CAPASTAT SULFATE- capreomycin injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

capreomycin sulfate (UNII: 9H8D3J7V21) (capreomycin - UNII:232HYX66HC)

Available from:

Akorn

INN (International Name):

capreomycin sulfate

Composition:

capreomycin 1 g

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 .

Product summary:

Capastat® Sulfate, Capreomycin for Injection, USP is a white to off-white lyophilized plug available in: NDC 17478-080-50          1 gram Single-dose Vial Prior to reconstitution, store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature]. Discard Unused Portion.

Authorization status:

New Drug Application

Summary of Product characteristics

CAPASTAT SULFATE- CAPREOMYCIN INJECTION, POWDER, FOR SOLUTION
AKORN
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CAPASTAT SULFATE
CAPREOMYCIN FOR INJECTION, USP
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
Capreomycin 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.
Each vial contains capreomycin sulfate approximately equivalent to 1
gram capreomycin
base.
The structural formula is as follows:
®
®
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 gr