Funzole
Generic Name
Fluconazole
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| funzole 50 mg capsule | ৳ 8.00 | N/A |
Description
Overview of the medicine
Fluconazole is an antifungal medication belonging to the azole class. It is used to treat various fungal infections, including vaginal, oral, esophageal, and systemic candidiasis, as well as cryptococcal meningitis and dermatophytosis.
Uses & Indications
Dosage
Adults
Dosage varies based on infection type and severity. For vaginal candidiasis: 150 mg single oral dose. For oropharyngeal candidiasis: 50-100 mg once daily for 7-14 days. For tinea infections: 50 mg once daily for 2-4 weeks. For systemic infections: 200-400 mg daily.
Elderly
No dosage adjustment is generally needed for the elderly unless there is evidence of renal impairment.
Renal_impairment
For patients with impaired renal function (creatinine clearance < 50 mL/min), the dosage should be reduced by 50% after an initial normal loading dose. For patients on hemodialysis, a single dose should be given after each dialysis session.
How to Take
Funzole 50 mg capsules are administered orally. They can be taken with or without food. Swallow the capsule whole with a glass of water.
Mechanism of Action
Fluconazole inhibits fungal cytochrome P450-dependent enzyme lanosterol 14-alpha-demethylase, which is essential for ergosterol synthesis. Ergosterol is a vital component of the fungal cell membrane; its depletion leads to increased cell permeability and cell death.
Pharmacokinetics
Onset
Peak plasma concentrations are typically reached within 1-2 hours after oral dosing.
Excretion
The primary route of excretion is renal; approximately 80% of the administered dose is excreted unchanged in the urine, and about 11% as metabolites.
Half life
The plasma elimination half-life is approximately 30 hours, allowing for once-daily dosing for many indications.
Absorption
Fluconazole is well absorbed orally, with a bioavailability exceeding 90% after oral administration. Peak plasma concentrations are achieved within 1-2 hours.
Metabolism
Fluconazole is minimally metabolized in humans. Approximately 11% of the dose is metabolized, primarily by CYP2C9, CYP2C19, and CYP3A4, before being excreted.
Side Effects
Contraindications
- Hypersensitivity to fluconazole, other azole antifungals, or any excipients of the formulation.
- Concomitant administration of terfenadine, cisapride, astemizole, pimozide, or quinidine due to the risk of QT interval prolongation and serious cardiac arrhythmias.
Drug Interactions
Rifampin
Decreased fluconazole plasma concentrations; consider increasing fluconazole dose.
Warfarin
Increased prothrombin time, potentially leading to bleeding. INR monitoring recommended.
Phenytoin
Increased phenytoin serum levels, requiring monitoring and dosage adjustment.
Hydrochlorothiazide
Increased fluconazole plasma concentrations; no dosage adjustment typically needed.
Oral contraceptives
May increase or decrease hormone levels; typically not clinically significant.
Cyclosporine, Tacrolimus, Sirolimus
Increased levels of immunosuppressants, requiring monitoring.
Sulfonylureas (e.g., glibenclamide)
Increased blood glucose levels due to inhibition of sulfonylurea metabolism.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children. Do not freeze.
Overdose
In cases of overdose, symptoms may include hallucinations and paranoid behavior. Management should be symptomatic and supportive, and may include gastric lavage and forced diuresis to accelerate fluconazole excretion. Hemodialysis significantly reduces plasma levels of fluconazole.
Pregnancy & Lactation
Pregnancy Category D. Fluconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, especially with long-term high-dose use. It is excreted in human breast milk; use with caution during lactation, considering the benefits of breastfeeding and the potential risks to the infant.
Side Effects
Contraindications
- Hypersensitivity to fluconazole, other azole antifungals, or any excipients of the formulation.
- Concomitant administration of terfenadine, cisapride, astemizole, pimozide, or quinidine due to the risk of QT interval prolongation and serious cardiac arrhythmias.
Drug Interactions
Rifampin
Decreased fluconazole plasma concentrations; consider increasing fluconazole dose.
Warfarin
Increased prothrombin time, potentially leading to bleeding. INR monitoring recommended.
Phenytoin
Increased phenytoin serum levels, requiring monitoring and dosage adjustment.
Hydrochlorothiazide
Increased fluconazole plasma concentrations; no dosage adjustment typically needed.
Oral contraceptives
May increase or decrease hormone levels; typically not clinically significant.
Cyclosporine, Tacrolimus, Sirolimus
Increased levels of immunosuppressants, requiring monitoring.
Sulfonylureas (e.g., glibenclamide)
Increased blood glucose levels due to inhibition of sulfonylurea metabolism.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children. Do not freeze.
Overdose
In cases of overdose, symptoms may include hallucinations and paranoid behavior. Management should be symptomatic and supportive, and may include gastric lavage and forced diuresis to accelerate fluconazole excretion. Hemodialysis significantly reduces plasma levels of fluconazole.
Pregnancy & Lactation
Pregnancy Category D. Fluconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, especially with long-term high-dose use. It is excreted in human breast milk; use with caution during lactation, considering the benefits of breastfeeding and the potential risks to the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 36 months from the date of manufacture, when stored under recommended conditions.
Availability
Pharmacies, Hospitals
Approval Status
Approved by FDA/DGDA
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Fluconazole has been extensively studied in numerous clinical trials demonstrating its efficacy and safety across a wide range of fungal infections. These trials have supported its approval for various indications globally.
Lab Monitoring
- Liver function tests (ALT, AST, alkaline phosphatase, bilirubin) at baseline and periodically, especially in patients with pre-existing liver disease or prolonged therapy.
- Renal function (creatinine, BUN, creatinine clearance) for dosage adjustments.
- Electrolytes, particularly potassium, in patients at risk of electrolyte disturbances.
Doctor Notes
- Emphasize the importance of patient compliance with the full duration of therapy, even after symptomatic improvement, to prevent resistance and relapse.
- Counsel patients on potential drug interactions, especially with warfarin, sulfonylureas, and medications prolonging the QT interval.
- Advise monitoring of liver enzymes, particularly in patients receiving prolonged or high-dose therapy, or those with underlying liver conditions.
Patient Guidelines
- Take Funzole exactly as prescribed by your doctor. Do not stop taking it even if you feel better, as stopping early may lead to a relapse of the infection.
- Inform your healthcare provider about all other medications, supplements, and herbal products you are taking to avoid potential drug interactions.
- Seek immediate medical attention if you experience severe side effects such as rash, yellowing of the skin/eyes, dark urine, or unusual bleeding/bruising.
Missed Dose Advice
If you miss a dose of Funzole, 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
Funzole may cause dizziness or seizures in some individuals. If you experience these effects, avoid driving or operating machinery until you know how the medication affects you.
Lifestyle Advice
- Maintain good personal hygiene, especially in areas prone to fungal infections, to help prevent recurrence.
- For skin and nail infections, keep the affected areas clean and dry. Avoid wearing tight-fitting clothing or footwear that traps moisture.
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