Nispore
Generic Name
Fluconazole
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| nispore 150 mg capsule | ৳ 22.00 | ৳ 220.00 |
Description
Overview of the medicine
Nispore 150 mg Capsule contains Fluconazole, an antifungal medication used to treat a variety of fungal and yeast infections. It is effective against infections of the mouth, throat, esophagus, lungs, urinary tract, and systemic candidiasis, as well as cryptococcal meningitis.
Uses & Indications
Dosage
Adults
For vaginal candidiasis: A single oral dose of 150 mg. For other indications, dosage varies (e.g., 50-400 mg daily), often with a loading dose, for specific durations as prescribed by a physician.
Elderly
No dosage adjustment is generally required for elderly patients with normal renal function. If renal impairment is present, dosage should be adjusted as for other patients with impaired renal function.
Renal_impairment
In patients with impaired renal function, the initial loading dose is typically 50-400 mg (as indicated for the specific infection), followed by a reduced daily dose based on creatinine clearance (e.g., 50% of the standard dose if CrCl <50 mL/min).
How to Take
Nispore capsules can be taken orally with or without food. Swallow the capsule whole with water. It is important to complete the full course of treatment as prescribed by your doctor, even if symptoms improve.
Mechanism of Action
Fluconazole works by inhibiting fungal cytochrome P450-dependent 14-alpha-demethylase, which is essential for the synthesis of ergosterol, a vital component of the fungal cell membrane. This inhibition leads to an accumulation of 14-alpha-methyl sterols and a decrease in ergosterol, ultimately impairing fungal cell membrane integrity and inhibiting fungal growth.
Pharmacokinetics
Onset
Peak plasma concentrations are usually reached within 1 to 2 hours after oral administration.
Excretion
The primary route of excretion is renal, with approximately 80% of the dose appearing in the urine as unchanged drug.
Half life
The plasma elimination half-life is approximately 30 hours, allowing for once-daily dosing for many indications.
Absorption
Fluconazole is well absorbed following oral administration, with bioavailability exceeding 90%. Oral absorption is not significantly affected by food.
Metabolism
Fluconazole undergoes minimal hepatic metabolism (approximately 11% of the dose is metabolized). It is a moderate inhibitor of CYP2C9 and CYP2C19, and a weak inhibitor of CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to Fluconazole or other azole antifungals
- Co-administration with terfenadine, astemizole, cisapride, pimozide, or quinidine due to risk of QT prolongation and serious arrhythmias
Drug Interactions
Warfarin
Increased prothrombin time, monitor INR.
Phenytoin
Increased phenytoin levels, monitor levels.
Amiodarone
Increased amiodarone levels, risk of cardiotoxicity.
Rifampicin
Decreased fluconazole levels, dose adjustment may be needed.
Theophylline
Increased plasma theophylline levels, monitor levels.
Hydrochlorothiazide
Increased fluconazole plasma concentrations.
Oral Hypoglycemics (sulfonylureas)
Increased plasma concentrations, risk of hypoglycemia.
Cyclosporine, Tacrolimus, Sirolimus
Increased levels of immunosuppressants, monitor levels.
Storage
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, symptomatic and supportive measures should be instituted as necessary. Gastric lavage may be considered. Fluconazole is largely excreted unchanged in urine, and a 3-hour hemodialysis session decreases plasma levels by approximately 50%.
Pregnancy & Lactation
Pregnancy Category D. Use during pregnancy should be avoided unless the benefits outweigh the potential risks to the fetus. Fluconazole is excreted in human milk, so breastfeeding is not recommended during treatment.
Side Effects
Contraindications
- Hypersensitivity to Fluconazole or other azole antifungals
- Co-administration with terfenadine, astemizole, cisapride, pimozide, or quinidine due to risk of QT prolongation and serious arrhythmias
Drug Interactions
Warfarin
Increased prothrombin time, monitor INR.
Phenytoin
Increased phenytoin levels, monitor levels.
Amiodarone
Increased amiodarone levels, risk of cardiotoxicity.
Rifampicin
Decreased fluconazole levels, dose adjustment may be needed.
Theophylline
Increased plasma theophylline levels, monitor levels.
Hydrochlorothiazide
Increased fluconazole plasma concentrations.
Oral Hypoglycemics (sulfonylureas)
Increased plasma concentrations, risk of hypoglycemia.
Cyclosporine, Tacrolimus, Sirolimus
Increased levels of immunosuppressants, monitor levels.
Storage
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, symptomatic and supportive measures should be instituted as necessary. Gastric lavage may be considered. Fluconazole is largely excreted unchanged in urine, and a 3-hour hemodialysis session decreases plasma levels by approximately 50%.
Pregnancy & Lactation
Pregnancy Category D. Use during pregnancy should be avoided unless the benefits outweigh the potential risks to the fetus. Fluconazole is excreted in human milk, so breastfeeding is not recommended during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
3 years from the date of manufacture.
Availability
Available in pharmacies nationwide
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Fluconazole has undergone extensive clinical trials supporting its efficacy and safety for various fungal infections. Ongoing research explores its role in emerging resistant strains and new indications.
Lab Monitoring
- Liver function tests (LFTs) should be monitored periodically, especially in patients with pre-existing liver conditions or during prolonged therapy. Renal function tests should be performed in patients with kidney impairment.
Doctor Notes
- Advise patients to complete the entire course of therapy to prevent relapse and development of resistance.
- Caution in patients with pre-existing liver dysfunction; monitor LFTs during prolonged treatment.
- Review concomitant medications for potential drug interactions, especially those affecting QT interval.
Patient Guidelines
- Complete the full course of medication, even if symptoms improve, to prevent recurrence.
- Report any unusual side effects or worsening symptoms to your doctor immediately.
- Do not share your medication with others.
- Avoid alcohol during treatment, as it may increase the risk of liver side effects.
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 take a double dose to make up for a missed one.
Driving Precautions
Nispore may cause dizziness or seizures in some individuals. Patients should be advised not to drive or operate machinery if they experience these effects.
Lifestyle Advice
- Maintain good personal hygiene, especially in affected areas, to prevent further spread or recurrence of fungal infections.
- Wear breathable clothing and avoid tight, synthetic garments to reduce moisture and promote healing.
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