Mycocure
Generic Name
Fluconazole
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| mycocure 250 mg tablet | ৳ 40.00 | ৳ 400.00 |
Description
Overview of the medicine
Fluconazole is an antifungal medication used to treat a variety of fungal infections, including vaginal, oral, esophageal, and systemic candidiasis, and cryptococcal meningitis. It belongs to the azole class of antifungals.
Uses & Indications
Dosage
Adults
Dosages vary widely by indication. For vaginal candidiasis, a single 150 mg oral dose is common. For systemic infections, initial loading dose of 400 mg followed by 200-400 mg daily. For dermatophytosis, 150 mg once weekly or 50 mg once daily for 2-4 weeks. A 250 mg tablet might be prescribed for specific severe or resistant cases, or as a higher weekly dose. Always consult a physician for specific dosing.
Elderly
Similar to adults, but dosage adjustment may be needed for renal impairment. Closely monitor renal function.
Renal_impairment
Dosage reduction is recommended based on creatinine clearance. For CrCl <50 mL/min, the dose should be reduced by 50% after the initial loading dose.
How to Take
Mycocure tablets can be taken with or without food. Swallow the tablet whole with a glass of water. It should be taken at approximately the same time each day to maintain consistent drug levels.
Mechanism of Action
Fluconazole inhibits fungal cytochrome P450-dependent 14α-demethylation of lanosterol, which is an essential step in fungal ergosterol biosynthesis. Ergosterol is a vital component of the fungal cell membrane, and its disruption leads to increased cell permeability and cell death.
Pharmacokinetics
Onset
Varies by infection type, generally symptomatic relief within days. Steady-state levels are achieved within 5-10 days with daily dosing.
Excretion
Primarily renal, with about 80% of the dose excreted unchanged in urine.
Half life
Approximately 30 hours, allowing for once-daily or less frequent dosing.
Absorption
Well absorbed orally, with bioavailability >90%. Peak plasma concentrations are reached within 0.5 to 1.5 hours.
Metabolism
Minor hepatic metabolism (approximately 11% of the dose), primarily by CYP2C9.
Side Effects
Contraindications
- Known hypersensitivity to fluconazole, other azole antifungals, or any excipients of the product.
- Coadministration with drugs known to prolong the QT interval and are metabolized by CYP3A4, such as terfenadine, astemizole, cisapride, pimozide, quinidine, and erythromycin.
Drug Interactions
Warfarin
Increased prothrombin time (INR) requiring careful monitoring and dose adjustment of warfarin.
Phenytoin
Increased phenytoin serum concentrations; monitor levels and adjust phenytoin dose.
Amiodarone
Increased risk of Torsades de Pointes; avoid coadministration.
Rifampicin
Decreased fluconazole plasma levels; consider increasing fluconazole dose.
Cyclosporine
Increased cyclosporine plasma concentrations; monitor cyclosporine levels.
Hydrochlorothiazide
Increased fluconazole plasma concentrations.
Oral Hypoglycemics (sulfonylureas)
Increased risk of hypoglycemia; monitor blood glucose levels closely.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach and sight of children.
Overdose
In case of overdose, symptomatic and supportive treatment should be initiated. Gastric lavage may be considered. Hemodialysis significantly reduces plasma levels of fluconazole.
Pregnancy & Lactation
Pregnancy Category D. High doses and chronic use during the first trimester have been associated with increased risk of congenital abnormalities. Use only if the potential benefit justifies the potential risk to the fetus. Fluconazole is excreted in breast milk; use with caution during lactation, especially with single high doses or prolonged use.
Side Effects
Contraindications
- Known hypersensitivity to fluconazole, other azole antifungals, or any excipients of the product.
- Coadministration with drugs known to prolong the QT interval and are metabolized by CYP3A4, such as terfenadine, astemizole, cisapride, pimozide, quinidine, and erythromycin.
Drug Interactions
Warfarin
Increased prothrombin time (INR) requiring careful monitoring and dose adjustment of warfarin.
Phenytoin
Increased phenytoin serum concentrations; monitor levels and adjust phenytoin dose.
Amiodarone
Increased risk of Torsades de Pointes; avoid coadministration.
Rifampicin
Decreased fluconazole plasma levels; consider increasing fluconazole dose.
Cyclosporine
Increased cyclosporine plasma concentrations; monitor cyclosporine levels.
Hydrochlorothiazide
Increased fluconazole plasma concentrations.
Oral Hypoglycemics (sulfonylureas)
Increased risk of hypoglycemia; monitor blood glucose levels closely.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach and sight of children.
Overdose
In case of overdose, symptomatic and supportive treatment should be initiated. Gastric lavage may be considered. Hemodialysis significantly reduces plasma levels of fluconazole.
Pregnancy & Lactation
Pregnancy Category D. High doses and chronic use during the first trimester have been associated with increased risk of congenital abnormalities. Use only if the potential benefit justifies the potential risk to the fetus. Fluconazole is excreted in breast milk; use with caution during lactation, especially with single high doses or prolonged use.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture. Check the expiry date on the packaging.
Availability
Pharmacies, hospitals
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Fluconazole has undergone extensive clinical trials demonstrating its efficacy and safety across various fungal infections. These trials have established its role in treating both superficial and systemic mycoses, and in prophylaxis for immunocompromised patients.
Lab Monitoring
- Liver function tests (LFTs) should be monitored periodically, especially in patients with pre-existing liver conditions or during prolonged therapy.
- Renal function monitoring in patients with renal impairment or at risk of kidney injury.
- Electrolyte levels (e.g., potassium) should be monitored in susceptible patients due to potential for QT prolongation.
Doctor Notes
- Ensure proper diagnosis of fungal infection before initiating fluconazole, especially for systemic infections.
- Monitor liver function tests (LFTs) at baseline and periodically during prolonged therapy, particularly in patients with pre-existing hepatic impairment or those developing signs of liver dysfunction.
- Be cautious when co-administering with drugs known to prolong the QT interval; assess ECG and electrolyte status.
- Adjust dose for renal impairment based on creatinine clearance.
Patient Guidelines
- Take the full course of treatment as prescribed by your doctor, even if your symptoms improve, to prevent recurrence and resistance.
- Report any severe side effects, especially signs of liver problems (e.g., unusual fatigue, dark urine, yellowing of skin/eyes), immediately to your doctor.
- Inform your doctor about all medications, herbal supplements, and over-the-counter drugs you are taking.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Mycocure may cause dizziness or seizures in some individuals. If you experience these symptoms, avoid driving or operating machinery until you know how the medicine affects you.
Lifestyle Advice
- Maintain good personal hygiene to prevent the spread and recurrence of fungal infections.
- Wear loose, breathable clothing and avoid tight, synthetic garments, especially for skin and vaginal candidiasis.
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