Finished product reference

Caspofungin Acetate

Injection, Powder, for Solution · Parenteral · 70 mg

List code
6758

What it is and how it works

Mechanism of Action Caspofungin is an echinocandin antifungal drug .

Indications

Caspofungin acetate for injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: • Empirical therapy for presumed fungal infections in febrile, neutropenic patients. • Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. • Treatment of esophageal candidiasis. • Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. Empirical Therapy for Presumed Fungal Infections in Febrile, Neutropenic Patients Caspofungin acetate for injection is indicated as empirical therapy for presumed fungal infections in febrile, neutropenic adult and pediatric patients (3 months of age and older) . Treatment of Candidemia and Other Candida Infections Caspofungin acetate for injection is indicated for the treatment of candidemia and the following candida infections: intra-abdominal abscesses, peritonitis, and pleural space infections in adult and pediatric patients (3 months of age and older) .

Dosage and administration (summary)

Important Administration Instructions for All Patients : • Administer by slow intravenous (IV) infusion over approximately 1 hour. Do not administer by IV bolus administration. • Do not mix or co-infuse caspofungin acetate for injection with other medications. Do not use diluents containing dextrose (α-D-glucose). Dosage in Adults [18 years of age and older] : • Administer a single 70 mg loading dose on Day 1, followed by 50 mg once daily for all indications except esophageal candidiasis. • For esophageal candidiasis, use 50 mg once daily with no loading dose. Dosage in Pediatric Patients [3 months to 17 years of age] : • Dosing should be based on the patient's body surface area.

Contraindications

Caspofungin is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to any component of this product . • Caspofungin is contraindicated in patients with known hypersensitivity to any component of this product.

Warnings and precautions

• Hypersensitivity : Anaphylaxis, possible histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth or bronchospasm, and cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with use of caspofungin. Discontinue caspofungin at the first sign or symptom of a hypersensitivity reaction and administer appropriate treatment. • Hepatic Effects : Can cause abnormalities in liver enzymes. Isolated cases of hepatic dysfunction, hepatitis, or hepatic failure have been reported.

Pregnancy

Pregnancy Risk Summary Based on animal data, caspofungin may cause fetal harm (see Data) . There are insufficient human data to establish whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with caspofungin use in pregnant women.

Storage and supply

Caspofungin Acetate for Injection is supplied as follows: NDC Caspofungin Acetate for Injection Package Factor 68083-158-01 50 mg Single-Dose Vial 1 vial per carton 68083-159-01 70 mg Single-Dose Vial 1 vial per carton Caspofungin Acetate for Injection is a lyophilized white to off-white powder/cake for intravenous infusion in a vial with an alumin…

Source: Caspofungin Acetate (Caspofungin Acetate) — US FDA prescribing information, 2022-01-19, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Other presentations of the same active ingredient

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

Tell us the quantity, the market and the timing.

Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.

Telephone+98 21 8888 3325 · office hours 09:00–17:00, Tehran
OfficeHaniya Parsan Darou, 3rd floor, No. 326, Zafar Street, Africa Boulevard, Tehran 1968734974, Iran
Emailcontact@hanpars.com