Each gram of cream/ointment contains Clobetasol Propionate BP 0.5 mg.
Temovate® cream/ointment contains the active compound Clobetasol Propionate, a synthetic corticosteroid for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.
Temovate® is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Apply a thin layer of Temovate® to the affected skin area twice daily and rub in gently and completely.
Temovate® cream/ointment is contraindicated in patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions
In controlled trials with all Clobetasol Propionate formulations, the following adverse reactions have been reported:
Burning/stinging
Pruritus
Irritation
Erythema
Folliculitis
Cracking and fissuring of the skin
Numbness of the fingers
Tenderness in the elbow
Skin atrophy
Telangiectasia
Overdose:
Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse, the features of hypercortisolism may appear.
Precautions:
General: Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur readily even without occlusion.
Pregnancy and Lactation: The administration of Temovate® cream/ointment during pregnancy and lactation should be considered only if the expected benefit to the mother outweighs any possible risk to the fetus.
Pediatric Use: Safety and effectiveness of Temovate® in pediatric patients under 12 years have not been established.
Information for Patients:
It is for external use only.
Avoid contact with the eyes.
The treated skin area should not be bandaged.
Store at a temperature not exceeding 30°C. Protect from light.