Izic
Generic Name
Fluconazole
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| izic 50 mg capsule | ৳ 5.00 | ৳ 50.00 |
Description
Overview of the medicine
Izic 50 mg Capsule contains Fluconazole, an antifungal medication used to treat a variety of fungal infections, including vaginal yeast infections, oral thrush, esophageal candidiasis, and systemic fungal infections.
Uses & Indications
Dosage
Adults
For oropharyngeal candidiasis: 50 mg once daily for 7-14 days. For esophageal candidiasis: 50 mg once daily for 14-30 days. For vaginal candidiasis, a single 150 mg dose is typically used.
Elderly
No dosage adjustment is usually required in elderly patients with normal renal function. For patients with renal impairment, dosage should be adjusted as per renal impairment guidelines.
Renal_impairment
Dosage adjustment is necessary. For creatinine clearance 21-50 mL/min, administer 50% of the usual daily dose. For creatinine clearance <20 mL/min, administer 25% of the usual daily dose. A loading dose may be given on the first day.
How to Take
Take orally, with or without food. Swallow the capsule whole with water. Do not chew or crush.
Mechanism of Action
Fluconazole inhibits fungal cytochrome P450-dependent 14-alpha-demethylase, an enzyme necessary for the synthesis of ergosterol. Ergosterol is a vital component of the fungal cell membrane, and its inhibition leads to increased fungal cell permeability, leakage of cellular contents, and eventual cell death.
Pharmacokinetics
Onset
Within 1-2 hours (for peak plasma concentration).
Excretion
Primarily renal; approximately 80% of the dose is excreted unchanged in urine.
Half life
Approximately 30 hours (range 20-50 hours).
Absorption
Well absorbed orally, bioavailability is >90%. Peak plasma concentrations are reached within 1-2 hours.
Metabolism
Minimally metabolized; primarily by the liver, but only about 11% of the dose is metabolized.
Side Effects
Contraindications
- Hypersensitivity to fluconazole, other azole antifungals, or any excipients.
- Co-administration with terfenadine (if fluconazole dose is 400 mg/day or more).
- Co-administration with astemizole, cisapride, pimozide, quinidine, erythromycin due to risk of QT prolongation and torsade de pointes.
Drug Interactions
Warfarin
Increased prothrombin time, monitor INR.
Phenytoin
Increased phenytoin levels, monitor levels.
Rifampicin
Decreased fluconazole levels, consider increasing fluconazole dose.
Cyclosporine
Increased cyclosporine levels, monitor levels.
Hydrochlorothiazide
Increased fluconazole plasma concentrations.
Oral Contraceptives
Potential for altered contraceptive efficacy, though usually minor.
Sulfonylureas (e.g., Glibenclamide)
Increased blood glucose lowering effect.
Statins (e.g., Atorvastatin, Simvastatin)
Increased statin levels, leading to increased risk of myopathy/rhabdomyolysis.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include hallucinations and paranoid behavior. Treatment is symptomatic and supportive, with gastric lavage if necessary, and hemodialysis may enhance clearance.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if potential benefit justifies the potential risk to the fetus. Avoid high doses and long-term use. Fluconazole is excreted in human milk; use with caution during lactation.
Side Effects
Contraindications
- Hypersensitivity to fluconazole, other azole antifungals, or any excipients.
- Co-administration with terfenadine (if fluconazole dose is 400 mg/day or more).
- Co-administration with astemizole, cisapride, pimozide, quinidine, erythromycin due to risk of QT prolongation and torsade de pointes.
Drug Interactions
Warfarin
Increased prothrombin time, monitor INR.
Phenytoin
Increased phenytoin levels, monitor levels.
Rifampicin
Decreased fluconazole levels, consider increasing fluconazole dose.
Cyclosporine
Increased cyclosporine levels, monitor levels.
Hydrochlorothiazide
Increased fluconazole plasma concentrations.
Oral Contraceptives
Potential for altered contraceptive efficacy, though usually minor.
Sulfonylureas (e.g., Glibenclamide)
Increased blood glucose lowering effect.
Statins (e.g., Atorvastatin, Simvastatin)
Increased statin levels, leading to increased risk of myopathy/rhabdomyolysis.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include hallucinations and paranoid behavior. Treatment is symptomatic and supportive, with gastric lavage if necessary, and hemodialysis may enhance clearance.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if potential benefit justifies the potential risk to the fetus. Avoid high doses and long-term use. Fluconazole is excreted in human milk; use with caution during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, specific to manufacturer.
Availability
Available in pharmacies worldwide
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established the efficacy and safety of fluconazole for various fungal infections. Ongoing post-marketing surveillance and studies continue to monitor its use.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, bilirubin) especially during prolonged therapy or in patients with liver disease.
- Renal function tests (serum creatinine, BUN) in patients with renal impairment.
- INR in patients on warfarin.
- Electrolyte levels (potassium, magnesium, calcium) especially in patients at risk of arrhythmias.
Doctor Notes
- Counsel patients on the importance of completing the full course of therapy.
- Advise patients to report any signs of liver dysfunction (e.g., jaundice, dark urine) immediately.
- Caution about potential drug interactions, especially with warfarin, phenytoin, and statins.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking the medicine early, even if your symptoms improve, to prevent recurrence.
- Report any severe skin rash, yellowing of skin/eyes, or unusual fatigue immediately to your doctor.
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 two doses at once to make up for a missed dose.
Driving Precautions
Fluconazole may cause dizziness or seizures in some individuals. If you experience these side effects, avoid driving or operating machinery.
Lifestyle Advice
- Maintain good hygiene to prevent recurrence of fungal infections.
- Avoid sharing personal items like towels and clothing.
- For vaginal yeast infections, avoid tight-fitting clothing and maintain proper vaginal hygiene.
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