Voriconazole for Injection 200 mg Powder Vial by Fosun Pharma (RX)

Voriconazole for Injection 200 mg by Fosun Pharma is a sterile, lyophilized powder designed for reconstitution and intravenous administration. It contains the active antifungal agent, voriconazole, specifically formulated to treat severe fungal infections. Manufactured by Fosun Pharma, this medication meets stringent quality standards to ensure safety and efficacy. 

Voriconazole for Injection 200 mg
Manufacturer: Fosun Pharma
Pharmaceutical Form: Lyophilized Powder for Solution for Infusion
Active Ingredient: Voriconazole (200 mg per vial)

Packaging:

Each vial contains 200 mg of voriconazole as a lyophilized powder. The product is usually supplied in sterilized glass vials sealed with a rubber stopper and an aluminum crimp seal with a flip-off cap.

Appearance:

Voriconazole is presented as a white to off-white lyophilized powder.

Indications:

Voriconazole for Injection is indicated for the treatment of several serious systemic fungal infections, including:

• Acute invasive aspergillosis.
  
• Severe infections caused by Scedosporium apiospermum.
  
• Severe infections caused by Fusarium species.
  
• Flucytosine-resistant and fluconazole-resistant serious Candida infections.

This antimicrobial agent is typically used in patients who have not responded to other antifungal treatments or who are intolerant to other therapies. It is especially crucial in immunocompromised patients, such as those undergoing hematopoietic stem cell transplantation or chemotherapy.

Mechanism of Action:

Voriconazole is a triazole antifungal agent. It exerts its effect by inhibiting the enzyme 14α-sterol demethylase. This inhibition disrupts ergosterol synthesis, a vital component of fungal cell membranes, thereby compromising membrane integrity, growth, and replication of fungi.

Administration and Dosage:

Voriconazole for Injection must be reconstituted and further diluted for intravenous infusion. The dosage and duration of therapy should be guided by patient condition, type of infection, and response to treatment. Typical dosing instructions are as follows:

Initial intravenous loading dose (Day 1): 6 mg/kg every 12 hours for 24 hours.
Following maintenance dose: 4 mg/kg every 12 hours intravenously.

Reconstitution and Dilution:

1. Reconstitute each vial with 19 ml of sterile water for injection to achieve a concentration of 10 mg/ml.
2. Gently shake the mixture to ensure complete dissolution.
3. Further dilute the reconstituted solution with a compatible infusion fluid (e.g., 0.9% sodium chloride injection, 5% dextrose injection) to achieve a final voriconazole concentration of 0.5 - 5 mg/ml for intravenous administration.

Pharmacokinetics:

• Absorption: Rapidly distributed following injection.
  
• Distribution: Widely distributed into tissues with high penetration into the cerebrospinal fluid.
  
• Metabolism: Extensively metabolized in the liver by the cytochrome P450 enzymes.
  
• Elimination: Primarily excreted through the urine, predominantly as metabolites.

Storage Conditions:

• Store unopened vials at 20° to 25°C (68° to 77°F) in a dry place. 
  
• After reconstitution, unused solution must be discarded if not used within specified time frames, generally within 24 hours if stored under refrigeration.

Precautions and Contraindications:

• Contraindicated in patients with known hypersensitivity to voriconazole or to any of the components of the formulation.
  
• Caution is advised in patients with hepatic or renal impairment.
  
• Voriconazole can cause QT prolongation; use with caution in patients with pro-arrhythmic conditions.
  
• Regular monitoring of liver function tests, renal function, and electrolyte levels is recommended.
  
• Not recommended in pregnant and breastfeeding women unless the potential benefit justifies the potential risk to the fetus/infant.

Possible Side Effects:

Common side effects include, but are not limited to:

• Visual disturbances
  
• Fever
  
• Rash
• Nausea and vomiting
  
• Elevated liver enzymes
  
• Flushing and headache

Serious but less common side effects may include severe liver impairment, severe cutaneous reactions, and cardiac arrhythmias.

Voriconazole for Injection 200 mg Powder Vial by Fosun Pharma is a critical antifungal medication for the treatment of severe and invasive fungal infections. Given under proper medical supervision, its clinical utility is invaluable in combating complicated mycotic diseases, especially in immunocompromised individuals where other treatments are ineffective or not tolerated. The administration must follow specific reconstitution and infusion protocols to ensure patient safety and drug efficacy.