SEROMYCIN- 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.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS AND USAGE 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. 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 susceptible to the drug. CONTRAINDICATIONS Administration is contraindicated in patients with any of the following: • Hypersensitivity to Seromycin

Product summary:

HOW SUPPLIED Seromycin ® 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 13845-1200-2. Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SEROMYCIN- CYCLOSERINE CAPSULE
PARSOLEX GMP CENTER, INC.
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SEROMYCIN
CYCLOSERINE CAPSULES, USP
DESCRIPTION
Seromycin
(CycloSERINE Capsules, USP) D-Cycloserine, (R)-4-amino-3-isoxazol-
idinone, 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.
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, titanium
dioxide, sodium lauryl sulfate, benzyl alcohol, sodium propionate,
edetate calcium
disodium, butylparaben, methylparaben, propylparaben, and
carboxymethylcellulose.
CLINICAL PHARMACOLOGY
After oral administration, Seromycin
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% of a single dose of
Seromycin
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 Seromycin
results from inhibition
of cell-wall synthesis in susceptible strains of gram