Naftifine (Naftin Gel)
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Naftifine (Naftin Gel)

NAFTIN®
(naftifine HCL 1%) Gel

DRUG DESCRIPTION

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

Structural Formula

NAFTIN® (naftifine HCL) Structural Formula Illustration

naftifine hydrochloride

Chemical Name:

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

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

Contains:

Active Ingredient: Naftifine...........1%.

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

What are the possible side effects of naftifine topical (Naftin)?

Serious side effects of naftifine topical use are not expected. Stop using naftifine topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

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. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Naftin Gel »

What are the precautions when taking naftifine (Naftin Gel)?

Before using naftifine, tell your doctor or pharmacist if you are allergic to it; or to other allylamine antifungals (e.g., terbinafine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Naftin Gel »

Last reviewed on RxList: 6/11/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Naftin® (naftifine) 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 tonsurans* and Epidermophyton floccosum.*

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

DOSAGE AND ADMINISTRATION

A sufficient quantity of Naftin® (naftifine) 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® (naftifine) Gel, 1%, the patient should be re-evaluated.

HOW SUPPLIED

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

20g - NDC 0259-4770-20
40g - NDC 0259-4770-40
60g - NDC 0259-4770-60

Note: Store at room temperature.

Manufactured for: Merz Pharmaceuticals, Greensboro, NC 27410. Rev 4/04. FDA rev date: 9/26/2007

Last reviewed on RxList: 6/11/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

During clinical trials with Naftin® (naftifine) 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%).

Read the Naftin Gel (naftifine) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 6/11/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

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

PRECAUTIONS

General: Naftin® (naftifine) Gel, 1% is for external use only. If irritation or sensitivity develops with the use of Naftin® (naftifine) 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.

Carcinogenesis, mutagenesis, impairment of fertility: Long-term studies to evaluate the carcinogenic potential of Naftin® (naftifine) 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® (naftifine) Gel, 1% is administered to a nursing woman.

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

Last reviewed on RxList: 6/11/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

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

Last reviewed on RxList: 6/11/2008
This monograph has been modified to include the generic and brand name in many instances.

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® (naftifine) Gel, 1% has only been shown to be clinically effective against the disease entities listed in the INDICATIONS 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.

Last reviewed on RxList: 6/11/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

The patient should be told to:

  1. Avoid the use of occlusive dressings or wrappings unless otherwise directed by the physician.
  2. Keep Naftin® (naftifine) Gel, 1% away from the eyes, nose, mouth and other mucous membranes.

Last reviewed on RxList: 6/11/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

The patient should be told to:

  1. Avoid the use of occlusive dressings or wrappings unless otherwise directed by the physician.
  2. Keep Naftin® (naftifine) Gel, 1% away from the eyes, nose, mouth and other mucous membranes.

Last reviewed on RxList: 6/11/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Naftin Gel Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

NAFTIFINE - TOPICAL

(NAFF-teh-feen)

COMMON BRAND NAME(S): Naftin

USES: This medication is used to treat a variety of fungal skin infections such as ringworm, athlete's foot, and jock itch. Naftifine is an antifungal that works by preventing the growth of fungus.

HOW TO USE: Use this medication on the skin only. Clean and thoroughly dry the area to be treated. Apply a thin layer of the medication to and around the affected area and gently rub in. This medication is usually applied once daily if you are using the cream, or twice daily (morning and evening) if you are using the gel, or as directed by your doctor. Wash your hands after using unless the area to be treated includes the hands. Do not wrap, cover, or bandage the area unless directed to do so by your doctor.

Do not use the medication in the eyes, nose, mouth, or inside the vagina. If you do get the medication in those areas, flush with plenty of water.

Length of treatment is based on your medical condition and response to therapy.

Do not apply more often or use longer than prescribed. This may increase the risk of side effects.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.

Continue to use this medication until the full prescribed treatment period is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition worsens or does not improve.

Disclaimer

Naftin Gel Consumer (continued)

SIDE EFFECTS: Burning, stinging, irritation, redness, dry skin, or itching at application site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Naftin Gel (naftifine) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using naftifine, tell your doctor or pharmacist if you are allergic to it; or to other allylamine antifungals (e.g., terbinafine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Naftin Gel Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: This medication may be harmful if swallowed. If overdose or swallowing is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and heat. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised February 2012. Copyright(c) 2012 First Databank, Inc.

Naftin Gel Patient Information Including Side Effects

Brand Names: Naftin

Generic Name: naftifine topical (Pronunciation: NAF ti feen)

What is naftifine topical (Naftin Gel)?

Naftifine topical is an antifungal medication. Naftifine topical prevents fungus from growing on your skin.

Naftifine topical is used to treat skin infections such as athlete's foot, jock itch, and ringworm infections.

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

What are the possible side effects of naftifine topical (Naftin Gel)?

Serious side effects of naftifine topical use are not expected. Stop using naftifine topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

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. You may report side effects to FDA at 1-800-FDA-1088.

Read the Naftin Gel (naftifine) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about naftifine topical (Naftin Gel)?

Use this medication for the full amount of time prescribed by your doctor even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth.

Side Effects Centers

Naftin Gel Patient Information including How Should I Take

Who should not use naftifine topical (Naftin Gel)?

Do not use naftifine topical if you have had an allergic reaction to it in the past.

It is not known whether naftifine topical will harm an unborn baby. Do not use naftifine topical without first talking to your doctor if you are pregnant.

It is not known whether naftifine passes into breast milk. Do not use naftifine topical without first talking to your doctor if you are breast-feeding a baby.

How should I use naftifine topical (Naftin Gel)?

Use naftifine topical exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the cream once daily, or the gel twice daily, as directed for the specified length of time.

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

If the infection does not clear up in 4 weeks, or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in your eyes, nose, or mouth.

Store naftifine topical at room temperature away from moisture and heat.

Side Effects Centers

Naftin Gel Patient Information including If I Miss a Dose

What happens if I miss a dose (Naftin Gel)?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of naftifine topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose (Naftin Gel)?

An overdose of naftifine topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used, or that naftifine topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using naftifine topical (Naftin Gel)?

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

What other drugs will affect naftifine topical (Naftin Gel)?

Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of naftifine topical.

Where can I get more information?

Your pharmacist has additional information about naftifine topical written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.06. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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