Description and Composition of Divasoral
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Divasoral is an imidazole antifungal agent used in the prevention and treatment of a variety of fungal infections. It contains Ketoconazole as its active pharmaceutical ingredient. It functions by preventing the synthesis of ergosterol, the fungal equivalent of cholesterol, thereby increasing membrane fluidity and preventing growth of the fungus. Divasoral can come as an oral tablet, topical cream, topical foam, shampoo, and topical gel.
Indications and uses of Divasoral
Divasoral tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections.
Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.
Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.
Contraindication of Divasoral
Divasoral should not be used in patients with a known hypersensitivity to ketoconazole.
Dosage of Divasoral
There should be laboratory as well as clinical documentation of infection prior to starting ketoconazole therapy. The usual duration of therapy for systemic infection is 6 months. Treatment should be continued until active fungal infection has subsided.
The recommended starting dose of ketoconazole Tablets is a single daily administration of 200 mg (one tablet). If clinical responsiveness is insufficient within the expected time, the dose of Ketoconazole Tablets may be increased to 400 mg (two tablets) once daily.
In small numbers of children over 2 years of age, a single daily dose of 3.3 to 6.6 mg/kg has been used. Ketoconazole Tablets have not been studied in children under 2 years of age
Side Effects of Divasoral
Some side effects of Divasoral which occur rarely include the following:
- Nausea and vomiting
Adverse Reactions of Divasoral
The risk of developing hepatitis may increase in relation to duration of Divasoral tablet treatment. This is because Ketoconazole is hepatotoxic.
Use in Pregnancy:
Divasoral should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Use for Nursing Mothers:
Since Divasoral is probably excreted in the milk, mothers who are under treatment should not breast feed.
- Gastric acid suppressants (e.g., antacids, histamine H2-blockers, proton pump inhibitors) have been shown to reduce plasma concentrations of ketoconazole.
- Ketoconazole is a substrate and potent inhibitor of CYP3A4. Therefore, drug interactions may occur when it is co-administered with other drugs that interact with CYP3A4. Inducers of CYP3A4 may decrease the plasma concentrations of ketoconazole while inhibitors of CYP3A4 may do the opposite.
- Antacids, cimetidine, ranitidine, rifampicin: decrease effectiveness of Ketoconazole.
- Cyclosporine: increases blood cyclosporine levels.
- Concomitant alcohol intake causes acute facial flushing and nausea. None has been reported on local application.
The U.S. Food and Drug Administration (FDA) is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating these conditions, which are not approved uses of the drug.
Store below 25°C. Protect from moisture & light.