VORICONAZOLE MYLAN POWDER FOR SOLUTION FOR INJECTION 200 MG/VIAL

Mylan Laboratories Ltd Hosur Steriles Facility (HSF) (INDIA)🇸🇬 Health Sciences Authority

Approval Date: Dec 20, 2022
Approval ID: 38714bec38f2251d
Company: Mylan Laboratories Ltd Hosur Steriles Facility (HSF) (INDIA)
Type: Therapeutic

Approval Details

Approval Id: 38714bec38f2251d
Drug Name: VORICONAZOLE MYLAN POWDER FOR SOLUTION FOR INJECTION 200 MG/VIAL
Product Name: VORICONAZOLE MYLAN POWDER FOR SOLUTION FOR INJECTION 200 MG/VIAL
Approval Number: SIN16656P
Approval Date: 2022-12-20
Registrant: VIATRIS PHARMACEUTICALS PTE. LTD.
Licence Holder: VIATRIS PHARMACEUTICALS PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Dosage: DOSAGE AND ADMINISTRATION Intravenous infusion: Voriconazole requires reconstitution and dilution (see Section CAUTIONS FOR USAGE – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) prior to administration as an intravenous infusion. Voriconazole powder for solution for infusion is not recommended for bolus injection. It is recommended that voriconazole be administered at a maximum rate of 3 mg/kg per hour over 1 to 3 hours. Blood products and concentrated electrolytes Voriconazole must not be infused concomitantly with any blood product or any short-term infusion of concentrated electrolytes, even if the two infusions are running in separate intravenous lines (or cannulas). Electrolyte disturbances such as hypokalemia, hypomagnesemia and hypocalcemia should be corrected prior to initiation of voriconazole therapy (see Section SPECIAL WARNINGS AND PRECAUTIONS FOR USE – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Intravenous solutions containing (non-concentrated) electrolytes Voriconazole can be infused at the same time as other intravenous solutions containing (non-concentrated) electrolytes, but must be infused through a separate line. Total parenteral nutrition (TPN) Voriconazole can be infused at the same time as total parenteral nutrition, but must be infused in a separate line. If infused through a multiple-lumen catheter, TPN needs to be administered using a different port from the one used for voriconazole (see Section INCOMPATIBILITIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Other intravenous products Voriconazole must not be infused into the same line or cannula concomitantly with other intravenous products. Use in adults Therapy must be initiated with the specified loading dose regimen of intravenous voriconazole to achieve plasma concentrations on Day 1 that are close to steady state. Detailed information on dosage recommendations is provided in the following table: <img src="/TGIF/VoriconazoleMylan-Table1.png" alt="Voriconazole Mylan Dosage Table 1" /> Dosage adjustment Intravenous administration: If patient response at 3 mg/kg every 12 hours is inadequate, the intravenous maintenance dose may be increased to 4 mg/kg every 12 hours. If patients are unable to tolerate 4 mg/kg every 12 hours, reduce the intravenous maintenance dose to a minimum of 3 mg/kg every 12 hours. Phenytoin may be co-administered with voriconazole if the maintenance dose of voriconazole is increased to 5 mg/kg intravenously every 12 hours (see Sections SPECIAL WARNINGS AND PRECAUTIONS FOR USE and DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Treatment duration depends upon patients’ clinical and mycological response. Use in the elderly No dose adjustment is necessary for elderly patients. Use in patients with renal impairment Intravenous infusion: In patients with moderate to severe renal dysfunction (creatinine clearance < 50 mL/min), accumulation of the intravenous vehicle, sulphobutylether β-cyclodextrin sodium (SBECD) occurs. Oral voriconazole should be administered to these patients, unless an assessment of the risk benefit to the patient justifies the use of intravenous voriconazole. Serum creatinine levels should be closely monitored in these patients and, if increases occur, consideration should be given to changing to oral voriconazole therapy. Voriconazole is hemodialyzed with a clearance of 121 mL/min. A four-hour hemodialysis session does not remove a sufficient amount of voriconazole to warrant dose adjustment. The intravenous vehicle, SBECD, is hemodialyzed with a clearance of 55 mL/min. Use in patients with hepatic impairment No dose adjustment is necessary in patients with acute hepatic injury, manifested by elevated liver function tests (ALT, AST). Continued monitoring of liver function tests for further elevations is recommended. It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh A and B) receiving voriconazole. Voriconazole has not been studied in patients with severe chronic hepatic cirrhosis (Child-Pugh C). Voriconazole has been associated with elevations in liver function tests and clinical signs of liver damage, such as jaundice, and must only be used in patients with severe hepatic impairment if the benefit outweighs the potential risk. Patients with severe hepatic impairment must be carefully monitored for drug toxicity. Use in pediatrics Safety and effectiveness in pediatric patients below the age of 2 years has not been established (see also Section PHARMACODYNAMIC PROPERTIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Therefore, voriconazole is not recommended for children less than 2 years of age. The recommended maintenance dosing regimen in pediatric patients 2 to <12 years is as follows: <img src="/TGIF/VoriconazoleMylan-Table2.png" alt="Voriconazole Mylan Dosage Table 2" /> If pediatric patients are unable to tolerate an intravenous dose of 7 mg/kg twice daily, a dose reduction from 7 mg/kg to 4 mg/kg twice daily may be considered based on the population pharmacokinetic analysis. This provides equivalent exposure to 3 mg/kg twice daily in adults (see Section DOSAGE AND ADMINISTRATION, Use in adults). Use in pediatric patients aged 2 to <12 years with hepatic or renal insufficiency has not been studied (see Sections SIDE EFFECTS and PHARMACOKINETIC PROPERTIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Adolescents (12 to 16 years of age) should be dosed as adults.
Route Of Administration: INTRAVENOUS
Indication Info: INDICATIONS Voriconazole is a broad spectrum, triazole antifungal agent and is indicated as follows: <ul> <li>Treatment of invasive aspergillosis;</li> <li>Treatment of candidemia in non-neutropenic patients;</li> <li>Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei);</li> <li>Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.;</li> </ul> Prophylaxis in patients ≥ 12 years old who are at high risk of developing invasive fungal infections. The indication is based on a study which includes patients ≥ 12 years old undergoing allogeneic haematopoietic stem cell transplantation.
Contraindications: CONTRAINDICATIONS Voriconazole is contraindicated in patients with known hypersensitivity to voriconazole or to any of the excipients. Co-administration of the CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide, quinidine or ivabradine with voriconazole is contraindicated since increased plasma concentrations of these medicinal products can lead to QTc prolongation and rare occurrences of torsades de pointes (see Section DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Co-administration of voriconazole with naloxegol is contraindicated because voriconazole may significantly increase plasma concentrations of naloxegol which may precipitate opioid withdrawal symptoms (see Section DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Co-administration of voriconazole with tolvaptan is contraindicated because voriconazole may significantly increase plasma concentrations of tolvaptan (see Section DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Co-administration of voriconazole with venetoclax is contraindicated at initiation and during the venetoclax dose titration phase since voriconazole is likely to significantly increase plasma concentrations of venetoclax and increase risk of tumour lysis syndrome (see Section DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Co-administration of voriconazole with lurasidone is contraindicated since it may result in significant increases in lurasidone exposure and the potential for serious adverse reactions (see Section DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Co-administration of voriconazole and sirolimus is contraindicated, since voriconazole has been shown to significantly increase plasma concentrations of sirolimus in healthy subjects (see Section DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Co-administration of voriconazole with rifabutin, rifampicin, carbamazepine and long-acting barbiturates (e.g., phenobarbital) is contraindicated since these medicinal products are likely to decrease plasma voriconazole concentrations significantly. (see Section DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Co-administration of standard doses of voriconazole with efavirenz doses of 400 mg QD or higher is contraindicated because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at this dose. Voriconazole also significantly increases efavirenz plasma concentrations (see Section DRUG INTERACTIONS, for lower doses see Section SPECIAL WARNINGS AND PRECAUTIONS FOR USE – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Co-administration of ergot alkaloids (ergotamine, dihydroergotamine), which are CYP3A4 substrates, is contraindicated since increased plasma concentrations of these medicinal products can lead to ergotism. Co-administration of voriconazole with high-dose ritonavir (400 mg and above twice daily) is contraindicated because ritonavir significantly decreases plasma voriconazole concentrations in healthy subjects at this (see Section DRUG INTERACTIONS, for lower doses see Section SPECIAL WARNINGS AND PRECAUTIONS FOR USE – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Co-administration of voriconazole with St. John’s Wort is contraindicated (see Section DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Atc Code: J02AC03
Atc Item Name: voriconazole
Pharma Manufacturer Name: mylan pharmaceuticals pte. ltd.

Active Ingredients

Voriconazole

200mg/vial

VORICONAZOLE

200 MG/VIAL

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Dec 20, 2022

Approval ID

38714bec38f2251d

Type

Therapeutic

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