Flugard
Generic Name
Fluconazole 50 mg
Manufacturer
Drug International Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| flugard 50 mg capsule | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
Flugard 50 mg Capsule contains Fluconazole, an antifungal medication used to treat a variety of fungal infections, including candidiasis (vaginal, oral, esophageal, systemic), cryptococcal meningitis, and dermatophytosis.
Uses & Indications
Dosage
Adults
Dosage varies by indication. For oropharyngeal candidiasis: 50 mg once daily for 7-14 days. For esophageal candidiasis: 50-200 mg once daily for 14-30 days. For recurrent vaginal candidiasis: 150 mg once monthly for 4-12 months. For dermatophytosis: 50 mg once daily for 2-4 weeks (up to 6 weeks for Tinea pedis).
Elderly
No dose adjustment is usually needed unless there is renal impairment. Dose should be adjusted based on creatinine clearance.
Renal_impairment
For creatinine clearance 21-50 mL/min, reduce dose by 50%. For creatinine clearance ≤20 mL/min, reduce dose by 75% or administer half of the recommended dose every 48 hours.
How to Take
Take the capsule orally with or without food. Swallow the capsule whole with a glass of water. Do not chew or crush.
Mechanism of Action
Fluconazole selectively inhibits fungal cytochrome P450-dependent 14α-demethylation of lanosterol, an essential step in fungal ergosterol biosynthesis. This leads to an accumulation of 14α-methyl sterols and a concomitant decrease in ergosterol, disrupting fungal cell membrane integrity and function, thereby inhibiting fungal growth.
Pharmacokinetics
Onset
Clinical effects may be observed within a few days, though complete resolution of symptoms can take longer depending on the infection.
Excretion
Mainly by renal excretion, with approximately 80% of the dose appearing in the urine as unchanged drug and 11% as metabolites.
Half life
Approximately 30 hours, allowing for once-daily dosing for many indications.
Absorption
Well absorbed orally, bioavailability is >90% and unaffected by food. Peak plasma concentrations are reached within 0.5-1.5 hours.
Metabolism
Only a small proportion is metabolized (approximately 11% of the dose is eliminated as metabolites). Primarily excreted unchanged.
Side Effects
Contraindications
- Hypersensitivity to fluconazole, other azole antifungals, or any excipients of the product.
- Co-administration with terfenadine, astemizole, cisapride, pimozide, quinidine, or erythromycin in patients receiving multiple doses of fluconazole due to risk of QTc prolongation and serious cardiac arrhythmias.
Drug Interactions
Warfarin
Increases prothrombin time (INR), requiring careful monitoring.
Phenytoin
Increases phenytoin levels, requiring dose adjustment.
Rifampicin
Decreases fluconazole plasma concentrations, may require increased fluconazole dose.
Cyclosporine
Increases cyclosporine levels, monitor cyclosporine concentrations.
Hydrochlorothiazide
Increases fluconazole plasma concentrations.
Benzodiazepines (e.g., Midazolam)
Increases benzodiazepine concentrations, leading to prolonged effects.
Oral Hypoglycemics (sulfonylureas)
Prolongs half-life and increases risk of hypoglycemia.
Statins (e.g., Atorvastatin, Simvastatin)
Increases statin levels, increasing risk of myopathy/rhabdomyolysis.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
In the event of an overdose, symptomatic and supportive measures should be taken. Gastric lavage may be considered. Hemodialysis significantly reduces plasma levels of fluconazole.
Pregnancy & Lactation
Pregnancy Category C. Fluconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, especially after single-dose treatment for vaginal candidiasis. Fluconazole is excreted in human milk; therefore, nursing is not recommended during treatment.
Side Effects
Contraindications
- Hypersensitivity to fluconazole, other azole antifungals, or any excipients of the product.
- Co-administration with terfenadine, astemizole, cisapride, pimozide, quinidine, or erythromycin in patients receiving multiple doses of fluconazole due to risk of QTc prolongation and serious cardiac arrhythmias.
Drug Interactions
Warfarin
Increases prothrombin time (INR), requiring careful monitoring.
Phenytoin
Increases phenytoin levels, requiring dose adjustment.
Rifampicin
Decreases fluconazole plasma concentrations, may require increased fluconazole dose.
Cyclosporine
Increases cyclosporine levels, monitor cyclosporine concentrations.
Hydrochlorothiazide
Increases fluconazole plasma concentrations.
Benzodiazepines (e.g., Midazolam)
Increases benzodiazepine concentrations, leading to prolonged effects.
Oral Hypoglycemics (sulfonylureas)
Prolongs half-life and increases risk of hypoglycemia.
Statins (e.g., Atorvastatin, Simvastatin)
Increases statin levels, increasing risk of myopathy/rhabdomyolysis.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
In the event of an overdose, symptomatic and supportive measures should be taken. Gastric lavage may be considered. Hemodialysis significantly reduces plasma levels of fluconazole.
Pregnancy & Lactation
Pregnancy Category C. Fluconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, especially after single-dose treatment for vaginal candidiasis. Fluconazole is excreted in human milk; therefore, nursing is not recommended during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from manufacturing date
Availability
Available in pharmacies nationwide
Approval Status
Approved (FDA/DGDA)
Patent Status
Off-patent (Generic available)
WHO Essential Medicine
YesClinical Trials
Fluconazole has undergone extensive clinical trials demonstrating its efficacy and safety in various fungal infections across diverse patient populations. Post-market surveillance also continues to monitor its long-term effects.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, bilirubin) especially during prolonged therapy or in patients with pre-existing hepatic impairment.
- Renal function tests (Creatinine, BUN) in patients with renal impairment to guide dose adjustments.
Doctor Notes
- Consider drug interactions, especially with narrow therapeutic index drugs like warfarin, phenytoin, and cyclosporine. Adjust dosages as necessary.
- Monitor liver function tests (LFTs) periodically, especially in patients with pre-existing hepatic disease or on prolonged therapy.
- Educate patients on the importance of completing the full course of treatment to prevent resistance and recurrence.
Patient Guidelines
- Complete the full course of medication as prescribed, even if symptoms improve, to prevent recurrence.
- Report any severe side effects, especially unusual tiredness, yellowing of skin/eyes, or severe skin rash, to your doctor immediately.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Flugard may cause dizziness or seizures in some individuals. Patients should be cautioned about driving or operating machinery until they know how fluconazole affects them.
Lifestyle Advice
- Maintain good personal hygiene to help prevent fungal infections.
- For skin infections, keep the affected area clean and dry. Avoid sharing personal items like towels or clothing.
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