Terbinafine Hydrochloride 250 mg/1
Terbinafine Hydrochloride · TABLET · Aphena Pharma Solutions - Tennessee, LLC
Terbinafine Hydrochloride is a tablet containing terbinafine hydrochloride at 250 mg/1, taken oral. Manufactured by Aphena Pharma Solutions - Tennessee, LLC.
Key Facts
- Brand Name
- Terbinafine Hydrochloride
- Generic Name
- Terbinafine Hydrochloride
- NDC Code (Product)
43353-893- Manufacturer
- Aphena Pharma Solutions - Tennessee, LLC
- Strength
- 250 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA077714
- Marketing Start
- 08/22/2012
Recall History
Novartis Consumer Health
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Novartis Consumer Health
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Novartis Consumer Health
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Novartis Consumer Health
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Novartis Consumer Health
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot..
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1. INDICATIONS AND USAGE Terbinafine tablets 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 [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). ( 1 )
Dosage & Administration
2. DOSAGE AND ADMINISTRATION Prior to administering, evaluate patients for evidence of chronic or active liver disease. ( 2.1 ) Fingernail onychomycosis: One tablet, once daily for 6 weeks. ( 2.2 ) Toenail onychomycosis: One tablet, once daily for 12 weeks. ( 2.2 ) 2.1 Assessment Prior to Initiation Before administering Terbinafine tablets, evaluate patients for evidence of chronic or active liver disease [see Contraindications (4) and Warnings and Precautions (5.1) ] . 2.2 Dosage 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.
Contraindications
4. CONTRAINDICATIONS Terbinafine tablets are contraindicated in patients with: Chronic or active liver disease [see Warnings and Precautions (5.1) ] History of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see Adverse Reactions (6.2) ] Chronic or active liver disease. ( 4 ) History of allergic reaction to oral terbinafine because of the risk of anaphylaxis. ( 4 )
Drug Interactions
7. DRUG INTERACTIONS Terbinafine is an inhibitor of CYP450 2D6 isozyme and has an effect on metabolism of desipramine. Drug interactions have also been noted with cimetidine, fluconazole, cyclosporine, rifampin, and caffeine. ( 7.1 ) 7.1 Drug-Drug Interactions In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Coadministration of Terbinafine tablets should be done with careful monitoring and may require a reduction in dose of the 2D6-metabolized drug. In a study to assess the effects of terbinafine on desipramine in healthy volunteers characterized as normal metabolizers, the administration of terbinafine resulted in a 2-fold increase in C max and a 5-fold increase in area under the curve (AUC). In this study, these effects were shown to persist at the last observation at 4 weeks after discontinuation of Terbinafine tablets. In studies in healthy subjects characterized as e…
Adverse Reactions
6. ADVERSE REACTIONS Common (greater than 2% of patients treated with Terbinafine tablets) reported adverse events include headache, diarrhea, rash, dyspepsia, liver enzyme abnormalities, pruritus, taste disturbance, nausea, abdominal pain, and flatulence. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc. at 1-800-367-3395, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported adverse events observed in the 3 US/Canadian placebo-controlled trials are listed in the Table 1. The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. Changes in the ocular lens and retina have been reported following the use of Terbinafine tablets in controlled trials. The clinical significance of these changes is unknown. …
Frequently Asked Questions
What is Terbinafine Hydrochloride used for?
Terbinafine Hydrochloride contains Terbinafine Hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Terbinafine Hydrochloride a controlled substance?
Terbinafine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Terbinafine Hydrochloride?
The generic name for Terbinafine Hydrochloride is Terbinafine Hydrochloride. There are 6 other brand versions of Terbinafine Hydrochloride.
What is the NDC code for Terbinafine Hydrochloride 250 mg/1?
The NDC (National Drug Code) for Terbinafine Hydrochloride 250 mg/1 is 43353-893, listed by Aphena Pharma Solutions - Tennessee, LLC.