Fluconazole prescribing information

Posted: MastiX Date of post: 21-Feb-2019
FDA Drug Safety Communication FDA to review study examining use.

FDA Drug Safety Communication FDA to review study examining use.

Group: antifungal agent Suspension, 50 mg/5 ml, 200 mg/5 ml Solution for infusion, 2 mg/ml in 25 ml and 100 ml ampoule[non-EDL]Tablet, 50 mg, 100 mg, 200 mg [non-EDL] General information Fluconazole is a fungistatic triazole derivative that is particularly effective against Cryptococcus neoformans. It is well absorbed and passes readily across the blood-brain barrier into the cerebrospinal fluid. Clinical information Uses Dosage and administration: Cryptococcal meningitis Following treatment with amphotericin B For either two weeks or until the condition has stabilised or improved: fluconazole 800 mg either orally or intravenously for two days followed by 400 mg once a day for 8 weeks, reduced to fluconazole 200 mg oral once a day thereafter. Oesophageal and resistant oropharyngeal candidiasis 200 mg as an initial loading dose followed by 100 mg daily until symptoms have resolved. Doses of up to 400 mg daily have been used in very resistant cases. Coccidioidomycosis 400 mg orally or intravenously daily in patients unable to tolerate amphotericin B. Contraindications Hypersensitivity to azole derivatives. Precautions Dosage should be reduced in accordance with the creatinine clearance rate in patients with renal impairment. Use in pregnancy Safe use in pregnancy has not been established. The need for treatment must be determined by the condition of the mother. Fluconazole is used to treat fungal infections, including yeast infections of the vagina, mouth, throat, esophagus (tube leading from the mouth to the stomach), abdomen (area between the chest and waist), lungs, blood, and other organs. Fluconazole is also used to treat meningitis (infection of the membranes covering the brain and spine) caused by fungus. Fluconazole is also used to prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before a bone marrow transplant (replacement of unhealthy spongy tissue inside the bones with healthy tissue). Fluconazole is in a class of antifungals called triazoles. It works by slowing the growth of fungi that cause infection. Fluconazole comes as a tablet and a suspension (liquid) to take by mouth. It is usually taken once a day, with or without food.

DIFLUCAN® <b>fluconazole</b> FDA-Approved Patient Labeling Pfizer.

DIFLUCAN® fluconazole FDA-Approved Patient Labeling Pfizer.

QT prolongation Torsades de pointes Alopecia Anaphylactic reactions Angioedema Cholestasis Dizziness Dyspnea Hepatic failure Hepatitis Hypertriglyceridemia Hypokalemia Increased alkaline phosphatase Increased ALT/AST Jaundice Leukopenia Pallor Seizures Stevens-Johnson syndrome Taste perversion Thrombocytopenia Toxic epidermal necrolysis Hypersensitivity to other azoles Use caution in proarrhythmic conditions and renal impairment Use extreme caution or avoid in congenital long-QT patients and patients with conditions that increase QT-prolongation risk Fluconazole inhibits CYP2C9, CYP2C19, and CYP3A4 isoenzymes; coadministration with drugs that are substrates if these isoenzymes may be contraindicated or warrant dosage modifications Capsules contain lactose and should not be given to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Powder for oral suspension contains sucrose and should not be used in patients with hereditary fructose, glucose/galactose malabsorption or sucrase-isomaltase deficiency Syrup contains glycerol; may cause headache, stomach upset, and diarrhea Hepatotoxicity reported with use; use with caution in patients with hepatic impairment Rare exfoliative skin disorders reported; monitor closely if rash develops and discontinue if it progresses When driving vehicles or operating machines, it should be taken into account that dizziness or seizures may occasionally occur Candida krusei is inherently resistant Convenience and efficacy of single dose oral tablet of fluconazole regimen for the treatment of vaginal yeast infections should be weighed against acceptability of higher incidence of drug related adverse events with fluconazole (26%) versus intravaginal agents (16%) If drug is used during pregnancy or if patient becomes pregnant while taking the drug, patient should be informed of potential hazard to fetus; effective contraceptive measures should be considered in women of child-bearing potential who are being treated with 400 to 800 mg/day and should continue throughout the treatment period and for approximately 1 week (5 to 6 half-lives) after the final dose Highly selective inhibitor of fungal cytochrome P-450-dependent enzyme lanosterol 14-alpha-demethylase Subsequent loss of normal sterols correlates with accumulation of 14 alpha-methyl sterols in fungi and may be responsible for the fungistatic activity of fluconazole Additive: TMP-SMX Y-site: Amphotericin B, amphotericin B cholesteryl sulfate, ampicillin, calcium gluconate, cefotaxime, ceftazidime(? ), ceftriaxone, cefuroxime, chloramphenicol, clindamycin, co-trimoxazole, diazepam, digoxin, erythromycin lactobionate, furosemide, haloperidol, hydroxyzine, imipenem/cilastatin, pentamidine, piperacillin, ticarcillin, TMP-SMX Solution: D5W, LR Additive: Acyclovir, amikacin, amphotericin B, cefazolin, ceftazidime, ciprofloxacin, clindamycin, gentamicin, heparin, meropenem, metronidazole, morphine, piperacillin, potassium chloride, ranitidine with ondansetron, theophylline Y-site: Acyclovir, aldesleukin, allopurinol, amifostine, amikacin, aminophylline, amiodarone, ampicillin-sulbactam, aztreonam, benztropine, bivalirudin, cefazolin, cefepime, cefotetan, cefoxitin, cefpirome, chlorpromazine, cimetidine, cisatracurium, dexamethasone sodium phosphate, dexmedetomidine, diltiazem, diphenhydramine, dobutamine, docetaxel, dopamine, doxorubicin liposomal, droperidol, etoposide PO4, famotidine, fenoldopam, filgrastim, fludarabine, foscarnet, ganciclovir, gatifloxacin, gemcitabine, gentamicin, granisetron, heparin, hetastarch, hydrocortisone, immune globulin, leucovorin, linezolid, lorazepam, melphalan, meperidine, meropenem, metoclopramide, metronidazole, midazolam, morphine, nafcillin, nitroglycerin, ondansetron, oxacillin, paclitaxel, pancuronium, penicillin G, phenytoin, piperacillin-tazobactam, prochlorperazine, promethazine, propofol, quinupristin-dalfopristin, ranitidine, remifentanil, sargramostim, tacrolimus, teniposide, theophylline, thiotepa, ticarcillin-clavulanate, tobramycin, vancomycin, vecuronium, vinorelbine, zidovudine Tablets: Store below 86° F (30° C) Dry powder: Store below 86° F (30° C); reconstituted suspension should be stored between 86° F (30° C) and 41° F (5° C), and unused portion should be discarded after 2 weeks; protect from freezing Injection (glass bottles): Store between 86° F (30° C) and 41° F (5° C); protect from freezing Injection (Viaflex Plus plastic containers): Store between 77° F (25° C) and 41° F (5° C); protect from freezing The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985 You may also contact the U. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or gov/Med Watch If you are looking for information about Pfizer studies currently recruiting new patients in your area, you can begin your search on our website. For questions about a Pfizer Clinical Trial, call (800) 718-1021 or email Pfizer Rx Pathways® connects eligible patients, regardless of their insurance status, to a range of assistance programs that offer insurance support, co-pay help, and medicines for free or at a savings. For more information, please call (844) 989-7284 or visit Eligible patients can register for valuable savings offers for nearly 40 brand name medications.

HIGHLIGHTS OF <i>PRESCRIBING</i> <i>INFORMATION</i> Do not administer to persons with.
HIGHLIGHTS OF PRESCRIBING INFORMATION Do not administer to persons with.

See full prescribing information for NOXAFIL. to Itraconazole and/or Fluconazole Noxafil oral suspension is indicated for the treatment of oropharyngeal. 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 No. 40 aluminum lake dye, and magnesium stearate.

Fluconazole prescribing information
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