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Terbinafine is a brand name for Terbinafine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE 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 [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy]…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Prior to administering, evaluate patients for evidence of chronic or active liver disease. 1 ) Fingernail onychomycosis: One 250 mg tablet, once daily for 6 weeks. 2 ) Toenail onychomycosis: One 250 mg tablet, once daily for 12 weeks.
1) ]. 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.
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.
1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. gov/medwatch. 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 three 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. In general, the adverse events were mild, transient, and did not lead to discontinuation from study participation.
Table 1. Most frequently reported adverse events observed in the 3 US/Canadian placebo-controlled trials *Liver enzyme abnormalities greater than or equal to 2x the upper limit of normal range. 2 Postmarketing Experience The following adverse events have been identified during post-approval use of terbinafine tablets.
Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 7 ) ], serum sickness-like reaction Psychiatric disorders: Anxiety and depressive symptoms independent of taste disturbance have been reported with use of terbinafine tablets.
5 WARNINGS AND PRECAUTIONS Liver failure, sometimes leading to liver transplant or death, has occurred with the use of oral terbinafine. Obtain pretreatment serum transaminases. Prior to initiating treatment and periodically during therapy, assess liver function tests.
Discontinue terbinafine tablets if liver injury develops. 1 ) Taste disturbance, including taste loss, has been reported with the use of terbinafine tablets. Taste disturbance can be severe, may be prolonged, or may be permanent. Discontinue terbinafine tablets if taste disturbance occurs.
2 ) Smell disturbance, including loss of smell, has been reported with the use of terbinafine tablets. Smell disturbance may be prolonged, or may be permanent. Discontinue terbinafine tablets if smell disturbance occurs. 3 ) Depressive symptoms have been reported with terbinafine use.
Prescribers should be alert to the development of depressive symptoms. 4 ) Severe neutropenia has been reported. If the neutrophil count is less than or equal to 1,000 cells/mm 3 , terbinafine tablets should be discontinued. 5 ) Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome have been reported with oral terbinafine use.
If signs or symptoms of drug reaction occur, treatment with terbinafine tablets should be discontinued. 1 Hepatotoxicity Terbinafine tablets are contraindicated for patients with chronic or active liver disease. Before prescribing terbinafine 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 tablets in individuals with and without preexisting liver disease. In the majority of liver cases reported in association with use of terbinafine tablets, the patients had serious underlying systemic conditions.
1) ] Chronic or active liver disease. ( 4 ) History of allergic reaction to oral terbinafine because of the risk of anaphylaxis. ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4 ) ] Nervous system disorders: Cases of taste disturbance, including taste loss, have been reported with the use of terbinafine tablets. It can be severe enough to result in decreased food intake, weight loss, anxiety, and depressive symptoms.
3 ) ]. Cases of paresthesia and hypoesthesia have been reported with the use of terbinafine tablets. 1 ) ], idiosyncratic and symptomatic hepatic injury. 1 )] have been seen with the use of terbinafine tablets. 6 )], acute generalized exanthematous pustulosis, psoriasiform eruptions or exacerbation of psoriasis, photosensitivity reactions, hair loss Musculoskeletal and connective tissue disorders: Rhabdomyolysis, arthralgia, myalgia General disorders and administration site conditions: Malaise, fatigue, influenza-like illness, pyrexia Investigations: Altered prothrombin time (prolongation and reduction) in patients concomitantly treated with warfarin and increased blood creatine phosphokinase have been reported.
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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 tablets, if biochemical or clinical evidence of liver injury develops.
Warn patients prescribed terbinafine 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. 2 Taste Disturbance Including Loss of Taste Taste disturbance, including taste loss, has been reported with the use of terbinafine 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 one year), or may be permanent.
If symptoms of a taste disturbance occur, terbinafine tablets should be discontinued. 3 Smell Disturbance Including Loss of Smell Smell disturbance, including loss of smell, has been reported with the use of terbinafine tablets. Smell disturbance may resolve after discontinuation of treatment, but may be prolonged (greater than one year), or may be permanent.
If symptoms of a smell disturbance occur, terbinafine tablets should be discontinued. 4 Depressive Symptoms Depressive symptoms have occurred during postmarketing use of terbinafine tablets. Prescribers should be alert to the development of depressive symptoms, and patients should be instructed to report depressive symptoms to their physician.
5 Hematologic Effects Transient decreases in absolute lymphocyte counts (ALCs) have been observed in controlled clinical trials. 2%) had decreases in ALC to below 1000/mm 3 on two or more occasions. In patients with known or suspected immunodeficiency, physicians should consider monitoring complete blood counts if treatment continues for more than six weeks.
Cases of severe neutropenia have been reported. These were reversible upon discontinuation of terbinafine 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 1,000 cells/mm 3 , terbinafine tablets should be discontinued and supportive management started. , 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 tablets should be discontinued.
7 Lupus Erythematosus During postmarketing experience, precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported in patients taking terbinafine tablets. Terbinafine tablets should be discontinued in patients with clinical signs and symptoms suggestive of lupus erythematosus.
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.