RiteMED Clobetasol

Clobetasol propionate.

Each gram contains: Clobetasol propionate, USP 500 mcg.

Pharmacology: Clobetasol propionate cream is a synthetic corticosteroid for topical dermatological use. It has anti-inflammatory, antipruritic, and vasoconstrictive properties.
Mechanism of Action: Corticosteroids diffuse across cell membranes and form complexes with specific cytoplasmic receptors. These complexes then enter the cell nucleus, bind to DNA (chromatin), and stimulate transcription of messenger RNA (mRNA) and subsequent protein synthesis of various inhibitory enzymes responsible for the anti-inflammatory effects of topical corticosteroids.
The vehicle of the formulations containing topical corticosteroids may also contribute to the therapeutic effect by providing an emollient or drying action or by increasing the transdermal absorption of the corticosteroid.
Absorption is systemic. The absorption degree of a topical pharmaceutical form may depend on the vehicle used in each formulation. Systemic side effects may occur with topical corticosteroid preparations, particularly when these preparations are used over large areas or for an extended period of time or with occlusive dressings. Rectal absorption increases when the intestinal mucosa is inflamed.
Systemic absorption of topical corticosteroids through the oral mucosa increases as the potency increases.
Metabolism of fluorinated compounds such as Clobetasol is slower in the skin therefore, they are systemically absorbed to a higher degree.

Clobetasol propionate is indicated for mild to moderate atopic dermatitis, contact dermatitis, mild nummular dermatitis, facial seborrheic dermatitis or intertriginous areas, and other forms of mild to moderate dermatitis. Other mild to moderate inflammatory dermatoses. Intertrigo. Lichen planus on the face and intertriginous areas. Polymorphous solar eruption. Anogenital pruritus. Senile pruritus. Psoriasis on the face and intertriginous areas. Xerosis in the inflammatory phase. Discoid lupus erythematosus, granuloma annulare, plaque-type psoriasis and psoriasis affecting the palms of hands, soles of feet, elbows or knees.
Alopecia areata. Generalized exfoliative dermatitis. Moderate to severe nummular dermatitis. Granuloma annulare. Reduction of keloids. Simple chronic lichen. Pretibial myxedema. Pemphigus. Pemphigoid. Pityriasis rosea. Sarcoidosis. Sunburn.

Dose for adults: Apply a thin even layer to the affected area once or twice a day. It should be used as a short-term therapy. Do not use occlusive dressing.
Dose for children: Usage is not recommended for children under 12 years old.

Topical chronic overdose: Since there is no specific antidote available, treatment is symptomatic and supportive. Usage should be discontinued immediately. Sometimes, gradual withdrawal of use is required.
Accidental overdose: In case of accidental intake, treatment consists of dilution with oral liquids.

Hypersensitivity to any of its components.
If concomitant skin infection is present, an appropriate antimicrobial agent should be used concurrently.
Pre-existing skin atrophy.
Prolonged use of potent topical corticosteroids may cause: Cataract (corticosteroids may enhance progress of cataract, especially if products of high or very high potency are used in the periorbital area).
Diabetes Mellitus (loss of diabetes control may occur due to possible glucose increase in the blood).
Glaucoma (intra-ocular pressure may increase, especially if products of high or very high potency are used in the periorbital area).
Tuberculosis (Corticosteroids may exacerbate or reactivate tuberculosis. Appropriate antituberculous and prophylactic chemotherapy should be administered concurrently).

Topical corticosteroids are not for ophthalmic use.
Corticosteroids may be absorbed percutaneously; for such reason, patients with local prolonged therapy are likely to develop systemic effects.
In case of irritation, usage should be discontinued immediately. In case of infection, an antimycotic or antibiotic agent should be administered. If there is no favorable response, usage of corticosteroids should be discontinued until infection has lessened.
Occlusive dressing is not recommended since systemic absorption increases with its use.

No appropriate studies have been carried out to specify possible teratogenicity of topical corticosteroids; mutagenicity studies with other corticosteroids have given negative results.
Patients receiving super-potent corticosteroids should not be treated for more than 2 weeks at a time. This should be carefully evaluated particularly if it is administered on more than 5 to 10% of the body surface or if occlusive dressing is used.
Use in Pregnancy: Safety and efficacy have not been absolutely determined. It should not be applied extensively or in higher quantities or for a prolonged period of time.
Use in Lactation: It is not known whether topically administered corticosteroids are excreted in breast milk. Studies in humans have not been reported. On the other hand, systemic corticosteroids are secreted into breast milk where they may cause unwanted effects in the infant such as growth suppression. Topical corticosteroids should not be applied on the breasts of a nursing mother.
Use in Children: Children have larger skin surface area to body weight ratio compared to adults; therefore, children are likely to absorb higher quantities of corticosteroid than older patients.
Absorption is also higher in premature infants than newborn babies due to incomplete development of the stratus corneum. Cushing's syndrome, intracranial hypertension and growth retardation due to systemic absorption of topical corticosteroids have been reported. Caution is needed when topical corticosteroids are applied to children and growing adolescents, especially if there are factors that will increase absorption. In such cases, low-potency corticosteroids are recommended.
Use in the Elderly: No studies on topical corticosteroids have been carried out regarding the geriatric population. Elderly-specific problems are not expected to limit their usefulness. However, there is a tendency to have pre-existing skin atrophy related to age. Skin injuries may be consequently more prevalent in elderly people when using topical corticosteroids. Topical corticosteroids should not be used frequently and only for short periods of time under strict medical supervision.

Use in Pregnancy: Safety and efficacy have not been absolutely determined. It should not be applied extensively or in higher quantities or for a prolonged period of time.
Use in Lactation: It is not known whether topically administered corticosteroids are excreted in breast milk. Studies in humans have not been reported. On the other hand, systemic corticosteroids are secreted into breast milk where they may cause unwanted effects in the infant such as growth suppression. Topical corticosteroids should not be applied on the breasts of a nursing mother.

Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with super-high potency corticosteroids such as clobetasol propionate (and, in the case of cream and ointment, with the use of occlusive dressings). These reactions are listed in an approximately decreasing order of occurrence: dryness, hypertrichosis (emollient and gel only), acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation (cream, ointment, and gel only), striae, and miliaria.
In controlled clinical trials, the most frequent adverse reactions reported for clobetasol propionate cream were burning and stinging sensation in 1% of treated patients. Less frequent adverse reactions were itching, skin atrophy, and cracking and fissuring of the skin.

No interactions have been described in this form of presentation. In case of significant systemic absorption, measures of 17 hydrocorticosteroid or urine free cortisol or plasma cortisol may decrease, as well as the function of hypothalamic-pituitary-adrenal axis, especially in children. Eosinophil count may decrease if plasma concentration of cortisol decreases. The glucose concentration in the blood may increase.

Incompatibilities: Not described.

Store at a temperature not exceeding 30°C.

Topical Corticosteroids

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

Rx