Solbina

A white cream.
Each gram contains Clobetasol propionate, USP 0.5 mg.

Pharmacology: Pharmacodynamics: Mechanism of action: Topical corticosteroids act as anti-inflammatory agents via multiple mechanisms to inhibit late phase allergic reactions including decreasing the density of mast cells, decreasing chemotaxis and activation of eosinophils, decreasing cytokine production by lymphocytes, monocytes, mast cells and eosinophils, and inhibiting the metabolism of arachidonic acid.
Topical corticosteroids, have anti-inflammatory, antipruritic, and vasoconstrictive properties.
Pharmacokinetics: Absorption: Topical corticosteroids can be systemically absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption.
Distribution: The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary due to the fact that circulating levels are well below the level of detection.
Metabolism: Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolized, primarily in the liver.
Elimination: Topical corticosteroids are excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

Corticosteroid-responsive dermatoses including psoriasis (excluding widespread plaque psoriasis), recalcitrant dermatoses, lichen planus, discoid lupus erythematosus, and other skin conditions which do not respond satisfactorily to less potent steroids.

Apply cream onto affected area twice a day. Treatment should not be continued for more than 4 weeks. If continuous treatment is necessary, a less potent preparation should be used. The maximum weekly dose should not exceed 50 grams/week.
Direction of Use: Before applying, cleanse hands and the skin infected with soap and water then pat to dry. Put a thin layer of clobetasol cream on the affected areas then gently rub in circular motion. Wash hands after applying to prevent ingestion.
External use only.

Topically applied clobetasol may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur; however, in the case of chronic overdosage or misuse, the features of hypercortisolism may occur.
In the event of overdose, clobetasol should be withdrawn gradually by reducing the frequency of application or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency.
Further management should be as clinically indicated or as recommended by the national poisons center, where available.

Known hypersensitivity to the active ingredient. Long-term treatment of ulcerative conditions, rosacea, pruritus; presence of acute infections.

Misuse, abuse, and abrupt stop of topical corticosteroids result in Topical Steroids Withdrawal (TSW) ("Topical Steroid Addiction" or "Red Skin Syndrome"). It results from prolonged (usually more than 12 months), frequent, and inappropriate use of moderate to high potency topical corticosteroids, especially on the face and genital area. Several different medical conditions that can result from excessive topical corticosteroids use were identified such as atrophy, rosacea, acne, perioral dermatitis and symptoms includes redness of the skin, burning sensation, followed by skin peeling, which appears to be distinct from a flare-up of the underlying condition. The signs and symptoms occur within days to weeks after topical corticosteroids discontinuation.
Do not swallow the contents of the cream. Accidental ingestion may lead to nausea and epigastric pain.
Avoid direct contact with eyes.
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation for further information.

Pregnancy: Category C. There are limited data from the use of clobetasol in pregnant women.
Lactation: The safe use of topical corticosteroids during lactation has not been established. Administration of clobetasol during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant. If used during lactation, it should not be applied to the breasts to avoid accidental ingestion by the infant.

Prolonged usage of large amount of clobetasol propionate can lead to sufficient systemic levels to produce adrenal suppression, Cushing's syndrome, diabetes and hypertension.

Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir and itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. The extent to which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.

Store at temperatures not exceeding 30°C. Keep in a dry place.
Keep the container well closed.

Topical Corticosteroids

D07AD01 - clobetasol ; Belongs to the class of very potent (group IV) corticosteroids. Used in the treatment of dermatological diseases.

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