Capastat Sulfate (Capreomycin) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Nephrotoxicity: In 36% of 722 patients treated with Capastat Sulfate, 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 (1 g) and aminosalicylic acid daily for 1 month. This patient developed renal insufficiency and oliguria and died. Autopsy showed subsiding acute tubular necrosis.

Electrolyte disturbances resembling Bartter's syndrome have been reported in 1 patient.

Ototoxicity: Subclinical auditory loss was noted in approximately 11% of 722 patients undergoing treatment with Capastat Sulfate. 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.

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 in combination with other antituberculosis agents that also are known to cause changes in hepatic function. The role of Capastat Sulfate 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. 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 and other antituberculosis drugs were given concomitantly.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO CAPASTAT SULFATE

Possible Capastat Sulfate side effects / adverse reactions in 57 year old male

Reported by a physician from South Africa on 2007-03-01

Patient: 57 year old male weighing 38.0 kg (83.6 pounds)

Reactions: Vomiting, Diarrhoea, General Physical Health Deterioration, Hypokalaemia

Adverse event resulted in: death

Suspect drug(s):
Capastat Sulfate

Other drugs received by patient: Pyrazinamide; Ethambutol Hydrochloride; Ethionamide; Ofloxacin; Terizidone; Para-Aminosalicylate Acid Powder; Kanamycin

Possible Capastat Sulfate side effects / adverse reactions in 57 year old male

Reported by a physician from South Africa on 2007-03-23

Patient: 57 year old male weighing 38.0 kg (83.6 pounds)

Reactions: Blood Bilirubin Increased, Vomiting, Diarrhoea, Blood Chloride Decreased, Blood Potassium Decreased, Blood Albumin Decreased, General Physical Health Deterioration, Protein Total Decreased, Blood Creatinine Increased, Hypokalaemia

Adverse event resulted in: death

Suspect drug(s):
Capastat Sulfate

Other drugs received by patient: Pyrazinamide; Ethambutol Hydrochloride; Ethionamide; Ofloxacin; Terizidone; Para-Aminosalicylate Acid Powder; Kanamycin

Possible Capastat Sulfate side effects / adverse reactions in 57 year old male

Reported by a physician from South Africa on 2007-03-30

Patient: 57 year old male weighing 38.0 kg (83.6 pounds)

Reactions: Vomiting, Diarrhoea, General Physical Health Deterioration, Hypokalaemia

Adverse event resulted in: death

Suspect drug(s):
Capastat Sulfate

Other drugs received by patient: Pyrazinamide; Ethambutol Hydrochloride; Ethionamide; Ofloxacin; Terizidone; Para-Aminosalicylate Acid Powder; Kanamycin