Capricyn (Powder) Instructions for Use

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

ATC Code

J04AB30 (Capreomycin)

Active Substance

Capreomycin (Rec.INN registered by WHO)

Dosage Form

Capricyn

Powder for solution for intravenous and intramuscular administration 1 g: vial. 1 pc.

Dosage Form, Packaging, and Composition

Vials (1) – cardboard packs.

Clinical-Pharmacological Group

Antibiotic of the aminosalicylic acid derivative group. Antituberculosis drug

Pharmacotherapeutic Group

Antibiotic

Pharmacological Action

A polypeptide antibiotic isolated from Streptomyces capreolus. It has a bacteriostatic effect on various strains of Mycobacterium tuberculosis. Cross-resistance is observed between capreomycin and viomycin, kanamycin, and neomycin.

Indications

• Treatment of pulmonary forms of tuberculosis caused by mycobacteria sensitive to capreomycin when first-line antituberculosis drugs are ineffective or intolerable.

ICD codes

Dosage Regimen

Administer intramuscularly or intravenously after reconstitution.

The standard adult dosage is 1 g once daily for an initial period of 60 to 120 days, followed by 1 g two to three times per week.

Adjust the dosage based on renal function and patient tolerance; reduce the frequency in patients with impaired renal function.

Administer deep into a large muscle mass for intramuscular injection to minimize local discomfort.

Adverse Reactions

Monitor for nephrotoxicity and ototoxicity, which are the most significant adverse effects; these include increased blood urea nitrogen, serum creatinine, and hearing loss or vestibular dysfunction.

Observe for electrolyte disturbances, particularly hypokalemia; other reported reactions include leukocytosis, leukopenia, eosinophilia, and thrombocytopenia.

With combination therapy, changes in liver function tests, urticaria, maculopapular rash, and fever may occur; injection site reactions include pain, induration, excessive bleeding, and sterile abscess formation.

Contraindications

• Hypersensitivity to capreomycin or any component of the formulation.
• Concomitant use with other parenteral drugs possessing significant ototoxic or nephrotoxic potential due to the risk of additive toxicity.

Use in Pregnancy and Lactation

The safety of use during pregnancy and lactation (breastfeeding) has not been established.

Use in Renal Impairment

In case of impaired renal function, dosage regimen adjustment is required depending on the creatinine clearance.

Pediatric Use

The safety of use in children has not been established.

Special Precautions

In case of impaired renal function, dosage regimen adjustment is required depending on the creatinine clearance. Capreomycin in high doses can cause partial neuromuscular blockade.

Use with caution in patients with a tendency to allergic reactions, especially drug allergies. During treatment, renal function parameters should be regularly monitored, audiometry and vestibular function assessment should be performed, and plasma potassium levels should be monitored.

The safety of use in children has not been established.

Drug Interactions

Avoid concomitant use with other parenteral antituberculosis drugs that have ototoxic and nephrotoxic properties, such as streptomycin.

Exercise extreme caution when co-administering with other nephrotoxic or ototoxic agents, including polymyxin, colistin, amikacin, gentamicin, tobramycin, vancomycin, kanamycin, and neomycin, due to the risk of additive toxicity.

Concurrent use with neuromuscular blocking agents may potentiate neuromuscular blockade.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.