Fungata
Generic Name
Fluconazole
Manufacturer
Acme Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
fungata 150 mg capsule | ৳ 22.00 | ৳ 220.00 |
Description
Overview of the medicine
Fluconazole is an antifungal medication primarily used to treat various fungal infections, especially those caused by Candida species. It works by inhibiting the growth of fungi.
Uses & Indications
Dosage
Adults
For vaginal candidiasis: 150 mg as a single oral dose. For other indications, dosage varies (e.g., 50-400 mg daily for several weeks).
Elderly
Dose adjustment usually not required unless severe renal impairment (creatinine clearance < 50 mL/min).
Renal_impairment
For creatinine clearance 21-50 mL/min, administer 50% of the usual dose. For creatinine clearance < 20 mL/min, administer 25% of the usual dose.
How to Take
Fungata-150 mg Capsule can be taken orally with or without food. Swallow the capsule whole with water.
Mechanism of Action
Fluconazole inhibits fungal cytochrome P450-dependent enzyme lanosterol 14-alpha-demethylase. This enzyme is responsible for the conversion of lanosterol to ergosterol, an essential component of the fungal cell membrane. Inhibition of ergosterol synthesis leads to cell membrane disruption and fungal cell death.
Pharmacokinetics
Onset
Therapeutic effects typically begin within 24-48 hours, with full effect for some conditions taking 1-2 days.
Excretion
Primarily renal excretion, with about 80% of the dose excreted unchanged in urine. Renal impairment significantly prolongs the half-life.
Half life
Approximately 30 hours (range: 20-50 hours), which allows for once-daily dosing.
Absorption
Well absorbed orally; bioavailability is greater than 90% and is unaffected by food. Peak plasma concentrations are achieved within 1-2 hours.
Metabolism
Minimal hepatic metabolism. Approximately 11% of the drug is metabolized by CYP2C9, CYP2C19, and CYP3A4 enzymes.
Side Effects
Contraindications
- Hypersensitivity to fluconazole, other azole antifungals, or any excipients of the product.
- Concomitant administration of terfenadine, astemizole, cisapride, pimozide, or quinidine with fluconazole due to the risk of QT prolongation and potential serious cardiac arrhythmias.
Drug Interactions
Warfarin
Increased prothrombin time and INR; monitor coagulation parameters.
Phenytoin
Increased phenytoin levels; monitor phenytoin levels and adjust dosage if necessary.
Rifampicin
Decreased fluconazole levels; consider increasing fluconazole dose.
Hydrochlorothiazide
Increases fluconazole plasma concentrations; clinical significance usually minor.
Cyclosporine/Tacrolimus
Increased levels of these immunosuppressants; monitor drug levels and adjust dosage.
Benzodiazepines (e.g., Midazolam)
Increased benzodiazepine levels; dose reduction may be needed.
Oral Hypoglycemics (sulfonylureas)
Potentiates the effect of sulfonylureas, leading to a risk of hypoglycemia; monitor blood glucose.
Statins (e.g., Atorvastatin, Simvastatin)
Increased statin levels, leading to increased risk of myopathy/rhabdomyolysis; monitor for muscle pain.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include hallucinations and paranoid behavior. Management is symptomatic and supportive. Gastric lavage may be considered. Hemodialysis can significantly enhance fluconazole elimination.
Pregnancy & Lactation
Pregnancy Category D: Use in pregnancy only if the potential benefit justifies the potential risk to the fetus, especially for non-life-threatening vaginal candidiasis where a single high dose is used. Excreted in breast milk; caution is advised in nursing mothers, and breastfeeding should be discontinued during high-dose or prolonged treatment.
Side Effects
Contraindications
- Hypersensitivity to fluconazole, other azole antifungals, or any excipients of the product.
- Concomitant administration of terfenadine, astemizole, cisapride, pimozide, or quinidine with fluconazole due to the risk of QT prolongation and potential serious cardiac arrhythmias.
Drug Interactions
Warfarin
Increased prothrombin time and INR; monitor coagulation parameters.
Phenytoin
Increased phenytoin levels; monitor phenytoin levels and adjust dosage if necessary.
Rifampicin
Decreased fluconazole levels; consider increasing fluconazole dose.
Hydrochlorothiazide
Increases fluconazole plasma concentrations; clinical significance usually minor.
Cyclosporine/Tacrolimus
Increased levels of these immunosuppressants; monitor drug levels and adjust dosage.
Benzodiazepines (e.g., Midazolam)
Increased benzodiazepine levels; dose reduction may be needed.
Oral Hypoglycemics (sulfonylureas)
Potentiates the effect of sulfonylureas, leading to a risk of hypoglycemia; monitor blood glucose.
Statins (e.g., Atorvastatin, Simvastatin)
Increased statin levels, leading to increased risk of myopathy/rhabdomyolysis; monitor for muscle pain.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include hallucinations and paranoid behavior. Management is symptomatic and supportive. Gastric lavage may be considered. Hemodialysis can significantly enhance fluconazole elimination.
Pregnancy & Lactation
Pregnancy Category D: Use in pregnancy only if the potential benefit justifies the potential risk to the fetus, especially for non-life-threatening vaginal candidiasis where a single high dose is used. Excreted in breast milk; caution is advised in nursing mothers, and breastfeeding should be discontinued during high-dose or prolonged treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the date of manufacture. Refer to the specific packaging for exact expiry.
Availability
Pharmacies, Hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Expired
WHO Essential Medicine
YesClinical Trials
Fluconazole has been extensively studied in numerous clinical trials demonstrating its efficacy and safety for various fungal infections. Post-marketing surveillance data also contributes to its safety profile.
Lab Monitoring
- Liver function tests (ALT, AST, alkaline phosphatase, bilirubin) periodically, especially during prolonged treatment or in patients with pre-existing liver disease.
- Renal function (creatinine clearance) in patients with impaired renal function.
Doctor Notes
- Advise patients to complete the full course of therapy to prevent relapse and resistance.
- Monitor liver function tests, especially in patients on prolonged therapy or with pre-existing hepatic impairment.
- Caution with concomitant use of drugs metabolized by CYP2C9 and CYP3A4, as fluconazole can inhibit these enzymes, leading to increased drug levels.
- Educate patients on signs of severe adverse reactions, such as liver toxicity or severe skin reactions, and to seek immediate medical attention if they occur.
Patient Guidelines
- Complete the full prescribed course of treatment even if symptoms improve to prevent recurrence and development of resistance.
- Report any severe side effects, especially signs of liver problems (e.g., unusual fatigue, dark urine, yellowing of skin/eyes), rash, or allergic reactions, to your doctor immediately.
- Inform your doctor about all other medications, including over-the-counter drugs and herbal supplements, you are taking.
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 resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Fungata-150 mg Capsule may cause dizziness or seizures in some individuals. Avoid driving or operating heavy machinery until you know how this medication affects you.
Lifestyle Advice
- Maintain good personal hygiene, especially in areas prone to fungal infections, to help prevent recurrence.
- For vaginal candidiasis, avoid tight-fitting clothing and opt for cotton underwear to allow proper air circulation.
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