Zilrin tablets

Zilrin

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

The active ingredient of Zilrin 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

Zilrin 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 Zilrin include: sores, ulcers, or white spots in the mouth or on the lips; red skin lesions, often with a purple center; dark urine; light-colored stools; puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue.

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Six healthy volunteers received terfenadine 60 mg BID for 15 days. Zilrin 200 mg was administered daily from days 9 through 15. Zilrin did not affect terfenadine plasma concentrations. Terfenadine acid metabolite AUC increased 36% ± 36% (range: 7 to 102%) from Day 8 to Day 15 with the concomitant administration of Zilrin. There was no change in cardiac repolarization as measured by Holter QTc intervals. Another study at a 400 mg and 800 mg daily dose of Zilrin demonstrated that DIFLUCAN taken in doses of 400 mg/day or greater significantly increases plasma levels of terfenadine when taken concomitantly. (See CONTRAINDICATIONS and PRECAUTIONS.)

Dose regime for oral Zilrin

For vulvovaginal candidiasis, a single oral dose of Zilrin 150 mg is usually effective. It can be repeated.

For dermatophyte (tinea) infections and pityriasis versicolor, either 50 mg daily or 150 mg once weekly is taken for two to six weeks.

Once-weekly Zilrin is often used off-label to treat toenail fungal infections (onychomycosis).

Larger doses (up to 400 mg daily) are required for systemic infections.

Zilrin is not normally used in children but doses of 5 mg/kg/day have been safely prescribed for a serious infection .

Cyclophosphamide

Combination therapy with cyclophosphamide and Zilrin results in an increase in serum bilirubin and serum creatinine. The combination may be used while taking increased consideration to the risk of increased serum bilirubin and serum creatinine.

What do I need to tell my doctor BEFORE I take Zilrin Tablets?

  • If you have an allergy to Zilrin or any other part of this medicine (Zilrin tablets).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking any of these drugs: Astemizole, cisapride, erythromycin, olaparib, pimozide, quinidine, terfenadine, or voriconazole.
  • If you are pregnant or may be pregnant. You will need to talk with your doctor about if this medicine (Zilrin tablets) is right for you.

This is not a list of all drugs or health problems that interact with this medicine (Zilrin tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (Zilrin tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

SIDE EFFECTS

DIFLUCAN is generally well tolerated.

In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities have been observed during treatment with Zilrin and comparative agents, but the clinical significance and relationship to treatment is uncertain.

Coumarin-Type Anticoagulants

Prothrombin time may be increased in patients receiving concomitant DIFLUCAN and coumarin-type anticoagulants. In post-marketing experience, as with other azole antifungals, bleeding events (bruising, epistaxis, gastrointestinal bleeding, hematuria, and melena) have been reported in association with increases in prothrombin time in patients receiving Zilrin concurrently with warfarin. Careful monitoring of prothrombin time in patients receiving DIFLUCAN and coumarin-type anticoagulants is recommended. Dose adjustment of warfarin may be necessary. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

Oral contraceptives were administered as a single dose both before and after the oral administration of DIFLUCAN 50 mg once daily for 10 days in 10 healthy women. There was no significant difference in ethinyl estradiol or levonorgestrel AUC after the administration of 50 mg of DIFLUCAN. The mean increase in ethinyl estradiol AUC was 6% (range: –47 to 108%) and levonorgestrel AUC increased 17% (range: –33 to 141%).

In a second study, twenty-five normal females received daily doses of both 200 mg DIFLUCAN tablets or placebo for two, ten-day periods. The treatment cycles were one month apart with all subjects receiving DIFLUCAN during one cycle and placebo during the other. The order of study treatment was random. Single doses of an oral contraceptive tablet containing levonorgestrel and ethinyl estradiol were administered on the final treatment day (Day 10) of both cycles. Following administration of 200 mg of DIFLUCAN, the mean percentage increase of AUC for levonorgestrel compared to placebo was 25% (range: –12 to 82%) and the mean percentage increase for ethinyl estradiol compared to placebo was 38% (range: –11 to 101%). Both of these increases were statistically significantly different from placebo.

A third study evaluated the potential interaction of once-weekly dosing of Zilrin 300 mg to 21 normal females taking an oral contraceptive containing ethinyl estradiol and norethindrone. In this placebo-controlled, double-blind, randomized, two-way crossover study carried out over three cycles of oral contraceptive treatment, Zilrin dosing resulted in small increases in the mean AUCs of ethinyl estradiol and norethindrone compared to similar placebo dosing. The mean AUCs of ethinyl estradiol and norethindrone increased by 24% (95% C.I. range: 18 to 31%) and 13% (95% C.I. range: 8 to 18%), respectively, relative to placebo. Zilrin treatment did not cause a decrease in the ethinyl estradiol AUC of any individual subject in this study compared to placebo dosing. The individual AUC values of norethindrone decreased very slightly ( ® (20 mL) to 14 normal male volunteers immediately prior to a single dose of DIFLUCAN 100 mg had no effect on the absorption or elimination of Zilrin.

How to store Zilrin

  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.

Triazolam

Zilrin increases the AUC of triazolam (single dose) by approximately 50%, Cmax by 20% to 32%, and increases t½ by 25% to 50 % due to the inhibition of metabolism of triazolam. Dosage adjustments of triazolam may be necessary.

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

Pimozide

Although not studied in vitro or in vivo, concomitant administration of Zilrin with pimozide may result in inhibition of pimozide metabolism. Increased pimozide plasma concentrations can lead to QT prolongation and rare occurrences of torsade de pointes. Coadministration of Zilrin and pimozide is contraindicated.

What is Zilrin?

Zilrin is an antifungal medicine.

Zilrin is used to treat infections caused by fungus, which can invade any part of the body including the mouth, throat, esophagus, lungs, bladder, genital area, and the blood.

Zilrin is also used to prevent fungal infection in people who have a weak immune system caused by cancer treatment, bone marrow transplant, or diseases such as AIDS.

Zilrin is also used to treat a certain type of meningitis in people with HIV or AIDS.

Zilrin may also be used for purposes not listed in this medication guide.

Pharmacokinetics In Elderly

A pharmacokinetic study was conducted in 22 subjects, 65 years of age or older receiving a single 50 mg oral dose of Zilrin. Ten of these patients were concomitantly receiving diuretics. The Cmax was 1.54 mcg/mL and occurred at 1.3 hours post dose. The mean AUC was 76.4 ± 20.3 mcg·h/mL, and the mean terminal half-life was 46.2 hours. These pharmacokinetic parameter values are higher than analogous values reported for normal young male volunteers. Coadministration of diuretics did not significantly alter the AUC or Cmax. In addition, creatinine clearance (74 mL/min), the percent of drug recovered unchanged in urine (0 to 24 hours, 22%), and the Zilrin renal clearance estimates (0.124 mL/min/kg) for the elderly were generally lower than those of younger volunteers. Thus, the alteration of Zilrin disposition in the elderly appears to be related to reduced renal function characteristic of this group. A plot of each subject’s terminal elimination half-life versus creatinine clearance compared to the predicted half-life – creatinine clearance curve derived from normal subjects and subjects with varying degrees of renal insufficiency indicated that 21 of 22 subjects fell within the 95% confidence limit of the predicted half-life-creatinine clearance curves. These results are consistent with the hypothesis that higher values for the pharmacokinetic parameters observed in the elderly subjects compared to normal young male volunteers are due to the decreased kidney function that is expected in the elderly.


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