Naftin Gel

Dosage Form: gel
NAFTIN®

NAFTIFINE HCl 1% GEL

Rx Only

Naftin Gel Description

Naftin® Gel, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftin® Gel, 1% is for topical use only.

Chemical Name

(E)-N-Cinnamyl-N-methyl-1-naphthalenemethylamine hydrochloride.

Naftifine hydrochloride has an empirical formula of C21H21N•HCl and a molecular weight of 323.86.

Contains

Active Ingredient
Naftifine hydrochloride	1%

Inactive Ingredients

polysorbate 80, carbomer 934P, diisopropanolamine, edetate disodium, alcohol (52%v/v) and purified water.

Naftin Gel - Clinical Pharmacology

Naftifine hydrochloride is a synthetic allylamine derivative. The following in vitro data are available, but their clinical significance is unknown. Naftifine hydrochloride has been shown to exhibit fungicidal activity in vitro against a broad spectrum of organisms, including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Epidermophyton floccosum, Microsporum canis, Microsporum audouini, and Microsporum gypseum; and fungistatic activity against Candida species, including Candida albicans. Naftin® Gel, 1% has only been shown to be clinically effective against the disease entities listed in the INDICATIONS AND USAGE section.

Although the exact mechanism of action against fungi is not known, naftifine hydrochloride appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene 2, 3-epoxidase. This inhibition of enzyme activity results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells.

Pharmacokinetics

In vitro and in vivo bioavailability studies have demonstrated that naftifine penetrates the stratum corneum in sufficient concentration to inhibit the growth of dermatophytes.

Following single topical applications of 3H-labeled naftifine gel 1% to the skin of healthy subjects, up to 4.2% of the applied dose was absorbed. Naftifine and/or its metabolites are excreted via the urine and feces with a half-life of approximately two to three days.

Indications and Usage for Naftin Gel

Naftin® Gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans1 and Epidermophyton floccosum.1

1

Efficacy for this organism in this organ system was studied in fewer than 10 infections.

Contraindications

Naftin® Gel, 1% is contraindicated in individuals who have shown hypersensitivity to any of its components.

Warnings

Naftin® Gel, 1% is for topical use only and not for ophthalmic use.

Precautions

General

Naftin® Gel, 1% is for external use only. If irritation or sensitivity develops with the use of Naftin® Gel, 1%, treatment should be discontinued and appropriate therapy instituted. Diagnosis of the disease should be confirmed either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium.

Information for patients

The patient should be told to:

1. Avoid the use of occlusive dressings or wrappings unless otherwise directed by the physician.


2. Keep Naftin® Gel, 1% away from the eyes, nose, mouth and other mucous membranes.

Carcinogenesis, mutagenesis, impairment of fertility

Long-term studies to evaluate the carcinogenic potential of Naftin® Gel, 1% have not been performed. In vitro and animal studies have not demonstrated any mutagenic effect or effect on fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category B

Reproduction studies have been performed in rats and rabbits (via oral administration) at doses 150 times or more than the topical human dose and have revealed no evidence of impaired fertility or harm to the fetus due to naftifine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naftin® Gel, 1% is administered to a nursing woman.

Pediatric use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

During clinical trials with Naftin® Gel, 1%, the incidence of adverse reactions was as follows: burning/stinging (5.0%), itching (1.0%), erythema (0.5%), rash (0.5%), skin tenderness (0.5%).

Naftin Gel Dosage and Administration

A sufficient quantity of Naftin® Gel, 1% should be gently massaged into the affected and surrounding skin areas twice a day in the morning and evening. The hands should be washed after application.

If no clinical improvement is seen after four weeks of treatment with Naftin® Gel, 1%, the patient should be re-evaluated.

How is Naftin Gel Supplied

Naftin® (naftifine hydrochloride) 1% Gel is supplied in collapsible tubes in the following sizes:

40g – NDC 0259-4770-40

60g – NDC 0259-4770-60

90g -- NDC 0259-4770-90

Note: Store at room temperature.

Manufactured for: Merz Pharmaceuticals, Greensboro, NC 27410

5011343

© 2009 Merz Pharmaceuticals

Rev 2/09 Printed in U.S.A.

PRINCIPAL DISPLAY PANEL - 40g Carton

NDC 0259-4770-40

NAFTIN®

40g gel

NAFTIFINE HCl 1% GEL

Rx Only

MERZ®

NAFTIN  naftifine hydrochloride  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0259-4770 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength naftifine hydrochloride (naftifine) naftifine 10 mg  in 1 g

Inactive Ingredients Ingredient Name Strength POLYSORBATE 80   CARBOMER 934   DIISOPROPANOLAMINE   EDETATE DISODIUM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0259-4770-02 18 TUBE In 1 CARTON contains a TUBE 1 2 g In 1 TUBE This package is contained within the CARTON (0259-4770-02) 2 0259-4770-20 1 TUBE In 1 CARTON contains a TUBE 2 20 g In 1 TUBE This package is contained within the CARTON (0259-4770-20) 3 0259-4770-40 1 TUBE In 1 CARTON contains a TUBE 3 40 g In 1 TUBE This package is contained within the CARTON (0259-4770-40) 4 0259-4770-60 1 TUBE In 1 CARTON contains a TUBE 4 60 g In 1 TUBE This package is contained within the CARTON (0259-4770-60) 5 0259-4770-90 1 TUBE In 1 CARTON contains a TUBE 5 90 g In 1 TUBE This package is contained within the CARTON (0259-4770-90)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019356	10/01/1990

Labeler - Merz Pharmaceuticals, LLC (126209282)

Revised: 12/2009Merz Pharmaceuticals, LLC

More Naftin Gel resources

• Naftin Gel Side Effects (in more detail)
• Naftin Gel Use in Pregnancy & Breastfeeding
• Naftin Gel Support Group
• 2 Reviews for Naftin - Add your own review/rating

Compare Naftin Gel with other medications

• Tinea Corporis
• Tinea Cruris
• Tinea Pedis

Norsol

Norsol may be available in the countries listed below.

Ingredient matches for Norsol

Norfloxacin

Norfloxacin is reported as an ingredient of Norsol in the following countries:

• Argentina


• Switzerland

Prednisolone

Prednisolone 21-(disodium phosphate) (a derivative of Prednisolone) is reported as an ingredient of Norsol in the following countries:

• Turkey

International Drug Name Search

Bumetanide

Pronunciation: bue-MET-a-nide
Generic Name: Bumetanide
Brand Name: Bumex

This is a powerful fluid-reducing medicine. Using too much of Bumetanide can lead to serious water and mineral loss. Therefore, it is important that you be monitored by your doctor. Tell your doctor right away if you become very thirsty, have dry mouth, become confused, or develop muscle cramps/weakness.

Bumetanide is used for:

Treating swelling caused by excess body water associated with heart failure or kidney or liver disease. It may also be used for other conditions as determined by your doctor.

Bumetanide is a loop diuretic. It works by forcing the kidney to eliminate sodium, potassium, and water.

Do NOT use Bumetanide if:

• you are allergic to any ingredient in Bumetanide


• you have no urine formation


• you have kidney disease and a significant decrease in urine formation to less than 16 oz/day (500 mL/day)


• you have severe depletion of blood electrolytes (minerals in the blood [eg, sodium, calcium, potassium, chlorine, magnesium, bicarbonate])


• you have brain and nervous system problems caused by severe liver disease

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

Before using Bumetanide:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

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


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


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


• if you have excess fluid in or around your abdomen, hearing problems, high blood levels of nitrogen, diabetes, liver or kidney problems, low urine output, or high levels of uric acid


• if you are dehydrated or have had a heart attack


• if you have had a severe allergic reaction to sulfamethoxazole (a sulfa antibiotic) or any other sulfonamide medicine (eg, acetazolamide, celecoxib, hydrochlorothiazide, glyburide, probenecid, sulfamethoxazole, valdecoxib, zonisamide)


• if you have a skin rash or have ever developed a severe skin rash from taking another medicine

Some MEDICINES MAY INTERACT with Bumetanide. Tell your health care provider if you are taking any of the following medicines.

• Aminoglycosides (eg, gentamicin) because the risk of hearing loss may be increased


• Ibuprofen or indomethacin because they may decrease Bumetanide's effectiveness


• Chloral hydrate, digitalis glycosides, or lithium because their actions and the risk of their side effects may be increased by Bumetanide

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

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

• Bumetanide is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Bumetanide at home, a health care provider will teach you how to use it. Be sure you understand how to use Bumetanide. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Bumetanide may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.


• If your doctor directs you to switch to medicine that is taken by mouth, be sure you understand how to take it.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Bumetanide, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Bumetanide.

Important safety information:

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


• Bumetanide 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.


• Bumetanide may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Bumetanide. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Your doctor may have also prescribed a potassium supplement for you. If so, follow the dosing carefully. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.


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


• Lab tests, including kidney function, serum urea nitrogen (BUN), and electrolyte levels, may be performed while you use Bumetanide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Bumetanide with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood pressure.


• Bumetanide should not be used 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 Bumetanide while you are pregnant. It is not known if Bumetanide is found in breast milk. Do not breast-feed while taking Bumetanide.

Possible side effects of Bumetanide:

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

Dizziness or lightheadedness when sitting up or standing; drowsiness; headache; low blood pressure.

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); confusion; diarrhea; extreme thirst or dry mouth; loss of appetite; muscle cramps; nausea; pain, redness, or swelling at injection site; rapid or irregular heartbeat; red, blistered, swollen, or peeling skin; ringing in the ears or hearing loss; stomach cramps; weakness; vomiting.

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: Bumetanide 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; dry mouth; excessive urination followed by a decrease in amount of urine; muscle cramps; weak or irregular heartbeat; weakness.

Proper storage of Bumetanide:

Store Bumetanide at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Bumetanide, as well as needles and syringes, out of the reach of children and away from pets.

General information:

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


• Bumetanide 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 Bumetanide. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Bumetanide resources

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

• Bumetanide Prescribing Information (FDA)


• Bumetanide Monograph (AHFS DI)


• Bumetanide Professional Patient Advice (Wolters Kluwer)


• bumetanide Concise Consumer Information (Cerner Multum)


• bumetanide Advanced Consumer (Micromedex) - Includes Dosage Information


• Bumex Prescribing Information (FDA)

Compare Bumetanide with other medications

• Ascites
• Edema
• Pulmonary Edema

Nevanac

Generic Name: nepafenac ophthalmic (ne PA fan ak off THAL mik)

Brand Names: Nevanac

What is nepafenac ophthalmic?

Nepafenac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It reduces pain and inflammation in the eyes.

Nepafenac ophthalmic (for the eyes) is used to reduce pain and swelling after cataract surgery.

Nepafenac ophthalmic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about nepafenac ophthalmic?

Before using nepafenac ophthalmic, tell your doctor if you are allergic to any drugs or other eye drops

Also tell your doctor if you have diabetes, dry eye syndrome, rheumatoid arthritis, a bleeding or blood-clotting disorder, such as hemophilia, or arthritis.

Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using nepafenac before putting your contact lenses in. Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye. Do not use nepafenac ophthalmic for longer than 14 days after your surgery unless your doctor tells you to.

What should I discuss with my healthcare professional before using nepafenac ophthalmic?

You should not use this medication if you are allergic to nepafenac.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• 
  

  diabetes;

  
  


• 
  

  dry eye syndrome;

  
  


• 
  

  rheumatoid arthritis;

  
  


• 
  

  a bleeding or blood-clotting disorder, such as hemophilia; or

  
  


• 
  

  arthritis.

  
  

Do not use nepafenac ophthalmic while wearing contact lenses. If you wear contact lenses take them out or talk to your doctor before using the medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby, especially if during the last part of pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether nepafenac ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use nepafenac ophthalmic?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Nepafenac is usually given as 1 drop in the affected eye 3 times per day, starting 1 day before cataract surgery.

Do not use nepafenac ophthalmic for longer than 14 days after your surgery unless your doctor tells you to. Wash your hands before using the eye drops. Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using nepafenac before putting your contact lenses in. Shake the eye drops well just before you use them.

To apply the eye drops:

• 
  

  Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

  
  


• 
  

  Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.

  
  


• 
  

  Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

  
  

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Keep using any other eye drops your doctor has prescribed, including drops to treat glaucoma. Use only the eye medications your doctor has prescribed.

Store the drops at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of nepafenac ophthalmic is not likely to cause life-threatening symptoms.

What should I avoid while using nepafenac ophthalmic?

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any other eye medications that have not been prescribed or recommended by your doctor.

Do not use nepafenac ophthalmic while wearing contact lenses. If you wear contact lenses take them out or talk to your doctor before using the medication.

Nepafenac ophthalmic 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. Call your doctor at once if you have vision problems, crusting or drainage of your eyes, swollen eyelids, or severe eye pain.

Less serious side effects may be more likely to occur (some are effects of cataract surgery and not side effects of the medication):

• 
  

  dry or sticky feeling in the eye;

  
  


• 
  

  feeling like something is in your eye;

  
  


• 
  

  eye redness;

  
  


• 
  

  itching or watering of the eye;

  
  


• 
  

  increased sensitivity to light;

  
  


• 
  

  headache;

  
  


• 
  

  nausea, vomiting; or

  
  


• 
  

  stuffy nose.

  
  

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

What other drugs will affect nepafenac ophthalmic?

Before using this medication, tell your doctor if you also use any steroid medication, including steroids eye drops.

This list is not complete and there may be other drugs that can interact with nepafenac ophthalmic. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Nevanac resources

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

• Nevanac Prescribing Information (FDA)


• Nevanac Monograph (AHFS DI)


• Nevanac Advanced Consumer (Micromedex) - Includes Dosage Information


• Nevanac MedFacts Consumer Leaflet (Wolters Kluwer)


• Nevanac Consumer Overview

Compare Nevanac with other medications

• Postoperative Increased Intraocular Pressure
• Postoperative Ocular Inflammation

Where can I get more information?

• Your doctor or pharmacist can provide more information about nepafenac ophthalmic.

See also: Nevanac side effects (in more detail)

Amoxicillin MK

Amoxicillin MK may be available in the countries listed below.

Ingredient matches for Amoxicillin MK

Amoxicillin

Amoxicillin is reported as an ingredient of Amoxicillin MK in the following countries:

• Aruba


• Belize


• Jamaica

International Drug Name Search

Metronidazol Waldheim

Metronidazol Waldheim may be available in the countries listed below.

Ingredient matches for Metronidazol Waldheim

Metronidazole

Metronidazole is reported as an ingredient of Metronidazol Waldheim in the following countries:

• Austria

International Drug Name Search

Natural Vitamin Blend E-400IU

Generic Name: vitamin e (Oral route)

VYE-ta-min E

Commonly used brand name(s)

In the U.S.

• Alpha-E


• Aqua Gem-E


• Aquasol E


• D-Alpha Gems


• E-400


• E-600


• E-Gems


• Formula E 400


• Gamma E-Gems


• Gamma E Plus


• Key-E


• Natural Vitamin Blend E-400IU


• Nutr-E-Sol

Available Dosage Forms:

• Liquid


• Solution


• Tablet


• Capsule, Liquid Filled


• Tablet, Chewable


• Powder for Solution


• Capsule

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin E (class)

Uses For Natural Vitamin Blend E-400IU

Vitamins are compounds that you must have for growth and health. They are needed in only small amounts and are available in the foods that you eat. Vitamin E prevents a chemical reaction called oxidation, which can sometimes result in harmful effects in your body. It is also important for the proper function of nerves and muscles.

Some conditions may increase your need for vitamin E. These include:

• Intestine disease


• Liver disease


• Pancreas disease


• Surgical removal of stomach

Increased need for vitamin E should be determined by your health care professional.

Infants who are receiving a formula that is not fortified with vitamin E may be likely to have a vitamin E deficiency. Also, diets high in polyunsaturated fatty acids may increase your need for vitamin E.

Claims that vitamin E is effective for treatment of cancer and for prevention or treatment of acne, aging, loss of hair, bee stings, liver spots on the hands, bursitis, diaper rash, frostbite, stomach ulcer, heart attacks, labor pains, certain blood diseases, miscarriage, muscular dystrophy, poor posture, sexual impotence, sterility, infertility, menopause, sunburn, and lung damage from air pollution have not been proven. Although vitamin E is being used to prevent certain types of cancer, there is not enough information to show that this is effective.

Lack of vitamin E is extremely rare, except in people who have a disease in which it is not absorbed into the body.

Vitamin E is available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin E is found in various foods including vegetable oils (corn, cottonseed, soybean, safflower), wheat germ, whole-grain cereals, and green leafy vegetables. Cooking and storage may destroy some of the vitamin E in foods.

Vitamin supplements alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, small amounts of fat are needed so that vitamin E can be absorbed into the body.

The daily amount of vitamin E needed is defined in several different ways.

• For U.S.—


• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).


• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

• For Canada—


• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Vitamin E is available in various forms, including d- or dl-alpha tocopheryl acetate, d- or dl-alpha tocopherol, and d- or dl-alpha tocopheryl acid succinate. In the past, the RDA for vitamin E have been expressed in Units. This term has been replaced by alpha tocopherol equivalents (alpha-TE) or milligrams (mg) of d-alpha tocopherol. One Unit is equivalent to 1 mg of dl-alpha tocopherol acetate or 0.6 mg d-alpha tocopherol. Most products available in stores continue to be labeled in Units.

Normal daily recommended intakes in milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) and Units for vitamin E are generally defined as follows:

Persons	U.S.		Canada
	mg alpha-TE	Units	mg alpha-TE	Units
Infants and children Birth to 3 years of age	3–6	5–10	3–4	5–6.7
4 to 6 years of age	7	11.7	5	8.3
7 to 10 years of age	7	11.7	6–8	10–13
Adolescent and adult males	10	16.7	6–10	10–16.7
Adolescent and adult females	8	13	5–7	8.3–11.7
Pregnant females	10	16.7	8–9	13–15
Breast-feeding females	11–12	18–20	9–10	15–16.7

Before Using Natural Vitamin Blend E-400IU

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

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

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts. You should check with your health care professional if you are giving your baby an unfortified formula. In that case, the baby must get the vitamins needed some other way. Some studies have shown that premature infants may have low levels of vitamin E. Your health care professional may recommend a vitamin E supplement.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	A	Adequate studies in pregnant women have not shown an increased risk of fetal abnormalities.

Breast Feeding

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

Interactions with Medicines

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

Using this dietary supplement 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.

• Dicumarol

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

• Warfarin

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.

Other Medical Problems

The presence of other medical problems may affect the use of this dietary supplement. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems—Vitamin E, when taken in doses greater than 800 Units a day for long periods of time, may make this condition worse

Proper Use of vitamin e

This section provides information on the proper use of a number of products that contain vitamin e. It may not be specific to Natural Vitamin Blend E-400IU. Please read with care.

Dosing

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

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

• For oral solution dosage form:
  
  • To prevent the following deficiencies in infants:
    
    • Infants receiving a formula high in polyunsaturated fatty acids—15 to 25 Units per day or 7 Units per 32 ounces of formula.
    
    
    • Infants with certain colon problems—15 to 25 Units per kilogram (kg) (6.8 to 11 Units per pound) of body weight per day. The water-soluble form of vitamin E must be used.
    
    
    • Infants of normal birthweight—5 Units per 32 ounces of formula.
    
    
  
  


• For oral dosage forms (capsules, tablets, oral solution):
  
  • To prevent deficiency for individuals (other than infants), the amount taken by mouth is based on normal daily recommended intakes:
    
    • For the U.S.
    
    
    • Adult and teenage males—10 milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) or 16.7 Units per day.
    
    
    • Adult and teenage females—8 mg alpha-TE or 13 Units per day.
    
    
    • Pregnant females—10 mg alpha-TE or 16.7 Units per day.
    
    
    • Breast-feeding females—11 to 12 mg alpha-TE or 18 to 20 Units per day.
    
    
    • Children 4 to 10 years of age—7 mg alpha-TE or 11.7 Units per day.
    
    
    • Children birth to 3 years of age—3 to 6 mg alpha-TE or 5 to 10 Units per day.
    
    
    • For Canada
    
    
    • Adult and teenage males—6 to 10 mg alpha-TE or 10 to 16.7 Units per day.
    
    
    • Adult and teenage females—5 to 7 mg alpha-TE or 8.3 to 11.7 Units per day.
    
    
    • Pregnant females—8 to 9 mg alpha-TE or 13 to 15 Units per day.
    
    
    • Breast-feeding females—9 to 10 mg alpha-TE or 15 to 16.7 Units per day.
    
    
    • Children 7 to 10 years of age—6 to 8 mg alpha-TE or 10 to 13 Units per day.
    
    
    • Children 4 to 6 years of age—5 mg alpha-TE or 8.3 Units per day.
    
    
    • Children birth to 3 years of age—3 to 4 mg alpha-TE or 5 to 6.7 Units per day.
    
    
  
  
  • To treat deficiency:
    
    • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.
    
    
  
  

For individuals taking the oral liquid form of this dietary supplement:

• This preparation should be taken by mouth even though it comes in a dropper bottle.


• This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the dietary supplement 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.

Natural Vitamin Blend E-400IU 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:

With doses greater than 400 Units a day and long-term use

• Blurred vision


• diarrhea


• dizziness


• headache


• nausea or stomach cramps


• unusual tiredness or weakness

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.

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

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

More Natural Vitamin Blend E-400IU resources

• Natural Vitamin Blend E-400IU Use in Pregnancy & Breastfeeding
• Natural Vitamin Blend E-400IU Drug Interactions
• Natural Vitamin Blend E-400IU Support Group
• 2 Reviews for Natural Vitamin Blend E-400IU - Add your own review/rating

Compare Natural Vitamin Blend E-400IU with other medications

• Alzheimer's Disease
• Anemia, Sickle Cell
• Cystic Fibrosis
• Dietary Supplementation
• Nocturnal Leg Cramps
• Retinopathy Prophylaxis
• Tardive Dyskinesia
• Vitamin E Deficiency

Thelin

THELIN may be available in the countries listed below.

UK matches:

• Thelin (Sitaxentan) 100mg film-coated tablets (SPC)
• Thelin 100mg film-coated tablets (SPC)

Ingredient matches for THELIN

Sitaxentan

Sitaxentan is reported as an ingredient of THELIN in the following countries:

• Spain

Sitaxentan sodium (a derivative of Sitaxentan) is reported as an ingredient of THELIN in the following countries:

• Australia


• Austria


• Belgium


• Denmark


• France


• Germany


• Ireland


• Luxembourg


• Netherlands


• Sweden


• United Kingdom

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

adapalene and benzoyl peroxide Topical application

a-DAP-a-leen, BEN-zoe-il per-OX-ide

Commonly used brand name(s)

In the U.S.

• Epiduo

Available Dosage Forms:

• Gel/Jelly

Therapeutic Class: Antiacne

Chemical Class: Retinoid

Uses For adapalene and benzoyl peroxide

Adapalene and benzoyl peroxide combination is used to treat acne. It works by killing the bacteria that cause acne and by keeping the skin pores clean (tiny openings on the skin).

adapalene and benzoyl peroxide is available only with your doctor's prescription.

Before Using adapalene and benzoyl peroxide

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 adapalene and benzoyl peroxide, the following should be considered:

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of adapalene and benzoyl peroxide combination in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of adapalene and benzoyl peroxide combination in the elderly.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Other Medical Problems

The presence of other medical problems may affect the use of adapalene and benzoyl peroxide. Make sure you tell your doctor if you have any other medical problems, especially:

• Eczema (skin disorder) or


• Sunburn—Should not be used in patients with these conditions.

Proper Use of adapalene and benzoyl peroxide

It is very important that you use adapalene and benzoyl peroxide only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause your skin to become irritated. You may need to use adapalene and benzoyl peroxide for several weeks or months before your skin starts to look better. Applying extra medicine will not make it work faster.

adapalene and benzoyl peroxide comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

adapalene and benzoyl peroxide is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.

To use:

• Wash your hands with soap and water before and after using adapalene and benzoyl peroxide.


• Before applying adapalene and benzoyl peroxide, wash the affected area of your skin with water and a mild soap. Rinse well and pat dry.


• Apply a small amount of the medicine to each affected area of the skin (e.g., forehead, chin, cheeks, chest, shoulders), and gently rub it in.

Dosing

The dose of adapalene and benzoyl peroxide 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 adapalene and benzoyl peroxide. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For topical dosage form (gel):
  
  • For acne:
    
    • Adults, teenagers, and children 12 years of age and older—Apply a thin layer to the affected area(s) of the skin once a day.
    
    
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of adapalene and benzoyl peroxide, 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 the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using adapalene and benzoyl peroxide

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

adapalene and benzoyl peroxide may make your skin more sensitive to sunlight, wind, and cold weather. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. You may need to wear protective clothing, such as a hat.

Skin reactions such as dryness, redness, scaling, burning, or stinging can occur when you use adapalene and benzoyl peroxide. Use a moisturizer as needed to lessen these skin problems.

Do not use any other medicines on the treated skin areas without asking your doctor. Avoid using any skin care products that can dry or irritate your skin. These include rough skin cleansers, hair removal products, soaps or cosmetics that cause dryness, or products that contain alcohol, astringents, spices, or lime.

Do not use "waxing" as a hair removal method on skin areas treated with adapalene and benzoyl peroxide.

Allow adapalene and benzoyl peroxide to dry completely before getting dressed. adapalene and benzoyl peroxide may cause bleaching of clothes or hair.

adapalene and benzoyl peroxide Side Effects

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

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

More common

• Dryness and peeling of the skin


• flushing or redness of the skin


• unusually warm skin

Less common

• Blistering, burning, crusting, or flaking of the skin


• burning, itching, redness, skin rash, swelling, or soreness at the application site


• scaling, severe redness, or swelling of the skin

Incidence not known

• Pain of the skin


• sunburn

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:

Incidence not known

• Burning, dry, or itching eyes


• change in the color of the treated skin


• discharge or excessive tearing


• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid


• skin rash, encrusted, scaly, and oozing


• swelling of the face

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.

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

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

More adapalene and benzoyl peroxide Topical application resources

• Adapalene and benzoyl peroxide Topical application Use in Pregnancy & Breastfeeding
• Adapalene and benzoyl peroxide Topical application Drug Interactions
• Adapalene and benzoyl peroxide Topical application Support Group
• 29 Reviews for Adapalene and benzoyl peroxide Topical application - Add your own review/rating

Compare adapalene and benzoyl peroxide Topical application with other medications

• Acne

Phillips’ Milk of Magnesia

1. Name Of The Medicinal Product

Phillips' Milk of Magnesia

2. Qualitative And Quantitative Composition

Magnesium Hydroxide BP 415 mg per 5 ml suspension.

3. Pharmaceutical Form

Oral Suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

Milk of Magnesia is indicated as an antacid for the symptomatic relief of stomach discomfort, indigestion, hyperacidity, heartburn and flatulence; and as a laxative for constipation.

4.2 Posology And Method Of Administration

Use a 5 ml spoon or the dosing cup provided.

Doses may be taken with milk or water if desired.

Do not exceed the stated dose.

As an antacid:
Adults:	5-10 ml (one or two 5 ml spoonfuls or fill the dosing cup to the first or second line). Repeat as necessary to a maximum of 60 ml in 24 hours.
Children aged 3-12 years:	5 ml (one spoonful or first line in dosing cup). Repeat as necessary to a maximum of 30 ml in 24 hours.
As a laxative:
Adults:	30-45 ml at bedtime. Repeat nightly, reducing dose each night until constipation is relieved.
Children aged over 3 years:	5-10 ml at bedtime.
Children aged under 3 years:	to be given only on the advice of a doctor.
Elderly:	As adult dose.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Adequate fluid intake should be maintained during use. If diarrhoea occurs especially in children or the elderly, discontinue use immediately. In case of renal impairment a doctor should be consulted as hypermagnesaemia may occur. If symptoms persist or worsen, a doctor or pharmacist should be consulted.

Do not use as a laxative for more than three consecutive days, or as an antacid for more than fourteen consecutive days.

If a laxative dose is needed every day or if there is a persistent abdominal pain further medical advice should be sought.

Users taking medicines either physician prescribed or self-prescribed should consult a doctor or pharmacist before use.

Keep out of the reach and sight of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Magnesium hydroxide may interfere locally with the absorption of other drugs taken orally by increasing gastric pH. This can be avoided by giving other drugs 2-3 hours before the administration of magnesium hydroxide on the advice of a doctor.

Milk of Magnesia may interact with tetracycline, digoxin, dicoumerol and cimetidine. Magnesium hydroxide may increase the absorption of ibuprofen and decrease the absorption of penicallamine, bisphosphates, ketoconazole and tetracycline.

The excretion of salicylates will be increased by changes in urinary pH.

Co-administration of sodium polystyrene sulphonate results in a relative excess of bicarbonate ions, which are absorbed, and may lead to metabolic alkylosis.

4.6 Pregnancy And Lactation

For Magnesium hydroxide no clinical data on exposed pregnancies are available.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.

Magnesium crosses the placenta and is excreted in small amounts in breast milk. Use during pregnancy and lactation should be avoided unless on the advice of a doctor.

4.7 Effects On Ability To Drive And Use Machines

Magnesium hydroxide is unlikely to cause any effects on the ability to drive and use machines.

4.8 Undesirable Effects

Diarrhoea may occur which is dose related.

In patients with impaired renal function there may be sufficient accumulation of magnesium to produce toxic effects (see section 4.9).

4.9 Overdose

Symptoms and Signs

Symptoms of overdose include gastrointestinal irritation and watery diarrhoea. Magnesium poisoning may produce hypermagnesaemia, symptoms of which include nausea, vomiting, flushing, thirst, hypotension, drowsiness, confusion, loss of tendon reflexes, muscle weakness, respiratory depression, cardiac arrhythmias, coma and cardiac arrest.

Treatment

Treatment consists of the intravenous administration of calcium gluconate injection 10% in a dose of 10-20ml to counteract respiratory depression or heart block. If renal function is normal, adequate fluids should be given to assist removal of magnesium from the body. Dialysis may be necessary in patients with renal impairment or severe hypermagnesaemia.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Magnesium hydroxide is practically insoluble in water and solution is not effected until the hydroxide reacts with hydrochloric acid in the stomach to form magnesium chloride. Its neutralising action is almost equal to that of sodium bicarbonate. When the dose is in excess of that required to neutralise the acid the intragastric pH may reach pH 8 or 9. Acid rebound following magnesium hydroxide is clinically insignificant.

Magnesium hydroxide has an indirect cathartic effect resulting from water retention in the intestinal lumen.

5.2 Pharmacokinetic Properties

Magnesium hydroxide exerts its antacid therapeutic effect rapidly within the gastro-intestinal tract following oral administration and this action is therefore independent of pharmacokinetic properties. Following oral administration, about one third to half the magnesium is absorbed very slowly from the small intestine. Magnesium salts are excreted mainly in the urine with small amounts in the faeces and saliva.

5.3 Preclinical Safety Data

Magnesium hydroxide has been used for many years and no further data are presented in this section.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium Hydrogen Carbonate EP, Oil of Peppermint EP, Glycerol EP, Sodium Saccharin EP, Purified Water EP.

6.2 Incompatibilities

None.

6.3 Shelf Life

36 months; after opening, 6 months.

6.4 Special Precautions For Storage

Store below 25°C. Do not freeze.

6.5 Nature And Contents Of Container

Blue HDPE bottles with blue LDPE screw turn tamper evident inner cap and external click on dosing cap. Pack size 100ml and 200ml.

6.6 Special Precautions For Disposal And Other Handling

Shake bottle well before use. Use within 6 months of opening.

ADMINISTRATIVE DATA

7. Marketing Authorisation Holder

SmithKline Beecham (SWG) Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as

GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00071/0309

9. Date Of First Authorisation/Renewal Of The Authorisation

22^nd March 1999

10. Date Of Revision Of The Text

22/12/2009

FluLaval

Pronunciation: IN-floo-EN-za
Generic Name: Influenza Virus Vaccine
Brand Name: Examples include Afluria and Fluzone

FluLaval is used for:

Protecting against certain strains of influenza (flu).

FluLaval is a vaccine. It works by stimulating the body to produce antibodies against certain types of the flu virus, which helps your body to fight the infection.

Do NOT use FluLaval if:

• you are allergic to any ingredient in FluLaval, including egg proteins, or to egg products


• you have had a severe allergic reaction (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) to a prior flu vaccination

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

Before using FluLaval:

Some medical conditions may interact with FluLaval. 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 are allergic to neomycin, polymyxin, rubber, latex, or thimerosal (a preservative)


• if you have a fever, cold, respiratory tract infection, or other infection or recent illness


• if you have asthma or other breathing problems, a nervous system disorder, or blood or bleeding problems (eg, hemophilia, low blood platelet levels)


• if you have cancer or immune system problems (eg, HIV, weakened immune system)


• if you are receiving radiation treatment or chemotherapy


• if you have a history of Guillain-Barré syndrome

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

• Anticoagulants (eg, warfarin) because the risk of bleeding at the injection site may be increased


• Digoxin because its effects may be increased or decreased by certain brands of FluLaval


• Corticosteroids (eg, prednisone) or other medicines that may weaken the immune system because they may decrease FluLaval's effectiveness. Ask your doctor if you are unsure if any of your medicines may weaken the immune system


• Phenytoin or theophylline because the risk of their side effects may be increased by FluLaval

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

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

• FluLaval is usually given once a year in September, October, or November.


• FluLaval is given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.


• Certain influenza vaccines are approved for use in children. Some children may need to receive more than 1 dose of the vaccine. Discuss your child's flu vaccine history with your doctor. Be sure to follow the vaccination schedule provided by your doctor.


• Do not use FluLaval if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• If you miss a dose of FluLaval, contact your doctor right away.

Ask your health care provider any questions you may have about how to use FluLaval.

Important safety information:

• If you have a fever, cold, respiratory tract infection, or other illness, contact your doctor before you receive FluLaval. You may need to receive your injection at a later time.


• FluLaval is not a cure for the flu. It must be given before you are exposed to the flu in order to be effective.


• FluLaval contains killed viruses. It cannot cause you to develop the flu.


• FluLaval is only effective for 1 flu season. You will need to receive the flu vaccine each year.


• FluLaval is not effective against all strains of the flu virus. It may also not protect everyone who receives it.


• FluLaval does not protect against other respiratory viruses.


• Tell your doctor if you will be receiving any other vaccines.


• Some of these products contain thimerosal (a preservative). If you have ever had an allergic reaction to thimerosal, ask your pharmacist if your product has thimerosal in it.


• The tip cap of some of these products may contain natural rubber latex. If you have ever had an allergic reaction to latex, ask your pharmacist if your product has latex in it.


• Tell your doctor or dentist that you have used FluLaval before you receive any medical or dental care, emergency care, or surgery.


• Use FluLaval with caution in the ELDERLY; its effectiveness may be decreased in elderly patients.


• Fever or seizures accompanied with fever have occurred in CHILDREN using certain brands of FluLaval, especially in children who are younger than 5 years old. Contact your doctor if you have questions about this information.


• Caution is advised when using FluLaval in CHILDREN; they may be more sensitive to its effects, especially fever, muscle pain, and general body discomfort.


• FluLaval should be used with extreme caution in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.


• Some brands of FluLaval are not approved for use in CHILDREN younger than 18 years old. If the patient is a child, check with your doctor to determine whether this brand is approved for children.


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

Possible side effects of FluLaval:

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:

Back pain; chills or shivering; cough; diarrhea; general body discomfort; headache; irritability; mild bruising, pain, redness, swelling, or tenderness at the injection site; mild fever; muscle aches; sore throat; stuffy nose.

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; unusual hoarseness); decreased movement of the face muscles; decreased movement or sensation in the arm or shoulder; loss of appetite; muscle weakness; numbness or tingling of the hands or feet; seizures; severe or persistent headache or fever; vision changes; vomiting.

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: FluLaval 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 FluLaval:

FluLaval is usually handled and stored by a health care provider. If you are using FluLaval at home, store FluLaval as directed by your pharmacist or health care provider. Keep this product, as well as syringes and needles, out of the reach of children and away from pets.

General information:

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


• FluLaval 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 FluLaval. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More FluLaval resources

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

Compare FluLaval with other medications

• Influenza Prophylaxis

Triaminic Pediatric

Generic Name: pheniramine/pyrilamine/phenylpropanolamine (fen IR a meen/pie RILL a meen/fen ill proe pa NOLE a meen)

Brand Names: Liqui-Minic Infant, Triactin, Triaminic Infant, Triaminic Pediatric

What is Triaminic Pediatric (pheniramine/pyrilamine/phenylpropanolamine)?

Pheniramine and pyrilamine are antihistamines. They block the effects of the naturally occurring chemical histamine in the body. Pheniramine and pyrilamine prevent sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal and respiratory (breathing) passages to open up.

Pheniramine/pyrilamine/phenylpropanolamine is used to treat nasal congestion and sinusitis (inflammation of the sinuses) associated with allergies, hay fever, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Pheniramine/pyrilamine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Triaminic Pediatric (pheniramine/pyrilamine/phenylpropanolamine)?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Pheniramine/pyrilamine/phenylpropanolamine may cause dizziness or drowsiness. Avoid climbing and other hazardous activities while taking this medication. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking pheniramine/pyrilamine/phenylpropanolamine.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.

Who should not take Triaminic Pediatric (pheniramine/pyrilamine/phenylpropanolamine)?

Do not take pheniramine/pyrilamine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• kidney disease,


• liver disease,


• 
  

  diabetes,

  
  


• 
  

  glaucoma,

  
  


• 
  

  any type of heart disease or high blood pressure,

  
  


• 
  

  thyroid disease,

  
  


• 
  

  emphysema or chronic bronchitis, or

  
  


• 
  

  difficulty urinating or have an enlarged prostate.

  
  

You may not be able to take pheniramine/pyrilamine/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Pheniramine/pyrilamine/phenylpropanolamine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from pheniramine/pyrilamine/phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Triaminic Pediatric (pheniramine/pyrilamine/phenylpropanolamine)?

Take pheniramine/pyrilamine/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Do not crush, chew, or break the long-acting or sustained-release forms of this medication. Swallow them whole. If you are unsure of the formulation of the medicine, ask your pharmacist for help. If you cannot swallow the tablets or capsules, look for a liquid form of the medication.

To ensure that you get a correct dose, measure the liquid forms of pheniramine/pyrilamine/phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm.

Do not take pheniramine/pyrilamine/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.

Store pheniramine/pyrilamine/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a pheniramine/pyrilamine/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, and vomiting.

What should I avoid while taking pheniramine/pyrilamine/ phenylpropanolamine?

Pheniramine/pyrilamine/phenylpropanolamine may cause dizziness or drowsiness. Avoid climbing and other hazardous activities while taking this medication. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking pheniramine/pyrilamine/phenylpropanolamine.

Pheniramine/pyrilamine/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if pheniramine/pyrilamine/phenylpropanolamine is taken with any of these medications.

Pheniramine/ pyrilamine/phenylpropanolamine side effects

Serious side effects are unlikely to occur. Stop taking pheniramine/pyrilamine/ phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take pheniramine/pyrilamine/phenylpropanolamine and talk to your doctor or try another similar medication if you experience

• 
  

  dryness of the eyes, nose, and mouth;

  
  


• 
  

  drowsiness or dizziness;

  
  


• 
  

  blurred vision;

  
  


• 
  

  difficulty urinating; or

  
  


• 
  

  excitation in children.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect pheniramine/ pyrilamine/phenylpropanolamine?

Do not take pheniramine/pyrilamine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking pheniramine/pyrilamine/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain pheniramine, pyrilamine phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Pheniramine/pyrilamine/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if pheniramine/pyrilamine/phenylpropanolamine is taken with any of these medications.

Drugs other than those listed here may also interact with pheniramine/pyrilamine/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

More Triaminic Pediatric resources

• Triaminic Pediatric Drug Interactions
• Triaminic Pediatric Support Group
• 0 Reviews for Triaminic Pediatric - Add your own review/rating

• Triactin MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Triaminic Pediatric with other medications

• Allergies
• Eye Redness/Itching
• Hay Fever
• Nasal Congestion
• Pruritus
• Sinusitis
• Upper Respiratory Tract Infection

Where can I get more information?

• Your pharmacist has additional information about pheniramine/pyrilamine/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Pheniramine/pyrilamine/phenylpropanolamine is available over the counter under the brand name Triaminic Oral Infant Drops. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.