Nurasel tablets

Nurasel

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

The active ingredient of Nurasel 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

Nurasel 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 Nurasel include: nausea and vomiting; numbness or tingling in the hands, feet, or lips; stomach pain, continuing; red skin lesions, often with a purple center; stomach discomfort or upset; Fearfulness, suspiciousness, or other mental changes; unusual tiredness or weakness; joint or muscle pain.

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Six healthy volunteers received terfenadine 60 mg BID for 15 days. Nurasel 200 mg was administered daily from days 9 through 15. Nurasel 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 Nurasel. 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 Nurasel 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.)

Summary

Diflucan (Nurasel) is a drug prescribed to treat fungal infections caused by Candida, for example, vaginal, oral, esophageal, urinary tract, pneumonia, and peritonitis. Side effects include nausea, diarrhea, dizziness, rash, indigestion, and abdominal pain.

Drug interactions, and pregnancy and breastfeeding safety information should be reviewed prior to taking this medication.

Plasma zidovudine concentrations were determined on two occasions (before and following Nurasel 200 mg daily for 15 days) in 13 volunteers with AIDS or ARC who were on a stable zidovudine dose for at least two weeks. There was a significant increase in zidovudine AUC following the administration of Nurasel. The mean ± SD increase in AUC was 20% ± 32% (range: –27 to 104%). The metabolite, GZDV, to parent drug ratio significantly decreased after the administration of Nurasel, from 7.6 ± 3.6 to 5.7 ± 2.2.

Although not studied in vitro or in vivo, concomitant administration of Nurasel with quinidine may result in inhibition of quinidine metabolism. Use of quinidine has been associated with QT prolongation and rare occurrences of torsade de pointes. Coadministration of Nurasel and quinidine is contraindicated. (See CONTRAINDICATIONS and PRECAUTIONS.)

Triazolam

Nurasel 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.

Cyclophosphamide

Combination therapy with cyclophosphamide and Nurasel 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.

More common side effects

The more common side effects of Nurasel oral tablet depend on how much of the drug you need to take. These side effects can include:

  • headache
  • diarrhea
  • nausea or upset stomach
  • dizziness
  • stomach pain
  • vomiting
  • changes in the way food tastes
  • severe rash in people with lowered immunity

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Tofacitinib

Systemic exposure to tofacitinib is increased when tofacitinib is coadministered with Nurasel. Reduce the dose of tofacitinib when given concomitantly with Nurasel (i.e., from 5 mg twice daily to 5 mg once daily as instructed in the XELJANZ ® label). (See CLINICAL PHARMACOLOGY: Drug Interaction Studies.)

Rare Side Effects of Nurasel

Nurasel may cause some unpredictable side effects, including baldness and dizziness.


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