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Betnesone-G cream

 

COMPOSITION
Betamethasone base(as Betamethasone-17-valerate BP)    0.1 % w/w

Gentamicin base (as Gentamicin Sulphate BP)    0.1 % w/w

ACTIONS
Gentamicin is an aminoglycoside antibiotic with bactericidal actions against many Gram-negative aerobes including Pseudomonas aeroginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella-Enterobacter-Serratia species, Citrobacter species, and against Staphylococcus species (coagulase-positive and coagulase-negative). It acts by inhibiting normal protein synthesis in susceptible organisms. Enterococci, streptococci and anaerobes are resistant to gentamicin.

Betamethasone-17-valerate is a glucocorticoid with anti-inflammatory, anti-pruritic and vasoconstrictive actions.

INDICATIONS
Treatment of allergic or inflammatory dermatoses complicated by secondary bacterial infections with a Gram-negative component.

DOSAGE AND ADMINISTRATION
Apply a small amount of cream to the affected area twice daily, or as prescribed. In mild cases once daily application may suffice.

SIDE EFFECTS
In general, topically applied gentamicin is not absorbed systemically. Topical corticosteroids can be absorbed through the skin in sufficient amounts to cause systemic side effects including hypothalamic-pituitary-adrenal axis suppression.

Local adverse reactions may include burning, itching, irritation, hypertrichosis, acneiform eruptions, hypopigmentation, allergic contact dermatitis, skin atrophy and striae. These reactions may occur more frequently if occlusive dressings are used.

CONTRAINDICATIONS
Contraindicated in patients with known allergy or history of serious toxic reactions to gentamicin or other aminoglycosides, or to any of the components in the preparation.

PRECAUTIONS
Betnesone-G Cream is for external use only. It should not be used in patients with tuberculosis of the skin, herpes simplex, vaccinia or varicella. Avoid contact with the eyes.

Since gentamicin is not effective against fungi, patients with superficial fungus or yeast infections must also receive specific antifungal therapy.

Topical corticosteroids can be absorbed through the skin in sufficient amounts to cause systemic side effects, particularly when the preparation is applied over a large surface area, when use is prolonged or when occlusive dressings are used.

Safety of topical corticosteroids in pregnant women has not been established. Therefore, topical corticosteroids should not be used extensively in pregnant patients, in large amounts or for prolonged periods of time.

Prolonged use of topical antibiotic may cause super-infection with resistant organisms such as fungi.


WARNING
Use of topical gentamicin in closed hospital settings is actively discouraged.


SHELF LIFE

4 years

STORAGE CONDITIONS

Store below 30C.
Keep container tightly closed.

Protect from light.

PRESENTATION

Tubes of 5, 10 or 15g

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