Vori
Generic Name
Voriconazole
Manufacturer
Generic Manufacturer (e.g., Beximco Pharmaceuticals)
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| vori 200 mg injection | ৳ 2,000.00 | N/A |
Description
Overview of the medicine
Voriconazole is a broad-spectrum triazole antifungal agent used to treat serious and life-threatening fungal infections, particularly in immunocompromised patients. It is effective against a wide range of yeasts and molds.
Uses & Indications
Dosage
Adults
For most indications, a loading dose of 6 mg/kg IV every 12 hours for two doses, followed by a maintenance dose of 4 mg/kg IV every 12 hours. Dosing may vary by specific indication and patient response.
Elderly
No dosage adjustment is generally required based on age alone, but monitor closely for adverse effects.
Renal_impairment
The intravenous formulation contains sulfobutylether beta-cyclodextrin (SBECD), which can accumulate in patients with moderate to severe renal impairment (creatinine clearance < 50 mL/min). In such patients, oral voriconazole is preferred. If IV voriconazole is essential, monitor serum creatinine and consider alternative therapies or dose adjustment based on clinical judgment.
How to Take
Administer via intravenous infusion over 1 to 2 hours, at a rate not exceeding 3 mg/kg per hour. Do not administer as a rapid intravenous bolus injection.
Mechanism of Action
Voriconazole inhibits fungal cytochrome P450-dependent 14α-lanosterol demethylation, an essential step in fungal ergosterol biosynthesis. This leads to the accumulation of 14α-methyl sterols and a decrease in ergosterol, disrupting fungal cell membrane function and growth.
Pharmacokinetics
Onset
Rapid, typically within 1-2 hours for steady-state concentrations after loading dose.
Excretion
Primarily excreted in the urine as inactive metabolites (about 80%), with a small amount excreted in feces.
Half life
Dose-dependent, ranging from approximately 6 to 10 hours at therapeutic doses, but can be longer due to saturable metabolism.
Absorption
Rapid and complete oral absorption (not directly applicable for IV, which is 100% bioavailable immediately).
Metabolism
Extensively metabolized in the liver, primarily by CYP2C19, but also by CYP2C9 and CYP3A4. Exhibits non-linear pharmacokinetics.
Side Effects
Contraindications
- Hypersensitivity to voriconazole or any component of the formulation.
- Co-administration with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenobarbital, St. John's wort) due to significant reduction in voriconazole plasma concentrations.
- Co-administration with CYP3A4 substrates with narrow therapeutic windows (e.g., terfenadine, astemizole, cisapride, pimozide, quinidine) due to increased risk of QT prolongation and torsades de pointes.
- Co-administration with ergot alkaloids (e.g., ergotamine, dihydroergotamine).
- Co-administration with sirolimus (due to significant increase in sirolimus levels).
Drug Interactions
Statins
Increased risk of myopathy. Consider temporary discontinuation or dose reduction of statin.
Warfarin
May increase INR. Monitor INR closely.
Phenytoin
May significantly decrease voriconazole levels and increase phenytoin levels. Co-administration generally avoided.
Cyclosporine, Tacrolimus
May increase levels of immunosuppressants. Reduce dose and monitor levels.
Rifampicin, Carbamazepine
Significant decrease in voriconazole levels. Contraindicated.
Benzodiazepines (e.g., Midazolam)
Increased benzodiazepine levels. Dose adjustment may be necessary.
Storage
Store unopened vials below 30°C (86°F). Protect from light. Do not freeze.
Overdose
There is no specific antidote for voriconazole. In case of overdose, discontinue the infusion, provide symptomatic treatment and supportive measures. Voriconazole is hemodialyzed, and the excipient SBECD is also hemodialyzable.
Pregnancy & Lactation
**Pregnancy:** Pregnancy Category D. Voriconazole may cause fetal harm when administered to a pregnant woman. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. **Lactation:** Voriconazole is excreted in breast milk. A decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to voriconazole or any component of the formulation.
- Co-administration with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenobarbital, St. John's wort) due to significant reduction in voriconazole plasma concentrations.
- Co-administration with CYP3A4 substrates with narrow therapeutic windows (e.g., terfenadine, astemizole, cisapride, pimozide, quinidine) due to increased risk of QT prolongation and torsades de pointes.
- Co-administration with ergot alkaloids (e.g., ergotamine, dihydroergotamine).
- Co-administration with sirolimus (due to significant increase in sirolimus levels).
Drug Interactions
Statins
Increased risk of myopathy. Consider temporary discontinuation or dose reduction of statin.
Warfarin
May increase INR. Monitor INR closely.
Phenytoin
May significantly decrease voriconazole levels and increase phenytoin levels. Co-administration generally avoided.
Cyclosporine, Tacrolimus
May increase levels of immunosuppressants. Reduce dose and monitor levels.
Rifampicin, Carbamazepine
Significant decrease in voriconazole levels. Contraindicated.
Benzodiazepines (e.g., Midazolam)
Increased benzodiazepine levels. Dose adjustment may be necessary.
Storage
Store unopened vials below 30°C (86°F). Protect from light. Do not freeze.
Overdose
There is no specific antidote for voriconazole. In case of overdose, discontinue the infusion, provide symptomatic treatment and supportive measures. Voriconazole is hemodialyzed, and the excipient SBECD is also hemodialyzable.
Pregnancy & Lactation
**Pregnancy:** Pregnancy Category D. Voriconazole may cause fetal harm when administered to a pregnant woman. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. **Lactation:** Voriconazole is excreted in breast milk. A decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months for unopened vials. Reconstituted solution is stable for 24 hours at 2-8°C.
Availability
Hospitals, retail pharmacies
Approval Status
FDA Approved
Patent Status
Patent expired, generics available
Clinical Trials
Voriconazole has been extensively studied in numerous clinical trials for its efficacy and safety in treating a wide range of invasive fungal infections, including randomized controlled trials against conventional amphotericin B and other antifungals.
Lab Monitoring
- Liver function tests (AST, ALT, alkaline phosphatase, bilirubin)
- Renal function tests (creatinine, BUN)
- Electrolytes (especially potassium, magnesium, calcium)
- Therapeutic drug monitoring (TDM) of voriconazole plasma concentrations is recommended in certain situations
Doctor Notes
- Always ensure proper loading and maintenance dosing based on patient weight and indication.
- Monitor liver function tests, renal function, and electrolytes regularly.
- Therapeutic drug monitoring (TDM) of voriconazole plasma levels is recommended for optimized efficacy and safety, especially in specific patient populations (e.g., pediatric, hepatic/renal impairment, drug interactions).
- Be aware of the SBECD accumulation risk in renal impairment for IV formulation.
Patient Guidelines
- Report any changes in vision (e.g., blurred vision, altered color perception) or light sensitivity immediately to your doctor.
- Report any new or worsening skin rash, especially after sun exposure.
- Complete the full course of treatment as prescribed, even if you start to feel better.
- Inform your doctor about all other medications, herbal products, and supplements you are taking.
Missed Dose Advice
If a dose is missed, administer it as soon as possible. If it is almost time for the next dose, skip the missed dose and resume the regular dosing schedule. Do not double the dose to catch up. Consult your doctor.
Driving Precautions
Voriconazole can cause transient and reversible visual disturbances (e.g., blurred vision, altered color perception). Patients should be cautioned against driving, operating machinery, or engaging in activities requiring clear vision if they experience these effects.
Lifestyle Advice
- Avoid prolonged exposure to direct sunlight and use protective measures (e.g., sunscreen, protective clothing) due to increased risk of photosensitivity.
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