Diprogen (Betamethasone Dipropionate – Gentamicin)

DIPROGEN®

Schering

Betamethasone Dipropionate – Gentamicin

Corticosteroid – Antibiotic

Action And Clinical Pharmacology: Betamethasone dipropionate with gentamicin combines the anti-inflammatory, antipruritic and vasoconstrictive activity of a synthetic corticosteroid, betamethasone dipropionate, with the broad spectrum anti-bacterial effect of gentamicin.

In secondary skin infections, gentamicin facilitates the treatment of the underlying dermatosis by controlling the infection. Bacteria susceptible to the action of gentamicin include sensitive strains of streptococci (group A beta hemolytic, alpha hemolytic), S. aureus (coagulase positive, coagulase negative, and some penicillinase producing strains), and the gram-negative bacteria P. aeruginosa, E. aerogenes, E. coli, Proteus (both indole positive and indole negative), K. pneumoniae, and S. marcescens.

Diprogen cream is slightly acidic so that it is within the pH range of the normal skin. On application, it leaves minimum residue without stickiness or greasiness. The presence of petrolatum in both cream and ointment offers lubricating qualities and helps to prevent excessive drying.

Indications And Clinical Uses: The topical treatment of corticosteroid responsive dermatoses when complicated by secondary infection caused by organisms sensitive to gentamicin or when the possibility of such infection is suspected.

The cream is recommended for wet, oozing primary infections, and greasy, secondary infections such as pustular acne or infected seborrheic dermatitis.

The ointment helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin.

Contra-Indications: Viral diseases including vaccinia, varicella, herpes simplex, fungal infections, tuberculosis of the skin and hypersensitivity to any of the components.

Manufacturers’ Warnings In Clinical States: Pregnancy and Lactation: Since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients. Since it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk, a decison should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. This drug should not be used in or near the eyes since the vehicle is not formulated for ophthalmic use.

Children: Any of the side effects that have been reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.

Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. Use of topical corticosteroids in children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with growth and development of children.

Precautions: Gentamicin is not effective against fungi, yeasts or viruses. Patients with superficial fungus or yeast infections also must receive specific therapy and the use of the drug may have to be discontinued. The use of such topical preparations may result in an overgrowth of non-susceptible organisms.

Suitable precautions should be taken in using topical corticosteroids in patients with stasis dermatitis and other skin diseases with impaired circulation.

Prolonged use of corticosteroid preparations may produce striae or atrophy of the skin or s.c. tissue. If this occurs, treatment should be discontinued.

Causal factors should be sought and eliminated whenever possible and the sensitivity of an infecting organism to gentamicin should be verified.

Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.

While no systemic effects have been observed following the topical application of gentamicin, toxic systemic concentrations can cause permanent impairment of vestibular function in the presence of renal insufficiency or existing 8th cranial nerve damage.

Caution should be exercised if gentamicin is used in individuals who are known to be sensitive to topically applied antibacterials. If irritation or sensitization develops, treatment should be discontinued.

Application over extensive lesions may result in significant systemic absorption producing hypercortisonism manifesting itself by adrenal suppression, moon face, striae and suppression of growth in children.

Patients should be followed up regularly, and the product should be discontinued when the infection has cleared.

Occlusive dressing should not be used.

Adverse Reactions: The following local adverse skin reactions have been reported with the use of topical steroids: dryness, itching, burning, local irritation, striae, skin atrophy, hypertrichosis, change in pigmentation and secondary infection. Adrenal suppression has also been reported following topical corticosteroid therapy. Posterior subcapsular cataracts have been reported following systemic use of corticosteroids.

Symptoms And Treatment Of Overdose: Symptoms: Excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency, and produce manifestations of hypercorticism, including Cushing’s disease.

Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawal of corticosteroids is advised.

Dosage: A sufficient quantity of the cream or ointment should be applied to cover completely the affected area and should be massaged gently and thoroughly into the skin. The usual frequency of application is twice daily although some patients may be maintained adequately with less frequent application.

Availability And Storage: Cream: Each g of cream contains: betamethasone (as dipropionate USP) 0.5 mg and gentamicin (as sulfate USP) 1 mg in a cream base. Nonmedicinal ingredients: cetostearyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, phosphoric acid, polyethylene glycol 1 000 monocetyl ether, sodium hydroxide, white petrolatum and water. Tubes of 30 g.

Ointment: Each g of ointment contains: betamethasone (as dipropionate USP) 0.5 mg and gentamicin (as sulfate USP) 1 mg in an ointment base. Nonmedicinal ingredients: white petrolatum. Tubes of 30 g.

Store under 30°C.

DIPROGEN® Schering Betamethasone Dipropionate – Gentamicin Corticosteroid – Antibiotic

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