Flurit-D tablets

Flurit-D

  • Active Ingredient: Fluconazole
  • 200 mg, 150 mg, 50 mg
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What is Flurit-D?

The active ingredient of Flurit-D 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

Flurit-D 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 Flurit-D include: general feeling of tiredness or weakness; Hair loss or thinning of the hair; difficulty with swallowing; chills; fast heartbeat; blistering, peeling, or loosening of the skin; Fearfulness, suspiciousness, or other mental changes; dizziness.

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What other drugs will affect Flurit-D?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Flurit-D can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect Flurit-D, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Pregnancy and Flurit-D

In general, it's not recommended that pregnant women take this medication.

Flurit-D can harm the fetus and should only be taken in situations when there are no other safer options available.

Regardless, you should tell your doctor if you are pregnant or plan to become pregnant before taking this medication.

Flurit-D has been found to pass into breast milk, so alert your physician if you are breastfeeding or plan to breastfeed.

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 Flurit-D (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 Flurit-D did not eliminate or diminish this effect. Concomitant administration of voriconazole and Flurit-D at any dose is not recommended. Close monitoring for adverse events related to voriconazole is recommended if voriconazole is used sequentially after Flurit-D, especially within 24 h of the last dose of Flurit-D. (See PRECAUTIONS.)

Is Diflucan (Flurit-D) safe to use during pregnancy or while breastfeeding?

  • There are no adequate studies of Diflucan in pregnant women. There are reports of harmful effects to the fetus when high dose Flurit-D was administered to pregnant women for a few months. Use of Flurit-D during pregnancy is not recommended.
  • Diflucan is secreted in breast milk at concentrations similar to the mother's blood level. However, Flurit-D is used for treating neonates with fungal infections and for treating lactation associated Candida infections. Available evidence suggests that use of Flurit-D during breastfeeding has little risk.

Tacrolimus

Flurit-D may increase the serum concentrations of orally administered tacrolimus up to 5 times due to inhibition of tacrolimus metabolism through CYP3A4 in the intestines. No significant pharmacokinetic changes have been observed when tacrolimus is given intravenously. Increased tacrolimus levels have been associated with nephrotoxicity. Dosage of orally administered tacrolimus should be decreased depending on tacrolimus concentration. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

General

Some azoles, including Flurit-D, have been associated with prolongation of the QT interval on the electrocardiogram. Flurit-D causes QT prolongation via the inhibition of Rectifier Potassium Channel current (Ikr). The QT prolongation caused by other medicinal products (such as amiodarone) may be amplified via the inhibition of cytochrome P450 (CYP) 3A4. (See DRUG INTERACTIONS.) During post-marketing surveillance, there have been rare cases of QT prolongation and torsade de pointes in patients taking Flurit-D. Most of these reports involved seriously ill patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities, and concomitant medications that may have been contributory. Patients with hypokalemia and advanced cardiac failure are at an increased risk for the occurrence of life-threatening ventricular arrhythmias and torsade de pointes.

Flurit-D should be administered with caution to patients with these potentially proarrhythmic conditions.

Concomitant use of Flurit-D and erythromycin has the potential to increase the risk of cardiotoxicity (prolonged QT interval, torsade de pointes) and consequently sudden heart death. This combination should be avoided.

Flurit-D should be administered with caution to patients with renal dysfunction.

Adrenal insufficiency has been reported in patients receiving azoles, including Flurit-D. Reversible cases of adrenal insufficiency have been reported in patients receiving Flurit-D.

DIFLUCAN Powder for Oral Suspension contains sucrose and should not be used in patients with hereditary fructose, glucose/galactose malabsorption, and sucrase-isomaltase deficiency.

When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or seizures may occur.

What is Diflucan (Flurit-D)? How does it work (mechanism of action)?

Diflucan (Flurit-D) is an anti-fungal medication related to clotrimazole (Lotrimin), ketoconazole (Nizoral), itraconazole (Sporanox), and miconazole (Micatin, Monistat). Flurit-D prevents growth of fungi by preventing production of the membranes that surround fungal cells.

Terfenadine

Because of the occurrence of serious cardiac dysrhythmias secondary to prolongation of the QTc interval in patients receiving azole antifungals in conjunction with terfenadine, interaction studies have been performed. One study at a 200 mg daily dose of Flurit-D failed to demonstrate a prolongation in QTc interval. Another study at a 400 mg and 800 mg daily dose of Flurit-D demonstrated that DIFLUCAN taken in doses of 400 mg/day or greater significantly increases plasma levels of terfenadine when taken concomitantly. The combined use of Flurit-D at doses of 400 mg or greater with terfenadine is contraindicated. (See CONTRAINDICATIONS and CLINICAL PHARMACOLOGY: Drug Interaction Studies.) The coadministration of Flurit-D at doses lower than 400 mg/day with terfenadine should be carefully monitored.

In Patients Receiving Multiple Doses For Other Infections

Sixteen percent of over 4000 patients treated with DIFLUCAN (Flurit-D) in clinical trials of 7 days or more experienced adverse events. Treatment was discontinued in 1.5% of patients due to adverse clinical events and in 1.3% of patients due to laboratory test abnormalities.

Clinical adverse events were reported more frequently in HIV infected patients (21%) than in non-HIV infected patients (13%); however, the patterns in HIV infected and non-HIV infected patients were similar. The proportions of patients discontinuing therapy due to clinical adverse events were similar in the two groups (1.5%).

The following treatment-related clinical adverse events occurred at an incidence of 1% or greater in 4048 patients receiving DIFLUCAN for 7 or more days in clinical trials: nausea 3.7%, headache 1.9%, skin rash 1.8%, vomiting 1.7%, abdominal pain 1.7%, and diarrhea 1.5%.

Which drugs or supplements interact with Diflucan (Flurit-D)?

  • Hydrochlorothiazide increases the blood concentration of Flurit-D by 40%. However, dosage modification is not recommended when both drugs are combined.
  • Rifampin (Rifadin, Rimactane, Rifadin, Rifater, Rifamate) reduces the blood concentration of oral Flurit-D, probably by increasing the elimination of Flurit-D in the liver; therefore, reducing the effectiveness of Flurit-D.
  • Flurit-D may increase the concentration of warfarin (Coumadin, Jantoven) in blood by reducing the elimination of warfarin. Therefore, the effect of warfarin may increase, leading to an increased tendency to bleed.
  • phenytoin (Dilantin),
  • cyclosporine,
  • zidovudine (Retrovir),
  • saquinavir (Invirase),
  • theophylline (Theo-Dur, Respbid, Slo-Bid, Theo-24, Theolair, Uniphyl, Slo-Phyllin),
  • tolbutamide,
  • glyburide (Micronase, Diabeta, Glynase),
  • glipizide,
  • triazolam (Glucotrol),
  • midazolam (Versed),
  • celecoxib (Celebrex),
  • fentanyl (Sublimaze),
  • atorvastatin (Lipitor),
  • simvastatin (Zocor), and
  • lovastatin (Mevacor).
  • As a result, the risk of side effects from the above drugs may increase.
  • Combining Flurit-D with amiodarone (Cordarone), pimozide (Orap), bepridil (Vascor) or other drugs that affect heart rhythm may increase the risk of abnormal heart rhythms.
  • Fentanyl

    One fatal case of possible fentanyl-Flurit-D interaction was reported. The author judged that the patient died from fentanyl intoxication. Furthermore, in a randomized crossover study with 12 healthy volunteers, it was shown that Flurit-D delayed the elimination of fentanyl significantly. Elevated fentanyl concentration may lead to respiratory depression.

    Olaparib

    Moderate inhibitors of CYP3A4 such as Flurit-D increase olaparib plasma concentrations; concomitant use is not recommended. If the combination cannot be avoided, reduce the dose of olaparib as instructed in the LYNPARZA ® (Olaparib) Prescribing Information.

    Phenytoin AUC was determined after 4 days of phenytoin dosing (200 mg daily, orally for 3 days followed by 250 mg intravenously for one dose) both with and without the administration of Flurit-D (oral DIFLUCAN 200 mg daily for 16 days) in 10 normal male volunteers. There was a significant increase in phenytoin AUC. The mean ± SD increase in phenytoin AUC was 88% ± 68% (range: 16 to 247%). The absolute magnitude of this interaction is unknown because of the intrinsically nonlinear disposition of phenytoin. (See PRECAUTIONS.)

    Concomitant oral administration of 100 mg DIFLUCAN and 50 mg hydrochlorothiazide for 10 days in 13 normal volunteers resulted in a significant increase in Flurit-D AUC and Cmax compared to DIFLUCAN given alone. There was a mean ± SD increase in Flurit-D AUC and Cmax of 45% ± 31% (range: 19 to 114%) and 43% ± 31% (range: 19 to 122%), respectively. These changes are attributed to a mean ± SD reduction in renal clearance of 30% ± 12% (range: –10 to –50%).

    Examples of Flurit-D in a Sentence

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