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Generic Name: fluconazole, dosage Form: tablets, powder for oral suspension, medically reviewed on April 1, 2018. Show On This Page, view All, diflucan Description. Diflucan (fluconazole the diflucan 75 mg first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration, as a powder for oral suspension. Fluconazole is designated chemically as benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is: Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Diflucan Tablets contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD C Red. 40 aluminum lake dye, and magnesium stearate. Diflucan for Oral Suspension contains 350 mg or 1400 mg of fluconazole and the following inactive ingredients: sucrose, sodium citrate dihydrate, citric acid anhydrous, sodium benzoate, titanium dioxide, colloidal silicon dioxide, xanthan gum, and natural orange flavor. After reconstitution with 24 mL of distilled water or Purified Water (USP each mL of reconstituted suspension contains 10 diflucan 75 mg mg or 40 mg of fluconazole. Diflucan - Clinical Pharmacology, pharmacokinetics and Metabolism, the pharmacokinetic properties of fluconazole are similar following administration by the intravenous or oral routes. In normal volunteers, the bioavailability of orally administered fluconazole is over 90 compared with intravenous administration. Bioequivalence was established between the 100 mg tablet and both suspension strengths when administered as a single 200 mg dose. Peak plasma concentrations (Cmax) in fasted normal volunteers occur between 1 and 2 hours with a terminal plasma elimination half-life of approximately 30 hours (range: 20 to 50 hours) after oral administration. In fasted normal volunteers, administration of a single oral 400 mg dose of Diflucan (fluconazole) leads to a mean Cmax.72 g/mL (range:.12.08 g/mL) and after single oral doses of 50 to 400 mg, fluconazole plasma concentrations and area under the. The Cmax and AUC data from a food-effect study involving administration of Diflucan (fluconazole) tablets to healthy volunteers under fasting conditions and with a high-fat meal indicated that exposure to the drug is not affected by food. Therefore, Diflucan may be taken without regard to meals. administration of a single oral 150 mg tablet of Diflucan (fluconazole) to ten lactating women resulted in a mean Cmax.61 g/mL (range:.57.65 g/mL). Steady-state concentrations are reached within 5to 10 days following oral doses of 50to 400 mg given once daily. Administration of a loading dose (on Day 1) of twice the usual daily dose results in plasma concentrations close to steady-state by the second day. The apparent volume of distribution of fluconazole approximates that of total body water. Plasma protein binding is low (11 to 12). Following either single- or multiple oral doses for up to 14 days, fluconazole penetrates into all body fluids studied (see table below). In normal volunteers, saliva concentrations of fluconazole were equal to or slightly greater than plasma concentrations regardless of dose, route, or duration of dosing. In patients with bronchiectasis, sputum concentrations of fluconazole following a single 150 mg oral dose were equal to plasma concentrations at both 4 and 24 hours post dose. In patients with fungal meningitis, fluconazole concentrations in the cerebrospinal fluid (CSF) are approximately 80 of the corresponding plasma concentrations. A single oral 150 mg dose of fluconazole administered to 27 patients penetrated into vaginal tissue, resulting in tissue: plasma ratios ranging from.94.14 over the first 48 hours following dosing. A single oral 150 mg dose of fluconazole administered to 14 patients penetrated into vaginal fluid, resulting in fluid: plasma ratios ranging from.36.71 over the first 72 hours following dosing.
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