Terbinafine
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Terbinafine tablets, USP are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.History
There is currently no drug history available for this drug.
Other Information
Terbinafine tablets contain the synthetic allylamine antifungal compound terbinafine hydrochloride.
Chemically, terbinafine hydrochloride, USP is (E)- N-(6,6-dimethyl-2-hepten-4-ynyl)- N-methyl-1-naphthalenemethanamine hydrochloride. The empirical formula C 21H 26CIN with a molecular weight of 327.90, and the following structural formula:
Terbinafine hydrochloride, USP is a white to off-white fine crystalline powder. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water.
Each tablet contains:
Active Ingredients: terbinafine hydrochloride (equivalent to 250 mg of terbinafine)
Inactive Ingredients: colloidal silicon dioxide NF, hypromellose USP, magnesium stearate NF, microcrystalline cellulose NF, and sodium starch glycolate NF.
Sources
Terbinafine Manufacturers
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Exelan Pharmaceuticals Inc.
![Terbinafine Tablet [Exelan Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Terbinafine | Exelan Pharmaceuticals Inc.
Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.
Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.
The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.
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Aurobindo Pharma Limited
Terbinafine | Aurobindo Pharma Limited
Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.
Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.
The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail. -
Harris Pharmaceutical, Inc.
Terbinafine | Harris Pharmaceutical, Inc.
Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.
Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.
The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.
![Terbinafine (Terbinafine Hydrochloride) Tablet [Aurobindo Pharma Limited]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6600e2b3-65df-4fc3-8081-d574537d27e3&name=terbinafine-fig1.jpg)
![Terbinafine Tablet [Harris Pharmaceutical, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9912d2e8-e71e-4986-bb7c-3f2387be8e29&name=terbinafine-tablets-usp-2.jpg)
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