Voriderm 50

Indications for Use:

Voriderm is a powerful azole antifungal treatment designed to combat serious fungal infections. It is suitable for patients aged 12 years and older and is specifically indicated for the following conditions:

• Invasive Aspergillosis
• Candidemia (non-neutropenic) and Disseminated Candidiasis, including infections of the skin, abdomen, kidneys, bladder wall, and wounds
• Esophageal Candidiasis
• Serious Fungal Infections caused by Scedosporium apiospermum and Fusarium species, including Fusarium solani
• Patients who are intolerant to or have not responded to alternative antifungal therapies

Always follow the guidance of a registered healthcare provider when using this medication.

Pharmacology:

Voriderm contains Voriconazole, a potent triazole antifungal agent. It works by inhibiting the synthesis of ergosterol, an essential component of fungal cell membranes. This action disrupts the fungal cell structure, leading to its destruction. Voriconazole achieves this by blocking CYP450-dependent 14-alpha sterol demethylase, an enzyme crucial for ergosterol production.

Dosage & Administration:

Oral Administration:

Voriderm is available in tablet and powder forms for suspension. It should be taken at least one hour before or after meals.

• For patients ≥40 kg:
  • Loading Dose: 400 mg (10 ml) every 12 hours for the first 24 hours
  • Maintenance Dose: 200 mg (5 ml) twice daily after the initial 24 hours
• For patients <40 kg:
  • Loading Dose: 200 mg (5 ml) every 12 hours for the first 24 hours
  • Maintenance Dose: 100 mg (2.5 ml) twice daily after the initial 24 hours
  • Or as directed by a registered physician.

Injection Administration:

For more severe infections, Voriderm may be administered intravenously.

• Invasive Aspergillosis:
  • Loading Dose: 6 mg/kg every 12 hours for the first 24 hours
  • Maintenance Dose: 4 mg/kg every 12 hours after 24 hours
• Candidemia & Deep Tissue Candida Infections:
  • Loading Dose: 6 mg/kg every 12 hours for the first 24 hours
  • Maintenance Dose: 3-4 mg/kg every 12 hours after the first 24 hours
• Scedosporiosis & Fusariosis:
  • Loading Dose: 6 mg/kg every 12 hours for the first 24 hours
  • Maintenance Dose: 4 mg/kg every 12 hours after the first 24 hours

Always follow the instructions of your prescribing physician.

Drug Interactions:

• Voriderm may interact with CYP3A4, CYP2C9, and CYP2C19 inhibitors and inducers. Careful monitoring and dose adjustments may be required to avoid adverse effects.
• Voriderm can increase the concentration of drugs metabolized by these enzymes. Reduce doses of these medications and monitor closely for side effects.
• When combined with Phenytoin or Efavirenz, an increase in Voriderm’s dosage may be necessary.

Contraindications:

Voriderm should not be used if you are allergic to Voriconazole or any of its components. Additionally, it is contraindicated in the following cases:

• Co-administration with drugs like terfenadine, astemizole, cisapride, pimozide, and quinidine due to serious side effects.
• Co-administration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids, and St. John’s Wort due to the risk of reduced effectiveness.

Side Effects:

Common side effects of Voriderm include:

• Abdominal pain
• Anemia
• Blurred vision
• Headache
• Chest pain
• Nausea and vomiting
• Diarrhea

If you experience any unusual side effects, consult your healthcare provider immediately.

Pregnancy & Lactation:

There is limited data on the use of Voriderm during pregnancy. It should only be prescribed during pregnancy if the potential benefits outweigh the risks to the fetus. It is not known whether Voriderm is excreted in breast milk, so caution is advised when using it during breastfeeding.

Precautions & Warnings:

• Prolonged use (greater than 180 days) requires careful evaluation of the benefits and risks, as long-term treatment with Voriderm has been associated with the development of squamous cell carcinoma (SCC) of the skin.
• Voriderm has not been evaluated for efficacy in children under 12 years old, so it is not recommended for use in this population.

Overdose:

Currently, there is limited information on the effects of Voriderm overdose. If an overdose occurs, seek medical attention immediately.

Therapeutic Class:

Other Antifungal Preparations

Reconstitution Instructions:

For the suspension form of Voriderm, follow these steps:

1. Shake the bottle before opening to loosen the powder.
2. Add 25 ml of boiled and cooled water (equivalent to 5 teaspoons of the provided spoon) to the bottle.
3. Shake the bottle vigorously until the powder is fully dissolved.
4. Store the reconstituted suspension between 15°C to 30°C.
5. Dispose of any unused suspension 14 days after reconstitution.

Storage Conditions:

• Keep out of reach of children.
• Store the powder in a dry place, below 25°C and protected from light.
• Store the suspension in the refrigerator between 2°C to 8°C.