Drug Detail:Seromycin (Cycloserine [ sye-kloe-ser-een ])
Drug Class: Streptomyces derivatives
Mechanism of Action: The antibacterial activity of Seromycin ® results from inhibition of cell-wall synthesis in susceptible strains of gram-positive and gram-negative bacteria.
Antibacterial Activity: Seromycin® has been shown to be active against most isolates of the following microorganism, both in vitro and in clinical infections [see Indications and Usage]: Mycobacterium tuberculosis.
Carcinogenesis, Mutagenicity, and Impairment of Fertility: Studies
have not been performed to determine potential for carcinogenicity. The Ames test and unscheduled DNA repair test were negative. A study in 2 generations of rats showed no impairment of fertility relative to controls for the first mating but somewhat lower fertility in the second mating.
Geriatric Use: Clinical studies of Seromycin® did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. 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.
This drug 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. The toxicity of Seromycin® is closely related to excessive blood levels (above 30 µg/mL) as determined by high dosage or inadequate renal clearance (see WARNINGS).
Blood levels should be determined at least weekly for patients with reduced renal function, for individuals receiving a daily dosage of more than 500 mg, and for those showing signs and symptoms suggestive of toxicity. The dosage should be adjusted to keep the blood level below 30 µg/mL (see PRECAUTIONS, Laboratory Tests).
SEROMYCIN
cycloserine capsule |
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Labeler - Parsolex Gmp Center, Inc. (159802532) |
Registrant - Parsolex Gmp Center, Inc. (159802532) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Parsolex Gmp Center, Inc. | 159802532 | manufacture(13845-1203) |