naftifine (Rx)

Brand and Other Names:Naftin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical cream

  • 1%
  • 2%

topical gel

  • 1%
  • 2%

Dermatophytoses

1% cream or gel: Apply BID to the affected areas plus a 0.5-inch margin of healthy surrounding skin for 4 weeks

2% cream or gel: Apply qDay to the affected areas plus a 0.5-inch margin of healthy surrounding skin for 2 weeks

Indications

  • 1% cream: Indicated for treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum
  • 1% gel: Indicated for treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton Tonsurans, and Epidermophyton floccosum
  • 2% cream or gel: Indicated for treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum

Dosage Forms & Strengths

topical cream

  • 2%

topical gel

  • 2%

Tinea Pedis

2% cream or gel: Indicated for treatment of interdigital tinea pedis caused by the organism Trichophyton rubrum

<12 years: Safety and efficacy not established

12-17 years

  • Use 2% cream or gel
  • Apply cream or gel qDay to the affected areas plus a 0.5-inch margin of healthy surrounding skin for 2 weeks

Tinea Cruris

Indicated for treatment of tinea cruris caused by the organism Trichophyton rubrum

<12 years: Safety and efficacy not established

12-17 years

  • Use 2% cream
  • Apply cream qDay to the affected areas plus a 0.5-inch margin of healthy surrounding skin for 2 weeks

Tinea Corporis

Indicated for treatment of tinea corporis caused by the organism Trichophyton rubrum

<2 years: Safety and efficacy not established

&ge2 years

  • Use 1% topical cream
  • Apply cream qDay to the affected areas plus a 0.5-inch margin of healthy surrounding skin for 2 weeks
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Adverse Effects

1-10%

Transient burning/stinging (5-6%)

Skin tenderness (0.5-3%)

Dryness

Erythema

Pruritus

Local irritation

Rash

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Warnings

Contraindications

Hypersensitivity

Cautions

Avoid use of occlusive dressings or wrappings

Keep the cream away from eyes, nose, mouth, & other mucous membranes

Reevaluate dx if no improvement after 4 wk

Discontinue treatment if irritation or sensitivity develops with use; direct patients to contact their physician if these conditions develop

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Pregnancy & Lactation

Pregnancy: There are no available data in pregnant women to inform the drug-associated risk for major birth defects and miscarriage; in animal reproduction studies, no adverse effects on embryofetal development were seen at oral doses administered during period of organogenesis up to 18 times maximum recommended human dose (MRHD) in pregnant rats or subcutaneous doses administered during period of organogenesis up to 2 times the MRHD in pregnant rats or 4 times the MRHD in pregnant rabbits

Lactation: There is no information available on presence of drug in human milk, effects of drug on breastfed infant, or effects of drug on milk production; lack of clinical data during lactation precludes clear determination of risk of drug to infant during lactation; consider development and health benefits of breastfeeding along with mother’s clinical need for drug and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Interferes with sterol biosynthesis by inhibiting squalene monooxygenase (squalene 2,3-epoxidase)

Absorption

3-6%

Metabolism

Liver

Elimination

Excretion: 40-60% urine; 40-60% feces

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
naftifine topical
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1 % cream
naftifine topical
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1 % cream
naftifine topical
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2 % cream
naftifine topical
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2 % cream
naftifine topical
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2 % cream
naftifine topical
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1 % cream
naftifine topical
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2 % cream
naftifine topical
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2 % cream
naftifine topical
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1 % gel
naftifine topical
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1 % gel
naftifine topical
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1 % gel
naftifine topical
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2 % cream
Naftin topical
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2 % cream

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
naftifine topical

NAFTIFINE 2% GEL - TOPICAL

(NAF-ti-feen)

COMMON BRAND NAME(S): Naftin

USES: This medication is used to treat athlete's foot, a type of fungal skin infection. It helps to get rid of the redness, itching, and scaling. 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. Apply this medication as directed by your doctor, usually once daily for 2 weeks. Wash your hands after use. 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 get the medication in any of these areas, flush with plenty of water.Do not apply more often or use for 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 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 persists or worsens.

SIDE EFFECTS: Mild irritation at the application site may occur. If this persists or worsens, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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, get medical help right away 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 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using naftifine, tell your doctor or pharmacist if you are allergic to it; or to other antifungals (such as 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.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Avoid applying near the breast area if breast-feeding. Consult your doctor before breast-feeding.

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 medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can 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 your doctor tells you to.

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. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature. Keep all medications 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 August 2021. Copyright(c) 2021 First Databank, Inc.

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.

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.