Country: United States
Language: English
Source: NLM (National Library of Medicine)
FLUCONAZOLE (UNII: 8VZV102JFY) (FLUCONAZOLE - UNII:8VZV102JFY)
Baxter Healthcare Corporation
FLUCONAZOLE
FLUCONAZOLE 200 mg in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
Fluconazole in Sodium Chloride Injection, USP is indicated for the treatment of: Prophylaxis: Fluconazole in Sodium Chloride Injection, USP 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 identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly. Fluconazole in Sodium Chloride Injection, USP is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. There is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. Caution should be used in prescribing Fluconazole in Sodium Chloride Injection, USP to patients with hypersensitivity to other azoles. Coadministration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as erythromycin, pimozide, and quinidine are contraindicated in patients receiving fluconazole. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies and PRECAUTIONS.)
Fluconazole in Sodium Chloride Injection, USP for intravenous infusion administration is formulated as sterile iso-osmotic solution containing 2 mg/mL of fluconazole. It is supplied in Intravia plastic containers containing volumes of 100 mL or 200 mL, affording doses of 200 mg and 400 mg of fluconazole, respectively. Fluconazole in Sodium Chloride Injection, USP in Intravia Plastic Containers: 2J1446 NDC 0338-6046-48 Fluconazole in Sodium Chloride Diluent 200 mg/100 mL x 10 2J1445 NDC 0338-6045-37 Fluconazole in Sodium Chloride Diluent 400 mg/200 mL x 10 Store between 77°F (25°C) and 41°F (5°C). Brief exposure up to 104°F (40°C) does not adversely affect the product. Protect from freezing. Avoid excessive heat. Rx only
Abbreviated New Drug Application
FLUCONAZOLE- FLUCONAZOLE INJECTION, SOLUTION BAXTER HEALTHCARE CORPORATION ---------- FLUCONAZOLE IN SODIUM CHLORIDE INJECTION, USP FOR INTRAVENOUS INFUSION ONLY IN INTRAVIA PLASTIC CONTAINER DESCRIPTION Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in INTRAVIA plastic containers. 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 in Sodium Chloride Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of fluconazole in a sodium chloride diluent. Each mL contains 2 mg of fluconazole and 9 mg of sodium chloride. The pH ranges from 4.0 to 6.5 in the sodium chloride diluent. Injection volumes of 100 mL and 200 mL are packaged in INTRAVIA plastic containers. The flexible container is manufactured from a specially designed multilayer plastic (PL 2408). Solutions in contact with the plastic container can leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. The flexible container has a foil overwrap. Water can permeate the plastic into the overwrap, but the amount is insufficient to significantly affect the premixed solution. Fluconazole in Sodium Chloride Injection, USP meets USP Organic Impurities Procedure 3. CLINICAL PHARMACOLOGY PHARMACOKINETICS AND METABOLISM 1 13 12 2 6 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 p Read the complete document