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APO-TERBINAFINE is a brand name for Terbinafine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-TERBINAFINE (terbinafine tablets) is indicated for: • the treatment of fungal infections of the skin and nails caused by dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis, Epidermophyton floccosum. • the treatment of onychomycosis (fungal…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Special Populations • Liver Impairment: APO-TERBINAFINE tablets are contraindicated for patients with chronic or active hepatic disease. See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS. • Renal Impairment: The use of terbinafine tablets has not been adequately studied in patients with renal impairment and is therefore not recommended in this population.
2 Recommended Dose and Dosage Adjustment ▪ Adults: 250 mg once daily. 1 Dosing Considerations. ▪ The duration of treatment varies according to the indication and the severity of infection: TABLE 1 Indication Duration of Treatment Onychomycosis (of fingers and toes)* 6 weeks to 3 months Skin Infections** Tinea pedis (interdigital & plantar/moccasin type) 2-6 weeks Tinea corporis, cruris 2-4 weeks * In patients with fingernail infections or toenail infections other than the big toe, or in younger patients, treatment periods of less than 3 months may be adequate.
In patients with infections of the big toenail, treatment for 3 months is usually sufficient, although some patients may require treatment for 6 months or longer. Poor nail outgrowth during the first weeks of treatment may enable identification of those patients in APO-TERBINAFINE (Terbinafine Tablets) Page 6 of 48 whom longer therapy is required.
In onychomycosis 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 tissue. ** Complete resolution of the signs and symptoms may not occur until several weeks after mycolological cure.
4 Administration The scored tablets are taken orally with water. They should preferably be taken at the same time each day and can be taken on an empty stomach or after a meal. 5 Missed Dose If a dose of APO-TERBINAFINE tablets is missed, the patient should be advised to take it as soon as he/she remembers.
However, if it is almost time of the next dose (up to 4 hours), the patient should skip the missed dose and go back to the regular dosing schedule. The patient should not double dose.
APO-TERBINAFINE (Terbinafine Tablets) Page 5 of 48 3 SERIOUS WARNINGS AND PRECAUTIONS BOX • HEPATIC: APO-TERBINAFINE is contraindicated in patients with pre-existing chronic or active hepatic disease. Serious and life-threatening hepatic adverse reactions (including hepatic failure leading to death and liver transplant) have been reported in patients with or without pre-existing chronic or active hepatic disease receiving terbinafine tablets for the treatment of onychomycosis and dermatomycosis.
• Baseline liver function test should be recommended before initiating treatment with APO-TERBINAFINE. APO-TERBINAFINE tablets should be discontinued if biochemical or clinical evidence of liver injury develops. See 7 WARNINGS AND PRECAUTIONS, Hepatic.
1 Dosing Considerations Special Populations • Liver Impairment: APO-TERBINAFINE tablets are contraindicated for patients with chronic or active hepatic disease. See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS. • Renal Impairment: The use of terbinafine tablets has not been adequately studied in patients with renal impairment and is therefore not recommended in this population.
2 Recommended Dose and Dosage Adjustment ▪ Adults: 250 mg once daily. 1 Dosing Considerations. ▪ The duration of treatment varies according to the indication and the severity of infection: TABLE 1 Indication Duration of Treatment Onychomycosis (of fingers and toes)* 6 weeks to 3 months Skin Infections** Tinea pedis (interdigital & plantar/moccasin type) 2-6 weeks Tinea corporis, cruris 2-4 weeks * In patients with fingernail infections or toenail infections other than the big toe, or in younger patients, treatment periods of less than 3 months may be adequate.
In patients with infections of the big toenail, treatment for 3 months is usually sufficient, although some patients may require treatment for 6 months or longer. Poor nail outgrowth during the first weeks of treatment may enable identification of those patients in APO-TERBINAFINE (Terbinafine Tablets) Page 6 of 48 whom longer therapy is required.
• APO-TERBINAFINE (terbinafine tablets) is contraindicated in patients with a known hypersensitivity to terbinafine or to any of the excipients of APO-TERBINAFINE or component of the container. See 6 DOSAGE FORMS, STRENGTHS, and COMPOSITION AND PACKAGING.
• APO-TERBINAFINE is contraindicated for patients with chronic or active hepatic disease. See 7 WARNINGS AND PRECAUTIONS, 8 ADVERSE REACTIONS. APO-TERBINAFINE (Terbinafine Tablets) Page 5 of 48
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In onychomycosis 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 tissue. ** Complete resolution of the signs and symptoms may not occur until several weeks after mycolological cure.
4 Administration The scored tablets are taken orally with water. They should preferably be taken at the same time each day and can be taken on an empty stomach or after a meal. 5 Missed Dose If a dose of APO-TERBINAFINE tablets is missed, the patient should be advised to take it as soon as he/she remembers.
However, if it is almost time of the next dose (up to 4 hours), the patient should skip the missed dose and go back to the regular dosing schedule. The patient should not double dose. 5 OVERDOSAGE A few cases of overdosage with terbinafine tablets (up to 5 g) have been reported giving rise to headache, nausea, epigastric pain and dizziness.
The recommended treatment of overdosage consists of eliminating the drug, primarily by the administration of activated charcoal and giving, symptomatic supportive therapy, if needed. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING TABLE 2 - Dosage Forms, Strengths, Composition and Packaging. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral 250 mg tablet Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and methylcellulose.
APO-TERBINAFINE 250 mg tablets:
Each white, round, biconvex tablet with bevelled-edges, engraved “APO” on one side, “TER” over “250” and scored through the center on the other, contains terbinafine hydrochloride equivalent to 250 mg terbinafine. Available in bottles of 100 and 500 and unit dose packages of 14, 28 and 30.
APO-TERBINAFINE (Terbinafine Tablets) Page 7 of 48 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. Carcinogenesis and Mutagenesis An increase in liver tumors was observed in male rats at the highest dose level (69 mg/kg) during a life-time (123 weeks) carcinogenicity study.
The changes included increased enzyme activity, peroxisome proliferation and altered triglyceride metabolism. The changes have been shown to be species specific since they were not seen in mice or monkeys.
Driving and Operating Machinery Effects on ability to drive and use machines:
No studies on the effects of terbinafine tablets treatment on the ability to drive and use machines have been performed. Patients who experience dizziness as an undesirable effect should avoid driving vehicles or using machines. Endocrine and Metabolism In vitro and in vivo studies have shown that terbinafine inhibits the CYP2D6 metabolism.
g. certain members of the following drug classes, tricyclic antidepressants (TCAs), β-blockers, selective serotonine reuptake inhibitors (SSRIs), antiarrhythmics class 1A, 1B and 1C and monoamine oxidase inhibitors (MAO-Is) Type B, should be followed up, if the co-administered drug has a narrow therapeutic window.
See