Zolen
Generic Name
Fluconazole
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zolen 150 mg capsule | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Fluconazole is an antifungal medication used to treat a variety of fungal infections, including vaginal candidiasis, oral thrush, esophageal candidiasis, and systemic infections.
Uses & Indications
Dosage
Adults
Vaginal candidiasis: 150 mg as a single oral dose. For other indications, dosage varies, typically 50-400 mg daily depending on the infection type and severity.
Elderly
Dosage adjustments may be necessary based on renal function. No specific dose adjustment solely based on age is typically required.
Renal_impairment
Dose reduction may be required. For creatinine clearance < 50 mL/min, 50% of the usual dose is recommended after a loading dose.
How to Take
May be taken with or without food. Swallow the capsule whole with water.
Mechanism of Action
Fluconazole inhibits fungal cytochrome P450 enzyme 14α-demethylase, which is essential for the biosynthesis of ergosterol. Ergosterol is a vital component of the fungal cell membrane. Inhibition leads to increased cellular permeability and leakage of cellular components, ultimately causing fungal cell death.
Pharmacokinetics
Onset
Varies by infection type, symptomatic relief typically within a few days.
Excretion
Primarily renal (80% as unchanged drug in urine).
Half life
Approximately 30 hours.
Absorption
Well absorbed orally (>90%). Peak plasma concentrations are achieved within 1-2 hours.
Metabolism
Minor hepatic metabolism (about 11% to inactive metabolites).
Side Effects
Contraindications
- Hypersensitivity to fluconazole or other azole antifungal agents.
- Concomitant use with drugs known to prolong the QTc interval and metabolized by CYP3A4 (e.g., terfenadine, cisapride, astemizole, pimozide, quinidine)
Drug Interactions
Warfarin
May increase prothrombin time; monitor INR closely.
Phenytoin
May increase phenytoin serum concentrations; monitor phenytoin levels.
Rifampicin
May decrease fluconazole plasma concentrations; consider increasing fluconazole dose.
Hydrochlorothiazide
May increase fluconazole plasma concentrations; clinical significance usually minor.
Cyclosporine, Tacrolimus, Sirolimus
May increase levels of these immunosuppressants; monitor drug levels.
Oral Hypoglycemics (e.g., sulfonylureas)
May prolong their half-life and increase hypoglycemic risk; monitor blood glucose.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include hallucinations and paranoid behavior. Management involves symptomatic and supportive treatment. Gastric lavage may be considered if ingestion is recent. Hemodialysis significantly reduces plasma levels of fluconazole.
Pregnancy & Lactation
Pregnancy Category C. High doses and prolonged use in pregnancy, especially during the first trimester, should generally be avoided due to potential risks. A single 150 mg dose for vaginal candidiasis may be acceptable after careful risk-benefit assessment. Fluconazole is excreted in breast milk; use with caution in lactating mothers.
Side Effects
Contraindications
- Hypersensitivity to fluconazole or other azole antifungal agents.
- Concomitant use with drugs known to prolong the QTc interval and metabolized by CYP3A4 (e.g., terfenadine, cisapride, astemizole, pimozide, quinidine)
Drug Interactions
Warfarin
May increase prothrombin time; monitor INR closely.
Phenytoin
May increase phenytoin serum concentrations; monitor phenytoin levels.
Rifampicin
May decrease fluconazole plasma concentrations; consider increasing fluconazole dose.
Hydrochlorothiazide
May increase fluconazole plasma concentrations; clinical significance usually minor.
Cyclosporine, Tacrolimus, Sirolimus
May increase levels of these immunosuppressants; monitor drug levels.
Oral Hypoglycemics (e.g., sulfonylureas)
May prolong their half-life and increase hypoglycemic risk; monitor blood glucose.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include hallucinations and paranoid behavior. Management involves symptomatic and supportive treatment. Gastric lavage may be considered if ingestion is recent. Hemodialysis significantly reduces plasma levels of fluconazole.
Pregnancy & Lactation
Pregnancy Category C. High doses and prolonged use in pregnancy, especially during the first trimester, should generally be avoided due to potential risks. A single 150 mg dose for vaginal candidiasis may be acceptable after careful risk-benefit assessment. Fluconazole is excreted in breast milk; use with caution in lactating mothers.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Fluconazole has undergone numerous clinical trials to establish its efficacy and safety for various fungal infections, leading to its widespread approval and use.
Lab Monitoring
- Liver function tests (baseline and periodically, especially with prolonged use or in patients with underlying liver disease)
- Renal function (if prolonged use or pre-existing renal impairment)
- Electrolytes (if risk of QTc prolongation)
Doctor Notes
- Counsel patients on completing the full course of therapy to prevent recurrence and resistance.
- Monitor liver function tests, especially in patients receiving prolonged therapy or those with pre-existing hepatic impairment.
- Be aware of potential drug-drug interactions, particularly with CYP3A4 substrates and drugs that prolong the QTc interval.
Patient Guidelines
- Complete the full course of treatment as prescribed by your doctor, even if symptoms improve.
- Report any unusual side effects, particularly severe rash, yellowing of skin/eyes, or dark urine.
- Inform your doctor or pharmacist about all other medications, including over-the-counter drugs and herbal supplements, before starting Zolen.
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
Zolen may cause dizziness or seizures in some individuals. Caution is advised when driving or operating machinery until you know how this medicine affects you.
Lifestyle Advice
- Maintain good personal hygiene to prevent fungal reinfections.
- Avoid sharing personal items like towels, clothing, or combs to limit the spread of infection.
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