Rx Item-Capastat Sulfate 1 gm Vial By Akorn Pharma

CAPASTAT SULFATE- capreomycin sulfate injection, powder, for solution
Akorn

For Intramuscular and Intravenous Infusion Only

NOT FOR PEDIATRIC USE

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.

DESCRIPTION
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.

Capreomycin is supplied as the disulfate salt and is soluble in water. In complete solution, it is almost colorless.

CLINICAL PHARMACOLOGY
Human Pharmacology
Capreomycin is not absorbed in significant quantities from the gastrointestinal tract and must be administered parenterally. In 2 studies of 10 patients each, peak serum concentrations following 1 g of capreomycin given intramuscularly were achieved 1 to 2 hours after administration, and average peak levels reached were 28 and 32 μg/mL respectively (range, 20 to 47 μg/mL). Low serum concentrations were present at 24 hours. However, 1 g of capreomycin daily for 30 days or more produced no significant accumulation in subjects with normal renal function. Two patients with marked reduction of renal function had high serum concentrations 24 hours after administration of the drug. When a 1-g dose of capreomycin was given intramuscularly to normal volunteers, 52% was excreted in the urine within 12 hours.
INDICATIONS AND USAGE
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.

Rx Item-Capastat Sulfate 1 gm Vial By Ak
Item No.: RX810937/C NDC No.17478008050 UPC No.:317478080503 NDC No. 17478-0080-50 UPC/GTIN No. 3-17478-08050-3 MPN No. 8050 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic

Capastat Sulfate 1 G Vial by A
BRAND: CAPASTAT NDC: 17478-0080-50,17478008050 UPC: 3-17478-08050-3,317478080503 Akorn Inc NDC: 17478-0080-50 UPC: 317478080503

CAPREOMYCIN SULFATE INJEC
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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