per kg (2.8 mg per pound) of body weight, injected into a vein or muscle every six hours.

For penicillin G:
- For bacterial infections:
  - For oral dosage form (oral solution, oral suspension, and tablets):
    - Adults and teenagers—200,000 to 500,000 Units (125 to 312 milligrams [mg]) every four to six hours.
    - Infants and children less than 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 4167 to 30,000 Units per kilogram (kg) (189 to 13,636 Units per pound) of body weight every four to eight hours.
      - For benzathine injection dosage form:
        Adults and teenagers—1,200,000 to 2,400,000 Units injected into a muscle as a single dose.
        
        Infants and children—300,000 to 1,200,000 Units injected into a muscle as a single dose; or 50,000 Units per kg (22,727 Units per pound) of body weight injected into a muscle as a single dose.
        For injection dosage forms (potassium and sodium salts):
        Adults and teenagers—1,000,000 to 5,000,000 Units, injected into a vein or muscle every four to six hours.
        
        Older infants and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 8333 to 25,000 Units per kg (3788 to 11,363 Units per pound) of body weight, injected into a vein or muscle every four to six hours.
        
        Premature infants and newborns—Dose is based on body weight and must be determined by your doctor. The usual dose is 30,000 Units per kg (13,636 Units per pound) of body weight, injected into a vein or muscle every twelve hours.
        For procaine injection dosage form:
        Adults and teenagers—600,000 to 1,200,000 Units injected into a muscle once a day.
        
        Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 50,000 Units per kg (22,727 Units per pound) of body weight, injected into a muscle once a day.

For penicillin V:
- For bacterial infections:
  - For the benzathine salt oral dosage form (oral solution):
    - Adults and teenagers—200,000 to 500,000 Units every six to eight hours.
    - Children—100,000 to 250,000 Units every six to eight hours.
      - For the potassium salt oral dosage forms (oral solution, oral suspension, and tablets):
        Adults and teenagers—125 to 500 milligrams (mg) every six to eight hours.
        
        Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2.5 to 16.7 mg per kilogram (kg) (1.1 to 7.6 mg per pound) of body weight every four to eight hours.

For piperacillin:
- For bacterial infections:
  - For injection dosage form:
    - Adults and teenagers—3 to 4 grams, injected into a vein or muscle every four to six hours.
    - Infants and children—Dose must be determined by your doctor.

For pivampicillin:
- For bacterial infections:
  - For oral dosage form (oral suspension):
    - Adults, teenagers, and children 10 years of age and older—525 to 1050 milligrams (mg) two times a day.
    - Children 7 to 10 years of age—350 mg two times a day.
    - Children 4 to 6 years of age—262.5 mg two times a day.
    - Children 1 to 3 years of age—175 mg two times a day.
    - Infants 3 to 12 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 to 30 mg per kilogram (kg) (9.1 to 13.6 mg per pound) of body weight two times a day.
      - For oral dosage form (tablets):
        Adults, teenagers, and children 10 years of age and older—500 mg to 1 gram two times a day.
        
        Children up to 10 years of age—Dose must be determined by your doctor.

For pivmecillinam:
- For bacterial infections:
  - For oral dosage form (tablets):
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—200 milligrams (mg) two to four times a day for three days.
    - Children up to 40 kg (88 pounds)—Dose must be determined by your doctor.

For ticarcillin:
- For bacterial infections:
  - For injection dosage form:
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—3 grams injected into a vein every four hours; or 4 grams injected into a vein every six hours.
    - Children up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 33.3 to 75 milligrams (mg) per kg (15 to 34 mg per pound) of body weight, injected into a vein every four to six hours.

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 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.

Precautions While Using Ampicillin Sodium

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

Penicillins may cause diarrhea in some patients.

Check with your doctor if severe diarrhea occurs. Severe diarrhea may be a sign of a serious side effect. Do not take any diarrhea medicine without first checking with your doctor. Diarrhea medicines may make your diarrhea worse or make it last longer.

For mild diarrhea, diarrhea medicine containing kaolin or attapulgite (e.g., Kaopectate tablets, Diasorb) may be taken. However, other kinds of diarrhea medicine should not be taken. They may make your diarrhea worse or make it last longer.

If you have any questions about this or if mild diarrhea continues or gets worse, check with your health care professional.

Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking ampicillin, amoxicillin, or penicillin V. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking any of these penicillins. If you have any questions about this, check with your health care professional.

For diabetic patients:

Penicillins may cause false test results with some urine sugar tests. Check with your doctor before changing your diet or the dosage of your diabetes medicine.

Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Ampicillin Sodium 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.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Less common

Fast or irregular breathing

fever

joint pain

lightheadedness or fainting (sudden)

puffiness or swelling around the face

red, scaly skin

shortness of breath

skin rash, hives, itching

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

Rare

Abdominal or stomach cramps and pain (severe)

abdominal tenderness

convulsions (seizures)

decreased amount of urine

diarrhea (watery and severe), which may also be bloody

mental depression

nausea and vomiting

pain at place of injection

sore throat and fever

unusual bleeding or bruising

yellow eyes or skin

Rare - For penicillin G procaine only

Agitation or combativeness

anxiety

confusion

fear of impending death

feeling, hearing, or seeing things that are not real

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

Diarrhea (mild)

headache

sore mouth or tongue

vaginal itching and discharge

white patches in the mouth and/or on the tongue

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: Ampicillin Sodium 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.

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More Ampicillin Sodium resources

Ampicillin Sodium Side Effects (in more detail)
Ampicillin Sodium Use in Pregnancy & Breastfeeding
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Ampicillin Sodium Drug Interactions
Ampicillin Sodium Support Group
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Compare Ampicillin Sodium with other medications

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Monday, 12 March 2012

trifluridine Ophthalmic

trye-FLURE-i-deen

Commonly used brand name(s)

In the U.S.

Viroptic

Available Dosage Forms:

Solution

Therapeutic Class: Antiviral

Pharmacologic Class: Viral DNA Thymidylate Synthetase Inhibitor

Chemical Class: Pyrimidine Nucleoside Analog

Uses For trifluridine

Trifluridine ophthalmic preparations are used to treat virus infections of the eye.

Trifluridine is available only with your doctor's prescription.

Before Using trifluridine

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 trifluridine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to trifluridine 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

Although there is no specific information comparing the use of trifluridine in children with use in other age groups, it is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of trifluridine in the elderly with use in other age groups.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Proper Use of trifluridine

The bottle is only partially full to provide proper drop control.

To use:

First, wash your hands. Then tilt the head back and pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.

If you think you did not get the drop of medicine into your eye properly, use another drop.

To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

Do not use trifluridine more often or for a longer time than your doctor ordered. To do so may cause problems in the eyes. If you have any questions about this, check with your doctor.

To help clear up your infection completely, keep using trifluridine for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of trifluridine 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 trifluridine. If your dose is different, do not change it unless your doctor tells you to do so.

For ophthalmic solution dosage forms:
- For viral eye infection:
  - Adults and children 6 years of age and older—One drop every two hours while you are awake. After healing has occurred, the dose may be reduced for seven more days to one drop every four hours (at least 5 doses a day) while you are awake.
  - Children up to 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of trifluridine, apply 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.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using trifluridine

It is very important that you keep your appointment with your doctor. If your symptoms become worse, check with your doctor sooner.

trifluridine 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 as soon as possible if any of the following side effects occur:

Rare

Blurred vision or other change in vision

dryness of eye

irritation of eye

itching, redness, swelling, or other sign of irritation not present before use of trifluridine

More common

Burning or stinging

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: trifluridine Ophthalmic side effects (in more detail)

More trifluridine Ophthalmic resources

Trifluridine Ophthalmic Side Effects (in more detail)
Trifluridine Ophthalmic Use in Pregnancy & Breastfeeding
Trifluridine Ophthalmic Support Group
0 Reviews for Trifluridine Ophthalmic - Add your own review/rating

trifluridine ophthalmic Concise Consumer Information (Cerner Multum)

Viroptic Prescribing Information (FDA)

Viroptic Monograph (AHFS DI)

Viroptic Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare trifluridine Ophthalmic with other medications

Herpetic Keratitis

Gaviscon Peppermint Tablets

1. Name Of The Medicinal Product

Gaviscon Peppermint Tablets.

2. Qualitative And Quantitative Composition

Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate 133.5 mg and calcium carbonate 80 mg.

Excipients: Aspartame (E951) 3.75 mg per tablet.

For a full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Chewable tablet.

An off-white to cream, slightly mottled tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion (related to reflux), for example, following meals or during pregnancy or in patients with symptoms related to reflux oesophagitis.

4.2 Posology And Method Of Administration

For oral use, after being thoroughly chewed.

Adults and children 12 years and over: Two to four tablets after meals and at bedtime.

Elderly: No dose modifications necessary for this age group.

4.3 Contraindications

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients.

4.4 Special Warnings And Precautions For Use

The sodium content of a four-tablet dose is 246 mg (10.6 mmol). This should be taken into account when a highly restricted salt diet is recommended, e.g. in some cases of congestive cardiac failure and renal impairment.

Each four-tablet dose contains 320 mg (3.2 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

Due to its aspartame content this medicinal product should not be given to patients with phenylketonuria.

There is a possibility of reduced efficacy in patients with very low levels of gastric acid.

If symptoms do not improve after seven days, the clinical situation should be reviewed.

Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Due to the presence of calcium carbonate which act as an antacid, a time-interval of 2 hours should be considered between Gaviscon intake an the administration of other medicinal products, especially H2-antihistaminics tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroxine, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, and diphosphonates.

4.6 Pregnancy And Lactation

Open controlled studies in 281 pregnant women did not demonstrate any significant adverse effects of Gaviscon on the course of pregnancy or on the health of the foetus/new-born child. Based on this and previous experience the medicinal product may be used during pregnancy and lactation. Nevertheless, taking into account the presence of calcium carbonate (see Section 5.3), it is recommended to limit the treatment duration as much as possible.

4.7 Effects On Ability To Drive And Use Machines

Not relevant.

4.8 Undesirable Effects

Very rarely (

4.9 Overdose

In the event of overdose symptomatic treatment should be given. The patient may notice abdominal distension.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD) ATC code: A02BX.

On ingestion the medicinal product reacts rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats on the stomach contents effectively impeding gastro-oesophageal reflux. In severe cases the raft itself may be refluxed into the oesophagus, in preference to the stomach contents, and exert a demulcent effect.

5.2 Pharmacokinetic Properties

The mechanism of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.

5.3 Preclinical Safety Data

There is limited evidence in some reports in animals of delay in calcification of foetal skeleton/bone abnormalities relating to calcium carbonate.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Peppermint flavour

Macrogol 20,000

Mannitol (E421)

Aspartame (E951)

Acesulfame potassium (E950)

Magnesium stearate

Copovidone

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Do not store above 30°C

6.5 Nature And Contents Of Container

Unprinted, glass-clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blisters packed into cartons.

Blister containing 4, 6 or 8 individually sealed tablets.

Larger packs (16, 24, 32, 48 and 64) will be made up of multiples of the above units and packed into cartons.

Pack sizes 4, 6, 8, 16, 24, 32, 48 or 64 tablets

Polypropylene container containing 8, 12, 16, 18, 20, 22 or 24 tablets.

Multiple packs (2 x 16, 2 x 18, 2 x 20, 2 x 22 or 2 x 24) will be packed into cartons.

Pack sizes 8, 12, 16, 18, 20, 22 24, 2 x 16, 2 x 18, 2 x 20, 2 x 22 or 2 x 24 tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS

United Kingdom.

8. Marketing Authorisation Number(S)

PL 00063/0134

9. Date Of First Authorisation/Renewal Of The Authorisation

07/10/2008

10. Date Of Revision Of The Text

07/10/2008

Sunday, 11 March 2012

vecuronium

Generic Name: vecuronium (VEK ue ROE nee um)

Brand names: Vecuronium Bromide, Norcuron

What is vecuronium?

Vecuronium is used to relax the muscles. It works by blocking the signals between your nerves and your muscles.

Vecuronium is given before general anesthesia in preparing you for surgery. Vecuronium helps keep your body still during surgery. It also relaxes your throat so a breathing tube can be more easily inserted before the surgery.

Vecuronium may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about vecuronium?

Before receiving vecuronium, tell your doctor if you are allergic to any drugs, or if you have kidney disease, heart disease or congestive heart failure, problems with circulation, or a nerve-muscle disorder such as ALS (Lou Gehrig's disease), MS (multiple sclerosis), or muscular dystrophy.

Tell your doctor if you are pregnant or breast-feeding.

It may take you longer to recover from the effects of vecuronium if you have cirrhosis or other liver disease.

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you recover from anesthesia.

What should I discuss with my health care provider before receiving vecuronium?

You should not receive this medication if you are allergic to vecuronium.

Before receiving vecuronium, tell your doctor if you are allergic to any drugs, or if you have:

myasthenia gravis;

cirrhosis or other liver disease;

a history of kidney disease;

heart disease or congestive heart failure;

problems with circulation; or

a nerve-muscle disorder such as ALS (Lou Gehrig's disease), MS (multiple sclerosis), or muscular dystrophy.

If you have any of these conditions, you may not be able to receive vecuronium, or you may need dosage adjustments or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Before receiving vecuronium, tell your doctor if you are breast-feeding a baby.

How is vecuronium given?

Vecuronium is given as an injection through a needle placed into a vein or muscle. You will receive this injection in a hospital or surgical setting.

Your caregivers will monitor your heart function, blood pressure, and breathing while you are under the effects of vecuronium.

It may take you longer to recover from the effects of vecuronium if you have cirrhosis or other liver disease.

What happens if I miss a dose?

Since vecuronium is usually given just for anesthesia, you are not likely to be on a dosing schedule.

What happens if I overdose?

An overdose of vecuronium is unlikely to occur since the medication is given by a doctor. Your vital signs will be closely watched while you are under anesthesia to make sure the medication is not causing any harmful effects.

What should I avoid after receiving vecuronium?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you recover from anesthesia.

Vecuronium side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers right away if you have any of these serious side effects:

trouble breathing;

ongoing muscle weakness; or

inability to move your muscles.

Less serious side effects may include:

feeling light-headed; or

itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Vecuronium Dosing Information

Usual Adult Dose for Anesthesia:

Initial dose: 0.08 to 0.1 mg/kg. Maintenance dose during prolonged surgical procedures: 0.01 to 0.015 mg/kg 25 to 40 minutes later, then as frequently as every 12 to 15 minutes.
Continuous infusion: Initiate with an intubating dose of 80 to 100 mcg/kg followed 20 to 40 minutes later with 0.8 to 1.2 mcg/kg/minute.

What other drugs will affect vecuronium?

There may be other drugs that can interact with vecuronium. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors.

More vecuronium resources

Vecuronium Side Effects (in more detail)
Vecuronium Dosage
Vecuronium Use in Pregnancy & Breastfeeding
Vecuronium Drug Interactions
Vecuronium Support Group
0 Reviews for Vecuronium - Add your own review/rating

Vecuronium MedFacts Consumer Leaflet (Wolters Kluwer)

Vecuronium Prescribing Information (FDA)

Norcuron Monograph (AHFS DI)

Vecuronium Bromide Professional Patient Advice (Wolters Kluwer)

Compare vecuronium with other medications

Anesthesia

Where can I get more information?

Your doctor or pharmacist can provide more information about vecuronium.

See also: vecuronium side effects (in more detail)

Saturday, 10 March 2012

Tazorac

tazarotene

Dosage Form: gel
Tazorac®

(tazarotene) Gel 0.05%

(tazarotene) Gel 0.1%

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.

DESCRIPTION

Tazorac® Gel is a translucent, aqueous gel and contains the compound tazarotene, a member of the acetylenic class of retinoids. It is for topical dermatologic use only. The active ingredient is represented by the following structural formula:

Formula: C21H21NO2S

Molecular Weight: 351.46

Chemical Name: Ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate

Contains:

Active: Tazarotene 0.05% or 0.1% (w/w)

Preservative: Benzyl alcohol 1% (w/w)

Inactives: Ascorbic acid, butylated hydroxyanisole, butylated hydroxytoluene, carbomer homopolymer type B, edetate disodium, hexylene glycol, poloxamer 407, polyethylene glycol 400, polysorbate 40, purified water, and tromethamine.

CLINICAL PHARMACOLOGY

Tazarotene is a retinoid prodrug which is converted to its active form, the cognate carboxylic acid of tazarotene (AGN 190299), by rapid deesterification in animals and man. AGN 190299 (“tazarotenic acid”) binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ, and RARγ but shows relative selectivity for RARβ, and RARγ and may modify gene expression. The clinical significance of these findings is unknown.

Psoriasis: The mechanism of tazarotene action in psoriasis is not defined. Topical tazarotene blocks induction of mouse epidermal ornithine decarboxylase (ODC) activity, which is associated with cell proliferation and hyperplasia. In cell culture and in vitro models of skin, tazarotene suppresses expression of MRP8, a marker of inflammation present in the epidermis of psoriasis patients at high levels. In human keratinocyte cultures, it inhibits cornified envelope formation, whose build-up is an element of the psoriatic scale. Tazarotene also induces the expression of a gene which may be a growth suppressor in human keratinocytes and which may inhibit epidermal hyperproliferation in treated plaques. However, the clinical significance of these findings is unknown.

Acne: The mechanism of tazarotene action in acne vulgaris is not defined. However, the basis of tazarotene's therapeutic effect in acne may be due to its anti-hyperproliferative, normalizing-of-differentiation and anti-inflammatory effects. Tazarotene inhibited corneocyte accumulation in rhino mouse skin and cross-linked envelope formation in cultured human keratinocytes. The clinical significance of these findings is unknown.

Pharmacokinetics: Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. Little parent compound could be detected in the plasma. Tazarotenic acid was highly bound to plasma proteins (greater than 99%). Tazarotene and tazarotenic acid were metabolized to sulfoxides, sulfones and other polar metabolites which were eliminated through urinary and fecal pathways. The half-life of tazarotenic acid was approximately 18 hours, following topical application of tazarotene to normal, acne or psoriatic skin.

The human in vivo studies described below were conducted with tazarotene gel applied topically at approximately 2 mg/cm2 and left on the skin for 10 to 12 hours. Both the peak plasma concentration (Cmax) and area under the plasma concentration time curve (AUC) refer to the active metabolite only.

Two single, topical dose studies were conducted using 14C-tazarotene gel. Systemic absorption, as determined from radioactivity in the excreta, was less than 1% of the applied dose (without occlusion) in six psoriatic patients and approximately 5% of the applied dose (under occlusion) in six healthy subjects. One non-radiolabeled single-dose study comparing the 0.05% gel to the 0.1% gel in healthy subjects indicated that the Cmax and AUC were 40% higher for the 0.1% gel.

After 7 days of topical dosing with measured doses of tazarotene 0.1% gel on 20% of the total body surface without occlusion in 24 healthy subjects, the Cmax for tazarotenic acid was 0.72 ± 0.58 ng/mL (mean ± SD) occurring 9 hours after the last dose, and the AUC0-24hr for tazarotenic acid was 10.1 ± 7.2 ng·hr/mL. Systemic absorption was 0.91 ± 0.67% of the applied dose.

In a 14-day study in five psoriatic patients, measured doses of tazarotene 0.1% gel were applied daily by nursing staff to involved skin without occlusion (8 to 18% of total body surface area; mean ± SD: 13 ± 5%). The Cmax for tazarotenic acid was 12.0 ± 7.6 ng/mL occurring 6 hours after the final dose, and the AUC0-24hr for tazarotenic acid was 105 ± 55 ng·hr/mL. Systemic absorption was 14.8 ± 7.6% of the applied dose. Extrapolation of these results to represent dosing on 20% of total body surface yielded estimates for tazarotenic acid with Cmax of 18.9 ± 10.6 ng/mL and AUC0-24hr of 172 ± 88 ng·hr/mL.

An in vitro percutaneous absorption study, using radiolabeled drug and freshly excised human skin or human cadaver skin, indicated that approximately 4 to 5% of the applied dose was in the stratum corneum (tazarotene: tazarotenic acid = 5:1) and 2 to 4% was in the viable epidermis-dermis layer (tazarotene: tazarotenic acid = 2:1) 24 hours after topical application of the gel.

Clinical Studies

Psoriasis: In two large vehicle-controlled clinical studies, tazarotene 0.05% and 0.1% gels applied once daily for 12 weeks were significantly more effective than vehicle in reducing the severity of the clinical signs of stable plaque psoriasis covering up to 20% of body surface area. In one of the studies, patients were followed up for an additional 12 weeks following cessation of therapy with Tazorac® Gel. Mean baseline scores and changes from baseline (reductions) after treatment in these two studies are shown in the following table:

Plaque Elevation, Scaling, and Erythema in Two Controlled Clinical Trials for Psoriasis
Plaque elevation, scaling, and erythema scored on a 0-4 scale with 0=none, 1=mild, 2=moderate, 3=severe and 4=very severe. B=Mean Baseline Severity: C-12=Mean Change from Baseline at end of 12 weeks of therapy: C-24*=Mean Change from Baseline at week 24 (12 weeks after the end of therapy).
		Tazorac® 0.05% Gel				Tazorac® 0.1% Gel				Vehicle Gel
		Trunk/Arm/Leg Lesions		Knee/Elbow Lesions		Trunk/Arm/Leg Lesions		Knee/Elbow Lesions		Trunk/Arm/Leg Lesions		Knee/Elbow Lesions
		N=108	N=111	N=108	N=111	N=108	N=112	N=108	N=112	N=108	N=113	N=108	N=113
Plaque Elevation	B* C-12* C-24*	2.5 -1.4 -1.2	2.6 -1.3	2.6 -1.3 -1.1	2.6 -1.1	2.5 -1.4 -1.1	2.6 -1.4	2.6 -1.5 -1.0	2.6 -1.3	2.4 -0.8 -0.9	2.6 -0.7	2.6 -0.7 -0.7	2.6 -0.6
Scaling	B* C-12* C-24*	2.4 -1.1 -0.9	2.5 -1.1	2.5 -1.1 -0.8	2.6 -0.9	2.4 -1.3 -1.0	2.6 -1.3	2.5 -1.2 -0.8	2.7 -1.2	2.4 -0.7 -0.8	2.6 -0.7	2.5 -0.6 -0.7	2.7 -0.6
Erythema	B* C-12* C-24*	2.4 -1.0 -1.1	2.7 -0.8	2.2 -0.9 -0.7	2.5 -0.8	2.4 -1.0 -0.9	2.8 -1.1	2.3 -1.0 -0.8	2.5 -0.8	2.3 -0.6 -0.7	2.7 -0.5	2.2 -0.5 -0.6	2.5 -0.5

Global improvement over baseline at the end of 12 weeks of treatment in these two studies is shown in the following table:

	Tazorac® 0.05% Gel		Tazorac® 0.1% Gel		Vehicle Gel
	N=81	N=93	N=79	N=69	N=84	N=91
100% improvement	2 (2%)	1 (1%)	0	0	1 (1%)	0
≥75% improvement	23 (28%)	17 (18%)	30 (38%)	17 (25%)	10 (12%)	9 (10%)
≥50% improvement	42 (52%)	39 (42%)	51 (65%)	36 (52%)	28 (33%)	21 (23%)
1-49% improvement	21 (26%)	32 (34%)	18 (23%)	23 (33%)	27 (32%)	32 (35%)
No change or worse	18 (22%)	22 (24%)	10 (13%)	10 (14%)	29 (35%)	38 (42%)

The 0.1% gel was more effective than the 0.05% gel, but the 0.05% gel was associated with less local irritation than the 0.1% gel (see ADVERSE REACTIONS section).

Acne: In two large vehicle-controlled studies, tazarotene 0.1% gel applied once daily was significantly more effective than vehicle in the treatment of facial acne vulgaris of mild to moderate severity. Percent reductions in lesion counts after treatment for 12 weeks in these two studies are shown in the following table:

Reduction in Lesion Counts after Twelve Weeks of Treatment in Two Controlled Clinical Trials for Acne
	Tazorac® 0.1% Gel		Vehicle Gel
	N=150	N=149	N=148	N=149
Noninflammatory lesions	55%	43%	35%	27%
Inflammatory lesions	42%	47%	30%	28%
Total lesions	52%	45%	33%	27%

Global improvement over baseline at the end of 12 weeks of treatment in these two studies is shown in the following table:

	Tazorac® 0.1% Gel		Vehicle Gel
	N=105	N=117	N=117	N=110
100% improvement	1 (1%)	0	0	0
≥75% improvement	40 (38%)	21 (18%)	23 (20%)	11 (10%)
≥50% improvement	71 (68%)	56 (48%)	47 (40%)	32 (29%)
1-49% improvement	23 (22%)	49 (42%)	48 (41%)	46 (42%)
No change or worse	11 (10%)	12 (10%)	22 (19%)	32 (29%)

INDICATIONS AND USAGE

Tazorac® (tazarotene) Gel 0.05% and 0.1% are indicated for the topical treatment of patients with stable plaque psoriasis of up to 20% body surface area involvement.

Tazorac® (tazarotene) Gel 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity.

The efficacy of Tazorac® Gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established.

CONTRAINDICATIONS

Retinoids may cause fetal harm when administered to a pregnant woman.

In rats, tazarotene 0.05% gel, administered topically during gestation days 6 through 17 at 0.25 mg/kg/day (1.5 mg/m2/day) resulted in reduced fetal body weights and reduced skeletal ossification. Rabbits dosed topically with 0.25 mg/kg/day (2.75 mg/m2 total body surface area/day) tazarotene gel during gestation days 6 through 18 were noted with single incidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies. Systemic daily-exposure (AUCde) to tazarotenic acid at topical doses of 0.25 mg/kg/day tazarotene in a gel formulation in rats and rabbits represented 0.62 and 6.7 times, respectively, the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 of tazarotene gel 0.1% (extrapolated for topical application over a 20% body surface area), and 0.78 and 8.4 times, respectively, the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of tazarotene gel 0.1% over a 15% (targeted) body surface area.

As with other retinoids, when tazarotene was given orally to experimental animals, developmental delays were seen in rats, and teratogenic effects and post-implantation loss were observed in rats and rabbits at AUCde values that were 0.55 and 13.2 times, respectively, the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 of tazarotene gel 0.1% (extrapolated for topical application over a 20% body surface area), and 0.68 and 16.4 times, respectively, the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of tazarotene gel 0.1% over a 15% (targeted) body surface area.

In a study of the effect of oral tazarotene on fertility and early embryonic development in rats, decreased number of implantation sites, decreased litter size, decreased numbers of live fetuses, and decreased fetal body weights, all classic developmental effects of retinoids, were observed when female rats were administered 2 mg/kg/day from 15 days before mating through gestation day 7. A low incidence of retinoid-related malformations at that dose was reported to be related to treatment. This dose produced an AUCde that was 1.7 times the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 tazarotene gel 0.1% (extrapolated for topical application over a 20% body surface area) and 2.1 times the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of tazarotene gel 0.1% over a 15% (targeted) body surface area.

SYSTEMIC EXPOSURE TO TAZAROTENIC ACID IS DEPENDENT UPON THE EXTENT OF THE BODY SURFACE AREA TREATED. IN PATIENTS TREATED TOPICALLY OVER SUFFICIENT BODY SURFACE AREA, EXPOSURE COULD BE IN THE SAME ORDER OF MAGNITUDE AS IN THESE ORALLY TREATED ANIMALS. ALTHOUGH THERE MAY BE LESS SYSTEMIC EXPOSURE IN THE TREATMENT OF ACNE OF THE FACE ALONE DUE TO LESS SURFACE AREA FOR APPLICATION, TAZAROTENE IS A TERATOGENIC SUBSTANCE, AND IT IS NOT KNOWN WHAT LEVEL OF EXPOSURE IS REQUIRED FOR TERATOGENICITY IN HUMANS (SEE CLINICAL PHARMACOLOGY: PHARMACOKINETICS).

There were thirteen reported pregnancies in patients who participated in clinical trials for topical tazarotene. Nine of the patients were found to have been treated with topical tazarotene, and the other four had been treated with vehicle. One of the patients who was treated with tazarotene cream elected to terminate the pregnancy for non-medical reasons unrelated to treatment. The other eight pregnant women who were inadvertently exposed to topical tazarotene during clinical trials subsequently delivered apparently healthy babies. As the exact timing and extent of exposure in relation to the gestation times are not certain, the significance of these findings is unknown.

Tazorac® Gel is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient apprised of the potential hazard to the fetus. Women of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when Tazorac® Gel is used. The possibility that a woman of child-bearing potential is pregnant at the time of institution of therapy should be considered. A negative result for pregnancy test having a sensitivity down to at least 50 mIU/mL for human chorionic gonadotropin (hCG) should be obtained within 2 weeks prior to Tazorac® Gel therapy, which should begin during a normal menstrual period (see also PRECAUTIONS: Pregnancy: Teratogenic Effects).

Tazorac® Gel is contraindicated in individuals who have shown hypersensitivity to any of its components.

WARNINGS

Pregnancy Category X. See CONTRAINDICATIONS section. Women of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when Tazorac® Gel is used. The possibility that a woman of child-bearing potential is pregnant at the time of institution of therapy should be considered. A negative result for pregnancy test having a sensitivity down to at least 50 mIU/mL for hCG should be obtained within 2 weeks prior to Tazorac® Gel therapy, which should begin during a normal menstrual period.

PRECAUTIONS

General: Tazorac® Gel should be applied only to the affected areas. For external use only. Avoid contact with eyes, eyelids, and mouth. If contact with eyes occurs, rinse thoroughly with water. The safety of use of Tazorac® Gel over more than 20% of body surface area has not been established in psoriasis or acne.

Retinoids should not be used on eczematous skin, as they may cause severe irritation.

Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided unless deemed medically necessary, and in such cases, exposure should be minimized during the use of Tazorac® Gel. Patients must be warned to use sunscreens (minimum SPF of 15) and protective clothing when using Tazorac® Gel. Patients with sunburn should be advised not to use Tazorac® Gel until fully recovered. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using Tazorac® Gel and ensure that the precautions outlined in the Information for Patients subsection are observed.

Tazorac® Gel should be administered with caution if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of augmented photosensitivity.

Some individuals may experience excessive pruritus, burning, skin redness or peeling. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the dosing should be reduced to an interval the patient can tolerate. However, efficacy at reduced frequency of application has not been established. Alternatively, patients with psoriasis who are being treated with the 0.1% concentration can be switched to the lower concentration.

Weather extremes, such as wind or cold, may be more irritating to patients using Tazorac® Gel.

Information for Patients: See attached Patient Package Insert.

Drug Interactions: Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided. It is also advisable to "rest" a patient's skin until the effects of such preparations subside before use of Tazorac® Gel is begun.

In a study of 27 healthy female subjects between the ages of 20–55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethynyl estradiol, concomitant use of tazarotene did not affect the pharmacokinetics of norethindrone and ethynyl estradiol over a complete cycle.

The impact of tazarotene on the pharmacokinetics of progestin only oral contraceptives (i.e., minipills) has not been evaluated.

Carcinogenesis, Mutagenesis, Impairment of Fertility: A long-term study of tazarotene following oral administration of 0.025, 0.050, and 0.125 mg/kg/day to rats showed no indications of increased carcinogenic risks. Based on pharmacokinetic data from a shorter-term study in rats, the highest dose of 0.125 mg/kg/day was anticipated to give systemic exposure (AUCde) in the rat equivalent to 0.32 times the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 of tazarotene gel 0.1% (extrapolated for topical application over a 20% body surface area), and 0.38 times the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of tazarotene gel 0.1% over a 15% (targeted) body surface area.

In evaluation of photo co-carcinogenicity, median time to onset of tumors was decreased and the number of tumors increased in hairless mice following chronic topical dosing with intercurrent exposure to ultraviolet radiation at tazarotene concentrations of 0.001%, 0.005%, and 0.01% in a gel formulation for up to 40 weeks.

A long-term topical application study of up to 0.1% tazarotene in a gel formulation in mice terminated at 88 weeks showed that dose levels of 0.05, 0.125, 0.25, and 1 mg/kg/day (reduced to 0.5 mg/kg/day for males after 41 weeks due to severe dermal irritation) revealed no apparent carcinogenic effects when compared to vehicle control animals; untreated control animals were not completely evaluated. Systemic exposure (AUC0-12h) at the highest dose was 2 times the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 of tazarotene gel 0.1% (extrapolated for topical application over a 20% body surface area), and 2.5 times the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of tazarotene gel 0.1% over a 15% (targeted) body surface area.

Tazarotene was found to be non-mutagenic in the Ames assay using Salmonella and E. coli and did not produce structural chromosomal aberrations in a human lymphocyte assay. Tazarotene was also non-mutagenic in the CHO/HGPRT mammalian cell forward gene mutation assay and was non-clastogenic in the in vivo mouse micronucleus test.

No impairment of fertility occurred in rats when male animals were treated for 70 days prior to mating and female animals were treated for 14 days prior to mating and continuing through gestation and lactation with topical doses of tazarotene gel of up to 0.125 mg/kg/day. Based on data from another study, the systemic drug exposure (AUCde) in the rat would be equivalent to 0.31 times the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 of tazarotene gel 0.1% (extrapolated for topical application over a 20% body surface area), and 0.38 times the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of tazarotene gel 0.1% over a 15% (targeted) body surface area.

No impairment of mating performance or fertility was observed in male rats treated for 70 days prior to mating with oral doses of up to 1 mg/kg/day tazarotene, which produced an AUCde that was 0.95 times the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 of tazarotene gel 0.1% (extrapolated for topical application over a 20% body surface area), and 1.2 times the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of tazarotene gel 0.1% over a 15% (targeted) body surface area.

No effect on parameters of mating performance or fertility was observed in female rats treated for 15 days prior to mating and continuing through day 7 of gestation with oral doses of tazarotene up to 2 mg/kg/day. However, there was a significant decrease in the number of estrous stages and an increase in developmental effects at 2 mg/kg/day (see CONTRAINDICATIONS). This dose produced an AUC0-24h which was 1.7 times that observed in psoriatic patients treated with 2 mg/cm2 of tazarotene gel 0.1% (extrapolated for topical application over a 20% body surface area), and 2.1 times the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of tazarotene gel 0.1% over a 15% (targeted) body surface area.

Reproductive capabilities of F1 animals, including F2 survival and development, were not affected by topical administration of tazarotene gel to female F0 parental rats from gestation day 16 through lactation day 20 at the maximum tolerated dose of 0.125 mg/kg/day. Based on data from another study, the systemic drug exposure (AUCde) in the rat would be equivalent to 0.31 times the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 of tazarotene gel 0.1% (extrapolated for topical application over a 20% body surface area), and 0.38 times the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of tazarotene gel 0.1% over a 15% (targeted) body surface area.

Pregnancy

Teratogenic Effects: Pregnancy Category X: See CONTRAINDICATIONS section. Women of child-bearing potential should use adequate birth-control measures when Tazorac® Gel is used. The possibility that a woman of child-bearing potential is pregnant at the time of institution of therapy should be considered. A negative result for pregnancy test having a sensitivity down to at least 50 mIU/mL for hCG should be obtained within 2 weeks prior to Tazorac® Gel therapy, which should begin during a normal menstrual period. There are no adequate, well-controlled studies in pregnant women. Although there may be less systemic exposure in the treatment of acne of the face alone due to less surface area for application, tazarotene is a teratogenic substance, and it is not known what level of exposure is required for teratogenicity in humans (see CLINICAL PHARMACOLOGY: Pharmacokinetics).

Nursing Mothers

After single topical doses of 14C-tazarotene to the skin of lactating rats, radioactivity was detected in milk, suggesting that there would be transfer of drug-related material to the offspring via milk. It is not known whether this drug is excreted in human milk. Caution should be exercised when tazarotene is administered to a nursing woman.

Pediatric Use

The safety and efficacy of tazarotene have not been established in pediatric patients under the age of 12 years.

Geriatric Use

Of the total number of subjects in clinical studies of tazarotene gels, 0.05% and 0.1% for plaque psoriasis, 163 were over the age of 65. Subjects over 65 years of age experienced more adverse events and lower treatment success rates after 12 weeks of use of Tazorac® Gel compared with those 65 years of age and younger. Currently there is no other reliable clinical experience on the differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals can not be ruled out. Tazarotene gel for the treatment of acne has not been clinically evaluated in persons over the age of 65.

Adverse Reactions

In human dermal safety studies, tazarotene 0.05% and 0.1% gels did not induce allergic contact sensitization, phototoxicity or photoallergy.

Psoriasis: The most frequent adverse events reported with Tazorac® Gel 0.05% and 0.1% were limited to the skin. Those occurring in 10 to 30% of patients, in descending order, included pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, and skin pain. Events occurring in 1 to 10% of patients included rash, desquamation, irritant contact dermatitis, skin inflammation, fissuring, bleeding, and dry skin. Increases in “psoriasis worsening” and “sun-induced erythema” were noted in some patients over the 4th to 12th months as compared to the first three months of a 1 year study. In general, the incidence of adverse events with Tazorac® Gel 0.05% was 2 to 5% lower than that seen with Tazorac® Gel 0.1%.

Acne: The most frequent adverse events reported with Tazorac® Gel 0.1% in the treatment of acne occurring in 10 to 30% of patients, in descending order, included desquamation, burning/stinging, dry skin, erythema and pruritus. Events occurring in 1 to 10% of patients included irritation, skin pain, fissuring, localized edema and skin discoloration.

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of Tazorac® Gel 0.05% and 0.1% in clinical practice. Because they are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Tazorac® Gel. The reactions include: blister, rash, skin discoloration (including skin hyperpigmentation or skin hypopigmentation), and pain.

OVERDOSAGE

Excessive topical use of Tazorac® Gel may lead to marked redness, peeling, or discomfort (see PRECAUTIONS: General).

Tazorac® Gels 0.05% and 0.1% are not for oral use. Oral ingestion of the drug may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis A) or other retinoids. If oral ingestion occurs, the patient should be monitored, and appropriate supportive measures should be administered as necessary.

DOSAGE AND ADMINISTRATION

General: Application may cause excessive irritation in the skin of certain sensitive individuals. In cases where it has been necessary to temporarily discontinue therapy, or the dosing has been reduced to a lower concentration (in patients with psoriasis) or to an interval the patient can tolerate, therapy can be resumed, or the drug concentration or frequency of application can be increased as the patient becomes able to tolerate the treatment. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Efficacy has not been established for less than once daily dosing frequencies.

For Psoriasis: It is recommended that treatment start with Tazorac® 0.05% Gel, with strength increased to 0.1% if tolerated and medically indicated. Apply Tazorac® Gel once a day, in the evening, to psoriatic lesions, using enough (2 mg/cm2) to cover only the lesion with a thin film to no more than 20% of body surface area. If a bath or shower is taken prior to application, the skin should be dry before applying the gel. If emollients are used, they should be applied at least an hour before application of Tazorac® Gel. Because unaffected skin may be more susceptible to irritation, application of tazarotene to these areas should be carefully avoided. Tazorac® Gel was investigated for up to 12 months during clinical trials for psoriasis.

For Acne: Cleanse the face gently. After the skin is dry, apply a thin film of Tazorac® Gel 0.1% (2 mg/cm2) once a day, in the evening, to the skin where acne lesions appear. Use enough to cover the entire affected area. Tazorac® Gel was investigated for up to 12 weeks during clinical trials for acne.

HOW SUPPLIED

Tazorac® (tazarotene) Gel is available in concentrations of 0.05% and 0.1%. It is available in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white propylene screw cap, in 30 g and 100 g sizes.

	Tazorac® Gel 0.05%	Tazorac® Gel 0.1%
30 g	NDC 0023-8335-03	NDC 0023-0042-03
100 g	NDC 0023-8335-10	NDC 0023-0042-10

NOTE: Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F).

Rx Only

Revised: 03/2011

© 2011 Allergan, Inc.

Irvine, CA 92612, U.S.A.

® marks owned by Allergan, Inc.

U.S. Patents 5,914,334 and 6,258,830

Made in the U.S.A.

71722US13C

Pharmacist: Please cut or tear at dotted line and provide this patient package insert to your customer.

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Tazorac®

(tazarotene) Gel 0.05%

(tazarotene) Gel 0.1%

INFORMATION FOR PATIENTS

Please read this leaflet carefully before you start to use your medicine. Read the information you get every time you get more medicine. There may be new information about the drug. This leaflet does not take the place of talks with your doctor. If you have any questions, or are not sure about anything, ask your doctor or pharmacist.

USES

Tazorac® Gel 0.05% is used in the treatment of stable plaque psoriasis covering up to 20% of body surface area.

Tazorac® Gel 0.1% is used in the treatment of stable plaque psoriasis covering up to 20% of body surface area and in the treatment of mild to moderately severe facial acne.

BEFORE YOU USE THIS MEDICINE

You should be aware that:

(a) Tazorac® Gel should not be used if you are pregnant, attempting to become pregnant or at high risk of pregnancy. Consult your physician for adequate birth control measures if you are a female of child-bearing potential. If you are able to become pregnant, take a pregnancy test within 2 weeks prior to beginning to use Tazorac® Gel to be sure you are not pregnant. If you have menstrual periods, begin taking Tazorac® Gel during a normal menstrual period. These actions help assure that you are not pregnant when you begin use.

(b) Tazorac® Gel should be used with caution if you are also using other topical agents with a strong skin drying effect, products with high concentrations of alcohol, astringents, spices, the peel of lime, medicated soaps or shampoos, permanent wave solutions, electrolysis, hair depilatories or waxes, or other preparations or processes that might dry or irritate the skin, unless otherwise instructed by your health care practitioner.

(c) Tazorac® Gel should not be used if you have sunburn, eczema or other chronic skin condition(s). Tazorac® Gel may cause severe irritation if applied to eczematous skin. If you have sunburn, you should wait until full recovery before using Tazorac® Gel.

(d) Tazorac® Gel should not be used if you are inherently sensitive to sunlight.

(e) Tazorac® Gel should not be used if you are taking other drugs that increase your sensitivity to sunlight (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides). Inform your physician if you are taking any other medications.

(f) You should use protective clothing and sunscreens with minimum SPF of 15 during the day when being treated with Tazorac® Gel. You should avoid direct sun exposure as much as possible and avoid sunlamps totally while being treated with Tazorac® Gel, unless advised otherwise by your doctor.

(g) If you have considerable sun exposure due to occupation, particular caution as described above should be exercised when using Tazorac® Gel.

(h) Weather extremes, such as wind or cold, may be more irritating to your skin while you are using Tazorac® Gel.

BEFORE YOU USE THIS MEDICINE

Tell your doctor:

(a) if you are pregnant or are considering becoming pregnant.

(b) if you are breast-feeding. We do not know if tazarotene can pass through the milk to the baby. The potential harm to the baby is unknown.

(d) if you are already using other products that make your skin dry.

(e) if you have a skin condition called eczema.

(f) if you will be subject to excessive sun exposure.

(g) if you are taking Vitamin A supplements.

HOW TO USE THIS PRODUCT

Read the directions on your prescription label carefully. Ask your doctor or pharmacist to explain anything that you do not understand.

If you become pregnant while using Tazorac® Gel, you should immediately discontinue its use and contact your doctor.

If you use a cream or lotion to soften or lubricate your skin, apply Tazorac® Gel after ensuring that there is no more cream or lotion on the skin.

With use of Tazorac® Gel, some people notice a feeling of itching, burning or stinging. If irritation is excessive, consult your healthcare provider, who may adjust your medication temporarily to a more comfortable level. Effectiveness of this medication when used less often than once daily has not been proven.

Do not cover treated areas with dressings or bandages.

Never use more Tazorac® Gel than instructed and never use it more often than instructed, as application of larger amounts of medication than recommended will not lead to more rapid or better results, and marked redness, peeling or discomfort may occur.

Wash your hands after applying the medication unless you are treating your hands for psoriasis. If the gel accidentally gets on areas you do not need to treat, wash it off.

Keep Tazorac® Gel away from your eyes, eyelids, and mouth. If it gets in contact with your eyes, wash them with large amounts of cool water, and contact a doctor if eye irritation persists.

MISSED DOSES

If you forget or miss a dose of Tazorac® Gel, do not try to "make it up." Return to your normal application schedule as soon as you can.

INSTRUCTIONS SPECIFIC TO TREATMENT OF PSORIASIS

If you bathe or shower before using Tazorac® Gel, be sure the skin is dry before application. Apply a thin film of the gel to your psoriasis lesions once a day before going to bed.

Carefully avoid application to apparently uninvolved skin. Tazorac® Gel may be more irritating to non-lesional skin.

If you need to treat you

Monday, 5 March 2012

Niacin Flush Free

Pronunciation: in-OH-sih-tole nye-a-SIN-ate
Generic Name: Inositol Niacinate
Brand Name: Examples include Niacin Flush Free and Niacinol

Niacin Flush Free is used for:

Improving blood circulation in certain conditions and lowering cholesterol and triglycerides in the blood. It may also be used for other conditions as determined by your doctor.

Niacin Flush Free is a vasodilator and lipid-lowering agent. It improves circulation by releasing histamine, which causes the blood vessels to dilate (widen) and breaks up a protein needed for the clotting of blood. It also prevents the formation of lipids in the body, which helps to lower cholesterol and triglyceride levels.

Do NOT use Niacin Flush Free if:

you are allergic to any ingredient in Niacin Flush Free

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

Before using Niacin Flush Free:

Some medical conditions may interact with Niacin Flush Free. Tell your doctor or pharmacist 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 severe liver problems or disease, kidney problems, diabetes, gout, gallbladder disease, chest pain, heart disease, an active peptic ulcer, arterial bleeding, or severely low blood pressure

if you have a history of stomach ulcer or heart attack, or you drink alcohol on a regular basis

Some MEDICINES MAY INTERACT with Niacin Flush Free. Tell your health care provider if you are taking any other medicines, especially any of the following:

Aspirin, blood thinners (eg, warfarin), or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen) because they may increase the risk of side effects (eg, bleeding)

HMG Co-A reductase inhibitors (eg, lovastatin, simvastatin) because the risk of side effects, including muscle weakness, may be increased

Nicotine patches because the risk of side effects, including flushing and dizziness, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Niacin Flush Free 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 Niacin Flush Free:

Use Niacin Flush Free as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Niacin Flush Free by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Do not take Niacin Flush Free with alcohol, hot food, or hot beverages. This may increase flushing and itching.

If you miss a dose of Niacin Flush Free, 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 Niacin Flush Free.

Important safety information:

Niacin Flush Free may cause dizziness, lightheadedness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use Niacin Flush Free with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not substitute other forms of niacin for Niacin Flush Free.

Diabetes patients - Niacin Flush Free may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Lab tests may be performed while you use Niacin Flush Free. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Niacin Flush Free while you are pregnant. It is not known if Niacin Flush Free is found in breast milk. If you are or will be breast-feeding while you use Niacin Flush Free, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Niacin Flush Free:

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:

Diarrhea; dizziness; flushing; itching; loss of appetite; nausea; upset stomach; vomiting.

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); dark urine; severe stomach pain; yellowing of the skin.

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: Niacin Flush Free 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.

Proper storage of Niacin Flush Free:

Store Niacin Flush Free at room temperature, between 68 and 77 degrees F (20 and 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 Niacin Flush Free out of the reach of children and away from pets.

General information:

If you have any questions about Niacin Flush Free, please talk with your doctor, pharmacist, or other health care provider.

Niacin Flush Free is 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.

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

This information is a summary only. It does not contain all information about Niacin Flush Free. 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 Niacin Flush Free resources

Niacin Flush Free Side Effects (in more detail)
Niacin Flush Free Use in Pregnancy & Breastfeeding
Niacin Flush Free Support Group
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Sunday, 4 March 2012

Tasmar

Pronunciation: TOLE-ka-pone
Generic Name: Tolcapone
Brand Name: Tasmar

Severe and possibly fatal liver problems may occur in patients who take Tasmar. Tasmar should only be used in certain patients who cannot take or have not responded to other treatments. Patients who do not show an improvement in their symptoms after taking Tasmar for at least 3 weeks should stop taking it due to possible risk of liver injury. Patients who have liver disease or have had 2 abnormal liver function tests should not start taking Tasmar. Liver function tests will be performed before and during treatment to monitor side effects. However, these tests may not decrease the risk of developing serious liver problems. Make sure to keep all doctor and lab appointments. Contact your doctor at once if you develop dark urine, loss of appetite, pale stools, right-sided stomach pain, severe or persistent nausea or tiredness, sluggishness, or yellowing of the skin or eyes. Patients who develop liver problems while taking Tasmar should not take Tasmar again.

Patients who have a history of severe uncontrolled muscle movement (eg, jerking, twitching) should use Tasmar with extreme caution.

Tasmar is used for:

Treating Parkinson disease. It is used along with levodopa/carbidopa. It is only used in patients who cannot take or have not responded to other medications.

Tasmar is a catechol-O-methyltransferase (COMT) inhibitor. It works by prolonging the anti-Parkinson effect action of levodopa.

Do NOT use Tasmar if:

you are allergic to any ingredient in Tasmar

you have liver disease or have had 2 abnormal liver function tests

you had to stop taking Tasmar before because of liver problems

you have a history of certain muscle problems (rhabdomyolysis) or fever and confusion that may have been caused by Tasmar

you are taking a nonselective monoamine oxidase inhibitor (MAOI) (eg, phenelzine)

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

Before using Tasmar:

Some medical conditions may interact with Tasmar. Tell your doctor or pharmacist 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 kidney problems, liver problems (eg, cirrhosis), or abnormal liver function tests

if you have a history of severe, uncontrolled muscle movements (eg, uncontrolled jerking, twitching) or a certain severe muscle problem (rhabdomyolysis)

if you experience dizziness or lightheadedness when you stand up

Some MEDICINES MAY INTERACT with Tasmar. Tell your health care provider if you are taking any other medicines, especially any of the following:

Warfarin because the risk of bleeding may be increased

Desipramine or nonselectiveMAOIs (eg, phenelzine) because they may increase the risk of Tasmar's side effects

Apomorphine, dobutamine, isoproterenol, levodopa, methyldopa, or a sympathomimetic (eg, albuterol, pseudoephedrine) because the risk of their side effects may be increased by Tasmar

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tasmar 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 Tasmar:

Use Tasmar as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Tasmar by mouth with or without food.

Do not suddenly stop taking Tasmar. You may have an increased risk of Parkinson disease symptoms, fever, confusion, or muscle rigidity. If you need to stop Tasmar or add a new medicine, your doctor will gradually lower your dose.

If you miss a dose of Tasmar, 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 Tasmar.

Important safety information:

You must discuss the benefits and risks of Tasmar with your doctor and sign a patient acknowledgment form before you begin treatment with Tasmar.

Tasmar may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Tasmar with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tasmar; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Tasmar 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.

If your symptoms do not get better within 3 weeks or if they get worse, check with your doctor.

Some patients who take Tasmar may develop certain muscle movements that they cannot control. Tell your doctor at once if you have new or worsening muscle problems with your arms, legs, or your face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while you take Tasmar.

Tasmar may cause nausea or diarrhea. Nausea may be more likely when you first start taking Tasmar. If nausea or diarrhea occurs, discuss with your doctor ways to lessen the effects.

Some people have experienced new, unusual, or increased urges (eg, gambling, sexual urges) while using Tasmar. Tell your doctor right away if you notice such effects.

Patients with Parkinson disease may have an increased risk of developing a certain type of skin cancer (melanoma). It is not known if Tasmar also increases the risk of melanoma. You may need to have skin exams while you are using Tasmar. Tell your doctor if you notice any unusual skin growths or a change in the appearance of a mole. Discuss any questions or concerns with your doctor.

Use Tasmar with caution in the ELDERLY; they may be more sensitive to its effects, especially hallucinations.

Lab tests, including liver function tests, may be performed while you use Tasmar. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Tasmar is not recommended for use 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 Tasmar while you are pregnant. It is not known if Tasmar is found in breast milk. If you are or will be breast-feeding while you use Tasmar, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Tasmar:

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:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; gas; headache; increased sweating; lightheadedness when sitting up or standing; nausea; stomach upset; trouble sleeping; unusual or excessive dreams; upper respiratory tract infection; urine discoloration; vomiting.

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); blood in the urine; chest pain; confusion; fainting; falling; fever; hallucinations; mental or mood changes; muscle pain (with or without fever or confusion); new or worsening uncontrolled muscle movements of the arms or legs, or of the tongue face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements); rigid muscles; severe or persistent diarrhea; shortness of breath; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, right-sided stomach pain, severe or persistent nausea or tiredness, sluggishness, yellowing of the skin or eyes).

See also: Tasmar 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 dizziness; nausea; vomiting.

Proper storage of Tasmar:

Store Tasmar at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tasmar out of the reach of children and away from pets.

General information:

If you have any questions about Tasmar, please talk with your doctor, pharmacist, or other health care provider.

Tasmar is 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.

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

This information is a summary only. It does not contain all information about Tasmar. 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

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Commonly used brand name(s)

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Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

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Dosing

Missed Dose

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Interactions with Food/Tobacco/Alcohol

Proper Use of trifluridine

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1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

6.2 Incompatibilities

6.3 Shelf Life

6.4 Special Precautions For Storage

6.5 Nature And Contents Of Container

6.6 Special Precautions For Disposal And Other Handling

7. Marketing Authorisation Holder

8. Marketing Authorisation Number(S)

9. Date Of First Authorisation/Renewal Of The Authorisation

10. Date Of Revision Of The Text

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What should I discuss with my health care provider before receiving vecuronium?

How is vecuronium given?

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