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PRODUCT TYPE:- KETOCONAZOLE
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It Is A Imidazole Derivative Available In The Form Of Ointment And
Shampoo For Topical Administration. It Alters The Permeability Of
The Cell Wall By Blocking Fungal Cytochrome P-450; Inhibits Biosyntesis
Of Triglycerides And Phospolipids By Fangi; Inhibits Several Fungal
Enzymes That Results In A Bulid Up Of Toxic Concentrations Of Hydrogen
Peroxide.
INDICATIONS: Susceptible Fungal Infections,
Including Candidiasis, Histoplasmosis, Paracoccidiodomycosis,
Coccidiodomycosis, Chronic Mucocutaneous Candidiasis, Certain,
Recalcitrant Cutaneous Dermatophytes, T. Corporis, T.Cruris, Tinea
Versicolor And Cutaneous Candidiasis, Seborrheic Dermatitis.
CONTRAINDICATIONS: Hypersensitivity To Ketoconazole
Or Any Component, Cns Fungal Infections, Coadministration With
Terfenadine, Astemizole, Aastemizole Or Cisapride Due To Risk
Of Potential Cardiac Arrhythmia.
SAFETY PROFILE: Avoid Contact With Eyes; Avoid
Taking Antacids At The Same Time As Ketoconazole. May Cause Drwsines,
Impair Judgement Or Coordination. Notify Physician Of Unusual
Fatigue Anorexia, Vomiting, Dark Urine Or Pale Stool Rare Cases
Of Serious Cardiovascular Adverse Event Including Death, Ventricular
Tachycardia And Torsade De Points Have Been Observed Due To Increased
Terfenadine Concentrations Induced By Ketoconazole. Use With Caution
In Patients With Impaired Hepatic Function, Performed Periodic
Liver Function Tests.
ADVERSE EFFECTS: Pruritus, Severe Irritation,
Stinging, Increases Normal Hair Loss, Abnormal Hair Texture, Mild
Dryness Of Skin, Itching, Oiliness. Dryness Of Hair.
DOSAGE SHAMPOO: Apply Twice Weekly For 4 Weeks
With At Least 3 Days Between Each Shampoo. Topical Rub Gently
Into Affected Area Once Daily To Twice Daily.