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Product
Anti-infective Products (Forcan TZ KIT )
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Anti-infective Products (Forcan TZ KIT )
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Forcan TZ KIT
Fluconazole and Tinidazole
COMPOSITION
Each kit contains
(A)One Fluconazole Tablet
Each tablet contains .... Fluconazole 150 mg
Colour: Ponceau 4R
(B)Two Tinidazole Tablets IP
Each film-coated tablet contains ....Tinidazole IP 1000 mg
Colours: Titanium Dioxide IP and Lake Indigo Carmine
Description
Fluconazole is a bis-triazole antifungal structurally related to imidazole-derivative antifungals. The nitrogen of the azole ring of the triazole binds to the haem moiety of the fungal cytochrome P-450 enzyme lanosterol 14 -demethylase which halts conversion of lanosterol to ergosterol that leads to a cascade of abnormalities in membrane permeability. Fluconazole is active against many fungi including yeasts and dermatophytes. In vitro , fluconazole is active against strains of Candida , including strains of C. albicans and Torulopsis glabrata .
Tinidazole is a nitroimidazole, whichs has antimicrobial action against microaerophillic protozoa, Giardia lamblia, Trichomonas vaginalis and against obligate anaerobic bacteria. It acts by damage of DNA strands or inhibition of their synthesis |
Indications
Forcan-TZ is indicated in the management of vaginal candidiasis, vaginal trichomoniasis, and bacterial vaginosis. The kit should preferably be given to both the partners to minimise recurrences.
Dosage And Administration
One tablet of fluconazole and 2 tablets of tinidazole as a single oral dose. Both the partners should be treated with this dose to minimise recurrences.
Contraindications
Hypersensitivity to either azole group or nitroimidazole group of compounds and in those patients with a history of blood dyscrasias. Forcan-TZ kit is also contraindicated in pregnancy and lactation
Warnings and Precautions
Drug interactions
Anticoagulants:Fluconazole has been shown to prolong prothrombin time when given concomitantly with coumarin drugs,hence requires careful monitoring.
Cyclosporine:Concomitant administration of fluconazole and cyclosporine may result in increase in cyclosporine level.
Phenytoin:Fluconazole significantly increases phenytoin levels and AUC resulting in phenytoin toxicity.
Oral hypoglycaemics:Concomitant administration of fluconazole and oral hypoglycaemics such as sulphonylurea in diabetic patients results in increased plasma concentration and reduced metabolism of antidiabetic agents.
Rifampin: Rifampin enhances the metabolism of concurrently administered fluconazole. Depending on clinical circumstances, consideration should be given to increasing the dose of fluconazole when it is administered with rifampin.
Theophylline: Fluconazole increases the serum concentrations of theophylline. Careful monitoring of serum theophylline concentrations in patients receiving fluconazole and theophylline is recommended.
Alcohol: Patients taking Tinidazole should not drink alcohol.
Warfarin: Use of Tinidazole should be avoided as far as possible in patients taking warfarin
Pregnancy
It is contraindicated in first trimester of pregnancy. There are no adequate and well-controlled studies in pregnant women.
Lactation
Since the drug is secreted in breast milk, it should not be used in lactating women.
Renal impairment
Caution has to be taken as a pproximately 70% to 80% of a dose of fluconazole is excreted unchanged in the urine.
Hepatic Impairment
Patients who develop abnormal liver function should be monitored. Discontinue Forcan TZ in patients who develop signs and symptoms consistent with liver disease or elevations in hepatic function tests.
Side effects
Forcan TZ generally is well tolerated. Nausea, headache, skin rash, abdominal pain, vomiting, diarrhoea, metallic taste and mild nausea are commonly reported side effects.
Presentation
Each kit of Forcan-TZ contains
One tablet of Fluconazole (150 mg) and
Two tablets of Tinidazole (1000 mg)
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