Mycazole tablets

Mycazole

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

The active ingredient of Mycazole 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

Mycazole 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 Mycazole include: large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; mood changes; dark urine; Hair loss or thinning of the hair; clay-colored stools; lower back or side pain.

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Hepatotoxicity

Transient mild-to-moderate elevations in serum aminotransferase levels occur in up to 5% of patients treated with Mycazole, but these abnormalities are usually asymptomatic and resolve even with continuation of the medication. ALT elevations above 8 times the upper limit of normal are reported to occur in 1% of patients taking Mycazole and to represent the most common adverse event leading to early discontinuation of treatment. Clinically apparent hepatotoxicity due to Mycazole is rare, but well described. The liver injury is typically hepatocellular, arises within the first few weeks of therapy and can be accompanied by signs of hypersensitivity such as fever, rash and eosinophilia. Fatal instances of Mycazole induced liver injury have been reported (Case 1), but most cases are self-limited, although recovery may be delayed for several weeks after stopping Mycazole and may be slow requiring 2 to 3 months.

Likelihood score: B (likely cause of clinically apparent liver injury).

HMG-CoA Reductase Inhibitors

The risk of myopathy and rhabdomyolysis increases when Mycazole 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.

Drugs that should not be used with Mycazole

There are certain drugs that you should not use with Mycazole. When used with Mycazole, these drugs can cause dangerous effects in your body. Examples of these drugs include:

  • Terfenadine. When used with Mycazole at doses of 400 mg or higher, this drug can cause a life-threatening heart rhythm condition called torsades de pointes.
  • Pimozide, clarithromycin, erythromycin, ranolazine, lomitapide, donepezil, voriconazole, and quinidine. When used with Mycazole, these drugs can cause a life-threatening heart rhythm condition called torsades de pointes.

How should I take Mycazole (Diflucan)?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Your dose will depend on the infection you are treating. Vaginal infections are often treated with only one pill. For other infections, your first dose may be a double dose. Carefully follow your doctor's instructions.

You may take Mycazole with or without food.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Mycazole will not treat a viral infection such as the flu or a common cold.

Call your doctor if your symptoms do not improve, or if they get worse.

Store the tablets at room temperature away from moisture and heat.

You may store liquid Mycazole in a refrigerator, but do not allow it to freeze. Throw away any leftover liquid that is more than 2 weeks old.

Directions For Mixing The Oral Suspension

Prepare a suspension at time of dispensing as follows: tap bottle until all the powder flows freely. To reconstitute, add 24 mL of distilled water or Purified Water (USP) to Mycazole bottle and shake vigorously to suspend powder. Each bottle will deliver 35 mL of suspension. The concentrations of the reconstituted suspensions are as follows:

Note: Shake oral suspension well before using. Store reconstituted suspension between 86°F (30°C) and 41°F (5°C) and discard unused portion after 2 weeks. Protect from freezing.

Before taking this medicine

You should not use Mycazole if you are allergic to it.

Some medicines can cause unwanted or dangerous effects when used with Mycazole. Your doctor may change your treatment plan if you also use:

an antibiotic, antifungal, or antiviral medicine;

a blood thinner;

oral diabetes medicine;

heart or blood pressure medication;

medicine to prevent organ transplant rejection;

medicine to treat depression or mental illness;

an NSAID (nonsteroidal anti-inflammatory drug);

seizure medicine; or

Tell your doctor if you have ever had:

long QT syndrome (in you or a family member);

kidney disease; or

if you are allergic to other antifungal medicine (such as ketoconazole, itraconazole, miconazole, posaconazole, voriconazole, and others).

The liquid form of Mycazole contains sucrose. Talk to your doctor before using this form of Mycazole if you have a problem digesting sugars or milk.

It is not known whether Mycazole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

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 Mycazole and comparative agents, but the clinical significance and relationship to treatment is uncertain.

What should I avoid while using Mycazole?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Avoid driving or hazardous activity until you know how Mycazole will affect you. Your reactions could be impaired.


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