Vorifast
Generic Name
Voriconazole
Manufacturer
Healthcare Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
vorifast 200 mg injection | ৳ 2,000.00 | N/A |
Description
Overview of the medicine
Voriconazole is a triazole antifungal medication used to treat serious fungal infections, particularly invasive aspergillosis, candidemia in non-neutropenic patients, and other severe Candida infections.
Uses & Indications
Dosage
Adults
Loading dose: 6 mg/kg IV every 12 hours for 2 doses. Maintenance dose: 4 mg/kg IV every 12 hours. For esophageal candidiasis, maintenance dose may be 3 mg/kg IV every 12 hours.
Elderly
No dose adjustment generally required based on age alone, but careful monitoring for adverse effects is recommended.
Renal_impairment
The intravenous formulation should be avoided in patients with moderate to severe renal impairment (creatinine clearance <50 mL/min) due to accumulation of the excipient SBECD (sulfobutylether beta-cyclodextrin sodium). Oral formulation should be considered.
How to Take
Administer by intravenous infusion over 1 to 2 hours. The infusion rate should not exceed 3 mg/kg per hour. Not for bolus injection. Reconstitute and dilute according to manufacturer's instructions.
Mechanism of Action
Voriconazole inhibits fungal cytochrome P450-dependent 14α-sterol demethylation, which is an essential step in fungal ergosterol biosynthesis. This leads to depletion of ergosterol and accumulation of 14α-methyl sterols, disrupting the fungal cell membrane and inhibiting fungal growth.
Pharmacokinetics
Onset
Rapidly achieves steady-state plasma concentrations within 24 hours with appropriate loading doses.
Excretion
Primarily eliminated via hepatic metabolism, with less than 2% excreted unchanged in urine. About 80% of metabolites are excreted in urine and 10% in feces.
Half life
Dose-dependent, with a terminal half-life typically ranging from 6 to 9 hours at therapeutic doses. However, due to non-linear kinetics, it can vary significantly.
Absorption
Administered intravenously, providing rapid and high systemic exposure.
Metabolism
Extensively metabolized by hepatic cytochrome P450 enzymes (primarily CYP2C19, but also CYP2C9 and CYP3A4). Significant inter-individual variability due to CYP2C19 polymorphism.
Side Effects
Contraindications
- Hypersensitivity to voriconazole or any component of the formulation.
- Co-administration with terfenadine, astemizole, cisapride, pimozide, quinidine (due to risk of QT prolongation and torsade de pointes).
- Co-administration with rifampicin, carbamazepine, phenobarbital, and efavirenz (due to significant decrease in voriconazole plasma concentrations).
- Co-administration with high-dose ritonavir (≥400 mg every 12 hours), sirolimus, ergot alkaloids (ergotamine, dihydroergotamine), and St. John's wort (Hypericum perforatum).
Drug Interactions
Warfarin
May increase INR and risk of bleeding; close monitoring of prothrombin time/INR needed.
Phenytoin
Voriconazole may increase phenytoin levels, and phenytoin may decrease voriconazole levels; co-administration should be avoided unless benefits outweigh risks, with careful monitoring.
Rifampicin
Significantly decreases voriconazole plasma concentrations (contraindicated).
Cyclosporine
Voriconazole increases cyclosporine plasma concentrations; close monitoring of cyclosporine levels and dose adjustment needed.
Statins (e.g., Atorvastatin)
Increased risk of rhabdomyolysis and myopathy; dose reduction or temporary discontinuation of statins may be required.
Benzodiazepines (e.g., Midazolam)
Voriconazole may prolong the sedative effects; dose adjustment of benzodiazepines may be needed.
Storage
Store intact vials below 30°C (86°F). Protect from light. Do not freeze. Keep out of reach of children.
Overdose
In cases of overdose, patients should receive symptomatic and supportive care. Voriconazole is dialyzable, but the excipient SBECD (sulfobutylether beta-cyclodextrin sodium) in the intravenous formulation is not effectively removed by hemodialysis.
Pregnancy & Lactation
Pregnancy: Category D. Voriconazole may cause fetal harm when administered to a pregnant woman. It should not be used during pregnancy unless the benefits to the mother clearly outweigh the potential risks to the fetus. Lactation: It is unknown whether voriconazole is excreted in human milk. Due to potential serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment.
Side Effects
Contraindications
- Hypersensitivity to voriconazole or any component of the formulation.
- Co-administration with terfenadine, astemizole, cisapride, pimozide, quinidine (due to risk of QT prolongation and torsade de pointes).
- Co-administration with rifampicin, carbamazepine, phenobarbital, and efavirenz (due to significant decrease in voriconazole plasma concentrations).
- Co-administration with high-dose ritonavir (≥400 mg every 12 hours), sirolimus, ergot alkaloids (ergotamine, dihydroergotamine), and St. John's wort (Hypericum perforatum).
Drug Interactions
Warfarin
May increase INR and risk of bleeding; close monitoring of prothrombin time/INR needed.
Phenytoin
Voriconazole may increase phenytoin levels, and phenytoin may decrease voriconazole levels; co-administration should be avoided unless benefits outweigh risks, with careful monitoring.
Rifampicin
Significantly decreases voriconazole plasma concentrations (contraindicated).
Cyclosporine
Voriconazole increases cyclosporine plasma concentrations; close monitoring of cyclosporine levels and dose adjustment needed.
Statins (e.g., Atorvastatin)
Increased risk of rhabdomyolysis and myopathy; dose reduction or temporary discontinuation of statins may be required.
Benzodiazepines (e.g., Midazolam)
Voriconazole may prolong the sedative effects; dose adjustment of benzodiazepines may be needed.
Storage
Store intact vials below 30°C (86°F). Protect from light. Do not freeze. Keep out of reach of children.
Overdose
In cases of overdose, patients should receive symptomatic and supportive care. Voriconazole is dialyzable, but the excipient SBECD (sulfobutylether beta-cyclodextrin sodium) in the intravenous formulation is not effectively removed by hemodialysis.
Pregnancy & Lactation
Pregnancy: Category D. Voriconazole may cause fetal harm when administered to a pregnant woman. It should not be used during pregnancy unless the benefits to the mother clearly outweigh the potential risks to the fetus. Lactation: It is unknown whether voriconazole is excreted in human milk. Due to potential serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date, when stored properly. Reconstituted solution is stable for 24 hours at 2-8°C.
Availability
Hospitals, Pharmacies
Approval Status
FDA approved, widely approved
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of voriconazole in treating various invasive fungal infections, including randomized controlled trials against conventional amphotericin B for invasive aspergillosis.
Lab Monitoring
- Liver function tests (LFTs) at baseline and at least weekly during the first month of treatment, then monthly.
- Renal function tests, including serum creatinine and BUN.
- Electrolytes, particularly potassium and magnesium, to correct any abnormalities.
- Therapeutic drug monitoring (TDM) of voriconazole plasma concentrations may be beneficial in certain populations (e.g., liver impairment, drug interactions, pediatric patients) to optimize efficacy and minimize toxicity.
Doctor Notes
- Crucial to monitor liver function tests regularly, especially at treatment initiation and during the first month.
- Consider therapeutic drug monitoring (TDM) to guide dosing in patients with liver impairment, significant drug interactions, or in pediatric populations to ensure adequate exposure and minimize toxicity.
- Counsel patients on potential visual disturbances and photosensitivity, advising them to avoid direct sunlight and report changes promptly.
- Be vigilant for drug interactions, particularly with CYP3A4, CYP2C9, and CYP2C19 substrates/inhibitors/inducers.
- Avoid IV formulation in moderate to severe renal impairment due to SBECD accumulation; consider oral voriconazole if feasible.
Patient Guidelines
- Report any new or worsening visual disturbances immediately to your healthcare provider.
- Avoid direct exposure to sunlight and use protective measures (e.g., sunscreen, protective clothing) due to increased photosensitivity.
- Do not discontinue treatment without consulting your doctor, even if you feel better.
- Inform your doctor or pharmacist about all other medications, supplements, and herbal products you are taking.
- Be aware of potential liver problems; report symptoms like unusual tiredness, nausea, vomiting, yellowing of skin/eyes, or dark urine.
Missed Dose Advice
If a dose is missed, administer it as soon as possible unless it is almost time for the next scheduled dose. Do not double the dose to make up for a missed one. Contact your doctor for advice.
Driving Precautions
Voriconazole can cause temporary and reversible visual disturbances, including blurred vision, altered color perception, and photophobia. Patients should avoid driving or operating machinery if they experience these effects.
Lifestyle Advice
- Maintain good hygiene to prevent further infections.
- Avoid alcohol during treatment as it can exacerbate liver side effects.
- Stay adequately hydrated.
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