The use of Capastat® Sulfate (Capreomycin for Injection, USP) in patients with renal insufficiency or preexisting auditory impairment must be undertaken with great caution, and the risk of additional cranial nerve VIII impairment or renal injury should be weighed against the benefits to be derived from therapy.
Refer to ANIMAL PHARMACOLOGY for additional information.
Since other parenteral antituberculosis agents (streptomycin, viomycin) also have similar and sometimes irreversible toxic effects, particularly on cranial nerve VIII and renal function, simultaneous administration of these agents with Capastat Sulfate is not recommended. Use with nonantituberculosis drugs (polymyxin A sulfate, colistin sulfate, amikacin, gentamicin, tobramycin, vancomycin, kanamycin, and neomycin) having ototoxic or nephrotoxic potential should be undertaken only with great caution.
Usage in Pregnancy: The safety of the use of Capastat Sulfate in pregnancy has not been determined.
Pediatric Usage: Safety and effectiveness in pediatric patients have not been established.
CAPREOMYCIN FOR INJECTION, USP
For Intramuscular and Intravenous Infusion Only
NOT FOR PEDIATRIC USE
Capastat Sulfate is a polypeptide antibiotic isolated from Streptomyces capreolus. It is a complex of 4 microbiologically active components which have been characterized in part; however, complete structural determination of all the components has not been established. Capreomycin is supplied as the disulfate salt and is soluble in water. In complete solution, it is almost colorless. Each vial contains the equivalent of 1 g capreomycin activity.
Capastat Sulfate, which is to be used concomitantly with other appropriate antituberculosis agents, is indicated in pulmonary infections caused by capreomycin–susceptible strains of M. tuberculosis when the primary agents (isoniazid, rifampin, ethambutol, aminosalicylic acid, and streptomycin) have been ineffective or cannot be used because of toxicity or the presence of resistant tubercle bacilli.
Susceptibility studies should be performed to determine the presence of a capreomycin–susceptible strain of M. tuberculosis.
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Published Studies Related to Capastat (Capreomycin)
Polymorphisms associated with resistance and cross-resistance to aminoglycosides and capreomycin in Mycobacterium tuberculosis isolates from South Korean Patients with drug-resistant tuberculosis. [2010.02]
The aminoglycosides streptomycin, amikacin, and kanamycin and the cyclic polypeptide capreomycin are all widely used in second-line therapy for patients who develop multidrug-resistant tuberculosis. We have characterized a set of 106 clinical isolates of Mycobacterium tuberculosis using phenotypic drug susceptibility testing (DST) to determine the extent of resistance to each agent and cross-resistance between agents...
Preparation and in vivo evaluation of a dry powder for inhalation of capreomycin. [2008.04]
PURPOSE: To develop an aerosol system for efficient local lung delivery of a tuberculostatic drug... CONCLUSIONS: The results indicate that large doses of capreomycin in dry powder form can be efficiently delivered to the lungs of guinea pigs, which may result in high local drug exposure but significantly reduced systemic exposure as suggested by plasma concentrations in the present studies. These systems have considerable potential to provide more effective therapy for MDR-TB.
Inhaled large porous particles of capreomycin for treatment of tuberculosis in a guinea pig model. [2007.08]
Capreomycin is used for the treatment of multidrug-resistant tuberculosis (MDR-TB), but it is limited therapeutically by its severe side effects. The objectives of the present studies were (i) to design low-density porous capreomycin sulfate particles for efficient pulmonary delivery to improve local and systemic drug bioavailability and capacity to reduce the bacillary load in the lungs in a manner similar to that achieved with intramuscular injections; (ii) to determine pharmacokinetic parameters after pulmonary administration of these capreomycin particles; and (iii) to evaluate the efficacy of these particles in treating animals in a small-aerosol-inoculum guinea pig model of TB...
Preparation of large porous biodegradable microspheres by using a simple double-emulsion method for capreomycin sulfate pulmonary delivery. [2007.03.21]
The aim of this work was to evaluate if a simple double-emulsion method could be used for developing a new formulation of large porous microspheres (MS) potentially useful for capreomycin sulfate (CS) pulmonary delivery. Poly(DL-lactide-co-glycolide) was used for MS preparation... The use of RSM helped to establish the conditions to obtain formulations potentially useful for a possible CS pulmonary delivery, by using a simple preparation method with a consistent time, cost, and material saving.
Unilamellar vesicles as potential capreomycin sulfate carriers: preparation and physicochemical characterization. [2004.12.31]
The aim of this work was to evaluate unilamellar liposomes as new potential capreomycin sulfate (CS) delivery systems for future pulmonary targeting by aerosol administration. Dipalmitoylphosphatidylcholine, hydrogenated phosphatidylcholine, and distearoylphosphatidylcholine were used for liposome preparation...
Clinical Trials Related to Capastat (Capreomycin)
A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients. [Completed]
To determine the demographic, behavioral, clinical, and geographic risk factors associated
with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the
clinical and microbiological responses and overall survival of MDRTB patients who are treated
with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per
9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of
patients who show failure or relapse are due to the same strain or reinfection with a new
Among TB patients, there has been an increase in progressive disease due to the emergence of
antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify
patients at high risk for MDRTB increases the hazard for both treatment failure and
development of resistance to additional therapeutic agents. Efforts to improve survival in
patients with MDRTB will depend on improved methods of assessing the risk of acquisition of
MDRTB and identifying drug susceptibility patterns in a timely fashion.
Page last updated: 2014-02-27