Fungusol Lotion Plus

Therapeutic Class

Corticosteroid/anti-infective combinations, Skin

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Lotion (NRN: A4-1324): Miconazole nitrate 20 mg, Dexamethasone sodium phosphate 0.56 mg, Neomycin sulphate 6.65 mg.

Pack size: Bottles of 50 mL.

Pharmacology

Fungusol Plus is a combination of a synthetic antifungal agent (Miconazole), a broad spectrum antibacterial agent (Neomycin) and a potent topical corticosteroid (Dexamethasone).

Miconazole is a synthetic antifungal agent with antifungal activity against the common dermatopytes, yeasts and various other fungi.

Neomycin is a broad spectrum antibacterial agent used widely for topical application in a variety of infections of the skin and mucus membranes caused by susceptible micro organisms including dermatoses.

Dexamethasone is a corticosteroid applied topically in the management of various disorders in which corticosteroid is indicated.

Indications

Fungusol Plus is indicated for the topical treatment of inflammatory skin conditions complicated by bacterial and/or fungal skin infections.

Contra-indications

Hypersensitivity to any of the components.

Precautions/Warnings

• Fungusol plus must be used for short courses of treatment only.
• Regular review should be made of the necessity for continuing therapy.
• Long term continuous therapy, particularly occlusive dressings, should be avoided since it may cause side effects same as systemic administration of corticosteroid.
• Occasionally the overgrowth of nonsusceptible organisms, including fungi, may occur with the use of topical antibiotics.
• If a secondary microbial skin infection is present suitable concomitant antimicrobial therapy should be instituted.
• Fungusol plus should be used with particular caution in facial dermatoses and in the flexural eruptions and only for short periods. A steroid rosacea-like facies may be produced.
• Fungusol plus should be used with caution near the eyes.

Interactions

No major drug-drug interaction that is considered serious, however, consult your healthcare provider incase you are using any other medications.

Adverse Effects

Fungusol Plus is well tolerated. Local sensitivity reactions due to the miconazole and neomycin components may occur, whilst burning and itching due to miconazole have been reported.

Long-term continuous treatment with topical corticosteroids should be avoided as far as possible as this may cause atrophic changes in the skin leading to thinning, loss of elasticity, dilation of superficial blood vessels, telangiectasias and ecchymoses.

These changes are particularly likely to occur on the face and when occlusive dressings are used. Systemic absorption of topically applied corticosteroids may occur, particularly under the following conditions: when large quantities are used, or when application is made to wide areas of the body, or to damaged skin; when potent topical corticosteroids are used; and when the occlusive dressing technique is applied.

Depression of the hypothalamic-pituitary-adrenal (HPA) axis with consequent suppression of the adrenal gland may occur. These effects are most likely to be severe, in children. Growth may be retarded and a Cushingoid state may be produced.

Benign intracranial hypertension has been rarely reported.

Dosage & Administration

Apply and gently massage into the affected area 2-3 times daily.

Or as directed by the Physician.

Storage/Handling Recommendations

Store protected from light. Keep in a cool dry place and away from children.

For external use only.