COMPOSITION :
Hydrocortisone acetate Cream 2.5%, each gram contains : Hydrocortisone acetate equivalent to Hydrocortisone 25 mg.
DESCRIPTIONS :
Hydrocortisone acetate with active ingredient Hydrocortisone acetate (equivalent with Hydrocortisone) is available in cream 5 gram.
INDICATIONS :
- Inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
- Contact dermatitis, irritant dermatitis and insect bile reactions.
DOSAGE AND ADMINISTRATION :
Apply to the affected area as a thin film 2 to 4 times daily depending on the severity of the condition.
OVERDOSAGE :
There is no specific overdosage syndrome associated with the use of topical Hydrocortisone. No specific antidote is available. Treatment of acute oral overdose consist of dilution with fluids.
CONTRAINDICATIONS :
- Untreated infections of bacterial, viral, tuberculous or fungal origin.
- Acne rosacea or in perioral dermatoses.
- Plaque psoriasis.
- Not for use on the eye, face, in the anogenital region, on broken or infected skin, including cold sores, acne and athletes foot.
- Hypersensitivity to active ingredient or to excipients.
WARNINGS AND PRECAUTIONS :
- Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use and the addition of occlusive dressings.
- Hydrocortisone should only be used during pregnancy or during lactation if recommended by a physician.
- Administration of topical corticosteroid to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatrics patients.
ADVERSE REACTIONS :
Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
PRESENTATION :
Hydrocortisone acetate Cream 2.5% Box, 25 tube @ 5 gram Reg. No. GKL9402320129A1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
After packaging is opened, the product is stable for 30 days at storage below 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
