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.
Brief Bactericidal Activity of Anti-Tuberculosis Drugs [Not yet recruiting]
Multidrug-resistant (MDR) tuberculosis (TB), defined by resistance to isoniazid (INH) and
rifampicin (RMP), must be treated with second-line drugs (SLD) that are less effective, more
toxic, and more expensive. Treatment requires at least 20 months with 4 or more effective
drugs based on timely drug susceptibility test (DST) results. However, few laboratories test
SLD, and those that do usually test one representative drug from each class of closely
related drugs. However, there are many examples of closely related drugs with differing
Labs have found differences in DST results among the rifamycins, RMP and rifabutin (RBT);
the fluoroquinolones, ofloxacin and moxifloxacin; and the second-line injectable agents,
kanamycin, amikacin, and capreomycin. In a related finding, isolates resistant to 0. 2 mcg/ml
INH may be susceptible to higher concentrations. Additionally, some labs have reported
discrepancies between genotypic testing for RMP resistance (based on rpoB gene mutations)
and phenotypic DST for RMP resistance. In the Preserving Effective Tuberculosis Treatment
Study (PETTS), 32% of RMP-resistant isolates were susceptible to RBT, 41% of
kanamycin-resistant isolates were susceptible to capreomycin, and 45% of isolates resistant
to 0. 2 mcg/ml INH were susceptible to 1. 0 or 5. 0 mcg/ml (1). Other studies have demonstrated
differences in DST results between moxifloxacin and ofloxacin. These situations are
relatively common in MDR TB cases. However, whether these in vitro results translate into
clinical efficacy is completely unknown. Given the severely limited treatment options in MDR
TB, it would be exceedingly useful to determine whether these in vitro results translate
into evidence for clinically meaningful treatment decisions.
the investigators propose to determine the clinical bactericidal activity of certain
antibiotics against M. tb that appear to be effective in vitro even though closely related
drugs from the same class are ineffective in vitro. Further, the investigators propose to
determine the molecular genetic determinants of these differences.
Specifically, we plan to determine:
1. The bactericidal activity of RBT in patients whose baseline DST results demonstrate
susceptibility to RBT and resistance to RMP.
2. The bactericidal activity of high-dose INH in patients whose baseline DST results
demonstrate susceptibility to high concentrations of INH and resistance to low
concentrations of INH.
3. The bactericidal activity of RMP when an approved molecular assay demonstrates genetic
mutations associated with RMP resistance, but the phenotypic testing demonstrates
susceptibility to RMP.
4. The bactericidal activity of moxifloxacin in patients whose baseline DST results
demonstrate susceptibility to moxifloxacin and resistance to ofloxacin.
5. The bactericidal activity of amikacin and capreomycin in patients whose baseline DST
results demonstrate susceptibility to either of these two drugs and resistance to
6. The genetic mutations associated with both in vivo and in vitro drug resistance and
To achieve these objectives the investigators propose an innovative variation on the
methodology of so-called early bactericidal activity (EBA) studies. Pioneered in the 1970s,
EBA studies have become an essential component of evaluating new anti-TB drugs as well as
new uses of existing drugs. Patients at risk for MDR TB will be screened for RMP resistance
and INH resistance using molecular assays. In those with RMP-resistant or INH-resistant TB,
the investigators will quickly perform phenotypic DSTs using the direct method in the Bactec
Mycobacterium Growth Indicator Tube (MGIT) 960 system, so results will be available within
14-21 days. If the DST results show, for example, RMP resistance but susceptibility to RBT,
consenting patients will be treated with RBT by itself for 10 days. The investigators will
assess its effect with serial quantitative sputum cultures. If the concentration of viable
bacteria decreases significantly, the investigators will interpret this to mean the drug is
having an effect. If not, the drug is ineffective. After 10 days, the patients will resume
individualized multidrug treatment based on the full set of DST results.
In case the investigators identify drugs that are effective under these conditions, the
investigators will determine the minimum inhibitory concentration of the drug, and the
investigators will sequence known and putative genes associated with the action of these
drugs for the mycobacterial isolates from these patients.
The results would have immediate implications for treatment of MDR TB and for diagnostic
Patients Response to Early Switch To Oral:Osteomyelitis Study [Not yet recruiting]
Based on the current literature, investigators hypothesize that patients with osteomyelitis
who are treated with the standard approach of intravenous antibiotics for the full duration
of therapy will have the same clinical outcomes as patients treated with the experimental
approach of intravenous antibiotics with early switch to oral antibiotics.
The primary objective of this study is to compare patients with osteomyelitis treated with
the standard approach of intravenous antibiotics for the full duration of therapy versus
patients treated with intravenous antibiotics with an early switch to oral antibiotics in
relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy.
Secondary objectives of the study include the evaluation of adverse events related to the
use of antibiotics as well as the cost of care evaluated from the hospital perspective.
Page last updated: 2015-02-13