Active Pharmaceutical Ingredients

Catalog ID80017759

CAS NO.78628-80-5

Purity 98%

MDL NumberMFCD00145430

Molecular FormulaC21H25N.HCl

Molecular Weight327.8908

Melting point: 195~198°C

Aspect	Details
Mechanism of Action	Terbinafine HCl is an allylamine antifungal agent that selectively inhibits squalene epoxidase, an enzyme essential for the synthesis of ergosterol, a key component of fungal cell membranes. This inhibition leads to the accumulation of squalene, which weakens the fungal cell wall and results in fungal cell death.
Pharmacokinetics	– Absorption: Well absorbed orally (greater than 70%), with a bioavailability of approximately 40% due to first-pass metabolism.<br>- Distribution: Widely distributed in tissues, including sebum and skin.<br>- Metabolism: Metabolized by multiple CYP isoenzymes, including CYP2C9, CYP1A2, CYP3A4, CYP2C8, and CYP2C19.<br>- Elimination: Approximately 70% of the dose is excreted in urine.<br>- Half-Life: Terminal half-life is 200-400 hours, reflecting slow elimination from tissues.
Indications	– Treatment of fungal infections such as onychomycosis (nail fungus), tinea capitis (scalp ringworm), tinea corporis (body ringworm), tinea cruris (jock itch), tinea pedis (athlete’s foot), and pityriasis versicolor (tinea versicolor).<br>- Oral formulations are used for more severe or systemic fungal infections.
Adverse Effects	– Common: Gastrointestinal symptoms (e.g., nausea, diarrhea), skin reactions (e.g., rash, itching), and taste disturbances.<br>- Serious: Hepatotoxicity (liver injury), allergic reactions (e.g., anaphylaxis), depression, and severe skin reactions.
Storage Conditions	Store at room temperature (below 30°C), in a dry, light-protected area.
Special Considerations	– Liver Function Monitoring: Regular liver function tests are recommended, especially in patients with preexisting liver disease.<br>- Drug Interactions: Caution with concomitant use of drugs metabolized by CYP enzymes, as terbinafine may affect their metabolism.<br>- Pregnancy and Lactation: Use with caution; safety in pregnancy and breastfeeding is not fully established.<br>- Pediatric Use: Oral granules are approved for children aged 4 years and older.<br>- Depressive Symptoms: Monitor for signs of depression during treatment.<br>- Taste and Smell Disturbances: May cause temporary or permanent changes in taste or smell.

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