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Capreomycin (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 not tolerated.

ICD codes

ICD-10 code Indication
A15 Respiratory tuberculosis, bacteriologically and histologically confirmed
ICD-11 code Indication
1B10.0 Respiratory tuberculosis, bacteriologically or histologically confirmed

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the powder as a deep intramuscular injection at a dose of 1 g daily for the initial phase of treatment.

Adjust the dosage and frequency for the continuation phase based on the patient’s clinical response and tolerability.

Reconstitute the powder strictly according to the manufacturer’s instructions using the appropriate sterile solvent.

Powder

Administered intramuscularly at 1 g/day according to the regimen.

Adverse Reactions

Monitor for nephrotoxic effects, including elevated serum creatinine and BUN, and ototoxic effects, such as tinnitus, hearing loss, and vestibular disturbances.

Observe for hematological changes, including leukocytosis, leukopenia, and eosinophilia. Thrombocytopenia occurs rarely.

Report pain, induration, or sterile abscesses at the injection site. With combination therapy, watch for skin rashes, urticaria, fever, and abnormal liver function tests.

Contraindications

  • Hypersensitivity to capreomycin or any component of the formulation.
  • Concomitant use with other medications possessing significant ototoxic or nephrotoxic potential.
  • Administration to patients with pre-existing severe renal impairment or hearing loss, unless the potential benefits outweigh the significant risks.

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 the 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 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 assessment of vestibular function 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 are oto- and nephrotoxic due to the high risk of additive toxicity.

Exercise extreme caution when co-administering with polymyxin, colistin, amikacin, gentamicin, tobramycin, vancomycin, kanamycin, or neomycin, as these combinations significantly increase the risk of irreversible ototoxicity and nephrotoxicity.

Concurrent use with neuromuscular blocking agents or anesthetics may potentiate neuromuscular blockade.

Overdose

Overdose is characterized by an exacerbation of its known adverse reactions, particularly severe nephrotoxicity and ototoxicity, which may be irreversible.

Manage overdose with immediate discontinuation of the drug and institution of supportive and symptomatic treatment. Hemodialysis may remove a portion of the drug from the systemic circulation.

There is no specific antidote. Closely monitor renal function, auditory, and vestibular function for an extended period following an overdose event.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Khimpharm, JSC (Kazakhstan)

Dosage Form

Bottle Rx Icon Capreomycin sulfate Powder for solution for intravenous and intramuscular administration 1 g: vial 100 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for intravenous and intramuscular administration 1 vial
Capreomycin (as sulfate) 1 g

1 g – vials (100) – cardboard boxes.

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

Dosage Forms

Bottle Rx Icon Capreomycin-Ferein® Powder for solution for intravenous and intramuscular administration 500 mg: fl. 1, 5, or 10 pcs.
Powder for solution for intravenous and intramuscular administration 750 mg: vial 1, 5, or 10 pcs.
Powder for solution for intravenous and intramuscular administration 1000 mg: vial 1, 5, or 10 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for intravenous and intramuscular administration white or almost white in color.

1 vial
Capreomycin sulfate 622 mg
   Equivalent to capreomycin content 500 mg

500 mg – vials (1) – cardboard packs.
500 mg – vials (5) – contour cell packs (1) – cardboard packs.
500 mg – vials (5) – contour cell packs (2) – cardboard packs.
500 mg – vials (5) – contour cell packs (10) – cardboard packs (for hospitals).

Powder for solution for intravenous and intramuscular administration white or almost white in color.

1 vial
Capreomycin sulfate 932 mg
   Equivalent to capreomycin content 750 mg

750 mg – vials (1) – cardboard packs.
750 mg – vials (5) – contour cell packs (1) – cardboard packs.
750 mg – vials (5) – contour cell packs (2) – cardboard packs.
750 mg – vials (5) – contour cell packs (10) – cardboard packs (for hospitals).

Powder for solution for intravenous and intramuscular administration white or almost white in color.

1 vial
Capreomycin sulfate 1244 mg
   Equivalent to capreomycin content 1000 mg

1000 mg – vials (1) – cardboard packs.
1000 mg – vials (5) – contour cell packs (1) – cardboard packs.
1000 mg – vials (5) – contour cell packs (2) – cardboard packs.
1000 mg – vials (5) – contour cell packs (10) – cardboard packs (for hospitals).

Marketing Authorization Holder

Kolorit-Farma, LLC (Russia)

Manufactured By

Deko Company, LLC (Russia)

Dosage Forms

Bottle Rx Icon Capreomycin-DEKO Powder for solution for intravenous and intramuscular administration 0.5 g: vial 1 or 10 pcs.
Powder for solution for intravenous and intramuscular administration 0.75 g: vial 1 or 10 pcs.
Powder for solution for intravenous and intramuscular administration 1 g: vial 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Powder for solution for intravenous and intramuscular administration white or almost white in color, hygroscopic.

1 vial
Capreomycin (as sulfate) 0.5 g

Glass vials with a capacity of 10 ml (1) – cardboard packs.
Glass vials with a capacity of 10 ml (10) – cardboard packs.
Glass vials with a capacity of 10 ml (1) complete with solvent (water for injection – 2 ml, amp. 1 pc.) – contour cell packs (1) – cardboard packs.
Glass vials with a capacity of 10 ml (1) complete with solvent (water for injection – 5 ml, amp. 1 pc.) – contour cell packs (1) – cardboard packs.

Powder for solution for intravenous and intramuscular administration white or almost white in color, hygroscopic.

1 vial
Capreomycin (as sulfate) 0.75 g

Glass vials with a capacity of 10 ml (1) – cardboard packs.
Glass vials with a capacity of 10 ml (10) – cardboard packs.
Glass vials with a capacity of 10 ml (1) complete with solvent (water for injection – 2 ml, amp. 1 pc.) – contour cell packs (1) – cardboard packs.
Glass vials with a capacity of 10 ml (1) complete with solvent (water for injection – 5 ml, amp. 1 pc.) – contour cell packs (1) – cardboard packs.

Powder for solution for intravenous and intramuscular administration white or almost white in color, hygroscopic.

1 vial
Capreomycin (as sulfate) 1 g

Glass vials with a capacity of 10 ml (1) – cardboard packs.
Glass vials with a capacity of 10 ml (10) – cardboard packs.
Glass vials with a capacity of 10 ml (1) complete with solvent (water for injection – 2 ml, amp. 1 pc.) – contour cell packs (1) – cardboard packs.
Glass vials with a capacity of 10 ml (1) complete with solvent (water for injection – 5 ml, amp. 1 pc.) – contour cell packs (1) – cardboard packs.

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