Dermal Drugs
Salicylic Acid 2% - Petamethasone ( As Dipropinate) 0,05%
30ml Plastic Bottle - 30ml Glass Bottle
E.L-04
582/2011
18/12/2011
Excipients | Disodium edentate ‚ Hypromellose ‚ Sodium hydroxide ‚ Isopropyl alcohol ‚ Purified water |
INDICATIONS | Topical management of subacute and chronic hyperkeratotic and dry dermatoses responsive to corticosteroid therapy. |
CONTRAINDICATIONS | Kana-Salizone is contraindicated in viral diseases and fungal infections; also tuberculosis of the skin. Hypersensitivity to any one of the components. |
Side EFFECTS | The following local adverse reactions may occur rarely with the use of topical corticosteroids: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation. In addition, the salicylic acid component may cause local reddening of the skin, desquamation, pruritus and smarting. Hypersensitivity to salicylic acid may occur. |
WARNINGS | Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated, if long-term use is anticipated, or if the occlusive technique is used. Systemic absorption of topical corticosteroids produces hypercortisonism manifesting itself by adrenal suppression, moon facies, striae and suppression of growth. Suitable precautions should be taken under these conditions or, particularly in infants and children. The drug should not be used in or near the eyes, it should also be kept away from the genital area and other orifices. Suitable precautions should be taken in using topical corticosteroids in patients with stasis dermatitis and other skin diseases with impaired circulation. Prolonged use of corticosteroid preparations may produce striae or atrophy of the skin or subcutaneous tissue. If this occurs, treatment should be discontinued. If irritation, sensitization, excessive dryness, or unwanted scaling develop treatment should be discontinued. If an overt infection is present, appropriate antimicrobial treatment is indicated. If symptomatic response is not noted within a few days to a week, the local application of corticosteroids should be discontinued and the patient re-evaluated. Occlusive dressings should not be used. Children: Use of topical corticosteroids in children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with growth and development of children. |
Pregnancy And lactations | Topical corticosteroids 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 amounts or for prolonged periods of time in pregnant patients. Since it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption 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. |
Dosage And Administration | Topical Lotion: Apply a thin film to cover completely the affected areas of the scalp. The usual frequency of application is twice daily. |
OVERDOSE | Symptoms: Excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency, and produce manifestations of hypercorticism, including Cushing's disease. Overdosage of salicylates may cause temporary hearing or visual disturbances, drowsiness and nausea. If this occurs, discontinue use until symptoms disappear. Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawal of corticosteroids is advised. |
Storage Conditions | Store below 25 C Keep out of reach of children Prescription only medicine For external use only |