Capreostat (Powder) Instructions for Use

ATC Code

J04AB30 (Capreomycin)

Active Substance

Capreomycin (Rec.INN registered by WHO)

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 the powder as a deep intramuscular injection. The standard adult daily dose is 1 g (15-20 mg/kg), not to exceed 20 mg/kg/day.

After 2-4 months, a reduction to 1 g administered 2-3 times per week may be considered for continuation therapy. Adjust the dosage in patients with renal impairment based on creatinine clearance.

Adverse Reactions

Monitor for nephrotoxicity (elevated BUN, serum creatinine) and ototoxicity (tinnitus, hearing loss, vestibular disturbances).

Observe for hematological effects such as leukocytosis, leukopenia, and eosinophilia. Thrombocytopenia occurs rarely.

Other reactions include pain, induration, or sterile abscesses at the injection site; skin rashes ( urticaria, maculopapular); and fever. Hepatic enzyme elevations may occur with combination therapy.

Contraindications

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

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 adjustment is required depending on creatinine clearance.

Pediatric Use

The safety of use in children has not been established.

Special Precautions

In case of impaired renal function, dosage adjustment is required depending on 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 agents exhibiting oto- and nephrotoxicity due to the risk of additive toxic effects.

Exercise extreme caution when co-administering with other potentially nephrotoxic or ototoxic drugs, including aminoglycosides (e.g., amikacin, gentamicin, tobramycin, kanamycin, neomycin), polymyxins, colistin, and vancomycin.

Overdose

Symptoms of overdose may manifest as exaggerated adverse reactions, particularly nephrotoxicity and ototoxicity.

There is no specific antidote. Management involves immediate discontinuation of the drug and institution of supportive measures, including hemodialysis to enhance elimination. Carefully monitor renal function and auditory/vestibular function.

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.