Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
Fluconazole (UNII: 8VZV102JFY) (Fluconazole - UNII:8VZV102JFY)
Taro Pharmaceuticals U.S.A., Inc.
Fluconazole
Fluconazole 50 mg
ORAL
PRESCRIPTION DRUG
Fluconazole Tablet, USP is indicated for the treatment of: - Vaginal candidiasis (vaginal yeast infections due to Candida). - Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. - Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis. Fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and i
Pink rectangular tablets with rounded edges containing 50, 100, 150 or 200 mg of fluconazole are packaged in bottles or unit dose blisters and are supplied as follows: Fluconazole Tablets USP, 50 mg: Engraved with "FL50" on one side and "TARO" on the other side. Fluconazole Tablets USP, 100 mg: Engraved with "FL100" on one side and "TARO" on the other side. Fluconazole Tablets USP, 150 mg: Engraved with "FL150" on one side and "TARO" on the other side. Fluconazole Tablets USP, 200 mg: Engraved with "FL200" on one side and "TARO" on the other side. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
FLUCONAZOLE- FLUCONAZOLE TABLET Taro Pharmaceuticals U.S.A., Inc. ---------- PATIENT INFORMATION Fluconazole Tablets, USP This leaflet contains important information about Fluconazole Tablets, USP. It is not meant to take the place of your doctor's instructions. Read this information carefully before you take Fluconazole Tablets, USP. Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about Fluconazole Tablets, USP. What is Fluconazole Tablets, USP? Fluconazole Tablets, USP is a tablet you swallow to treat vaginal yeast infections caused by a yeast called Candida. Fluconazole Tablets, USP helps stop too much yeast from growing in the vagina so the yeast infection goes away. Fluconazole Tablets, USP is different from other treatments for vaginal yeast infections because it is a tablet taken by mouth. Fluconazole Tablets, USP is also used for other conditions. However, this leaflet is only about using Fluconazole Tablets, USP for vaginal yeast infections. For information about using Fluconazole Tablets, USP for other reasons, ask your doctor or pharmacist. See the section of this leaflet for information about vaginal yeast infections. What is a Vaginal Yeast Infection? It is normal for a certain amount of yeast to be found in the vagina. Sometimes too much yeast starts to grow in the vagina and this can cause a yeast infection. Vaginal yeast infections are common. About three out of every four adult women will have at least one vaginal yeast infection during their life. Some medicines and medical conditions can increase your chance of getting a yeast infection. If you are pregnant, have diabetes, use birth control pills, or take antibiotics you may get yeast infections more often than other women. Personal hygiene and certain types of clothing may increase your chances of getting a yeast infection. Ask your doctor for tips on what you can do to help prevent vaginal yeast infections. If you get a vaginal yeast infection, you may have any of the following sympto Les hele dokumentet
FLUCONAZOLE- FLUCONAZOLE TABLET TARO PHARMACEUTICALS U.S.A., INC. ---------- FLUCONAZOLE TABLETS, USP RX ONLY DESCRIPTION Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α -bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C H F N O and molecular weight of 306.3. The structural formula is: Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Tablets, USP contain 50, 100, 150, or 200 mg of fluconazole and the following inactive ingredients: colloidal silicon dioxide, D&C Red No. 6 Lake, dibasic calcium phosphate anhydrous, FD&C Red No. 40 Lake, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate. Meets USP Dissolution Test 2. 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 (C ) 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 fluconazole leads to a mean C of 6.72 µg/mL (range: 4.12 to 8.08 µg/mL) and after single oral doses of 50 to 400 mg, fluconazole plasma concentrations and AUC (area under the plasma concentration-time curve) are dose proportional. 1 13 12 2 6 max max The C and AUC data from a food-effect study involving administration of fluconazole tablets, USP to healthy volunteers under fasting conditions and with a high-fat meal indicated that Les hele dokumentet