Fungata
Generic Name
Fluconazole 50 mg capsule
Manufacturer
Aristopharma Limited
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
fungata 50 mg capsule | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
Fungata 50 mg capsule contains Fluconazole, an antifungal medicine used to treat various fungal infections, including vaginal yeast infections, oral thrush, esophageal candidiasis, and cryptococcal meningitis.
Uses & Indications
Dosage
Adults
Dosage varies with infection type and severity. For oropharyngeal candidiasis, typically 50-100 mg once daily for 7-14 days. For vaginal candidiasis, a single 150 mg dose is common (Fungata 50 mg is often used for maintenance or less severe cases). For severe systemic infections, up to 400 mg daily may be needed.
Elderly
No dosage adjustment is usually required for elderly patients with normal renal function. If renal impairment is present, adjust dosage as per renal impairment guidelines.
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
Take Fungata 50 mg capsule orally, with or without food, as directed by your physician. Swallow the capsule whole with a glass of water. Do not chew or crush.
Mechanism of Action
Fluconazole works by inhibiting fungal cytochrome P450 enzyme 14α-demethylase, which is essential for the synthesis of ergosterol, a vital component of fungal cell membranes. This disruption leads to altered cell membrane permeability and ultimately fungal cell death.
Pharmacokinetics
Onset
Therapeutic effects are typically observed within 1-2 days, though it varies based on the infection type and severity.
Excretion
Primarily excreted unchanged by the kidneys, with approximately 80% eliminated in urine.
Half life
Approximately 30 hours, allowing for once-daily dosing.
Absorption
Well-absorbed orally, with bioavailability exceeding 90%. Peak plasma concentrations are achieved within 1-2 hours.
Metabolism
Minimally metabolized; approximately 11% undergoes hepatic metabolism.
Side Effects
Contraindications
- Hypersensitivity to fluconazole or other azole antifungal agents.
- Co-administration with terfenadine, astemizole, cisapride, pimozide, quinidine, or erythromycin due to risk of serious cardiac arrhythmias.
Drug Interactions
Warfarin
Increased prothrombin time, monitor for bleeding.
Phenytoin
Increased phenytoin levels, monitor for toxicity.
Rifampicin
Decreased fluconazole plasma concentrations.
Hydrochlorothiazide
Increased fluconazole plasma concentrations.
Cyclosporine, Tacrolimus
Increased immunosuppressant levels, monitor renal function.
Sulfonylureas (e.g., glipizide)
Increased hypoglycemic effect, monitor blood glucose.
Benzodiazepines (e.g., midazolam)
Increased benzodiazepine levels, monitor for sedation.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
In case of overdose, hallucinations and paranoid behavior have been reported. Management should include symptomatic treatment and supportive measures. Gastric lavage may be considered. Hemodialysis significantly reduces plasma levels.
Pregnancy & Lactation
Pregnancy Category C. High doses and chronic use in the first trimester have been associated with severe birth defects. Use only if potential benefit justifies potential risk. Fluconazole is excreted in breast milk; use with caution during lactation.
Side Effects
Contraindications
- Hypersensitivity to fluconazole or other azole antifungal agents.
- Co-administration with terfenadine, astemizole, cisapride, pimozide, quinidine, or erythromycin due to risk of serious cardiac arrhythmias.
Drug Interactions
Warfarin
Increased prothrombin time, monitor for bleeding.
Phenytoin
Increased phenytoin levels, monitor for toxicity.
Rifampicin
Decreased fluconazole plasma concentrations.
Hydrochlorothiazide
Increased fluconazole plasma concentrations.
Cyclosporine, Tacrolimus
Increased immunosuppressant levels, monitor renal function.
Sulfonylureas (e.g., glipizide)
Increased hypoglycemic effect, monitor blood glucose.
Benzodiazepines (e.g., midazolam)
Increased benzodiazepine levels, monitor for sedation.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
In case of overdose, hallucinations and paranoid behavior have been reported. Management should include symptomatic treatment and supportive measures. Gastric lavage may be considered. Hemodialysis significantly reduces plasma levels.
Pregnancy & Lactation
Pregnancy Category C. High doses and chronic use in the first trimester have been associated with severe birth defects. Use only if potential benefit justifies potential risk. Fluconazole is excreted in breast milk; use with caution during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date
Availability
Available in pharmacies and hospitals
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Expired
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established the efficacy and safety of fluconazole for a wide range of fungal infections, including randomized controlled trials comparing it to other antifungals and placebos.
Lab Monitoring
- Liver function tests (LFTs) – especially in patients with pre-existing hepatic impairment or during prolonged treatment.
- Renal function tests – particularly if dosage adjustments are needed.
- Electrolyte levels (potassium, magnesium) – if there's a risk of QT prolongation.
- Complete blood count (CBC) – for prolonged treatment, to monitor for hematologic abnormalities.
Doctor Notes
- Educate patients on the importance of completing the full course of therapy to prevent recurrence and resistance.
- Monitor liver function tests (LFTs) periodically, especially in patients on prolonged therapy or with underlying liver disease.
- Be aware of significant drug interactions, particularly with QT-prolonging agents and CYP-mediated drugs.
- Counsel pregnant women on the potential risks, especially with high doses or chronic use in the first trimester.
Patient Guidelines
- Complete the full course of medication, even if symptoms improve.
- Report any new or worsening symptoms, especially rash, severe nausea, vomiting, or jaundice.
- Avoid sharing this medication with others.
- 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 resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Fungata may cause dizziness or seizures in some individuals. If you experience these effects, avoid driving or operating machinery.
Lifestyle Advice
- Practice good hygiene to help prevent recurrence of fungal infections.
- Avoid self-medication and always consult a healthcare professional.
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