TMI Blog2005 (1) TMI 237X X X X Extracts X X X X X X X X Extracts X X X X ..... l agent Ketoconazole. One ml contains 20 mg Ketoconazole. Properties Pharmacodynamics Keotocnazole, a synthetic imidazole dioxolane derivative has a potent antifungal activity against dermatophytes, such as Trichophyton sp. Epidermophyton sp. Microsporum sp. and yeasts, such as candida sp. and Malassezia furfur (Pityrosporum ovale). Ketoconazole shampoo rapidly relieves scaling and pruritus, which are usually associated with pityriasis versicolor seborrhoeic dermatitis and pityriasis capitis (dandruff). Pharmacokinetics Percutaneous absorption of Ketoconazole shampoo is negligible since blood levels cannot be detected, even after chronic use. Systemic effects, therefore, are not expected. Indications Treatment and prophylaxis of infections in which the yeast pityrosporum is involved, such as pityriasis versicolor (localized), seborrhoeic dermatitis and pityriasis capitis (dandruff). Contra-indications Known hypersensitivity to Ketoconazole or the excipient. Warnings and Precautions To prevent a rebound effect after stopping a prolonged treatment with topical corticosteroid it is recommended to continue applying the topical corticosteroid together with Nizral s ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... rder affecting the hairy scalp. Hence, no dandruff can exist without hair. It is characterized by two major symptoms - scaling and itching. Scaling takes the form of white, transparent flakes of varying size, depending on the stage of the disease. Particularly on dark clothes, the flakes are conspicuous, which can be rather embarrassing to the person involved. The itching can be so intense that - mostly unconsciously - one starts to scratch one's head as a result of which even more flakes fall on the clothing. Some people have been suffering from persistent dandruff for years. In others, it flares up periodically. The incidence seems to increase during the winter months. It would be a mistake to assume that dandruff is synonymous with poor or inadequate hygiene. Even people excessively concerned with personal hygiene may be affected by dandruff. What triggers dandruff? Medical science has recently succeeded in pinpointing the cause of dandruff. The scoundrel is a single celled organism, a kind of fungus with the scientific name Pityrosporum ovale. This fungus is always present on everyone's skin invisible to the naked eye, but it is perfectly harmless under normal conditions. I ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Dandruff-A Review (viii) Article by Johan McGrath G.M. Murphy - The control of Seborrhoeic Dermatitis and Dandruff by Antipityrosporal Drugs. (ix) Article by H. Dobrev and L. Zissova - Effect of Ketoconazole 2% Shampoo on scalp Sebum level in Patients with Seborrhoeic Dermatitis. (x) Article by Danby et al - Ketoconazole 2% versus Selenium Sulfide 2.5% Shampoo. (xi) Affidavits (xii) Order dated 10-4-1996 passed by Assistant Commissioner of Central Excise, Pune (xiii) Order dated 31-3-1997 passed by Assistant Commissioner of Central Excise, Bhandu Division, Mumbai-III They further claimed Keotoconazole 2% is therapeutic dosage and the effectiveness of this ingredient is its main function but not subsidiary. They also claim it is nowhere mentioned in the product literate that it is a preparation for use in hair. They further claim that the usage of shampoo mentioned in the patient information during the two phases in the treatment of dandruff, twice weekly for 2-4 weeks during the clean up phase and once a week during prophylactic phase also goes to prove it is a medicine-unlike other shampoos which can be used regularly without an ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... r a Laboratory. The pamphlet claims that the item is used for treatment and prophylaxis of infections in which the yeast pityrosporum is involved such as pityriasis versicolor (localized), seborrhoeic dermatitis and pityriasis capitis (dandruff). The procedure for treatment and the adverse reactions on such treatment due to overdose is also stated in the pamphlet. The Apex court, in the case of Muller Phipps (India) Ltd. v. CCE - 2004 (167) E.L.T. 347 (S.C.) has clearly held that once the item has been manufactured under a Drug licence and the Department has treated the item as a Drug, it would not cease to be one notwithstanding the fact that new Tariff Act has come into force. The Apex Court again held in the case of CCE v. Pandit D.P. Sharma - 2003 (154) E.L.T. 324 (S.C.) that once in the common parlance the item is treated as a medicament and manufactured under drug licence and the evidence is produced by the party with regard to the item being a medicament, then it should be treated as such and should not treat 'Himtaj Oil' as 'perfumed hair oil'. The Apex Court's ruling in the case of B.P.L. Pharmaceuticals Ltd. v. CCE - 1995 (77) E.L.T. 485 has held that 'Selsun' an anti-d ..... X X X X Extracts X X X X X X X X Extracts X X X X
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