Voriderm
Generic Name
Voriderm 200 mg Injection
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| voriderm 200 mg injection | ৳ 2,000.00 | N/A |
Description
Overview of the medicine
Voriderm 200 mg Injection is an antifungal medication used to treat severe fungal infections in adults and children.
Uses & Indications
Dosage
Adults
Loading dose: 6 mg/kg every 12 hours for two doses. Maintenance dose: 4 mg/kg every 12 hours. Dosage should be adjusted based on therapeutic drug monitoring.
Elderly
No dosage adjustment required for elderly patients, but careful monitoring is advised due to potential age-related decrease in metabolism.
Renal_impairment
The intravenous formulation contains a sulfobutylether beta-cyclodextrin sodium (SBECD) vehicle, which is renally cleared. In patients with moderate to severe renal impairment (creatinine clearance < 50 mL/min), accumulation of SBECD can occur. Oral formulation is preferred if possible. If IV use is unavoidable, switch to oral as soon as possible and monitor renal function closely.
How to Take
Voriderm 200 mg Injection is for intravenous infusion only. It should be administered slowly over 1 to 2 hours, not as a rapid bolus injection. It should be reconstituted and diluted as per manufacturer's instructions before administration.
Mechanism of Action
Voriderm works by inhibiting fungal cytochrome P450-mediated 14 alpha-lanosterol demethylation, an essential step in fungal ergosterol biosynthesis. This leads to the accumulation of 14 alpha-methyl sterols and a decrease in ergosterol, thereby disrupting the fungal cell membrane and inhibiting fungal growth.
Pharmacokinetics
Onset
Rapid, typically within 1-2 hours of infusion.
Excretion
Approximately 80% of the dose is excreted in the urine as metabolites, with less than 5% as unchanged drug. Renal excretion of the cyclodextrin vehicle should be considered in patients with renal impairment.
Half life
Variable and dose-dependent, typically ranging from 6 to 8 hours but can be longer with higher doses due to non-linear kinetics.
Absorption
Following intravenous administration, voriderm is rapidly and extensively absorbed, achieving 100% bioavailability. Peak plasma concentrations are reached shortly after infusion.
Metabolism
Primarily metabolized in the liver by cytochrome P450 isoenzymes, particularly CYP2C19, CYP2C9, and CYP3A4. Extensive first-pass metabolism occurs.
Side Effects
Contraindications
- Hypersensitivity to voriconazole or any component of the formulation.
- Co-administration with rifampicin, carbamazepine, phenobarbital, ritonavir (at high doses), efavirenz (at certain doses), ergot alkaloids (e.g., ergotamine, dihydroergotamine), sirolimus, quinidine, or short- and long-acting barbiturates, due to significant drug interactions.
Drug Interactions
Warfarin
Voriderm may increase warfarin levels, leading to increased prothrombin time and bleeding risk. Monitor INR closely.
Efavirenz
Co-administration results in significant drug interactions; contraindicated unless benefits outweigh risks and dose adjustments are made for both drugs.
Ritonavir
High doses of ritonavir (400 mg every 12 hours) significantly decrease voriconazole levels. Concomitant use is contraindicated. Lower doses (100 mg every 12 hours) may be used with caution and TDM.
Cyclosporine, Tacrolimus, Sirolimus
Voriderm can increase concentrations of these immunosuppressants. Reduce dose of immunosuppressant and monitor levels.
Statins (e.g., Lovastatin, Simvastatin)
Voriderm can increase statin levels, increasing risk of rhabdomyolysis. Consider dose reduction or discontinuation of statins.
Rifampicin, Carbamazepine, Phenobarbital
Strong inducers of CYP450, significantly decrease voriconazole plasma concentrations, leading to therapeutic failure. Concomitant use is contraindicated.
Storage
Store below 30°C in a dry place, protected from light. Do not freeze. Reconstituted solution should be used within 24 hours.
Overdose
In case of overdose, administer symptomatic and supportive treatment. There is no known specific antidote for voriconazole. Hemodialysis may remove the sulfobutylether beta-cyclodextrin vehicle but not voriconazole itself.
Pregnancy & Lactation
Pregnancy Category D. Voriderm should not be used during pregnancy unless the benefits outweigh the potential risks to the fetus. It is excreted in breast milk; therefore, breastfeeding should be discontinued during treatment.
Side Effects
Contraindications
- Hypersensitivity to voriconazole or any component of the formulation.
- Co-administration with rifampicin, carbamazepine, phenobarbital, ritonavir (at high doses), efavirenz (at certain doses), ergot alkaloids (e.g., ergotamine, dihydroergotamine), sirolimus, quinidine, or short- and long-acting barbiturates, due to significant drug interactions.
Drug Interactions
Warfarin
Voriderm may increase warfarin levels, leading to increased prothrombin time and bleeding risk. Monitor INR closely.
Efavirenz
Co-administration results in significant drug interactions; contraindicated unless benefits outweigh risks and dose adjustments are made for both drugs.
Ritonavir
High doses of ritonavir (400 mg every 12 hours) significantly decrease voriconazole levels. Concomitant use is contraindicated. Lower doses (100 mg every 12 hours) may be used with caution and TDM.
Cyclosporine, Tacrolimus, Sirolimus
Voriderm can increase concentrations of these immunosuppressants. Reduce dose of immunosuppressant and monitor levels.
Statins (e.g., Lovastatin, Simvastatin)
Voriderm can increase statin levels, increasing risk of rhabdomyolysis. Consider dose reduction or discontinuation of statins.
Rifampicin, Carbamazepine, Phenobarbital
Strong inducers of CYP450, significantly decrease voriconazole plasma concentrations, leading to therapeutic failure. Concomitant use is contraindicated.
Storage
Store below 30°C in a dry place, protected from light. Do not freeze. Reconstituted solution should be used within 24 hours.
Overdose
In case of overdose, administer symptomatic and supportive treatment. There is no known specific antidote for voriconazole. Hemodialysis may remove the sulfobutylether beta-cyclodextrin vehicle but not voriconazole itself.
Pregnancy & Lactation
Pregnancy Category D. Voriderm should not be used during pregnancy unless the benefits outweigh the potential risks to the fetus. It is excreted in breast milk; therefore, breastfeeding should be discontinued during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date when stored correctly.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by DGDA
Patent Status
Generic available
Clinical Trials
Voriderm's efficacy and safety have been established through pivotal clinical trials demonstrating its superiority or non-inferiority compared to other antifungal agents for specific indications. Post-marketing surveillance continues to monitor its long-term safety.
Lab Monitoring
- Liver function tests (ALT, AST, alkaline phosphatase, bilirubin) at baseline and at least twice weekly during treatment.
- Renal function tests (creatinine, BUN) and electrolyte monitoring.
- Therapeutic Drug Monitoring (TDM) to ensure adequate drug exposure and minimize toxicity, especially in patients with altered metabolism or drug interactions.
Doctor Notes
- Monitor liver function tests and renal function closely throughout treatment.
- Consider Therapeutic Drug Monitoring (TDM) to optimize dosing, especially in critically ill patients, those with altered metabolism, or on interacting medications.
- Be aware of potential drug interactions, particularly with CYP450 inhibitors/inducers, and adjust concomitant medications or monitor closely.
- Advise patients about potential visual disturbances and photosensitivity.
Patient Guidelines
- Inform your doctor about all medicines, including herbal remedies and supplements.
- Report any visual disturbances, skin rashes, or signs of liver problems immediately.
- Do not stop the medication suddenly without consulting your doctor, even if you feel better.
- Avoid direct sunlight and use protective measures if sun exposure is unavoidable.
Missed Dose Advice
If a dose of Voriderm injection is missed, it should be administered as soon as remembered. However, if it is almost time for the next scheduled dose, skip the missed dose and resume the regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Voriderm can cause transient and reversible visual disturbances, including blurred vision, altered color perception, and photophobia. Patients should be warned about these potential effects and advised not to drive or operate machinery if they experience them.
Lifestyle Advice
- Maintain good hygiene to prevent further infections.
- Avoid alcohol consumption during treatment as it may exacerbate liver side effects.
- Stay hydrated by drinking plenty of fluids.
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