TERBINAFINE HYDROCHLORIDE

TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride tablet
Wockhardt USA LLC.

1 INDICATIONS AND USAGE

Terbinafine hydrochloride 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.

2 DOSAGE AND ADMINISTRATION

2.1 Assessment Prior to Initiation

Before administering terbinafine hydrochloride 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.

3 DOSAGE FORMS AND STRENGTHS

Terbinafine hydrochloride tablets 250 mg, supplied as white circular, bi-convex, bevelled tablets embossed with ‘W’ on one side and ’743′ on other side.

4 CONTRAINDICATIONS

Terbinafine hydrochloride tablets are contraindicated in patients with:

  • History of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see Adverse Reactions (6.2) ]
  • Chronic or active liver disease [see Warnings and Precautions (5.1) ]

5 WARNINGS AND PRECAUTIONS

5.1 Hepatotoxicity

Terbinafine hydrochloride tablets are contraindicated for patients with chronic or active liver disease. Before prescribing terbinafine hydrochloride tablets, perform liver function tests because hepatotoxicity may occur in patients with and without preexisting liver disease. Cases of liver failure, some leading to liver transplant or death, have occurred with the use of terbinafine hydrochloride tablets in individuals with and without preexisting liver disease.

In the majority of liver cases reported in association with use of terbinafine hydrochloride tablets, the patients had serious underlying systemic conditions. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Periodic monitoring of liver function tests is recommended. Discontinue terbinafine hydrochloride tablets if biochemical or clinical evidence of liver injury develops.

Warn patients prescribed terbinafine hydrochloride tablets and/or their caregivers to report immediately to their healthcare providers any symptoms or signs of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine, or pale stools. Advise patients with these symptoms to discontinue taking oral terbinafine, and immediately evaluate the patient’s liver function.

5.2 Taste Disturbance Including Loss of Taste

Taste disturbance, including taste loss, has been reported with the use of terbinafine hydrochloride tablets. It can be severe enough to result in decreased food intake, weight loss, anxiety, and depressive symptoms. Taste disturbance may resolve within several weeks after discontinuation of treatment, but may be prolonged (greater than 1 year), or may be permanent. If symptoms of a taste disturbance occur, terbinafine hydrochloride tablets should be discontinued.

5.3 Smell Disturbance Including Loss of Smell

Smell disturbance, including loss of smell, has been reported with the use of terbinafine hydrochloride tablets. Smell disturbance may resolve after discontinuation of treatment, but may be prolonged (greater than 1 year), or may be permanent. If symptoms of a smell disturbance occur, terbinafine hydrochloride tablets should be discontinued.

5.4 Depressive Symptoms

Depressive symptoms have occurred during postmarketing use of terbinafine hydrochloride tablets. Prescribers should be alert to the development of depressive symptoms, and patients should be instructed to report depressive symptoms to their physician.

5.5 Hematologic Effects

Transient decreases in absolute lymphocyte counts (ALCs) have been observed in controlled clinical trials. In placebo-controlled trials, 8/465 subjects receiving terbinafine hydrochloride tablets (1.7%) and 3/137 subjects receiving placebo (2.2%) had decreases in ALC to below 1000/mm3 on 2 or more occasions. In patients with known or suspected immunodeficiency, physicians should consider monitoring complete blood counts if treatment continues for more than 6 weeks. Cases of severe neutropenia have been reported. These were reversible upon discontinuation of terbinafine hydrochloride tablets, with or without supportive therapy. If clinical signs and symptoms suggestive of secondary infection occur, a complete blood count should be obtained. If the neutrophil count is less than or equal to 1000 cells/mm3 , terbinafine hydrochloride tablets should be discontinued and supportive management started.

5.6 Serious Skin/Hypersensitivity Reactions

There have been postmarketing reports of serious skin/hypersensitivity reactions [e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome]. Manifestations of DRESS syndrome may include cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more organ complications such as hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. If progressive skin rash or signs/symptoms of the above drug reactions occur, treatment with terbinafine hydrochloride tablets should be discontinued.

5.7 Lupus Erythematosus

During postmarketing experience, precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported in patients taking terbinafine hydrochloride tablets. Terbinafine hydrochloride tablets should be discontinued in patients with clinical signs and symptoms suggestive of lupus erythematosus.

5.8 Thrombotic Microangiopathy

Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported with terbinafine. Discontinue terbinafine if clinical symptoms and laboratory findings consistent with TMA occur. The findings of unexplained thrombocytopenia and anemia should prompt further evaluation and consideration of diagnosis of TMA.

6 ADVERSE REACTIONS

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 below. 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 hydrochloride tablets in controlled trials. The clinical significance of these changes is unknown. In general, the adverse events were mild, transient, and did not lead to discontinuation from study participation.

*Liver enzyme abnormalities greater than or equal to 2x the upper limit of normal range.

Adverse Event Discontinuation
Terbinafine hydrochloride tablets (%) n=465 Placebo (%) n=137 Terbinafine hydrochloride tablets (%) n=465 Placebo (%) n=137
Headache 12.9 9.5 0.2 0.0
Gastrointestinal Symptoms:
Diarrhea 5.6 2.9 0.6 0.0
Dyspepsia 4.3 2.9 0.4 0.0
Abdominal Pain 2.4 1.5 0.4 0.0
Nausea 2.6 2.9 0.2 0.0
Flatulence 2.2 2.2 0.0 0.0
Dermatological Symptoms:
Rash 5.6 2.2 0.9 0.7
Pruritus 2.8 1.5 0.2 0.0
Urticaria 1.1 0.0 0.0 0.0
Liver Enzyme Abnormalities* 3.3 1.4 0.2 0.0
Taste Disturbance 2.8 0.7 0.2 0.0
Visual Disturbance 1.1 1.5 0.9 0.0
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