Gentriboston

POSOLOGY AND METHOD OF ADMINISTRATION

Posology

Adults and children over 12 years old 

A thin film of cream should be applied to cover completely the affected and surrounding skin areas twice daily, in the morning and at night.  

Duration of therapy varies depending upon the results of clinical examination, microbiological testing, and patient response to treatment.  

In the case of foot mycoses, a longer course of treatment (2-4 weeks) should be considered.  

Children 2 to 12 years old.  

Small amounts apply on affected skin areas only and massage gently. Use no more than twice in a day with an interval of at least 6-12 hours.  

Under the care of a physician, only the ointment should be applied to face, neck, scalp, genital area, rectal area, and intertrigo. The duration of treatment is limited to 5-7 days. 

Administration

For on the skin administration only. A thin film of cream should be applied to cover completely the affected to 1 -2 times a day. Wash your hands before and after applying the cream.

CONTRAINDICATIONS

Hypersensitivity to betamethasone or other corticosteroid or any other ingredient in this medicine.

History of hypersensitivity to aminoglycosides

Patient with diabetes, mental illness, bacterial and viral infections, systemic fungal infections

Avoid using for patient with myasthenia gravis, Parkinson’s syndrome, or symptoms of muscle weakness

Contraindicated in reaction skin to vaccines

WARNINGS AND PRECAUTIONS

Conditions requiring precautions for use

If irritation or sensitization develops with the use of Gentriboston treatment should be discontinued and appropriate treatment instituted. 

The systemic absorption of active ingredients for topical use may be increased if extensive body surface areas are treated with Gentriboston especially for prolonged periods or on the injured skin. At such circumstances, any of the side effects that have been reported following systemic use may also occur with topical use. Suitable precautions should be taken in these circumstances, particularly with children. 

Extensive use and the use of occlusive dressings should be monitored closely by physician.

Use on an open wound and damaged skin should be avoid. Not apply on eye area.

Patient should be informed to use the drug for current skin disease only and do not share the drug with other people

Gentamicin

A cumulative toxic effect should be expected (ototoxicity, nephrotoxicity) due to increased transcutaneous absorption when aminoglycosides for systemic use are co-administrated.

The probability of polyvalent allergy to other aminoglycosides should be taken into account.  

Prolonged use of antibiotic-containing preparations could result in growth of insensitive microorganisms. In such case or if a superinfection is developed the appropriative treatment should be started.

Clotrimazole

Patients should be asked to their physician immediately if there are signs of increased irritation in the application area (redness, itching, burning, blisters, swelling) and signs of hypersensitivity.

Avoid sources of infection or reinfection during treatment.

Betamethasone

Corticosteroids might mask symptoms of allergic skin reaction to ingredients of the drug.  

Betamethasone dipropionate is a potent corticosteroid, in case of using on the face or genitalia, the special care should be taken, and courses should be limited to 1 week.   

Continuous use during 2 to 3 weeks should not be exceed, if possible

Use in children: This preparation is not recommended for children under 2 years.  Pediatric patients may demonstrate greater susceptibility to corticosteroid than mature patients because of thinner skin and a greater skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.  Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intra-cranial hypertension include a bulging fontanelle, headaches, and bilateral papilledema.  

Precautions with excipients

This medicine contains:

Cetyl alcohol may cause local skin reactions (e.g. contact dermatitis)

Each 1-g cream of this medicine contains 50 mg propylene glycol. It should be used with caution due to the risk of  local skin reactions. Do not use this medicine in babies less than 4 weeks old with open wounds or large areas of broken or damaged skin (such as burns) without talking to your doctor or pharmacist.

Soya oil: If patients are allergic to peanut or soya, do not use this medicinal product.

Methyl paraben: May cause allergic reactions (possibly delayed).

Shelf-life

36 months from the manufacturing date. Do not use after the expiry date