For the use of a Registered Medical Practitioner/ Hospital/ Laboratory only

������������������������� �CLOBETSALIC 3% LOTION

Generic Name:
Clobetasol propionate 0.05% w/v+ salicylic acid 3% w/v lotion
Composition:
Each ml contain
Clobetasol propionate IP���� 0.05% w/v
salicylic acid IP���������������������� 3% w/v
Non Aqueous base����..��� q.s

FOR DERMATOLOGIC USE ONLY ( ATWO WEEKS THERAPY) NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE
Description:
Clobetsalic lotion contains the active compound clobetasol propionate, a synthetic corticosteroid and salicylic acid, a keratolytic agent for topical dermatologic use.
Clobetasol propionate� is an analog of Prednisolone having a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11?, 16?)-21-chloro-9- fluoro-11- hydroxyl-16methyl-17-(1-oxopropoxy)-pregna-1, 4-diene-3, 20-dione, with empirical formula C25H32CIFO3
Salicylic acid is a keratolytic and antiseptic agent
Action:
Like other topical corticosteroids, Clobetasol propionate also has anti-inflammatory, anti-pruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the tpical steroids is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Corticosteroids are also thought to act by the induction of phospholopase A2 proteins.
Topical Salicylic acid has Keratolytic properties as well as bateriostatic and fungicidal actions.
Pharmaacolinetics:
Topical corticosteroids can be absorbed from normal intact skin . The extent of percutaneous absorbtion of Topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
Indication and Usage:
Clobetsalic Lotion is the super�high potency corticosteroid formulation indicated for the relief of the inflammation manifestations of hyperkeratotic and dry corticosteroid-responsive dematoses such as: Psoriasis, chronic atopic dermatitis, Neurodermatitis(lichen simplex chronicus), lichen planus, eczema(including nummular eczema, hand eczemz, eczematous dermatitis), DYshidrosis(ppmpholyx), seborrheic dermatitis of the scalp, icthyosis vilgaris and other icthyotic conditions.
Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exeed 50 gm( 50 ml or 1.75fl.oz)/week because of the potential of drugto suppress the Hypothalamic-Pituitary-Adernal(HPA) axis.
�Use in pediatric patients under 12 years of age is not recommended.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved.
Dosage and Administration:
Apply a thin layer of Clobetsalic Lotion to the affected skin area twice daily and rub in gently and completely.
For some patients, adwquate maintenance therapy may be achieved with less frequent application.������ As with highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement� is seen� within 2weeks, reassessment of diagnosis may be necessary.
Clobetsalic Lotion should not be used with occlusive dressings.
Contraindications:
Clobetsalic Lotion is contraindicated in those patients with a history of sensitivity reactions to anyof its components.
Adverse Reactions:
The most frequent adverse reactions reported for clobetasol propionate were burning, irritation, and stinging sensation. Less frequent adverse reaction were itching, skin atrophy, cracking and fissuring of the skin, stinging, craking, erythema , Folliculitis and numbness of the fingers, skin and telangiectasia.
Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. The following additional local adverse reactions have been reported with topical� corticosteroids � dryness, acneform eruotions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.
Salicylic acid preparations may cause dermatitis
Patients applying a topical steroid to a large surface area to areas under occlusion should be evaluated periodically for evidence ofHPA axis suppression.
Mild to moderate hypersensitive reactions can be seen in patients allergic or sensitive to salicylic acid.
Precautions:
Clobetsalic Lotion should not be used ont the face, groin or axilla. Clobetsalic Lotion is not for ophthalmic use.
Systemic absorption of topical corticosteroids can procduce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.
Manifestations of crushing syndrome, hyperglycemia, and glucosuria cn also be produced in some patients by systemic absorptions of topical corticosteroids while on therapy.
Patients receiving super-potent cortiocosteroids should not be treated for more than 2 week at a time and only small area should be treated at any one time due to the increased rick of HPA suppression.
Clobetasol propionate produce HPA aixs suppression when used at doses as low as 2g/day for 1 week in patients with eczema.
Prediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to bady mass ratios.
If irritation or sensitization develops with the use of Clobetsalic Lotion, treatment should be discontinued and appropriate therapy instituted.
If concomitant skin infections are present or develops, an appropriate antifungal or antibacterial agent should be used, if a favorable response does not occur promptly, use of clobetsalic lotion should be discontinued until the infection has been adequately controlled.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: LONG-TERM ANIMAL STUDIES HAVE NOT BEEN PERFORMED TO EVALUATE the carcinogenic potential of clobetsol propionate. Studies in the rat following subcutaneous administration at dosage� level up to 50 mcg/kg/day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose. Clobetasol propionate was nonmutagenic in 3 different test systems: the Ames test, the Sacchamromyces cerevisiae gene conversion asay, and the E coil B WP2 fluctuation test.
USE IN SPECIAL PATIENT POPULATION:
Pregnancy and in nursing mothers: since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively in large amonts� or for prolonged periods of time in pregnanat patients.
since if it is not known whether topical administration of corticosteroids can result insufficient systemic absoption to produce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
PEDIATRIC/USE: Safety and effectiveness of Clobetsalic lotion in pediatric patients have not been established. Use in pediatric patients under 12 years of age is not recommended.HPA axis suppression, cushing�s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.
GERIATRIC USE: While the number of patients treated with topical clobetasol propionate is too small to permit separate analysis of analysis of efficacy and safety, the adverse reactions reported are similar to those reported by younger patients.
Overdosage:
Symptoms: Execessive use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondry adrenal insufficiency and produce manifestations of hypercorticism, including� Cuhing�s disease.
Treatment:Appropriate symptomatic treatment in indicated. Acute hypercorticoid sysmptoms are ussally reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawl of corticosteroids is advised.
INFORMATION FOR PATIENTS:
Patients using topical corticosteroids should receive the following information and instructions:
this medication is for external use only.
It is to be used as directedby the Dermatologist.
This medication should not be used for any disorder other than that for which it was prescribed.
Avoid contact with eyes.
The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the Dermatologist.
Patients should report any sign of local adverse rections to the Dermatologist.
Packing:
50 ml bottle in Drop Dispenser flip top presentation.
Shelf Life:
Not more that24 months, please seemfg. Date/Exp. Date printed on� pack. Do not use the product after the expiry date which is stated on the packing. The expiry date refers to the last day of that month.
Storage:
store in cool and dry place, protected from light.
lotion should be shaken before use.
Marketed by:
R S PHARMA GROUP
Araji no893 Plot-2B. Bairy Akbarpur Bangar,
singhpur kalyanpur road, Kanpur. U.P 208017