Fluvin tablets

Fluvin

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

The active ingredient of Fluvin 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

Fluvin 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 Fluvin include: unusual bleeding or bruising; sores, ulcers, or white spots in the mouth or on the lips; cough; loss of bladder control; nausea and vomiting; Black, tarry stools; stomach pain, continuing; intravenous injectable, intravenous solution.

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HMG-CoA Reductase Inhibitors

The risk of myopathy and rhabdomyolysis increases when Fluvin 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.

Geriatric Use

In non-A >1%) side effects, rash, vomiting, and diarrhea occurred in greater proportions of older patients. Similar proportions of older patients (2.4%) and younger patients (1.5%) discontinued Fluvin therapy because of side effects. In post-marketing experience, spontaneous reports of anemia and acute renal failure were more frequent among patients 65 years of age or older than in those between 12 and 65 years of age. Because of the voluntary nature of the reports and the natural increase in the incidence of anemia and renal failure in the elderly, it is however not possible to establish a causal relationship to drug exposure.

Controlled clinical trials of Fluvin did not include sufficient numbers of patients aged 65 and older to evaluate whether they respond differently from younger patients in each indication. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Fluvin is primarily cleared by renal excretion as unchanged drug. Because elderly patients are more likely to have decreased renal function, care should be taken to adjust dose based on creatinine clearance. It may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION.)

How to store Fluvin

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

Saquinavir

Fluvin increases the AUC of saquinavir by approximately 50%, Cmax by approximately 55%, and decreases the clearance of saquinavir by approximately 50% due to inhibition of saquinavir’s hepatic metabolism by CYP3A4 and inhibition of P-glycoprotein. Dosage adjustment of saquinavir may be necessary.

Fluvin Warnings

If you are allergic to Fluvin or any of its inactive ingredients, you should not take Fluvin.

If you are taking medications that can change the electrical activity in the heart you should not take this drug.

Also, if you have severe kidney problems (kidneys with a creatinine clearance, CrCl, or urine output 50 ml/ minute or less), your body may not be able to eliminate Fluvin as quickly as it should.

Your doctor may need to find a special dose that works best for you.

Be sure to let your doctor know that you have kidney problems before taking this medication. People who are on dialysis should receive the full dose of Fluvin after they have finished their dialysis procedure.

Talk to your doctor before taking Fluvin if you:

  • Are taking medications that change heart rhythm or conduction like Ery-tab (erythromycin), Orap (pimozide), or quinidine
  • Have kidney problems
  • Are pregnant

Additionally, if you are allergic to azoles (the building block of a certain class of antifungal drugs that includes Fluvin), you should not take Fluvin.

It should also be noted that people with certain sensitivities must be careful with various dosage forms of Fluvin.

For example, people who may have inherited certain genetic conditions, including intolerances to certain sugars, such as glucose-galactose, lapp lactase, or sucrose, should avoid Diflucan capsules because they contain lactose.

People with glycerol sensitivities should avoid Fluvin syrups because the glycerol may cause unpleasant symptoms like diarrhea, stomach discomfort, or headaches.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
  • A type of abnormal heartbeat (prolonged QT interval) has happened with this medicine (Fluvin tablets). Sometimes, this has led to another type of unsafe abnormal heartbeat (torsades de pointes). Call your doctor right away if you have a fast or abnormal heartbeat, or if you pass out.

How is this medicine (Fluvin Tablets) best taken?

Use this medicine (Fluvin tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • To gain the most benefit, do not miss doses.
  • Keep taking this medicine (Fluvin tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Vinca Alkaloids

Although not studied, Fluvin may increase the plasma levels of the vinca alkaloids (e.g., vincristine and vinblastine) and lead to neurotoxicity, which is possibly due to an inhibitory effect on CYP3A4.

Two adequate and well-controlled studies were conducted in the U.S. using the 150 mg tablet. In both, the results of the Fluvin regimen were comparable to the control regimen (clotrimazole or miconazole intravaginally for 7 days) both clinically and statistically at the one month post-treatment evaluation.

The therapeutic cure rate, defined as a complete resolution of signs and symptoms of vaginal candidiasis (clinical cure), along with a negative KOH examination and negative culture for Candida (microbiologic eradication), was 55% in both the Fluvin group and the vaginal products group.

Approximately three-fourths of the enrolled patients had acute vaginitis ( 4 episodes/12 months) and achieved 57% clinical cure, 47% mycologic eradication, and 40% therapeutic cure. The numbers are too small to make meaningful clinical or statistical comparisons with vaginal products in the treatment of patients with recurrent vaginitis.

Substantially more gastrointestinal events were reported in the Fluvin group compared to the vaginal product group. Most of the events were mild to moderate. Because Fluvin was given as a single dose, no discontinuations occurred.

Parameter Fluvin PO Vaginal Products Evaluable patients 448 422 With any adverse event 141 (31%) 112 (27%) Nervous System 90 (20%) 69 (16%) Gastrointestinal 73 (16%) 18 (4%) With drug-related event 117 (26%) 67 (16%) Nervous System 61 (14%) 29 (7%) Headache 58 (13%) 28 (7%) Gastrointestinal 68 (15%) 13 (3%) Abdominal pain 25 (6%) 7 (2%) Nausea 30 (7%) 3 (1%) Diarrhea 12 (3%) 2 (

Introduction

Fluvin is a triazole fungistatic agent used in the treatment of systemic and superficial fungal infections. Fluvin therapy can cause transient mild-to-moderate serum aminotransferase elevations and is a known cause of clinically apparent acute drug induced liver injury.

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 Fluvin 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.

Which drugs or supplements interact with Diflucan (Fluvin)?

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

    Diflucan (Fluvin) 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.


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