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SivoKetoconazole

Adpharm Pharmaceuticals Limited
60, Ajao Road, Surulere, Lagos State, Nigeria
Email: adpharm2010@yahoo.com; info@adpharmltd.com
Tel: +234(0)818-839-0519, +234(0)807-408-4334. Mobile: 08033481022
Website: http://adpharmltd.com/

Brand Name

SivoKetoconazole

Manufacturer

Globela Pharma Pvt. Ltd. 357, G.I.D.C., Sachin, Surat-394230 Gujarat State, INDIA. Mfg. Lic. No.: G/25/1749

Therapeutic Class

Antifungals, Systemic

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN:A4-8926): Each uncoated tablet contains: Ketoconazole USP 200 mg.

Pack size: 10 tablets blister packed in mono carton along with its package insert. Such 10 cartons packed in outer carton.

Sivoketoconazole Tablet

Pharmacology

Indications

Local treatment of vaginal candidiasis, dermatophytosis and Malassezia folliculitis either resistant to fluconazole, Terbinafine, or itraconazole or in patients intolerant to these antifungals, chronic mucocutaneous, cutaneous, and oropharyngeal candidiasis either resistant to fluconazole or itraconazole or in patients intolerant to these antifungals.

Contra-indications

Acute poryphyria.

Hepatic Impairment: Avoid

Pregnancy: Avoid unless potential benefit outweighs risks.

Breastfeeding: No information available, although avoid.

Precautions/Warnings

Predisposition to adrenocortical insufficiency.

Interactions

Adverse Effects

Diarrhea and rarely antibiotic-associated colitis, nausea and vomiting, abdominal pain, headache, dizziness, drowsiness and rash; also reported fatal liver damage, dyspepsia, raised intracranial pressure, paraesthesia, adrenocortical insufficiency, erectile dysfunction, menstrual disorders, azoospermia, gynaecomastia, thrombocytopenia, photophobia, photosensitivity, and alopecia.

Dosage & Administration

Dosage form: Uncoated tablets.

Dose 200 mg once daily, increased if response is  inadequate to 400 mg once daily; continued until symptoms have cleared and cultures negative, max.

Duration of treatment 4 weeks for Malassezia infection; CHILD body-weight 15-30 kg, 100 mg once daily; body-weight over 30 kg, adult dose.

Storage/Handling Recommendations

36 months from the date of manufacture.

Store in a cool, dry and dark place. Protect from light.

Review Date

2017-08-12 07:31:26