Fluconazole
Generic Name
fluconazole-50-mg-suspension
Manufacturer
Various (Generic)
Country
Global production
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
fluconazole 50 mg suspension | ৳ 65.00 | N/A |
Description
Overview of the medicine
Fluconazole 50 mg suspension is an antifungal medication used to treat various fungal infections, including those affecting the mouth, throat, esophagus, lungs, abdomen, urinary tract, and systemic candidiasis. It is particularly useful for pediatric patients and those who have difficulty swallowing tablets.
Uses & Indications
Dosage
Adults
Dosage varies significantly based on the 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 or cryptococcal meningitis: 200-400 mg once daily. For fluconazole 50 mg suspension, specific pediatric dosing or lower adult doses may apply, typically calculated per kg body weight for children.
Elderly
No dose adjustment is typically required in elderly patients with normal renal function. For patients with renal impairment, dose adjustment as per renal impairment guidelines is necessary.
Renal_impairment
For creatinine clearance (CrCl) >50 mL/min, use usual recommended dose. For CrCl ≤50 mL/min, reduce the dose by 50% after the initial loading dose. Patients on hemodialysis should receive the usual dose after each dialysis session.
How to Take
Take orally, with or without food. Shake the suspension bottle well before each use. Use the provided measuring device (oral syringe or spoon) for accurate dosing.
Mechanism of Action
Fluconazole inhibits fungal cytochrome P450-dependent 14-alpha-demethylation of lanosterol, an essential step in fungal ergosterol biosynthesis. Ergosterol is a vital component of the fungal cell membrane; its depletion leads to increased cell permeability and cell lysis.
Pharmacokinetics
Onset
Clinical effects typically observed within a few days, depending on the infection type and severity.
Excretion
Primarily renal; about 80% of the dose is excreted unchanged in the urine, and about 11% as metabolites.
Half life
Approximately 30 hours, allowing for once-daily dosing.
Absorption
Well absorbed orally, with a bioavailability of over 90% compared to intravenous administration. Peak plasma concentrations are achieved within 1 to 2 hours.
Metabolism
Minimally metabolized; approximately 11% of the drug is metabolized in the liver.
Side Effects
Contraindications
- Hypersensitivity to fluconazole, other azole antifungals, or any excipients of the formulation.
- Coadministration with drugs known to prolong the QT interval and which are metabolized via the cytochrome P450 (CYP) 3A4 enzyme, such as terfenadine, cisapride, astemizole, pimozide, and quinidine.
Drug Interactions
Warfarin
Increased prothrombin time, monitor INR.
Phenytoin
Increased phenytoin levels, monitor for toxicity.
Rifampicin
Decreased fluconazole plasma concentrations.
Theophylline
Increased theophylline levels, monitor for toxicity.
Sulfonylureas
Increased blood glucose lowering effect, risk of hypoglycemia.
Hydrochlorothiazide
Increased fluconazole plasma concentrations.
Midazolam/Triazolam
Increased sedation, monitor carefully.
Oral contraceptives
May alter effectiveness, monitor for breakthrough bleeding.
Cyclosporine/Tacrolimus/Sirolimus
Increased immunosuppressant levels, monitor for toxicity.
Statins (e.g., Atorvastatin, Simvastatin)
Increased risk of myopathy and rhabdomyolysis.
Terfenadine/Cisapride/Pimozide/Quinidine/Astemizole
Increased risk of serious cardiovascular events including Torsades de Pointes (contraindicated).
Storage
Store unopened bottles at controlled room temperature (20-25°C or 68-77°F), protected from moisture and light. Do not freeze. Refer to product label for specific storage conditions of reconstituted suspension.
Overdose
In case of overdose, supportive measures and symptomatic treatment should be instituted. Gastric lavage may be appropriate if performed within a short time after ingestion. Fluconazole is largely excreted in urine, and a 3-hour hemodialysis session decreases plasma levels by approximately 50%.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fluconazole is secreted into breast milk; caution should be exercised when administered to a nursing woman, especially with high doses or prolonged use.
Side Effects
Contraindications
- Hypersensitivity to fluconazole, other azole antifungals, or any excipients of the formulation.
- Coadministration with drugs known to prolong the QT interval and which are metabolized via the cytochrome P450 (CYP) 3A4 enzyme, such as terfenadine, cisapride, astemizole, pimozide, and quinidine.
Drug Interactions
Warfarin
Increased prothrombin time, monitor INR.
Phenytoin
Increased phenytoin levels, monitor for toxicity.
Rifampicin
Decreased fluconazole plasma concentrations.
Theophylline
Increased theophylline levels, monitor for toxicity.
Sulfonylureas
Increased blood glucose lowering effect, risk of hypoglycemia.
Hydrochlorothiazide
Increased fluconazole plasma concentrations.
Midazolam/Triazolam
Increased sedation, monitor carefully.
Oral contraceptives
May alter effectiveness, monitor for breakthrough bleeding.
Cyclosporine/Tacrolimus/Sirolimus
Increased immunosuppressant levels, monitor for toxicity.
Statins (e.g., Atorvastatin, Simvastatin)
Increased risk of myopathy and rhabdomyolysis.
Terfenadine/Cisapride/Pimozide/Quinidine/Astemizole
Increased risk of serious cardiovascular events including Torsades de Pointes (contraindicated).
Storage
Store unopened bottles at controlled room temperature (20-25°C or 68-77°F), protected from moisture and light. Do not freeze. Refer to product label for specific storage conditions of reconstituted suspension.
Overdose
In case of overdose, supportive measures and symptomatic treatment should be instituted. Gastric lavage may be appropriate if performed within a short time after ingestion. Fluconazole is largely excreted in urine, and a 3-hour hemodialysis session decreases plasma levels by approximately 50%.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fluconazole is secreted into breast milk; caution should be exercised when administered to a nursing woman, especially with high doses or prolonged use.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Generally 2-3 years for unopened bottles. Once reconstituted or opened, shelf life is typically 14-28 days when stored appropriately (e.g., refrigerated). Always check product specific label.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Off-patent (Generic available)
WHO Essential Medicine
YesClinical Trials
Fluconazole has undergone extensive clinical trials demonstrating its efficacy and safety across various fungal infections and patient populations, including pediatric and immunocompromised individuals. Ongoing studies continue to explore its role in emerging fungal pathogens and resistance.
Lab Monitoring
- Liver function tests (LFTs) should be monitored, especially in patients with pre-existing liver conditions or during prolonged therapy.
- Renal function should be monitored, especially in patients with impaired renal function, and dose adjustments made as necessary.
- Electrolyte levels (potassium, magnesium) may need to be monitored in patients at risk of QT prolongation.
Doctor Notes
- Counsel patients on the importance of completing the full course of therapy, even if symptoms resolve.
- Monitor liver function tests (LFTs) periodically, especially in patients on prolonged therapy or with pre-existing hepatic impairment.
- Be vigilant for drug interactions, particularly with QT-prolonging agents and drugs metabolized by CYP3A4 and CYP2C9.
- Educate parents/caregivers on proper suspension preparation, shaking, and accurate dose measurement using the provided device.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor, even if your symptoms improve.
- Complete the full course of treatment to prevent the infection from returning.
- Shake the bottle well before each use and use the provided measuring device for accurate dosing.
- Report any unusual side effects, especially severe rash, jaundice, or changes in heart rhythm, to your doctor 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 not to drive or operate machinery if they experience these symptoms.
Lifestyle Advice
- Maintain good personal hygiene to prevent recurrence of fungal infections.
- Avoid sharing personal items that come into contact with affected areas.
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