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.

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Cycloserine 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, cycloserine should be administered in conjunction with other effective chemotherapy and not as the sole therapeutic agent. Cycloserine may be effective in the treatment of acute urinary tract infections caused by susceptible strains of gram-positive and gram- negative bacteria. Use of cycloserine in these infections should be considered only when more conventional therapy has failed and when the organism has been demonstrated to be susceptible to the drug Administration is contraindicated in patients with any of the following: • Hypersensitivity to cycloserine • Epilepsy • Depression

Огляд продуктів:

Cycloserine is available as a 250 mg capsule with an opaque red cap and opaque gray body imprinted with “PGC” and “F04” in edible black ink on both the cap and the body. Aluminum blisters (a pack of 3 cards each with 10 capsules). NDC 13845-1202-2. Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

CYCLOSERINE- CYCLOSERINE CAPSULE
PARSOLEX GMP CENTER, INC.
----------
CYCLOSERINE CAPSULES, USP, 250 MG, BLISTER PACK × 30
DESCRIPTION
D -Cycloserine, (R)-4-amino-3-isoxazolidinone,
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 C 3H6N2O 2 . The structural
formula of cycloserine is as follows:
Each capsule contains cycloserine, 250 mg
(2.45 mmol); D & C Yellow No. 10, F D & C Blue
No. 1, F D & C Red No. 3, F D & C Yellow No.
6, gelatin, iron oxide, talc, and titanium dioxide.
CLINICAL PHARMACOLOGY
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, file, sputum, amniotic fluid,
and lung and lymph tissues. Approximately
65% of a single dose of cycloserine can
be recovered in the urine within 72 hours
after oral administration. The remaining
35% is apparently metabolized to unknown
substances. The maximum excretion rate
occurs 2 to 6 hours after administration, with
50% of the drug eliminated in 12 hours.
MECHANISM OF ACTION: The antibacterial activity
of Cycloserine results from inhibition of cell-wall
synthesis in susceptible strains of gram-positive
and gram-negative bacteria.
ANTIBACTERIAL ACTIVITY: Cycloserine has been
shown to be active against most isolates of the
following microorganism, both i