Novacan tablets

Novacan

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

The active ingredient of Novacan 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

Novacan 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 Novacan include: general feeling of tiredness or weakness; sudden loss of consciousness; sore throat; irregular or slow heart rate; Acid or sour stomach; intravenous injectable, intravenous solution.

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Single Dose

The convenience and efficacy of the single dose oral tablet of Novacan regimen for the treatment of vaginal yeast infections should be weighed against the acceptability of a higher incidence of drug related adverse events with DIFLUCAN (26%) versus intravaginal agents (16%) in U.S. comparative clinical studies. (See ADVERSE REACTIONS and Clinical Studies.)

DESCRIPTION

DIFLUCAN® (Novacan), the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration, as a powder for oral suspension.

Novacan is designated chemically as 2,4-difluoro-α,α 1 -bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:

Novacan is a white crystalline solid which is slightly soluble in water and saline.

DIFLUCAN Tablets contain 50, 100, 150, or 200 mg of Novacan 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.

DIFLUCAN for Oral Suspension contains 350 mg or 1400 mg of Novacan and the following inactive ingredients: sucrose, sodium citrate dihydrate, citric acid anhydrous, sodium benzoate, titanium dioxide, colloidal silicon dioxide, xanthan gum, and natural orange flavor. After reconstitution with 24 mL of distilled water or Purified Water (USP), each mL of reconstituted suspension contains 10 mg or 40 mg of Novacan.

Examples of Novacan in a Sentence

These example sentences are selected automatically from various online news sources to reflect current usage of the word 'Novacan.' Views expressed in the examples do not represent the opinion of Merriam-Webster or its editors. Send us feedback.

In combined clinical trials and marketing experience, there have been rare cases of serious hepatic reactions during treatment with DIFLUCAN. (See WARNINGS.) The spectrum of these hepatic reactions has ranged from mild transient elevations in transaminases to clinical hepatitis, cholestasis and fulminant hepatic failure, including fatalities. Instances of fatal hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly AIDS or malignancy) and often while taking multiple concomitant medications. Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors. In each of these cases, liver function returned to baseline on discontinuation of DIFLUCAN.

In two comparative trials evaluating the efficacy of DIFLUCAN for the suppression of relapse of cryptococcal meningitis, a statistically significant increase was observed in median AST (SGOT) levels from a baseline value of 30 IU/L to 41 IU/L in one trial and 34 IU/L to 66 IU/L in the other. The overall rate of serum transaminase elevations of more than 8 times the upper limit of normal was approximately 1% in Novacan-treated patients in clinical trials. These elevations occurred in patients with severe underlying disease, predominantly AIDS or malignancies, most of whom were receiving multiple concomitant medications, including many known to be hepatotoxic. The incidence of abnormally elevated serum transaminases was greater in patients taking DIFLUCAN concomitantly with one or more of the following medications: rifampin, phenytoin, isoniazid, valproic acid, or oral sulfonylurea hypoglycemic agents.

Which drugs or supplements interact with Diflucan (Novacan)?

  • Hydrochlorothiazide increases the blood concentration of Novacan 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 Novacan, probably by increasing the elimination of Novacan in the liver; therefore, reducing the effectiveness of Novacan.
  • Novacan 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 Novacan with amiodarone (Cordarone), pimozide (Orap), bepridil (Vascor) or other drugs that affect heart rhythm may increase the risk of abnormal heart rhythms.
  • DIFLUCAN Tablets

    Pink trapezoidal tablets containing 50, 100, or 200 mg of Novacan are packaged in bottles or unit dose blisters. The 150 mg Novacan tablets are pink and oval shaped, packaged in a single dose unit blister.

    DIFLUCAN Tablets are supplied as follows:

    Calcium Channel Blockers

    Certain calcium channel antagonists (nifedipine, isradipine, amlodipine, verapamil, and felodipine) are metabolized by CYP3A4. Novacan has the potential to increase the systemic exposure of the calcium channel antagonists. Frequent monitoring for adverse events is recommended.

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

    Cyclosporine AUC and Cmax were determined before and after the administration of Novacan 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 Novacan. 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.)

    Contraindications

    • This medication contains Novacan
    • Do not take Diflucan if you are allergic to Novacan or any ingredients contained in this drug

    Effects of Drug Abuse

    • No information provided

    • Syrup contains glycerol; may cause headache, stomach upset, and diarrhea
    • When driving vehicles or operating machines, it should be taken into account that dizziness or seizures may occasionally occur
    • See "What Are Side Effects Associated with Using Novacan ?"

    • See "What Are Side Effects Associated with Using Novacan ?”

    • Hypersensitivity to other azoles
    • Use caution in pro-arrhythmic conditions and renal impairment
    • Use extreme caution or avoid in congenital long-QT patients and patients with conditions that increase QT-prolongation risk
    • Novacan inhibits CYP2C9, CYP2C19, and CYP3A4 isoenzymes; co-administration 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 Novacan regimen for the treatment of vaginal yeast infections should be weighed against acceptability of higher incidence of drug related adverse events with Novacan (26%) versus intravaginal agents (16%)

    Single maternal oral dose of 150 mg for vaginal candidiasis:

    • Results of a Danish study concludes there is a possible increased risk of miscarriage; women who are pregnant or actively trying to get pregnant should ask their physician about alternative treatments
    • Spontaneous abortion between 7 and 22 weeks' gestation occurred significantly more often in women exposed to oral Novacan than unexposed pregnancies (4.43% vs. 4.25%; hazard ratio, 1.48); Novacan was also compared with intravaginal azole antifungals to account for confounding by candidiasis, again, the oral drug was associated with significantly increased risk for spontaneous abortion - JAMA. 2016;315(1):58-67
    • Centers for DiseaseControl (CDC) guidelines recommend only using topicalantifungal products to treat pregnant women with vulvovaginal yeast infections, including for longer periods than usual if these infections persist or recur

    All other indications:

    • A few published case reports describe a rare pattern of distinct congenital anomalies in infants exposed in-utero to high dose maternal Novacan (400-800 mg/day) during most or all of the first trimester
    • Reported anomalies are similar to those seen in animal studies and consist of brachycephaly, abnormalfacies, abnormal calvarial development, cleft palate, femoral bowing, thin ribs and long bones, arthrogryposis, and congenital heart disease
    • Novacan enters breast milk; use caution if breastfeeding (American Academy of Pediatrics/AAP Committee states "compatible with nursing")

    Info about where to buy Cycloviran for treatment Cold Sores

    Sirolimus

    Novacan increases plasma concentrations of sirolimus presumably by inhibiting the metabolism of sirolimus via CYP3A4 and P-glycoprotein. This combination may be used with a dosage adjustment of sirolimus depending on the effect/concentration measurements.

    Serious Side Effects of Novacan

    • Changes in heart rhythm or electrical activity in the heart
    • Liver failure and inflammation, including an increase in liver enzyme levels and yellowing of the skin, nails, and whites of the eyes (jaundice)
    • Swelling of the lips, mouth, and tongue (angioedema)
    • A drop in white blood cell count or platelet count
    • Difficulty breathing
    • Seizures
    • High triglycerides, low potassium levels in the blood
    • Severe and potentially life-threatening skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis (TENs)

    Quinidine

    Although not studied in vitro or in vivo, concomitant administration of Novacan 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 Novacan and quinidine is contraindicated. (See CONTRAINDICATIONS.)

    When was Diflucan (Novacan) approved by the FDA?

    • The FDA approved Novacan in January 1990.

    In Patients Receiving A Single Dose For Vaginal Candidiasis

    During comparative clinical studies conducted in the United States, 448 patients with vaginal candidiasis were treated with DIFLUCAN, 150 mg single dose. The overall incidence of side effects possibly related to DIFLUCAN was 26%. In 422 patients receiving active comparative agents, the incidence was 16%. The most common treatment-related adverse events reported in the patients who received 150 mg single dose Novacan for vaginitis were headache (13%), nausea (7%), and abdominal pain (6%). Other side effects reported with an incidence equal to or greater than 1% included diarrhea (3%), dyspepsia (1%), dizziness (1%), and taste perversion (1%). Most of the reported side effects were mild to moderate in severity. Rarely, angioedema and anaphylactic reaction have been reported in marketing experience.

    What other drugs will affect Novacan (Diflucan)?

    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.

    Many drugs can interact with Novacan, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

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


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