Terbinafine

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

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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:
structure

 

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.

Terbinafine Manufacturers


  • Exelan Pharmaceuticals Inc.
    Terbinafine Tablet [Exelan Pharmaceuticals Inc.]
  • Aurobindo Pharma Limited
    Terbinafine (Terbinafine Hydrochloride) Tablet [Aurobindo Pharma Limited]
  • Harris Pharmaceutical, Inc.
    Terbinafine Tablet [Harris Pharmaceutical, Inc.]

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