Itrazen-SB
Generic Name
Itraconazole (Super Bioavailable) 65 mg Capsule
Manufacturer
ACME Laboratories Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| itrazen sb 65 mg capsule | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Itrazen-SB 65 mg capsule is an antifungal medication containing Itraconazole in a super bioavailable formulation, used to treat various fungal infections.
Uses & Indications
Dosage
Adults
Dosage varies by indication. For onychomycosis, typically 65 mg once daily for 12 consecutive weeks. For systemic infections, 65 mg to 130 mg once or twice daily, depending on severity and type of infection.
Elderly
Use with caution; dose adjustment may be necessary based on renal or hepatic function.
Renal_impairment
Use with caution. Dosage adjustment may be required; specific recommendations should be consulted based on creatinine clearance.
How to Take
Capsules should be swallowed whole with a glass of water, preferably immediately after a full meal to enhance absorption. Do not open or chew the capsule.
Mechanism of Action
Itraconazole inhibits fungal cytochrome P450-dependent 14α-demethylase, which prevents the conversion of lanosterol to ergosterol, a vital component of the fungal cell membrane. This disrupts fungal cell growth and replication.
Pharmacokinetics
Onset
Peak plasma concentrations are typically reached within 2-5 hours.
Excretion
Excreted primarily in feces (3-18% as unchanged drug) and urine (less than 0.03% as unchanged drug), with metabolites also excreted through both routes.
Half life
Initial half-life is around 15-30 hours, extending to 30-45 hours with chronic dosing due to accumulation.
Absorption
Rapidly and extensively absorbed due to super bioavailable formulation. Absorption may be affected by food intake but generally better than conventional itraconazole.
Metabolism
Extensively metabolized in the liver primarily by CYP3A4 into several metabolites, including the active metabolite hydroxy-itraconazole.
Side Effects
Contraindications
- Hypersensitivity to itraconazole or any component of the formulation
- Congestive heart failure or a history of heart failure (except for life-threatening or other serious infections)
- Co-administration with certain CYP3A4 substrates that prolong QT interval (e.g., astemizole, cisapride, dofetilide, quinidine, terfenadine, levacetylmethadol, mizolastine)
- Pregnancy and lactation (unless benefits outweigh risks)
Drug Interactions
Warfarin
Enhanced anticoagulant effect, increased risk of bleeding. Monitor INR closely.
Calcium channel blockers (e.g., verapamil, amlodipine)
May increase levels of both drugs, requiring dose adjustment.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine)
Can decrease itraconazole plasma levels, potentially reducing efficacy. Avoid co-administration if possible.
Certain HMG-CoA reductase inhibitors (e.g., lovastatin, simvastatin)
Increased risk of myopathy/rhabdomyolysis. Co-administration is contraindicated.
Strong CYP3A4 inhibitors (e.g., clarithromycin, erythromycin, ritonavir)
Can increase itraconazole plasma levels, increasing risk of adverse effects. Dose reduction of itraconazole may be needed.
Storage
Store below 25°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
No specific antidote exists. In case of overdose, supportive measures should be taken, including gastric lavage if appropriate. Itraconazole is not removed by hemodialysis.
Pregnancy & Lactation
Itraconazole is generally contraindicated during pregnancy unless the benefits significantly outweigh the potential risks to the fetus. It is excreted in breast milk, so breastfeeding should be discontinued during treatment.
Side Effects
Contraindications
- Hypersensitivity to itraconazole or any component of the formulation
- Congestive heart failure or a history of heart failure (except for life-threatening or other serious infections)
- Co-administration with certain CYP3A4 substrates that prolong QT interval (e.g., astemizole, cisapride, dofetilide, quinidine, terfenadine, levacetylmethadol, mizolastine)
- Pregnancy and lactation (unless benefits outweigh risks)
Drug Interactions
Warfarin
Enhanced anticoagulant effect, increased risk of bleeding. Monitor INR closely.
Calcium channel blockers (e.g., verapamil, amlodipine)
May increase levels of both drugs, requiring dose adjustment.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine)
Can decrease itraconazole plasma levels, potentially reducing efficacy. Avoid co-administration if possible.
Certain HMG-CoA reductase inhibitors (e.g., lovastatin, simvastatin)
Increased risk of myopathy/rhabdomyolysis. Co-administration is contraindicated.
Strong CYP3A4 inhibitors (e.g., clarithromycin, erythromycin, ritonavir)
Can increase itraconazole plasma levels, increasing risk of adverse effects. Dose reduction of itraconazole may be needed.
Storage
Store below 25°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
No specific antidote exists. In case of overdose, supportive measures should be taken, including gastric lavage if appropriate. Itraconazole is not removed by hemodialysis.
Pregnancy & Lactation
Itraconazole is generally contraindicated during pregnancy unless the benefits significantly outweigh the potential risks to the fetus. It is excreted in breast milk, so breastfeeding should be discontinued during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 2-3 years from the date of manufacture, specific details on packaging.
Availability
Available in pharmacies and hospitals
Approval Status
Approved
Patent Status
Generic (Super Bioavailable formulation may have specific patents)
Clinical Trials
Clinical trials have demonstrated the enhanced bioavailability and efficacy of the SB formulation of itraconazole compared to conventional formulations, particularly for systemic fungal infections and onychomycosis.
Lab Monitoring
- Liver function tests (ALT, AST, alkaline phosphatase) should be performed at baseline and periodically during prolonged treatment, especially in patients with pre-existing hepatic impairment. Potassium levels should be monitored in patients at risk of hypokalemia.
Doctor Notes
- Ensure proper diagnosis of fungal infection before initiating itraconazole therapy.
- Carefully assess cardiac history, liver function, and current medications for potential interactions.
- Counsel patients on the importance of adherence, recognizing side effects, and avoiding contraindicated drugs.
- Consider therapeutic drug monitoring in specific cases (e.g., immunocompromised patients, treatment failures).
Patient Guidelines
- Complete the full course of treatment as prescribed, even if symptoms improve.
- Take the capsule with food for better absorption.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any signs of liver problems (e.g., unusual fatigue, dark urine, pale stools, yellowing of skin/eyes) or heart failure (e.g., shortness of breath, sudden weight gain, swelling) immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for the next dose. Do not double the dose to make up for a missed one.
Driving Precautions
Itraconazole may cause dizziness or visual disturbances in some patients. Patients should be cautioned about driving or operating machinery until they know how Itrazen-SB affects them.
Lifestyle Advice
- Maintain good hygiene to prevent recurrence of fungal infections. Avoid self-medication.
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