COMPOSITION :
Betamethasone Valerate Cream 0.1%, each gram contains : Betamethasone valerate equivalent to Betamethasone 1 mg.
DESCRIPTIONS :
Betamethasone Valerate Cream 0.1% contains Betamethasone valerate (equivalent to Betamethasone) as active ingredient is available in 5 g and 15 g cream.
INDICATIONS :
For inflammation of the skin caused by microorganisms, chemicals, thermic irritation, trauma or discoid eczema and atopic allergies, psoriasis.
DOSAGE AND ADMINISTRATIONS :
Applied to the inflamed area 2 – 3 times daily until improvement happens and can be given once a day or more rarely or as medical recommendation.
If there is no improvement after 2 – 4 weeks, then the treatment should be reviewed.
OVERDOSAGE :
Symptoms :
Application of large amounts or long-term topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency and cause hypercorticism manifestation, including Cushing’s disease.
Treatment :
Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms usually reversible. If necessary, treat the electrolyte unbalance. In chronic toxicity cases, it is recommended to stop the corticosteroid slowly.
CONTRAINDICATIONS :
- Rosacea, acne and perioral dermatitis. Primary cutaneous viral infections (e.g., herpes simplex, chickenpox).
- Hypersensitivity to any component of the preparation.
- The use of Betamethasone valerate cream skin preparation is not indicated in the treatment of primarily infected skin lesions caused by infections with fungi (e.g., candidiasis, tinea); or bacteria (e.g., impetigo); primary or secondary infections due to yeast; perianal and genital pruritus; dermatoses in children under 1 year of age, including dermatitis and napkin eruptions.
WARNINGS AND PRECAUTIONS :
- Stop treatment if there is irritation or sensitization.
- Give an appropriate therapy if there is an infection. When desired response does not occur immediately, discontinue corticosteroids until the infection is resolved.
- Every reported adverse effect in systemic corticosteroids therapy may occur, especially in infants and children.
- Corticosteroid’s systemic absorption will be increased when it is used on large body surface treatment and long-term continuous topical therapy.
- Do not cover or bandage the part of the body which applied by the drug.
- Do not use in the eye.
- Application in children :
Pediatric patients may demonstrate greater susceptibility to hypothalamic-pituitary-adrenal (HPA) suppression due to induction of topical corticosteroids and to the effects of exogenous corticosteroids than adults because of its larger absorption due to the ratio of surface area compared to body weight.
HPA porous suppression, Cushing’s syndrome, linear growth retardation, weight gain inhibition and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestation of adrenal suppression in children includes low cortisol plasma level and the absences of responses in ACTH stimulations. Manifestations from intracranial hypertension includes bulging fontanelle, headache and bilateral papilloedema.
Chronic corticosteroids therapy may interfere with the growth and development of children.
- Use in pregnancy and nursing mothers :
Because safety of topical corticosteroid usage in pregnant women has not been established, drugs from this class should only be used if its benefit ratio is in balance with its risk potency to the fetus.
Do not use in pregnant women in large amounts or for longer period of time. Because it is not known whether the topical administration of corticosteroids can lead to sufficient systemic absorption to produce a number of drugs that can be detected in breast milk, a decision should be made whether to stop breast milk or stop treatment, with consideration on the importance of drug for the mother.
ADVERSE REACTIONS :
- Like other topical corticosteroids, the use of large amounts continuously on a wide area can lead to systemic absorption.
- Use of topical corticosteroids lead to local side effects, irritation, dry skin, folliculitis, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy.
- Burning, itching, acneiform eruptions.
- Thinning of the skin, striae, miliaria, telangiectasia and senile type.
- Purpura usually seen in high absorption areas such as on the face, neck, axilla, perineum and genital.
PRESENTATIONS :
Betamethasone Valerate Cream 0.1% Box, 25 tube @ 5 g
Reg. No. GKL1702355529A1
Betamethasone Valerate Cream 0.1% Box, 100 tube @ 5 g
Reg. No. GKL1702355529A1
STORAGE :
STORE BELOW 30°C, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
