Micosone®

Miconazole

Prescribing Details



Description

Micosone® is a combination preparation of Miconazole Nitrate and Hydrocortisone which exhibits broad spectrum activity against pathogenic yeasts and dermatophytes and also effective against infection with gram-positive bacteria including many strains of Streptococcus and Staphylococcus susceptible to Miconazole. It also contains Hydrocortisone which possesses an antipruritic and antiallergic activity and also exhibits an antimitotic effect against human epidermal cells which may account for their effectiveness in the treatment of dermatoses such as psoriasis.


Uses

No Data


Indications

• Topical treatment of inflammed dermatoses, such as- intertrigo, infected eczema, moist or dry eczema or dermatitis including atopic eczema, primary irritant or contact allergic eczema or seborrhoeic eczema including that associated with acne.

• lntertriginous eczema including inflammatory intertrigo, perianal and genital dermatitis.


Dosage and administration

Adults : Micosone® cream and ointment should be applied topically to the affected area 2-3 times a day.

Children: Same as adults.

Infants: Long term continuous topical corticosteroid therapy should be avoided.
Micosone® cream is particularly suitable for moist or weeping surfaces and for flexures of the body. Micosone® ointment is suitable for dry, scaly lesions.

The cream and ointment is indicated for the initial stages of treatment. Once the inflammatory symptoms have disappeared (after about 7 days), treatment can be continued where necessary with Miconazole cream. Occlusive dressing is usually only necessary in case of nail lesions.
Elderly patients: Natural thinning of the skin occurs in the elderly, hence corticosteroid should be used sparingly and for short periods of time.


Use in pregnancy & lactation

Only small amounts of Miconazole are absorbed following local administration. However, Miconazole should be used with caution during pregnancy. Miconazole has shown no teratogenic effects but shows foetotoxic effect at high doses. As many drugs are excreted in human milk, caution should be exercised when Miconazole is administered to a nursing woman. 


Geriatric use
No Data

Precautions

Like other topical corticosteroid, care is advised with infants and children when hydrocortisone is to be applied to extensive surface areas or under occlusive dressings including baby napkins. Application to the face should be avoided.

Warnings
In infants, long term topical corticosteroid therapy should be avoided. Adrenal suppression can occur even without occlusion.


Side effects
Miconazole is generally well tolerated. Rarely local irritation and hypersensitivity reactions may occur.

Contraindications

Miconazole is contraindicated in patients with known hypersensitivity to any of the ingredients. It is also contraindicated to patients with tubercular or viral infections of the skin or those caused by gram-negative bacteria.


Drug interactions

Amphotericin antagonizes the effect of Miconazole.


Overdose
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used.

Preparation

No Data


Pharmaceutical precautions

Store in a cool (below 30oC) and dry place, protect from light and moisture.


Presentation

Micosone® Cream : Each g contains Miconazole Nitrate BP 20 mg & Hydrocortisone BP 10 mg.
Micosone® Ointment : Each g contains Miconazole Nitrate BP 20 mg & Hydrocortisone BP 10 mg.


Package quantities

Micosone® Cream: Tube of 10 g.
Micosone® Ointment: Tube of 10 g.