Product Information
Caspledge 70 mg Injection is formulated with Caspofungin Acetate, a semisynthetic lipopeptide antifungal belonging to the echinocandin class. It functions by inhibiting the enzyme β-(1,3)-D-glucan synthase, crucial for the formation of β-(1,3)-D-glucan in the fungal cell wall. This inhibition compromises cell wall integrity, resulting in osmotic instability and cell death.
Caspledge is effective against various Candida species and Aspergillus species, making it a valuable option for treating invasive fungal infections, especially in patients intolerant of or refractory to other antifungal therapies.
Indications
Caspledge 70 mg Injection is indicated for:
- Empirical Therapy: For presumed fungal infections in febrile, neutropenic patients.
- Candidemia and Other Candida Infections: Including intra-abdominal abscesses, peritonitis, and pleural space infections.
- Esophageal Candidiasis.
- Invasive Aspergillosis: In patients who are refractory to or intolerant of other therapies.
Composition
Each vial contains:
- Active Ingredient: 70 mg of Caspofungin (as Caspofungin Acetate).
- Inactive Ingredients: Sucrose, mannitol, glacial acetic acid, sodium hydroxide, and polysorbate 80.
Dosage and Administration
- Empirical Therapy and Candidemia:
- Loading Dose: 70 mg on Day 1.
- Maintenance Dose: 50 mg once daily thereafter.
- Invasive Aspergillosis:
- Loading Dose: 70 mg on Day 1.
- Maintenance Dose: 50 mg once daily thereafter.
- Esophageal Candidiasis:
- 50 mg once daily.
Note: For patients weighing more than 80 kg, consider increasing the maintenance dose to 70 mg once daily.
Administration: Reconstitute the lyophilized powder with sterile water for injection and further dilute with appropriate intravenous fluids. Administer by slow intravenous infusion over approximately 1 hour.
Precautions
- Hypersensitivity: Contraindicated in patients with known hypersensitivity to Caspofungin or any component of the formulation.
- Hepatic Impairment: Use with caution; dose adjustment may be necessary.
- Pregnancy and Lactation: Use only if the potential benefit justifies the potential risk to the fetus or infant.
- Drug Interactions: Monitor for interactions with cyclosporine, tacrolimus, and inducers of drug clearance (e.g., rifampin).
Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F).
- Protect from light; keep vials in the original carton until use.
- Do not freeze.
Note
- Monitoring: Regularly monitor liver function tests during therapy.
- Infusion-Related Reactions: Be vigilant for histamine-mediated symptoms; slow the infusion rate or discontinue if necessary.
- Pediatric Use: Safety and efficacy have not been established in children under 3 months of age.
