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Ternafin 250

Terbinafine Hydrochloride
250mg
SinoHealth Pharmaceuticals LTD

Description

💊 Ternafin 250 – Terbinafine 250 mg Tablet

Manufacturer: SinoHealth Pharmaceuticals LTD

1. Indications:

Ternafin 250 is indicated for:

Tablets:

  • Onychomycosis of toenails or fingernails caused by dermatophytes (Tinea Unguium)

Granules:

  • Tinea Capitis

Cream:

  • Superficial fungal skin infections (Tinea corporis, cruris, pedis, cutaneous candidiasis, pityriasis versicolor)

Spray (1%):

  • Tinea pedis, corporis/cruris, pityriasis versicolor

2. Pharmacology:

Terbinafine is an allylamine antifungal that inhibits Squalene Epoxidase, an enzyme essential for ergosterol synthesis in fungal cell membranes. This results in:

  • Fungal cell death due to accumulation of squalene

  • Increased membrane permeability

Active against most strains of:

  • Trichophyton mentagrophyte

  • Trichophyton rubrum

3. Dosage & Administration:

Tablets (250 mg):

  • Fingernail onychomycosis: 1 tablet once daily for 6 weeks

  • Toenail onychomycosis: 1 tablet once daily for 12 weeks

Clinical improvement may take months after mycological cure

Granules:

  • <25 kg: 125 mg/day up to 6 weeks

  • 25–35 kg: 187.5 mg/day up to 6 weeks

  • 35 kg: 250 mg/day up to 6 weeks

Cream:

  • Apply once or twice daily to affected areas for:

    • Tinea corporis/cruris: 1–2 weeks

    • Tinea pedis: 1 week

    • Cutaneous candidiasis: 2 weeks

    • Pityriasis versicolor: 2 weeks

Spray 1%:

  • Apply once or twice daily depending on the infection for 1 week

  • Tinea pedis: once daily, 1 week

  • Tinea corporis/cruris: once daily, 1 week

  • Pityriasis versicolor: twice daily, 1 week

4. Drug Interactions:

  • CYP2D6 inhibitor: May interact with tricyclic antidepressants, SSRIs, beta-blockers, antiarrhythmics (class 1C), and MAO-B inhibitors.

  • Co-administration requires careful monitoring and possible dose adjustment of 2D6-metabolized drugs.

5. Contraindications:

  • Hypersensitivity to terbinafine or formulation excipients

  • Pre-existing severe liver disease (for tablets)

  • Infants and children for tablet use (safety not established)

6. Side Effects:

Common: Gastrointestinal upset (diarrhea, dyspepsia, abdominal pain), mild rashes, urticaria, pruritus, taste disturbances.
Serious (rare):

  • Idiosyncratic liver injury, liver failure

  • Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)

  • Severe neutropenia, thrombocytopenia, angioedema, anaphylaxis

  • Other: malaise, fatigue, vomiting, arthralgia, myalgia, hair loss

7. Pregnancy & Lactation:

  • Tablets: Avoid during pregnancy; present in breast milk; not recommended during breastfeeding.

  • Cream: No clinical data in pregnant women; use only if benefits outweigh risks; avoid breastfeeding.

8. Precautions & Warnings:

  • Assess pre-existing liver disease before prescribing

  • Monitor ALT and AST prior to starting tablets

  • Discontinue if progressive skin rash or liver injury occurs

  • Cream: External use only, avoid contact with eyes

  • Use cautiously in elderly or patients with hepatic dysfunction

9. Use in Special Populations:

  • Pediatric: Safety not established for tablets

  • Elderly: No dosage adjustment required; monitor liver function if risk factors present

10. Overdose Effects:

  • Clinical data limited; doses up to 5 g (20× daily dose) tolerated

  • Symptoms: nausea, vomiting, abdominal pain, dizziness, rash, headache, frequent urination

  • Supportive treatment recommended

11. Therapeutic Class:

Other Antifungal Preparations / Topical Antifungal Preparations

12. Storage Conditions:

  • Store below 30°C, in a cool and dry place

  • Protect from light

  • Keep out of reach of children

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