Flucoder tablets

Flucoder

  • Active Ingredient: Fluconazole
  • 200 mg, 150 mg, 50 mg
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What is Flucoder?

The active ingredient of Flucoder brand is fluconazole. Fluconazole is an antifungal medicine. Fluconazole USP 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 USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40 aluminum lake dye, magnesium stearate, microcrystalline cellulose and povidone.

Used for

Flucoder is used to treat diseases such as: Blastomycosis, Bone Marrow Transplantation, Candida Urinary Tract Infection, Candidemia, Chronic Mucocutaneous Candidiasis, Coccidioidomycosis, Coccidioidomycosis, Meningitis, Cryptococcal Meningitis, Immunocompetent Host, Cryptococcal Meningitis, Immunosuppressed Host, Cryptococcosis, Esophageal Candidiasis, Fungal Infection Prophylaxis, Fungal Infection, Internal and Disseminated, Fungal Peritonitis, Fungal Pneumonia, Histoplasmosis, Onychomycosis, Fingernail, Onychomycosis, Toenail, Oral Thrush, Sporotrichosis, Systemic Candidiasis, Tinea Corporis, Tinea Cruris, Tinea Versicolor, Vaginal Yeast Infection.

Side Effect

Possible side effects of Flucoder include: increased thirst; pale skin; chest pain or discomfort; blistering, peeling, or loosening of the skin; puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue; hives, itching, or skin rash.

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Flucoder and Grapefruit Juice

The liver breaks down Flucoder and grapefruit juice the same way.

Grapefruit juice slows down how quickly the body is able to break down the Flucoder, which could cause Flucoder levels in the blood to rise dangerously high.

You should therefore avoid eating grapefruit and drinking grapefruit juice while taking Flucoder.

An open-label, comparative study of the efficacy and safety of DIFLUCAN (2 to 3 mg/kg/day) and oral nystatin (400,000 I.U. 4 times daily) in immunocompromised children with oropharyngeal candidiasis was conducted. Clinical and mycological response rates were higher in the children treated with Flucoder.

Clinical cure at the end of treatment was reported for 86% of Flucoder-treated patients compared to 46% of nystatin treated patients. Mycologically, 76% of Flucoder treated patients had the infecting organism eradicated compared to 11% for nystatin treated patients.

The proportion of patients with clinical relapse 2 weeks after the end of treatment was 14% for subjects receiving DIFLUCAN and 16% for subjects receiving nystatin. At 4 weeks after the end of treatment, the percentages of patients with clinical relapse were 22% for DIFLUCAN and 23% for nystatin.

Cyclosporine AUC and Cmax were determined before and after the administration of Flucoder 200 mg daily for 14 days in eight renal transplant patients who had been on cyclosporine therapy for at least 6 months and on a stable cyclosporine dose for at least 6 weeks. There was a significant increase in cyclosporine AUC, Cmax, Cmin (24-hour concentration), and a significant reduction in apparent oral clearance following the administration of Flucoder. The mean ± SD increase in AUC was 92% ± 43% (range: 18 to 147%). The Cmax increased 60% ± 48% (range: –5 to 133%). The Cmin increased 157% ± 96% (range: 33 to 360%). The apparent oral clearance decreased 45% ± 15% (range: –15 to –60%). (See PRECAUTIONS.)

Pharmacokinetics And Metabolism

The pharmacokinetic properties of Flucoder are similar following administration by the intravenous or oral routes. In normal volunteers, the bioavailability of orally administered Flucoder 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 (Flucoder) leads to a mean Cmax of 6.72 mcg/mL (range: 4.12 to 8.08 mcg/mL) and after single oral doses of 50 to 400 mg, Flucoder plasma concentrations and area under the plasma concentration-time curve (AUC) are dose proportional.

The Cmax and AUC data from a food-effect study involving administration of DIFLUCAN (Flucoder) 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. (See DOSAGE AND ADMINISTRATION.)

Steady-state concentrations are reached within 5 to 10 days following oral doses of 50 to 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 Flucoder 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, Flucoder penetrates into all body fluids studied (see table below). In normal volunteers, saliva concentrations of Flucoder were equal to or slightly greater than plasma concentrations regardless of dose, route, or duration of dosing. In patients with bronchiectasis, sputum concentrations of Flucoder 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, Flucoder concentrations in the cerebrospinal fluid (CSF) are approximately 80% of the corresponding plasma concentrations.

A single oral 150 mg dose of Flucoder administered to 27 patients penetrated into vaginal tissue, resulting in tissue: plasma ratios ranging from 0.94 to 1.14 over the first 48 hours following dosing.

A single oral 150 mg dose of Flucoder administered to 14 patients penetrated into vaginal fluid, resulting in fluid: plasma ratios ranging from 0.36 to 0.71 over the first 72 hours following dosing.

In normal volunteers, Flucoder is cleared primarily by renal excretion, with approximately 80% of the administered dose appearing in the urine as unchanged drug. About 11% of the dose is excreted in the urine as metabolites.

The pharmacokinetics of Flucoder are markedly affected by reduction in renal function. There is an inverse relationship between the elimination half-life and creatinine clearance. The dose of DIFLUCAN may need to be reduced in patients with impaired renal function. (See DOSAGE AND ADMINISTRATION.) A 3-hour hemodialysis session decreases plasma concentrations by approximately 50%.

In normal volunteers, DIFLUCAN administration (doses ranging from 200 mg to 400 mg once daily for up to 14 days) was associated with small and inconsistent effects on testosterone concentrations, endogenous corticosteroid concentrations, and the adrenocorticotropic hormone (ACTH)-stimulated cortisol response.

Carcinogenesis, Mutagenesis, And Impairment Of Fertility

Flucoder showed no evidence of carcinogenic potential in mice and rats treated orally for 24 months at doses of 2.5 mg/kg/day, 5 mg/kg/day, or 10 mg/kg/day (approximately 2 to 7 times the recommended human dose). Male rats treated with 5 mg/kg/day and 10 mg/kg/day had an increased incidence of hepatocellular adenomas.

Flucoder, with or without metabolic activation, was negative in tests for mutagenicity in four strains of S. typhimurium, and in the mouse lymphoma L5178Y system. Cytogenetic studies in vivo (murine bone marrow cells, following oral administration of Flucoder) and in vitro (human lymphocytes exposed to Flucoder at 1000 mcg/mL) showed no evidence of chromosomal mutations.

Flucoder did not affect the fertility of male or female rats treated orally with daily doses of 5 mg/kg, 10 mg/kg, or 20 mg/kg or with parenteral doses of 5 mg/kg, 25 mg/kg, or 75 mg/kg, although the onset of parturition was slightly delayed at 20 mg/kg PO. In an intravenous perinatal study in rats at 5 mg/kg, 20 mg/kg, and 40 mg/kg, dystocia and prolongation of parturition were observed in a few dams at 20 mg/kg (approximately 5 to 15 times the recommended human dose) and 40 mg/kg, but not at 5 mg/kg. The disturbances in parturition were reflected by a slight increase in the number of still born pups and decrease of neonatal survival at these dose levels. The effects on parturition in rats are consistent with the species specific estrogen-lowering property produced by high doses of Flucoder. Such a hormone change has not been observed in women treated with Flucoder. (See CLINICAL PHARMACOLOGY.)

Oral Contraceptives

Two pharmacokinetic studies with a combined oral contraceptive have been performed using multiple doses of Flucoder. There were no relevant effects on hormone level in the 50 mg Flucoder study, while at 200 mg daily, the AUCs of ethinyl estradiol and levonorgestrel were increased 40% and 24%, respectively. Thus, multiple-dose use of Flucoder at these doses is unlikely to have an effect on the efficacy of the combined oral contraceptive.

Short-Acting Benzodiazepines

Following oral administration of midazolam, Flucoder resulted in substantial increases in midazolam concentrations and psychomotor effects. This effect on midazolam appears to be more pronounced following oral administration of Flucoder than with Flucoder administered intravenously. If short-acting benzodiazepines, which are metabolized by the cytochrome P450 system, are concomitantly administered with Flucoder, consideration should be given to decreasing the benzodiazepine dosage, and the patients should be appropriately monitored. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

Voriconazole is a substrate for both CYP2C9 and CYP3A4 isoenzymes. Concurrent administration of oral Voriconazole (400 mg Q12h for 1 day, then 200 mg Q12h for 2.5 days) and oral Flucoder (400 mg on Day 1, then 200 mg Q24h for 4 days) to 6 healthy male subjects resulted in an increase in Cmax and AUCτ of voriconazole by an average of 57% (90% CI: 20% to 107%) and 79% (90% CI: 40% to 128%), respectively. In a follow-on clinical study involving 8 healthy male subjects, reduced dosing and/or frequency of voriconazole and Flucoder did not eliminate or diminish this effect. Concomitant administration of voriconazole and Flucoder at any dose is not recommended. Close monitoring for adverse events related to voriconazole is recommended if voriconazole is used sequentially after Flucoder, especially within 24 h of the last dose of Flucoder. (See PRECAUTIONS.)

A placebo-controlled, randomized, multiple-dose study examined the potential interaction of Flucoder with cisapride. Two groups of 10 normal subjects were administered Flucoder 200 mg daily or placebo. Cisapride 20 mg four times daily was started after 7 days of Flucoder or placebo dosing. Following a single dose of Flucoder, there was a 101% increase in the cisapride AUC and a 91% increase in the cisapride Cmax. Following multiple doses of Flucoder, there was a 192% increase in the cisapride AUC and a 154% increase in the cisapride Cmax. Flucoder significantly increased the QTc interval in subjects receiving cisapride 20 mg four times daily for 5 days. (See CONTRAINDICATIONS and PRECAUTIONS.)

Cisapride

There have been reports of cardiac events, including torsade de pointes, in patients to whom Flucoder and cisapride were coadministered. A controlled study found that concomitant Flucoder 200 mg once daily and cisapride 20 mg four times a day yielded a significant increase in cisapride plasma levels and prolongation of QTc interval. The combined use of Flucoder with cisapride is contraindicated. (See CONTRAINDICATIONS and CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

Can Flucoder cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with Flucoder. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

HMG-CoA Reductase Inhibitors

The risk of myopathy and rhabdomyolysis increases when Flucoder is coadministered with HMG-CoA reductase inhibitors metabolized through CYP3A4, such as atorvastatin and simvastatin, or through CYP2C9, such as fluvastatin. If concomitant therapy is necessary, the patient should be observed for symptoms of myopathy and rhabdomyolysis and creatinine kinase should be monitored. HMG-CoA reductase inhibitors should be discontinued if a marked increase in creatinine kinase is observed or myopathy/rhabdomyolysis is diagnosed or suspected.

What is Flucoder?

Flucoder is a triazole medicine used to treat fungal infections. It is effective against a broad spectrum of fungi including:

In New Zealand, Flucoder is available as 50 mg, 150 mg and 200 mg capsules on prescription (Diflucan®). There is also a 2 mg/ml injection for intravenous use. In New Zealand, the Pharmaceutical Schedule subs >over the counter .

Flucoder binds to the fungal p450 enzymes and stops the cells making ergosterol, the main component of the cell wall.

Flucoder is well absorbed orally with or without food. It is widely distributed in body tissues. It takes 22 to 30 hours for half of the medication to be cleared from the bloodstream and may take several days of continuous treatment to reach a steady concentration. The drug is eliminated unchanged in the urine so doses should be reduced if there is kidney disease.

Warnings

  • This medication contains Flucoder. Do not take Diflucan if you are allergic to Flucoder or any ingredients contained in this drug.
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

What Is Flucoder and How Does It Work?

Flucoder is used to treat vaginal yeast infections. It works by stopping the growth of common types of vaginal yeast (fungus). This medication belongs to a class of drugs called azole antifungals.

Flucoder is available under the following different brand names: Diflucan.

Dosages of Flucoder:

Adult and Pediatric Dosage Forms and Strengths

Dosage Considerations – Should be Given as Follows:

Adult: 200 mg orally on Day 1, THEN 100 mg once/day

Pediatric: 6 mg/kg orally on Day 1, THEN 3 mg/kg once/day; not to exceed 600 mg/day

  • Treatment should be administered for at least 2 weeks to decrease likelihood of relapse

Adult: 200 mg orally on Day 1, THEN 100 mg once/day; doses up to 400 mg/day may be used based on patient's response

Pediatric: 6 mg/kg orally on Day 1, THEN 3 mg/kg once/day

Doses up to 12 mg/kg/day may be used, based on patient's response

  • Treat for a minimum of 3 weeks and for at least 2 weeks following resolution of symptoms

Adult

  • 400 mg orally on Day 1, THEN 200 mg orally once/day
  • Dosage of up to 400 mg once/day may be used based on patient's response
  • Suppression of relapse in patients with AIDS: 200 mg orally once/day

  • 12 mg/kg orally/intravenously (IV) on Day 1, THEN 6 mg/kg once/day
  • Dose of 12 mg/kg once daily may be used, based on patient's response
  • Suppression in children with AIDS: 6 mg/kg once daily

  • Recommended duration of therapy is 10-12 weeks after cerebrospinal fluid becomes culture negative

Prophylaxis of Candidiasis with BMT

Prevention of candidiasis incidence in patients undergoing bone marrow transplant

400 mg orally once/day

  • Patients who are anticipated to have severe granulocytopenia should start prophylaxis several days before anticipated onset of neutropenia and continue for 7 days after neutrophil count rises greater than 1000 cells per mm³

Uncomplicated: 150 mg orally as a single dose

Complicated: 150 mg orally every 72 hours for 3 doses

Recurrent: 150 mg orally once/day for 10-14 days followed by 150 mg once weekly for 6 months

50-200 mg orally once/day

Systemic Candida Infections, Pediatric

6-12 mg/kg/day orally/intravenously (IV); not to exceed 600 mg/day

26-29 weeks' gestation: 6-12 mg/kg intravenously (IV)/orally

Maintenance: 3-6 mg/kg IV/orally once/day

Maintenance dose interval

  • 26-29 weeks' gestation: every 72 hours; administer every 24 hours after 2 weeks of life

Hepatic impairment: Not studied

  • Percent of recommended dose:
  • -CrCl greater than 50 mL/min: 100% of dose
  • -CrCl up to 50 mL/min: 50% dose
  • -Regular dialysis: 100% dose after each dialysis; on non-dialysis days, reduce dose according to creatinine clearance


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