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Capastat Sulfate (Capreomycin) - Summary

 
 



WARNINGS

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.

 

SUMMARY

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.

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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NEWS HIGHLIGHTS

Media Articles Related to Capastat Sulfate (Capreomycin)

Tuberculosis (TB)
Source: MedicineNet Amyloidosis Specialty [2014.12.08]
Title: Tuberculosis (TB)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 12/8/2014 12:00:00 AM

Tuberculosis (TB) Treatment and Vaccine
Source: MedicineNet isoniazid, INH Specialty [2014.10.30]
Title: Tuberculosis (TB) Treatment and Vaccine
Category: Doctor's & Expert's views on Symptoms
Created: 10/30/2014 12:00:00 AM
Last Editorial Review: 10/30/2014 12:00:00 AM

What Are the Symptoms and Signs of Tuberculosis (TB)?
Source: MedicineNet Tuberculosis Skin Test (PPD Skin Test) Specialty [2014.01.15]
Title: What Are the Symptoms and Signs of Tuberculosis (TB)?
Category: Doctor's & Expert's views on Symptoms
Created: 10/29/2014 12:00:00 AM
Last Editorial Review: 1/15/2014 12:00:00 AM

Provision of antiretroviral therapy for HIV-positive TB patients - 19 countries, sub-Saharan Africa, 2009-2013
Source: HIV / AIDS News From Medical News Today [2014.11.28]
All HIV-positive tuberculosis (TB) patients should receive antiretroviral therapy, which reduces the incidence of HIV-associated TB and reduces mortality among HIV-positive TB patients.

New database shows global increases in infection outbreaks, unique diseases rising since 1980
Source: Flu / Cold / SARS News From Medical News Today [2014.10.30]
Enterovirus. Tuberculosis. Cholera. Measles. Various strains of the flu and hepatitis.

more news >>

Published Studies Related to Capastat Sulfate (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...

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Clinical Trials Related to Capastat Sulfate (Capreomycin)

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 antimicrobial activities. 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 kanamycin. 6. The genetic mutations associated with both in vivo and in vitro drug resistance and bactericidal activity. 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 mycobacteriology.

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 strain.

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.

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.

more trials >>


Page last updated: 2014-12-08

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