Capreomycin sulfate warnings and precautions

Capreomycin Sulfate
CAPASTAT SULFATE® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

Warnings

For Intramuscular and Intravenous Infusion Only

NOT FOR PEDIATRIC USE

WARNING 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 PHARMACOLOGYfor 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.

Precautions

General

Audiometric measurements and assessment of vestibular function should be performed prior to initiation of therapy with Capastat Sulfate and at regular intervals during treatment.

Renal injury, with tubular necrosis, elevation of the blood urea nitrogen (BUN) or serum creatinine, and abnormal urinary sediment, has been noted. Slight elevation of the BUN and serum creatinine has been observed in a significant number of patients receiving prolonged therapy. The appearance of casts, red cells, and white cells in the urine has been noted in a high percentage of these cases. Elevation of the BUN above 30 mg/100 mL or any other evidence of decreasing renal function with or without a rise in BUN levels calls for careful evaluation of the patient, and the dosage should be reduced or the drug completely withdrawn. The clinical significance of abnormal urine sediment and slight elevation in the BUN (or serum creatinine) observed during long-term therapy with Capastat Sulfate has not been established.

The peripheral neuromuscular blocking action that has been attributed to other polypeptide antibiotics (colistin sulfate, polymyxin A sulfate, paromomycin, and viomycin) and to aminoglycoside antibiotics (streptomycin, dihydrostreptomycin, neomycin, and kanamycin) has been studied with Capastat Sulfate. A partial neuromuscular blockade was demonstrated after large intravenous doses of Capastat Sulfate. This action was enhanced by ether anesthesia (as has been reported for neomycin) and was antagonized by neostigmine.

Caution should be exercised in the administration of antibiotics, including Capastat Sulfate, to any patient who has demonstrated some form of allergy, particularly to drugs.

Laboratory Tests

Regular tests of renal function should be made throughout the period of treatment, and reduced dosage should be employed in patients with known or suspected renal impairment. Renal function studies should be made both before therapy with Capastat Sulfate is started and on a weekly basis during treatment. Since hypokalemia, hypomagnesemia and hypocalcemia may occur during therapy, these serum electrolyte levels should be determined frequently.

Drug Interactions

For neuromuscular blocking action of this drug, see PRECAUTIONS, GENERAL. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been performed to determine potential for carcinogenicity, mutagenicity, or impairment of fertility.

Pregnancy Category: C

Capastat Sulfate has been shown to be teratogenic in rats when given in doses 3 1/2 times the human dose. There are no adequate and well-controlled studies in pregnant women. Capastat Sulfate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus .

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Capastat Sulfate is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established .

Geriatric Use

Clinical studies of Capastat Sulfate did not analyze the safety and efficacy of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Capastat Sulfate is known to be substantially excreted by the kidney , and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Patients with reduced renal function should have dosage reduction based on creatinine clearance using the guidelines included in Table 1 .

The geriatric population is also more likely to have impaired hearing at baseline. Audiometric measurements and assessment of vestibular function should be performed prior to initiation of therapy with Capastat Sulfate and at regular intervals during treatment .

References

Adapted from the FDA Package Insert.