CYCLOSERINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Parsolex Gmp Center, Inc.

INN (International Name):

CYCLOSERINE

Composition:

CYCLOSERINE 250 mg in 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, 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 cycloserine in these infections should be considered only when more conventional therapy has failed and when the organism has been demonstrated to be

Product summary:

Cycloserine 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 13845-1201-3 Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYCLOSERINE- CYCLOSERINE CAPSULE
PARSOLEX GMP CENTER, INC.
----------
DESCRIPTION SECTION
Cycloserine, 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 indirect
methods1 of determining