Fungata
Generic Name
Fluconazole
Manufacturer
Reputable Pharmaceutical Company
Country
Global
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| fungata 50 mg suspension | ৳ 78.29 | N/A |
Description
Overview of the medicine
Fungata 50 mg Suspension is an antifungal medicine containing Fluconazole, used to treat a variety of fungal and yeast infections in different parts of the body, including the mouth, throat, esophagus, lungs, and urinary tract. It is particularly effective in treating candidiasis and cryptococcal infections. This medicine works by stopping the growth of fungi.
Uses & Indications
Dosage
Adults
Dosage varies by indication. For oropharyngeal candidiasis: 50-100 mg once daily for 7-14 days. For esophageal candidiasis: 100-200 mg once daily for 14-30 days. For vaginal candidiasis: 150 mg as a single oral dose. For systemic candidiasis: 400 mg on day 1, then 200-400 mg once daily. For children, dosage is based on body weight (e.g., 3-6 mg/kg/day).
Elderly
No dosage adjustment is required in elderly patients with normal renal function. For elderly patients with renal impairment, dose adjustment is necessary as per 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 a standard loading dose followed by 25% of the standard dose every 24 hours.
How to Take
Take the suspension orally, usually once daily, with or without food. Shake the bottle well before each use. Use the provided measuring device (e.g., spoon or oral syringe) to ensure an accurate dose.
Mechanism of Action
Fluconazole selectively inhibits fungal cytochrome P450-dependent 14α-lanosterol demethylation, which is an essential step in fungal ergosterol biosynthesis. Ergosterol is a vital component of the fungal cell membrane, and its impaired synthesis leads to increased cellular permeability and eventual cell death, thereby exerting its fungistatic effect.
Pharmacokinetics
Onset
Peak plasma concentrations are achieved within 1-2 hours after oral dosing.
Excretion
Primarily renal; approximately 80% of the dose is excreted unchanged in urine.
Half life
Approximately 20-50 hours (average ~30 hours), allowing for once-daily dosing.
Absorption
Rapid and almost complete absorption after oral administration; bioavailability is >90% of IV dose.
Metabolism
Minimally metabolized; approximately 11% of the dose is metabolized to inactive metabolites.
Side Effects
Contraindications
- Known hypersensitivity to fluconazole, other azole antifungals, or any component of the formulation.
- Co-administration with terfenadine in patients receiving multiple daily doses of fluconazole 400 mg or more.
- Co-administration with other drugs known to prolong the QT interval and metabolized via CYP3A4 (e.g., cisapride, astemizole, pimozide, quinidine, erythromycin).
Drug Interactions
Warfarin
Increased prothrombin time (INR); monitor INR and adjust warfarin dose.
Phenytoin
Increased phenytoin levels; monitor phenytoin levels and adjust dose.
Rifampicin
Decreased fluconazole levels; consider increasing fluconazole dose.
Cyclosporine
Increased cyclosporine levels; monitor cyclosporine levels.
Hydrochlorothiazide
Increased fluconazole levels; dosage adjustment may be necessary.
Oral Hypoglycemics (e.g., sulfonylureas)
Increased plasma concentration, leading to hypoglycemia; monitor blood glucose.
QT-prolonging drugs (e.g., amiodarone, quinidine)
Increased risk of QTc prolongation; avoid co-administration.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children. Do not freeze. Discard any unused portion after the specified period.
Overdose
Symptoms of overdose may include hallucinations, paranoid behavior, and seizures. In case of an overdose, symptomatic and supportive measures should be initiated. Gastric lavage may be appropriate, and hemodialysis can reduce plasma levels of fluconazole significantly.
Pregnancy & Lactation
Pregnancy Category D for prolonged or high-dose use, Category C for single-dose use. Fluconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human breast milk; therefore, caution should be exercised when administered to a nursing woman, especially with multiple or high doses.
Side Effects
Contraindications
- Known hypersensitivity to fluconazole, other azole antifungals, or any component of the formulation.
- Co-administration with terfenadine in patients receiving multiple daily doses of fluconazole 400 mg or more.
- Co-administration with other drugs known to prolong the QT interval and metabolized via CYP3A4 (e.g., cisapride, astemizole, pimozide, quinidine, erythromycin).
Drug Interactions
Warfarin
Increased prothrombin time (INR); monitor INR and adjust warfarin dose.
Phenytoin
Increased phenytoin levels; monitor phenytoin levels and adjust dose.
Rifampicin
Decreased fluconazole levels; consider increasing fluconazole dose.
Cyclosporine
Increased cyclosporine levels; monitor cyclosporine levels.
Hydrochlorothiazide
Increased fluconazole levels; dosage adjustment may be necessary.
Oral Hypoglycemics (e.g., sulfonylureas)
Increased plasma concentration, leading to hypoglycemia; monitor blood glucose.
QT-prolonging drugs (e.g., amiodarone, quinidine)
Increased risk of QTc prolongation; avoid co-administration.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children. Do not freeze. Discard any unused portion after the specified period.
Overdose
Symptoms of overdose may include hallucinations, paranoid behavior, and seizures. In case of an overdose, symptomatic and supportive measures should be initiated. Gastric lavage may be appropriate, and hemodialysis can reduce plasma levels of fluconazole significantly.
Pregnancy & Lactation
Pregnancy Category D for prolonged or high-dose use, Category C for single-dose use. Fluconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human breast milk; therefore, caution should be exercised when administered to a nursing woman, especially with multiple or high doses.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months for an unopened bottle. After reconstitution (if applicable), refer to the manufacturer's instructions, usually 14 days at room temperature.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Fluconazole has undergone extensive clinical trials demonstrating its efficacy and safety in various fungal infections, including randomized controlled trials for candidiasis, cryptococcal meningitis, and dermatophytosis, across diverse patient populations.
Lab Monitoring
- Liver function tests (ALT, AST, alkaline phosphatase, bilirubin) before and during treatment, especially in patients with pre-existing liver disease or those receiving prolonged therapy.
- Renal function tests (serum creatinine, BUN) periodically, especially in patients with renal impairment.
- Electrolytes (e.g., potassium) if QTc prolongation risk is a concern.
Doctor Notes
- Confirm fungal diagnosis before initiating therapy; ensure susceptibility if possible.
- Carefully assess for potential drug interactions, especially with narrow therapeutic index drugs and QTc prolonging agents.
- Monitor liver function tests (LFTs) and renal function, adjusting dose as necessary.
- Educate patients on the importance of completing the full course and recognizing signs of serious adverse effects.
Patient Guidelines
- Complete the full course of treatment as prescribed, even if symptoms improve, to prevent recurrence.
- Shake the suspension well before each use and measure the dose accurately using the provided device.
- Inform your doctor about all other medications you are taking to avoid potential drug interactions.
- Report any signs of liver problems (e.g., unusual tiredness, yellowing of skin/eyes, dark urine) or severe skin reactions immediately.
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
Fluconazole may cause dizziness or seizures in some individuals. Patients should be advised to exercise caution when driving or operating machinery until they know how fluconazole affects them.
Lifestyle Advice
- Maintain good hygiene to prevent fungal infections. Avoid self-medication and follow your doctor's advice strictly.
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