SEROMYCIN- cycloserine capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

CYCLOSERINE (UNII: 95IK5KI84Z) (CYCLOSERINE - UNII:95IK5KI84Z)

Доступна з:

Parsolex Gmp Center, Inc.

ІПН (Міжнародна Ім'я):

CYCLOSERINE

Склад:

CYCLOSERINE 250 mg in 250 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Seromycin is indicated in the treatment of active pulmonary and extrapulmonary tuberculosis (including renal disease) when the causative organisms are susceptible to this drug and when treatment with the primary medications (streptomycin, isoniazid, rifampin, and ethambutol) has proved inadequate. Like all antituberculosis drugs, Seromycin should be administered in conjunction with other effective chemotherapy and not as the sole therapeutic agent. Seromycin may be effective in the treatment of acute urinary tract infections caused by susceptible strains of gram–positive and gram–negative bacteria, especially Enterobacter  spp. and Escherichia coli . It is generally no more and is usually less effective than other antimicrobial agents in the treatment of urinary tract infections caused by bacteria other than mycobacteria. Use of Seromycin in these infections should be considered only when more conventional therapy has failed and when the organism has been demonstrated to be susceptib

Огляд продуктів:

Seromycin is available as a 250 mg capsule with an opaque red cap and opaque gray body imprinted with “CHAO” and “F04” in edible black ink on both the cap and the body.    Bottles of 40  NDC 13845-1200-3 Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP].

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

SEROMYCIN- CYCLOSERINE CAPSULE
PARSOLEX GMP CENTER, INC.
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DESCRIPTION SECTION
Seromycin (Cycloserine Capsules, USP), 3-isoxazolidinone, 4-amino –,
(R)– is a broad–
spectrum antibiotic that is produced by a strain of Streptomyces
orchidaceus and has
also been synthesized. Cycloserine is a white to off–white powder
that is soluble in water
and stable in alkaline solution. It is rapidly destroyed at a neutral
or acid pH.
Cycloserine has a pH between 5.5 and 6.5 in a solution containing 100
mg/mL. The
molecular weight of cycloserine is 102.09, and it has an empirical
formula of
C3H6N2O2.
INACTIVE INGREDIENT SECTION
Each capsule contains cycloserine, 250 mg (2.45 mmol); D and C Yellow
No. 10, FD and
C Blue No. 1, FD and C Red No. 3, FD and C Yellow No. 6, gelatin, iron
oxide, talc,
titanium dioxide, and other inactive ingredients.
CLINICAL PHARMACOLOGY SECTION
After oral administration, cycloserine is readily absorbed from the
gastrointestinal tract,
with peak blood levels occurring in 4 to 8 hours. Blood levels of 25
to 30 μg/mL can
generally be maintained with the usual dosage of 250 mg twice a day,
although the
relationship of plasma levels to dosage is not always consistent.
Concentrations in the
cerebrospinal fluid, pleural fluid, fetal blood, and mother’s milk
approach those found in
the serum. Detectable amounts are found in ascitic fluid, bile,
sputum, amniotic fluid, and
lung and lymph tissues. Approximately 65 percent of a single dose of
cycloserine can be
recovered in the urine within 72 hours after oral administration. The
remaining 35
percent is apparently metabolized to unknown substances. The maximum
excretion rate
occurs 2 to 6 hours after administration, with 50 percent of the drug
eliminated in
12 hours.
MICROBIOLOGY SECTION
Cycloserine inhibits cell–wall synthesis in susceptible strains of
gram–positive and gram–
negative bacteria and in Mycobacterium tuberculosis.
Susceptibility Tests
Cycloserine clinical laboratory standard powder is available for both
direct and indirec