Vorifast
Generic Name
Voriconazole
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
vorifast 50 mg tablet | ৳ 50.00 | ৳ 500.00 |
Description
Overview of the medicine
Voriconazole is a broad-spectrum triazole antifungal agent used to treat serious, life-threatening fungal infections, including invasive aspergillosis, candidemia, and infections caused by Scedosporium and Fusarium species.
Uses & Indications
Dosage
Adults
Oral: For invasive aspergillosis and other serious fungal infections, a loading dose of 400 mg every 12 hours for 24 hours, followed by a maintenance dose of 200 mg every 12 hours. Doses may be adjusted based on therapeutic drug monitoring (TDM) and patient response. 50 mg tablets may be used for dose titration or specific maintenance regimens.
Elderly
No dosage adjustment needed based on age alone, but monitor closely due to potential for decreased hepatic/renal function.
Renal_impairment
Oral voriconazole is generally preferred. No dosage adjustment for oral formulation in renal impairment. For IV formulation, monitor serum creatinine, as the excipient SBECD can accumulate in severe renal dysfunction.
How to Take
Vorifast tablets should be taken at least one hour before or one hour after a meal. Swallow the tablet whole with water. Do not crush or chew.
Mechanism of Action
Voriconazole inhibits fungal cytochrome P450-dependent 14-alpha-demethylase, an enzyme essential for the biosynthesis of ergosterol. Ergosterol is a key component of the fungal cell membrane, and its depletion leads to increased cell permeability and cell lysis, thus inhibiting fungal growth.
Pharmacokinetics
Onset
Within 1-2 hours of administration, peak plasma concentrations are achieved.
Excretion
Mainly through hepatic metabolism, followed by renal excretion of metabolites. Less than 2% of the dose is excreted unchanged in urine.
Half life
Dose-dependent, typically 6-12 hours in healthy adults at therapeutic doses. Non-linear kinetics lead to longer half-lives at higher doses.
Absorption
Rapid and almost completely absorbed after oral administration, with bioavailability of approximately 90%. Absorption is reduced when administered with a high-fat meal.
Metabolism
Primarily hepatic, mainly by CYP2C19, CYP2F9, and CYP3A4 enzymes. CYP2C19 exhibits genetic polymorphism, leading to variable metabolism.
Side Effects
Contraindications
- Hypersensitivity to voriconazole or any component of the formulation.
- Co-administration with strong CYP3A4 substrates that can prolong QT interval (e.g., astemizole, cisapride, pimozide, quinidine, terfenadine).
- Co-administration with rifampicin, rifabutin, carbamazepine, phenobarbital, ritonavir (at high doses), efavirenz (specific dose interactions apply), sirolimus, St. John's wort, ergot alkaloids.
Drug Interactions
Warfarin
Increases prothrombin time (INR); monitor INR closely.
Efavirenz
Complex interaction; concurrent use generally not recommended or requires specific dose adjustments for both drugs.
Phenytoin
Significantly decreases voriconazole levels; requires voriconazole dose adjustment and phenytoin level monitoring.
Cyclosporine, Tacrolimus, Sirolimus
Increases concentrations of these immunosuppressants; requires dose reduction and monitoring of levels.
Rifampicin, Carbamazepine, Phenobarbital
Significantly decrease voriconazole plasma concentrations; concomitant use is contraindicated.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
In case of overdose, symptomatic and supportive treatment should be initiated. There is no specific antidote. Hemodialysis is not effective in removing voriconazole from the body.
Pregnancy & Lactation
Pregnancy Category D. Voriconazole is embryotoxic and teratogenic in animals and is not recommended during pregnancy unless the benefits outweigh the potential risks to the fetus. It is unknown if voriconazole is excreted in human milk, therefore, breastfeeding should be discontinued during treatment.
Side Effects
Contraindications
- Hypersensitivity to voriconazole or any component of the formulation.
- Co-administration with strong CYP3A4 substrates that can prolong QT interval (e.g., astemizole, cisapride, pimozide, quinidine, terfenadine).
- Co-administration with rifampicin, rifabutin, carbamazepine, phenobarbital, ritonavir (at high doses), efavirenz (specific dose interactions apply), sirolimus, St. John's wort, ergot alkaloids.
Drug Interactions
Warfarin
Increases prothrombin time (INR); monitor INR closely.
Efavirenz
Complex interaction; concurrent use generally not recommended or requires specific dose adjustments for both drugs.
Phenytoin
Significantly decreases voriconazole levels; requires voriconazole dose adjustment and phenytoin level monitoring.
Cyclosporine, Tacrolimus, Sirolimus
Increases concentrations of these immunosuppressants; requires dose reduction and monitoring of levels.
Rifampicin, Carbamazepine, Phenobarbital
Significantly decrease voriconazole plasma concentrations; concomitant use is contraindicated.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
In case of overdose, symptomatic and supportive treatment should be initiated. There is no specific antidote. Hemodialysis is not effective in removing voriconazole from the body.
Pregnancy & Lactation
Pregnancy Category D. Voriconazole is embryotoxic and teratogenic in animals and is not recommended during pregnancy unless the benefits outweigh the potential risks to the fetus. It is unknown if voriconazole is excreted in human milk, therefore, breastfeeding should be discontinued during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, specific details on packaging.
Availability
Pharmacies, hospitals
Approval Status
Approved (FDA, DGDA for generic versions)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Voriconazole has undergone extensive clinical trials demonstrating its efficacy and safety in various severe fungal infections, leading to its global approval.
Lab Monitoring
- Liver function tests (LFTs) at baseline and during treatment.
- Renal function tests (serum creatinine).
- Electrolyte levels (potassium, magnesium, calcium).
- Therapeutic drug monitoring (TDM) of voriconazole plasma levels, especially in patients with hepatic impairment, renal impairment, or those on interacting medications, and in pediatric patients.
Doctor Notes
- Strictly monitor liver function tests (LFTs) throughout treatment.
- Consider Therapeutic Drug Monitoring (TDM) to optimize dosing and minimize toxicity, especially in high-risk patients.
- Be aware of extensive drug-drug interactions, particularly with CYP450 substrates and inhibitors.
- Advise patients about photosensitivity and the need for sun protection.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Complete the full course of treatment, even if your symptoms improve.
- Avoid direct sunlight and use protective measures (e.g., sunscreen, protective clothing) due to increased photosensitivity.
- Report any visual disturbances, skin rash, or signs of liver problems (e.g., yellowing skin/eyes, dark urine) to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Voriconazole can cause temporary and reversible visual disturbances, including blurred vision, altered color perception, and photophobia. Patients should be advised to exercise caution when driving or operating machinery, especially at night.
Lifestyle Advice
- Avoid excessive sun exposure and tanning beds due to the risk of photosensitivity and skin cancer.
- Avoid alcohol consumption as it may increase the risk of liver damage.
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