Osapiderm(Posaconazole)
Therapeutic Group: Skin
Presentation
Osapiderm™ 300 IV Injection: Each vial contains Posaconazole INN 300 mg in 16.7 ml solution for IV Injection.
Osapiderm™ 100 DR Tablet: Each delayed release tablet contains Posaconazole INN 100 mg.
Description
Posaconazole is a triazole antifungal agent. The primary mode of action of Posaconazole is the blockage of the cytochrome P-450 dependent enzyme, sterol 14α-demethylase, in fungi by binding to the heme cofactor located on the enzyme. This leads to the inhibition of the synthesis of ergosterol, a key component of the fungal cell membrane, and accumulation of methylated sterol precursors.
Indications
Osapiderm™ is indicated for the treatment of following fungal infections:
1. Invasive Aspergillosis
2. Fusariosis, chromoblastomycosis, and coccidioidomycosis in patients who are intolerant of amphotericin B;
3. Oropharyngeal candidiasis (OPC), including cases refractory to fluconazole and/or itraconazole.
Osapiderm™ is also indicated for the prophylaxis of following fungal infections:
1. Invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia.
2. Patients receiving remission-induction chemotherapy for Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndromes (MDS) and who are at high-risk of developing invasive fungal infections
Osapiderm™ Injection: Adults and pediatric patients 2 years of age and older.
Osapiderm™ delayed released tablet: Adults and pediatric patients 2 years of age and older who weigh greater than 40 kg.
Dosage & Administration
Administer via a central venous line, including a central venous catheter by slow infusion over approximately 90 minutes. Osapiderm infusion is
not for bolus administration. If a central venous catheter is not available, Osapiderm infusion may be administered through a peripheral venous
catheter only as a single dose in advance of central venous line placement or to bridge the period during which a central venous line is
replaced or is in use for other treatment. When multiple dosing is required, the infusion should be done via a central venous line. When
administered through a peripheral venous catheter, the infusion should be administered over approximately 30 minutes.
Preparation of solution for infusion
To prepare the solution of desired concentration, aseptically transfer one vial (16.7 mL) of OsapidermTM injection (containing 300 mg of
posaconazole in solution) to sufficient amount of Sodium Chloride 0.9% solution to get concentration (1-2) mg/ml.
Precautions
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Use in Pregnancy & Lactation
• Pregnancy: Based on animal data, may cause fetal harm.
• Lactating Mothers: The health benefits of breastfeeding baby should be considered along with the mother’s clinical need for Osapiderm and any
adverse effects on the breastfed child.
Commercial Pack
Osapiderm™ 300 IV Injection: Each pack contains a vial of Posaconazole INN 300 mg in 16.7 ml solution for IV Injection. The auxiliary box contains
one bottle 250 ml NaCl 0.9% solution with one 20 ml disposable syringe, one hanger, one alcohol pad, one first aid band and one infusion set.
Osapiderm™ 100 DR Tablet: Each pack contains 1 blister of 10 tablets.