Capastat Side Effects

Please note - some side effects for Capastat may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Capastat - for the Consumer

Capastat

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Capastat:

Pain, swelling, redness, or a hard lump at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased hearing or hearing loss; decreased urination or other urination problems; fever, chills, or sore throat; hearing loss; ringing in the ears; sensation that the room is spinning; severe bleeding at the injection site; signs of electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle pain, weakness, or cramping).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Capastat Side Effects - for the Professional

Capastat

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 including hypokalemia, hypomagnesemia and hypocalcemia, sometimes serious in nature, have been reported.

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.

Side Effects by Body System - for Healthcare Professionals

Renal

Renal side effects have included dose-related nephrotoxicity, including BUN elevations (greater than 20 mg/dL) (36%), BUN elevations (greater than 30 mg/dL) (10%), depression of PSP excretion, abnormal urine sediment, renal insufficiency, and oliguria. At least one case of toxic nephritis and acute tubular necrosis has been reported.

A patient with tuberculosis and portal cirrhosis experienced toxic nephritis and acute tubular necrosis coincident with capreomycin therapy. The patient was treated with capreomycin therapy (1 g) and aminosalicylic acid daily for 1 month. The patient developed renal insufficiency and oliguria and died. The autopsy showed subsiding acute tubular necrosis.

Nervous system

Nervous system side effects have included ototoxicity and vestibular toxicity including subclinical auditory loss (11%), clinically apparent hearing loss (3%), vertigo, and tinnitus.

Local

Local side effects have included pain, induration, and excessive bleeding at the injection site.

Hematologic

Hematologic side effects have included leukocytosis, leukopenia, and eosinophilia. Thrombocytopenia has also been reported rarely.

Hepatic

Hepatic side effects have included decreased BSP excretion.

Metabolic

Metabolic side effects including hypokalemia, hypocalcemia, hypomagnesemia, and electrolyte disturbances resembling Bartter's syndrome have been reported.

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