DIPROGENTA Cream / Ointment Ref.[50610] Active ingredients: Betamethasone Gentamicin

Source: Web Search  Revision Year: 2021  Publisher: Merck Sharp & Dohme (Israel-1996) Company Ltd., P.O.Box 7121, Petah-Tikva 49170, Israel

4.1. Therapeutic indications

Diprogenta Cream is indicated for the relief of the inflammatory manifestations of corticosteroidresponsive dermatoses when complicated by secondary infections caused by organisms susceptible to gentamycin.

Diprogenta Ointment is indicated for topical treatment of dermatosis complicated by secondary infection caused by organisms sensitive to Gentamicin.

4.2. Posology and method of administration

Adolescents and Adults

Apply a thin film to the affected skin areas twice daily and carefully rub in. Frequency of application should be determined by the physician according to the severity of the condition. For some patients, adequate maintenance therapy may be achieved with less frequent application. Duration of therapy varies depending upon the extent and location of disease and patient response. However, if clinical improvement is not achieved by two to three weeks, diagnosis should be reviewed.

Children 2 to 12 years old

Apply a thin film to only the affected skin and carefully rub in. Apply a sufficient amount no more frequently than twice daily with at least 6-12 hours between applications. Application to face, neck, scalp, genitalia, rectal area, and skin flexures should be applied under medical supervision. Limit treatment to no more than 5 to 7 days.

See “Special Warnings and precautions for use”, and “Use in paediatric patients”.

4.9. Overdose

Symptoms

Excessive or prolonged use of topical corticosteroids may lead to a suppression of the pituitary-adrenal function, and may cause secondary adrenal insufficiency and symptoms of adrenal cortex hyperactivity, including Cushing’s syndrome.

It cannot be excluded that a single excessive dose of gentamicin might induce such symptoms. Excessive and prolonged use of topically applied gentamicin may lead to an increased growth of fungi or non-susceptible bacteria at the site of skin lesions.

Treatment

Appropriate symptomatic treatment is indicated. Acute symptoms of adrenal cortex hyperactivity are usually reversible. Electrolyte imbalances should be treated where required. In cases of chronic toxicity, withdrawal of corticosteroids should be gradual.

If overgrowth by non-susceptible organisms occurs, stop treatment with Diprogenta Cream or Ointment and institute appropriate antimycotic or antibacterial treatment.

6.3. Shelf life

The expiry date of the product is indicated on the packaging materials.

6.4. Special precautions for storage

Store up to 25°C. After first opening, can be used up to 3 months.

Keep out of the reach and sight of children

6.5. Nature and contents of container

Diprogenta Cream is supplied in tubes of 15 g.

Diprogenta Ointment is supplied in tubes of 15 g.

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