Capreomycin

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Capreomycin

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Capreomycin

What is Capreomycin? An Overview

Property Description
Active ingredient Capreomycin sulfate
Form Sterile powder for injection (requires reconstitution)
Pharmacological class Antimycobacterial; Polypeptide Antibiotic
Typical use Reserve treatment for drug-resistant tuberculosis (MDR-TB)
Origin Derived from the bacterium Streptomyces capreolus

Capreomycin is a powerful, specialized antibiotic that is a cornerstone of second-line therapy for complex bacterial infections. It is formally classified as an Antimycobacterial agent due to its primary action against Mycobacterium tuberculosis, the bacteria that causes TB. Clinically recognized for its role in challenging cases, Capreomycin is reserved for use when initial, standard treatments are ineffective or cannot be tolerated. This indicates its importance as a critical fallback option in modern infection management.

Capreomycin is an international non-proprietary name (INN) and is administered as the active component Capreomycin sulfate. Its unique nature stems from its origin as a polypeptide antibiotic derived from the soil bacterium Streptomyces capreolus. This places it in a distinct structural group separate from many common antibiotics. While Capreomycin itself is the generic name, it has been marketed globally under the brand name Capastat, typically supplied as a sterile, lyophilized powder. This powder requires reconstitution into a solution, meaning its administration is strictly limited to the parenteral route (injection).

The unique value of Capreomycin is its ability to combat bacteria that have developed widespread resistance. Pharmacological studies confirm that it acts by disrupting the bacterial ribosome (the cell's protein-making machinery). This mechanism provides a proven and effective tool to stop bacterial proliferation when other drugs fail. Capreomycin is always used in combination with other anti-tuberculosis agents; it is not recommended for use as a single treatment.

Regulatory References

  1. Capreomycin Monograph (LiverTox)

What side effects are possible with Capreomycin?

Capreomycin: Possible Side Effects and Safety Information

Capreomycin carries a Boxed Warning from regulatory bodies indicating that its use for pulmonary multidrug-resistant tuberculosis (MDR-TB) may be associated with worse clinical outcomes, including decreased effectiveness and increased mortality, compared with alternative parenteral therapies. It is generally reserved for patients resistant to aminoglycosides and who have limited treatment options.

Serious and Clinically Significant Adverse Reactions

The most critical adverse reactions involve Nephrotoxicity (kidney damage) and Ototoxicity (damage to the eighth cranial nerve, affecting hearing and balance).

  • Nephrotoxicity: Signs include elevated blood urea nitrogen (BUN) and serum creatinine, abnormal urinary sediment, and potentially acute tubular necrosis. A significant number of patients may experience a slight elevation in BUN during prolonged therapy.
  • Ototoxicity: This can manifest as clinically apparent hearing loss, subclinical auditory loss (often in the high-frequency range), tinnitus (ringing in the ears), and vestibular symptoms such as dizziness and loss of balance.

Other serious adverse reactions include electrolyte disturbances such as hypokalemia, hypomagnesemia, and hypocalcemia, which can be serious in nature. Hypersensitivity reactions, including urticaria and maculopapular rashes, have also been reported.

Safety Monitoring and Restrictions

Due to the risks of toxicity, frequent and mandatory monitoring of renal function (BUN, creatinine, urine sediment) and audiometric/vestibular function is required throughout the course of treatment. The drug must be used with great caution in patients with pre-existing renal insufficiency or auditory impairment, as these conditions increase the risk of toxic reactions.

Simultaneous administration with other parenteral agents that have similar toxic effects on the kidneys and cranial nerve VIII, such as streptomycin or viomycin, is not recommended. Use with other nephrotoxic or ototoxic drugs, including other aminoglycosides, must be undertaken with great caution. Safety and effectiveness in pediatric patients have not been established.

Overdose and Emergency Response

Capreomycin Overdose and when to seek help

Element Regulatory Statement
Documented Manifestations Symptoms of overdose include signs of ototoxicity (ringing in the ears, severe dizziness, hearing problems), nephrotoxicity (little or no urinating, change in urine amount), and weak or shallow breathing. Severe electrolyte disturbances (hypokalemia, hypocalcemia) are also documented.
Life-Threatening Outcomes The official prescribing information documents the risk of acute tubular necrosis (nephrotoxicity) and potential irreversible damage to the eighth cranial nerve (auditory and vestibular divisions) as severe outcomes.
Immediate Action Mandate If an overdose is suspected, regulatory authorities mandate that patients call a poison control center or seek emergency medical attention immediately.
Population Consideration The risk of toxic reactions is considered greater in patients with impaired renal function. This increased risk extends to elderly patients, who may experience more severe reactions due to age-related decreases in kidney function.

Official Overdose Statements

  • Suspected overdose requires immediate emergency medical attention, as stated in the regulatory documentation.
  • Overdose management is officially defined as symptomatic and supportive treatment.
  • Monitoring includes immediate assessment of renal function and serum electrolyte levels.

Connection to the Overall Overdose Profile

The official overdose profile is defined by the severity of two primary toxic effects: nephrotoxicity and ototoxicity, which are documented as the source of symptomatic manifestations and severe outcomes. The potential for life-threatening complications, such as acute tubular necrosis, necessitates the regulatory mandate that any suspected overdose must trigger an immediate call for emergency medical attention and hospital observation.

Therapeutic Uses of Capreomycin

What Capreomycin Treats: Main Uses and Benefits

Capreomycin is utilized in the management of complex infectious diseases where additional support for symptom management is required. It is applied in clinical settings when initial treatments have proven unsuccessful. The medication is used in combination with other anti-tuberculosis medications to treat patients with tuberculosis that has become resistant to standard drugs.

The primary therapeutic domain for Capreomycin is the management of Tuberculosis (TB) strains that have developed resistance to first-line medications, specifically Multidrug-resistant Tuberculosis (MDR-TB). It is relevant in contexts where resistance to widely used agents is confirmed and where supportive symptom management is appropriate. It is indicated for the treatment of MDR-TB and serves as a component in specialized regimens for certain forms of Extensively Drug-resistant TB (XDR-TB) and severe cases that do not respond to initial care.

The medication is relevant for easing the debilitating systemic symptoms associated with active, chronic, and resistant infection. These include clusters such as recurring high fevers, drenching night sweats, and intense fatigue that compromise daily functioning. Capreomycin may assist in managing symptoms related to active resistant disease, helping patients cope more steadily with symptom fluctuations. This supports the patient during difficult episodes by easing distress and may assist with maintaining functional stability.

“This specialized antibiotic supports patients in situations where infectious symptoms remain chronic or resistant to widely used initial treatments.”


Quick Fact: Relief for Resistant Infection Symptoms

The medication is applied in conditions marked by increased physiological stress, helping to ease the overall symptom burden in patients with confirmed drug resistance.

Eligibility and Restrictions for Use

Eligibility for Capreomycin: Official Regulatory Requirements

Capreomycin eligibility is strictly defined by government regulatory agencies based on patient factors and pre-existing conditions. These requirements determine who can receive the medicine and under what restrictions.

Absolute Non-Eligibility

Category Regulatory Status Description
Hypersensitivity Contraindicated Patients with a known allergy or hypersensitivity to capreomycin must not use the medicine.
Pediatric Use Use Not Established Safety and effectiveness have not been established in children or infants; some labels specify that it is not for pediatric use.

Conditional and Restricted Use

Capreomycin may be used in certain populations only under conditions of great caution and with frequent monitoring:

  • Impaired Renal Function: Patients with kidney insufficiency require careful monitoring. Dosage reduction or drug withdrawal may be necessary upon evidence of decreasing renal function.
  • Pre-existing Auditory Impairment: Due to the risk of inner ear damage, use in patients with pre-existing hearing loss requires explicit caution, balancing potential risks against therapeutic benefits.
  • Pregnancy (Category C): Use during pregnancy is permitted only if the potential benefit justifies the potential risk to the fetus, as safety has not been determined.
  • Geriatric Patients: Older adults (65 and over) require cautious dose selection due to a higher likelihood of age-related decline in kidney function.
  • Lactation: Caution should be exercised when administering to a nursing mother, as it is not known if the drug is excreted in human milk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Capreomycin’s interaction profile is structured by the risk of additive toxicity when co-administered with other agents that share the potential to cause kidney or inner ear damage. This is based strictly on formal regulatory documentation.


Official Interaction Restrictions

Restriction Classification Interacting Agents (Examples)
Not Recommended Streptomycin, Viomycin (Parenteral antituberculosis agents with similar toxic effects on the kidney and cranial nerve VIII)
Use with Great Caution Non-antituberculosis drugs with ototoxic or nephrotoxic potential, including specific aminoglycosides (e.g., Amikacin, Gentamicin, Tobramycin, Kanamycin), Polymyxins, and Vancomycin
Enhanced Risk Potent Diuretics (e.g., Furosemide, Ethacrynic acid), Neuromuscular-Blocking Agents (including certain anesthetics)

Additional Interaction Context

Capreomycin has a pharmacodynamic interaction with specific agents that can cause an enhancement of neuromuscular blockade effects, particularly noted with the use of ether anesthesia.

Regarding substance interactions, consuming substantial quantities of ethanol (alcohol) may increase the risk of liver problems.

Official regulatory information emphasizes that the risk of toxic reactions from these interactions is greater in patients with impaired renal function and in elderly patients, due to the drug’s substantial excretion by the kidney.

Mechanism of Action

Interference with Bacterial Protein Synthesis and Ribosomal Function

Capreomycin acts primarily as an inhibitor by binding to the bacterial 70S ribosome —specifically across the 16S and 23S rRNA subunits—to block the translocation step of protein synthesis. This key pathway blockade prevents the pathogen from creating essential proteins for survival, leading to a bactericidal effect and the death of the susceptible Mycobacterium population.


Antagonism of Ribosomal Dynamics and Elongation Factor Activity

The drug's mechanism extends beyond simple physical blocking; it also acts as an antagonist by disrupting the function of the L12-L10 stalk on the 50S subunit, impairing the movement and activity of Elongation Factor G (EF-G). This targeted pathway interference results in the synthesis of faulty, truncated proteins that contribute to the physiological disruption of the bacterial cell.


Modulation of Host Neuromuscular and Renal Processes

Capreomycin's structural resemblance to aminoglycosides enables its interaction with host systems, resulting in non-therapeutic effects like the inhibition of acetylcholine release at the neuromuscular junction. This systemic modulation can lead to a physiological consequence of muscular weakness and causes drug accumulation in the kidney tubules, which results in renal tubular damage.

Dosage and Administration Information

Capreomycin is a specialized antibiotic administered exclusively via the parenteral route as either a deep Intramuscular (IM) injection or an Intravenous (IV) infusion. It is supplied as a sterile powder for injection and requires reconstitution with a suitable diluent, such as Sterile Water or 0.9% Sodium Chloride, with 2 to 3 minutes allowed for complete dissolution. The final IV infusion solution must then be administered slowly over a period of 60 minutes.

Official regimens divide the usage into two primary phases. In the initial intensive phase, the standard dose is 15 mg/kg body weight, not to exceed the 1 gram maximum daily dose, and is administered once daily for 60 to 120 days. The therapy then transitions to a maintenance phase where the frequency is reduced to 2 to 3 times per week. The total course of Capreomycin usage typically extends from 12 to 24 months and is an obligatory combination therapy, meaning it must always be used alongside other antituberculosis agents.

The dosing requires adjustment based on patient status. For older adults, dose selection begins cautiously at the low end of the dosing range. Crucially, patients with renal impairment must have their dosage or frequency reduced based on measured creatinine clearance, with some regimens specifying administration only 2 or 3 times per week to prevent drug accumulation.

Recent Clinical Evidence

Capreomycin: Recent Clinical Evidence

Evidence for use in Drug-Resistant Tuberculosis (MDR-TB)

The majority of research concerning Capreomycin was studied for use in drug-resistant tuberculosis (MDR-TB and XDR-TB). The foundation of knowledge relies on large-scale systematic reviews and international Individual Patient Data (IPD) Meta-analyses. These studies pool data from thousands of patients treated in combination regimens, providing context on patient patterns during the study of real-world settings.

The key outcomes evaluated in these studies included measurements of Favorable Treatment Outcome—a clinical endpoint measured in studies—and overall survival endpoints. Research describes patterns related to observed outcomes when Capreomycin was used alongside other anti-TB medicines. Because this medicine was studied for use only in combination with other agents, the research primarily describes patterns related to the outcomes of the full treatment regimen. A limitation noted is the absence of definitive Randomized Controlled Trials (RCTs) directly comparing Capreomycin against placebo or alternatives. Certainty remains low for drawing firm causal conclusions about comparative performance.

The Role of Long-Term Studies and Follow-up Data

Studies of Capreomycin regimens was evaluated in contexts relevant to long-course therapy. The injectable component was studied over approximately six months, with outcomes monitored over the entire course (18 to 24 months). These follow-up durations are aligned with the total period over which clinical endpoints were measured. However, long-term effects are not fully established, and evidence is limited regarding the durability of the response beyond the study follow-up period.

Evidence in Special Populations

Research was studied for and was observed in several specific patient populations, particularly Adult Patients with drug-resistant pulmonary tuberculosis. Studies examined patient cohorts with comorbidities like HIV co-infection and diabetes mellitus to understand patterns related to outcomes within the regimen.

However, significant gaps exist. The safety and effectiveness profile for the pediatric population is not established, and specific data remain insufficient. The results from the existing studies, therefore, apply only to the populations studied, and subgroup findings are uncertain.

What is Still Uncertain About the Research Base

This evidence quality varies across studies, contributing to ongoing research. Some findings were reported to be mixed when comparing the observed patterns against other second-line injectable agents. Furthermore, comparative evidence is lacking when comparing Capreomycin-containing regimens with newer, all-oral treatment strategies. This evidence helps show what has been observed so far, but research does not determine whether an individual will respond similarly to the group patterns described in the studies.

Frequently Asked Questions (FAQ)

Common questions about Capreomycin (FAQ)

Q: What is Capreomycin used for?

Capreomycin is an injectable antibiotic primarily used to treat multi-drug resistant tuberculosis (MDR-TB). It is typically reserved for cases where first-line tuberculosis treatments are ineffective or cannot be tolerated. Capreomycin belongs to a class of antibiotics known as polypeptides.


Q: How is Capreomycin administered?

Capreomycin is administered by injection, either intramuscularly (into the muscle) or intravenously (into a vein). It is not available as a pill taken by mouth. The injection must be given by a healthcare professional in a clinic, hospital, or appropriate outpatient setting.


Q: What are the main side effects of Capreomycin?

The most significant and serious side effects associated with Capreomycin treatment involve the kidneys (nephrotoxicity) and the ears (ototoxicity).

  • Kidney-related side effects can include changes in kidney function, often monitored through blood tests.
  • Ear-related side effects can include hearing loss and balance problems (vestibular toxicity). These effects can sometimes be permanent.

Other potential side effects include:

  • Pain or swelling at the injection site
  • Fever
  • Rash
  • Low levels of certain electrolytes, such as potassium or magnesium.

Regular monitoring and tests for hearing and kidney function are essential throughout treatment.


Q: Why is hearing and kidney function monitored so closely during treatment?

Close monitoring is necessary because Capreomycin carries a risk of serious and potentially irreversible damage to the kidneys and the eighth cranial nerve, which is responsible for hearing and balance. Regular tests help detect early signs of these toxicities, allowing the healthcare provider to adjust the dose or discontinue the drug before severe, lasting harm occurs.


Q: Can Capreomycin be used in pregnancy?

Capreomycin should generally not be used during pregnancy unless the treating physician determines the potential benefit outweighs the potential risk to the fetus. Studies suggest it may cause harm to the fetus, particularly affecting hearing. It is crucial to discuss pregnancy status or plans with a healthcare provider before starting treatment.


Q: What should I tell my doctor before starting Capreomycin?

Before starting Capreomycin, you should inform your doctor about:

  • Any known allergies to Capreomycin or other antibiotics.
  • Pre-existing kidney problems or history of kidney disease.
  • Pre-existing hearing problems or history of hearing loss.
  • Any conditions causing nerve or muscle weakness.
  • Pregnancy or plans to become pregnant, or if you are breastfeeding.
  • All other medications you are taking, including over-the-counter drugs and supplements, to check for potential drug interactions.

How should Capreomycin be stored and disposed of?

Official Storage and Disposal Requirements

Capreomycin is supplied as a powder for injection and requires specific handling as defined by regulatory bodies.

Product Form Mandatory Storage Condition Stability/Shelf-Life
Unopened Powder Vial Store at Controlled Room Temperature (15 C to 30 C), protected from light and heat. Standard Shelf-Life
Reconstituted Solution Store under refrigeration (2 C to 8 C). Stable for mathbf24 hours; discard unused portion.

To maintain potency, the powder must be kept away from excessive heat and light. After reconstitution, the resulting liquid solution is subject to a strict mathbf24-hour stability limit when refrigerated, after which it must be discarded. As a requirement for safety, the medication must always be stored out of the sight and reach of children. The disposal of any unused or expired product must follow local regulatory guidelines and should not be thrown into household trash or poured into wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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