Zolen
Generic Name
Fluconazole
Manufacturer
General Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zolen 50 mg capsule | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
Zolen 50 mg capsule contains Fluconazole, an antifungal medication used to treat various fungal infections including vaginal yeast infections, oral thrush, esophageal candidiasis, and certain systemic fungal infections.
Uses & Indications
Dosage
Adults
Dosage varies based on infection. For vaginal candidiasis: 150 mg single oral dose. For oropharyngeal candidiasis: 50-100 mg once daily for 7-14 days. For systemic infections: 400 mg on day 1, then 200-400 mg once daily. For Zolen 50 mg, specific indications might include initial or milder cases, or prophylaxis.
Elderly
Dosage adjustment may be necessary based on renal function. Use with caution.
Renal_impairment
For creatinine clearance <50 mL/min, the dose should be reduced by 50% after the initial loading dose.
How to Take
Take orally, with or without food. Swallow the capsule whole with water.
Mechanism of Action
Fluconazole selectively inhibits fungal cytochrome P450 enzyme 14α-demethylase, which is essential for the synthesis of ergosterol, a vital component of the fungal cell membrane. This inhibition leads to disruption of the fungal cell membrane integrity.
Pharmacokinetics
Onset
Clinical effects typically observed within 1-2 days, depending on the type and severity of infection.
Excretion
Primarily renal; approximately 80% of the dose is excreted unchanged in the urine.
Half life
Approximately 30 hours, allowing for once-daily dosing.
Absorption
Well absorbed orally (>90%). Peak plasma concentrations are achieved within 1-2 hours after oral administration.
Metabolism
Minimal hepatic metabolism (around 11% of the dose).
Side Effects
Contraindications
- Hypersensitivity to fluconazole or any other azole antifungal agents.
- Concomitant use with drugs known to prolong the QT interval and which are metabolized by CYP3A4 (e.g., astemizole, cisapride, terfenadine, erythromycin, pimozide, quinidine).
Drug Interactions
Warfarin
Increased prothrombin time, monitor INR.
Phenytoin
Increased phenytoin levels, monitor serum levels.
Rifampicin
Decreased fluconazole plasma concentrations, may require increased fluconazole dose.
Hydrochlorothiazide
Increased fluconazole plasma concentrations.
Oral Hypoglycemics (sulfonylureas)
Increased blood levels and risk of hypoglycemia.
CYP3A4 substrates (e.g., Midazolam, Triazolam)
Increased plasma concentrations of these drugs.
QT-prolonging drugs (e.g., Astemizole, Cisapride, Erythromycin)
Increased risk of serious cardiac arrhythmias (contraindicated).
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. Hemodialysis can significantly reduce plasma fluconazole concentrations.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Fluconazole is excreted in breast milk; caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to fluconazole or any other azole antifungal agents.
- Concomitant use with drugs known to prolong the QT interval and which are metabolized by CYP3A4 (e.g., astemizole, cisapride, terfenadine, erythromycin, pimozide, quinidine).
Drug Interactions
Warfarin
Increased prothrombin time, monitor INR.
Phenytoin
Increased phenytoin levels, monitor serum levels.
Rifampicin
Decreased fluconazole plasma concentrations, may require increased fluconazole dose.
Hydrochlorothiazide
Increased fluconazole plasma concentrations.
Oral Hypoglycemics (sulfonylureas)
Increased blood levels and risk of hypoglycemia.
CYP3A4 substrates (e.g., Midazolam, Triazolam)
Increased plasma concentrations of these drugs.
QT-prolonging drugs (e.g., Astemizole, Cisapride, Erythromycin)
Increased risk of serious cardiac arrhythmias (contraindicated).
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. Hemodialysis can significantly reduce plasma fluconazole concentrations.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Fluconazole is excreted in breast milk; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, refer to the product packaging for exact details.
Availability
Pharmacies, hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generic available (patent expired)
WHO Essential Medicine
YesClinical Trials
Fluconazole has been extensively studied in numerous clinical trials for its efficacy and safety across various fungal infections. Ongoing research explores its use in new indications and addresses resistance patterns.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin, alkaline phosphatase) at baseline and periodically, especially in patients with pre-existing hepatic impairment or those on prolonged therapy.
- Renal function (creatinine, BUN) for patients with renal impairment or elderly.
- Serum electrolytes (potassium, magnesium, calcium) in patients at risk for QT prolongation.
Doctor Notes
- Emphasize importance of completing the full course of therapy to minimize resistance and recurrence.
- Counsel patients on potential drug interactions, especially with QT-prolonging agents and CYP3A4 substrates.
- Monitor liver function tests periodically for patients on prolonged fluconazole therapy or with pre-existing hepatic conditions.
Patient Guidelines
- Take the medication for the full prescribed duration, even if symptoms improve, to prevent recurrence.
- Report any severe skin reactions, unusual fatigue, nausea, vomiting, dark urine, or yellowing of skin/eyes immediately.
- Do not share this medication with others, as it may not be suitable for their condition.
Missed Dose Advice
If a dose is missed, 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 dose.
Driving Precautions
Zolen may cause dizziness or seizures in some patients. Patients should be advised to exercise caution when driving or operating machinery until they know how fluconazole affects them.
Lifestyle Advice
- Maintain good personal hygiene to help prevent fungal infections.
- Wear breathable cotton underwear and avoid tight-fitting clothing for genital candidiasis.
- Avoid sharing personal items like towels or clothing.
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