Terbicon
Generic Name
Terbinafine
Manufacturer
ACI Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| terbicon 250 mg tablet | ৳ 60.00 | ৳ 360.00 |
Description
Overview of the medicine
Terbicon 250 mg Tablet contains Terbinafine, an antifungal medication used to treat a variety of fungal infections of the skin, hair, and nails. It is effective against dermatophytes (a type of fungus) that cause conditions like athlete's foot, jock itch, ringworm, and nail fungal infections (onychomycosis).
Uses & Indications
Dosage
Adults
250 mg once daily. Duration of treatment varies: 2-6 weeks for skin infections, 6 weeks to 6 months (or longer) for nail infections depending on the site (fingernails 6 weeks, toenails 12 weeks or longer).
Elderly
No evidence to suggest a different dosage is required in elderly patients, but caution is advised in those with pre-existing hepatic or renal impairment.
Renal_impairment
In patients with renal impairment (creatinine clearance < 50 mL/min or serum creatinine > 300 µmol/L), the dose should be reduced by half (e.g., 125 mg daily).
How to Take
Terbicon 250 mg Tablet should be taken orally once daily with or without food. It is recommended to take the tablet at the same time each day to maintain consistent drug levels.
Mechanism of Action
Terbinafine is an allylamine that interferes with fungal sterol biosynthesis. It specifically inhibits squalene epoxidase, an enzyme in the fungal cell membrane, which leads to a deficiency of ergosterol (an essential component of the fungal cell membrane) and accumulation of squalene within the cell. The accumulation of squalene is toxic to the fungal cell, leading to its death (fungicidal action).
Pharmacokinetics
Onset
Clinical improvement varies. For skin infections, weeks. For nail infections, several months due to slow nail growth and accumulation in the nail plate.
Excretion
Approximately 70-80% of the dose is excreted in the urine, predominantly as metabolites; a smaller proportion is excreted in the feces.
Half life
Terminal elimination half-life is approximately 200-400 hours due to slow release from skin and fatty tissue, but the initial distribution half-life is much shorter (~17 hours).
Absorption
Well absorbed from the gastrointestinal tract (oral bioavailability ~40%). Peak plasma concentrations are reached within 2 hours.
Metabolism
Extensively metabolized in the liver, primarily by CYP2C9, CYP1A2, CYP3A4, CYP2C8, and CYP2D6 enzymes. Metabolites are inactive.
Side Effects
Contraindications
- Hypersensitivity to terbinafine or any component of the tablet
- Patients with chronic or active liver disease
- Severe renal impairment (creatinine clearance < 50 mL/min) without dose adjustment
Drug Interactions
Cimetidine
Increases plasma concentration of terbinafine by inhibiting its metabolism.
Rifampicin
Decreases plasma concentration of terbinafine by inducing its metabolism.
Oral Contraceptives
May cause menstrual disturbances (e.g., irregular bleeding) in some women.
CYP2D6 inhibitors (e.g., Fluconazole, Amiodarone, Caffeine, Tricyclic Antidepressants, Beta-blockers)
Terbinafine inhibits CYP2D6, potentially increasing plasma levels of co-administered drugs metabolized by this enzyme.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, abdominal pain, headache, and dizziness. In case of an overdose, symptomatic and supportive treatment should be initiated. Activated charcoal may be used to reduce absorption.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm, but adequate and well-controlled studies in pregnant women are lacking. Should be used during pregnancy only if clearly needed. Terbinafine is excreted into breast milk; therefore, it should not be used by nursing mothers.
Side Effects
Contraindications
- Hypersensitivity to terbinafine or any component of the tablet
- Patients with chronic or active liver disease
- Severe renal impairment (creatinine clearance < 50 mL/min) without dose adjustment
Drug Interactions
Cimetidine
Increases plasma concentration of terbinafine by inhibiting its metabolism.
Rifampicin
Decreases plasma concentration of terbinafine by inducing its metabolism.
Oral Contraceptives
May cause menstrual disturbances (e.g., irregular bleeding) in some women.
CYP2D6 inhibitors (e.g., Fluconazole, Amiodarone, Caffeine, Tricyclic Antidepressants, Beta-blockers)
Terbinafine inhibits CYP2D6, potentially increasing plasma levels of co-administered drugs metabolized by this enzyme.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, abdominal pain, headache, and dizziness. In case of an overdose, symptomatic and supportive treatment should be initiated. Activated charcoal may be used to reduce absorption.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm, but adequate and well-controlled studies in pregnant women are lacking. Should be used during pregnancy only if clearly needed. Terbinafine is excreted into breast milk; therefore, it should not be used by nursing mothers.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from the date of manufacture
Availability
Available in pharmacies worldwide
Approval Status
Approved in various countries for fungal infections
Patent Status
Off-patent (generic available)
WHO Essential Medicine
YesClinical Trials
Terbinafine has undergone extensive clinical trials demonstrating its efficacy and safety in treating various dermatophyte infections, including onychomycosis, tinea pedis, tinea corporis, and tinea cruris.
Lab Monitoring
- Liver function tests (LFTs) should be performed before initiating treatment and periodically during treatment, especially if symptoms suggestive of liver dysfunction develop (e.g., unexplained nausea, anorexia, dark urine, jaundice, right upper quadrant pain).
- Complete blood count (CBC) if symptoms of blood dyscrasias appear.
Doctor Notes
- Emphasize the importance of completing the full course of therapy, particularly for onychomycosis, to achieve mycological cure and prevent relapse.
- Counsel patients on potential adverse effects, especially taste disturbance and hepatotoxicity, and advise them to report any concerning symptoms promptly.
- Consider baseline and periodic LFT monitoring for all patients, especially those with pre-existing liver conditions or on prolonged therapy.
Patient Guidelines
- Complete the full course of treatment as prescribed, even if symptoms improve, to prevent recurrence.
- Report any unusual symptoms, especially persistent nausea, vomiting, dark urine, yellowing of skin/eyes, or severe skin rash, to your doctor immediately.
- Be aware that taste disturbance is a possible side effect and usually reversible upon discontinuation, but can be prolonged.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Terbinafine is generally not expected to affect the ability to drive or operate machinery. However, if you experience dizziness or visual disturbances, avoid such activities.
Lifestyle Advice
- Maintain good hygiene, especially for foot infections, by keeping affected areas clean and dry.
- Wear breathable footwear and cotton socks, changing them frequently, for tinea pedis.
- Avoid sharing personal items like towels, shoes, and clothing to prevent spreading the infection.
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