Almovate 0.05% (Ointment)
Medicine Details
| Category | Details |
|---|---|
| Generic | Clobetasol propionate |
| Company | Albion laboratories limited |
Indications
- Psoriasis (excluding widespread plaque psoriasis)
- Recalcitrant dermatoses
- Lichen planus
- Discoid lupus erythematosus
- Other skin conditions which do not respond satisfactorily to less potent steroids
Composition
- Clobetasol Propionate Cream
- Clobetasol Propionate Ointment
- Clobetasol Propionate Scalp Application
- Clobetasol Propionate Shampoo
- Clobetasol Propionate Lotion
- Clobetasol Propionate Spray
Pharmacology
Clobetasol Propionate is a very potent topical corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. It shows anti-inflammatory activity via multiple mechanisms to inhibit late phase allergic reactions. It decreases the density of mast cells, chemotaxis and activation of eosinophils. It also reduces cytokine production and inhibits the metabolism of arachidonic acid.
Dosage
Adults, elderly and children over 1 year: Apply a thin layer of Clobetasol Propionate Cream or Ointment to the affected skin areas twice daily and rub in gently and completely. Repeated short courses of Clobetasol Propionate may be used to control exacerbations. In more resistant lesions, especially where there is hyperkeratosis, the effect of Clobetasol can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Clobetasol Propionate is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks. The maximum weekly dose should not be exceeded 50 gm/week.
Administration
Route of administration: Cutaneous. Creams are especially appropriate for moist or weeping surfaces. Ointments are especially appropriate for dry, lichenified or scaly lesions.
Interaction
Co-administered drugs that can inhibit CYP3A4 (eg ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.
Contraindications
- Rosacea, acne vulgaris and perioral dermatitis
- Primary cutaneous viral infections (e.g. herpes simplex, chickenpox)
- Hypersensitivity to the preparation
- The use of Clobetasol Propionate skin preparations is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi (e.g. candidiasis, tinea), or bacteria (e.g.impetigo): perianal and genital pruritus
- Dermatoses in children under one year of age, including dermatitis and napkin eruptions
Side Effects
- Prolonged use of large amounts, or treatment of extensive areas can result in systemic absorption
- Local atrophic changes in the skin such as thinning, striae and dilatation of the superficial blood vessels
- Rare instances of provoking the pustular form of psoriasis
- Pigmentation changes and hypertrichosis with topical steroids
- Exacerbation of symptoms may occur
Pregnancy & Lactation
There are limited data from the use of Clobetasol Propionate cream in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The administration of Clobetasol Propionate Cream during pregnancy and lactation should only be considered if the expected benefit to the mother outweighs the possible risks of treatment. It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.
Precautions & Warnings
Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur readily even without occlusion. If used in childhood or on the face, courses should be limited if possible to five days and occlusion should not be used. The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. If applied to the eye lids, care is needed to ensure that the preparation does not enter the eye, as glaucoma or cataract might result. Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important. Appropriate anti-microbial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of anti-microbial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied.
Use in Special Populations
In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur. Children are more susceptible to the use of topical corticosteroids which develops atrophic changes.
Overdose Effects
Acute overdosage is very unlikely to occur, however, in the case of chronic over-dosage or misuse the features of hypercortisolism may occur and in this situation topical steroid should be discontinued.
Therapeutic Class
Other Topical corticosteroids
Storage Conditions
Keep below 30°C temperature, protected from light and moisture. Do not freeze. Keep out of the reach of children.