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

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