Capremabol (Powder) Instructions for Use

Marketing Authorization Holder

PFC Prebend, LLC (Russia)

ATC Code

J04AB30 (Capreomycin)

Active Substance

Capreomycin (Rec.INN registered by WHO)

Dosage Form

Capremabol

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

Dosage Form, Packaging, and Composition

1 g – vials (1) – cardboard packs.

Clinical-Pharmacological Group

Antibiotic of the aminosalicylic acid derivative group. Antituberculosis drug

Pharmacotherapeutic Group

Antibiotic

Pharmacological Action

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, neomycin.

Indications

• Treatment of pulmonary forms of tuberculosis caused by mycobacteria sensitive to capreomycin.

Use only in cases of ineffectiveness or intolerance to first-line antituberculosis drugs.

ICD codes

Dosage Regimen

Administer intramuscularly at a dose of 1 g once daily according to the prescribed regimen.

Adjust the dosage regimen in patients with impaired renal function based on creatinine clearance (CrCl).

Administer the drug deeply into a large muscle mass to minimize local tissue irritation.

Adverse Reactions

Monitor for nephrotoxic and ototoxic effects, which are the most significant adverse reactions.

Observe for leukocytosis, leukopenia, and eosinophilia. Rarely, thrombocytopenia may occur.

During combination therapy, monitor for changes in liver function tests, urticaria, maculopapular rash, and fever.

Report pain at the injection site, induration, excessive bleeding, or the formation of “cold” abscesses.

Contraindications

• Hypersensitivity to capreomycin or any component of the formulation.

Avoid concurrent use with other parenteral antituberculosis drugs possessing significant ototoxic and nephrotoxic properties 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 CC (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 CC (creatinine clearance). Capreomycin in high doses can cause partial neuromuscular blockade.

Use with caution in patients with a tendency to allergic reactions, especially drug allergy. 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.

Exercise extreme caution when using with polymyxin, colistin, amikacin, gentamicin, tobramycin, vancomycin, kanamycin, or neomycin due to the high risk of additive nephrotoxicity and ototoxicity.

Be aware that high doses of capreomycin may potentiate the effects of neuromuscular blocking agents.

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.