"The FDA suspended the food facility registration of Roos Foods Inc. of Kenton Delaware on March 11, 2014 after the FDA determined there was a reasonable probability of food manufactured, processed, packed, or held by Roos Foods causing seri"...
Nephrotoxicity: In 36% of 722 patients treated with Capastat Sulfate (capreomycin for injection) , elevation of the BUN above 20 mg/100 mL has been observed. In many instances, there was also depression of PSP excretion and abnormal urine sediment. In 10% of this series, the BUN elevation exceeded 30 mg/100 mL.
Toxic nephritis was reported in 1 patient with tuberculosis and portal cirrhosis who was treated with Capastat Sulfate (capreomycin for injection) (1 g) and aminosalicylic acid daily for 1 month. This patient developed renal insufficiency and oliguria and died. Autopsy showed subsiding acute tubular necrosis.
Ototoxicity: Subclinical auditory loss was noted in approximately 11% of 722 patients undergoing treatment with Capastat Sulfate (capreomycin for injection) . This was a 5- to 10-decibel loss in the 4000- to 8000-CPS range. Clinically apparent hearing loss occurred in 3% of the 722 subjects. Some audiometric changes were reversible. Other cases with permanent loss were not progressive following withdrawal of Capastat Sulfate (capreomycin for injection) .
Tinnitus and vertigo have occurred.
Liver: Serial tests of liver function have demonstrated a decrease in BSP excretion without change in AST (SGOT) or ALT (SGPT) in the presence of preexisting liver disease. Abnormal results in liver function tests have occurred in many persons receiving Capastat Sulfate (capreomycin for injection) in combination with other antituberculosis agents that also are known to cause changes in hepatic function. The role of Capastat Sulfate (capreomycin for injection) in producing these abnormalities is not clear; however, periodic determinations of liver function are recommended.
Blood: Leukocytosis and leukopenia have been observed. The majority of patients treated have had eosinophilia exceeding 5% while receiving daily injections of Capastat Sulfate (capreomycin for injection) . This has subsided with reduction of the Capastat Sulfate dosage to 2 or 3 g weekly.
Pain and induration at the injection site have been observed. Excessive bleeding at the injection site has been reported. Sterile abscesses have been noted. Rare cases of thrombocytopenia have been reported.
Hypersensitivity:Urticaria and maculopapular skin rashes associated in some cases with febrile reactions have been reported when Capastat Sulfate (capreomycin for injection) and other antituberculosis drugs were given concomitantly.
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