Cycloserine is a human prescription drug labeled by 'Parsolex Gmp Center, Inc.'. National Drug Code (NDC) number for Cycloserine is 13845-1201. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Cycloserine drug includes Cycloserine - 250 mg/250mg . The currest status of Cycloserine drug is Active.

Cycloserine cycloserine titanium dioxide ferrosoferric oxide fd&c blue no. 1 fd&c red no. 3 fd&c yellow no. 6 d&c yellow no. 10 sodium lauryl sulfate gelatin benzyl alcohol sodium propionate propylparaben butylparaben methylparaben cycloserine cycloserine opaque red 353 opaque grey 284 chaofo4 chaofo4

Drug interactions section concurrent administration of ethionamide has been reported to potentiate neurotoxic side effects. alcohol and cycloserine are incompatible, especially during a regimen calling for large doses of the latter. alcohol increases the possibility and risk of epileptic episodes. concurrent administration of isoniazid may result in increased incidence of cns effects, such as dizziness or drowsiness. dosage adjustments may be necessary and patients should be monitored closely for signs of cns toxicity. 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.

Indications & usage section 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 orga Read more...

Warnings section administration of cycloserine should be discontinued or the dosage reduced if the patient develops allergic dermatitis or symptoms of cns toxicity, such as convulsions, psychosis, somnolence, depression, confusion, hyperreflexia, headache, tremor, vertigo, paresis, or dysarthria. the toxicity of cycloserine is closely related to excessive blood levels (above 30 μg/ml), as determined by high dosage or inadequate renal clearance. the ratio of toxic dose to effective dose in tuberculosis is small. the risk of convulsions is increased in chronic alcoholics. patients should be monitored by hematologic, renal excretion, blood level, and liver function studies.

Dosage & administration section cycloserine is effective orally and is currently administered only by this route. the usual dosage is 500 mg to 1 g daily in divided doses monitored by blood levels.2 the initial adult dosage most frequently given is 250 mg twice daily at 12–hour intervals for the first 2 weeks. a daily dosage of 1 g should not be exceeded.

Contraindications section administration is contraindicated in patients with any of the following: hypersensitivity to cycloserine epilepsy depression, severe anxiety, or psychosis severe renal insufficiency excessive concurrent use of alcohol

Adverse reactions section most adverse reactions occurring during therapy with cycloserine involve the nervous system or are manifestations of drug hypersensitivity. the following side effects have been observed in patients receiving cycloserine: nervous system symptoms (which appear to be related to higher dosages of the drug, i.e., more than 500 mg daily) convulsions drowsiness and somnolence headache tremor dysarthria vertigo confusion and disorientation with loss of memory psychoses, possibly with suicidal tendencies character changes hyperirritability aggression paresis hyperreflexia paresthesia major and minor (localized) clonic seizures coma cardiovascular sudden development of congestive heart failure in patients receiving 1 to 1.5 g of cycloserine daily has been reported allergy (apparently not related to dosage) skin rash miscellaneous elevated serum transaminase, especially in patients with preexisting liver disease

Drug interactions section concurrent administration of ethionamide has been reported to potentiate neurotoxic side effects. alcohol and cycloserine are incompatible, especially during a regimen calling for large doses of the latter. alcohol increases the possibility and risk of epileptic episodes. concurrent administration of isoniazid may result in increased incidence of cns effects, such as dizziness or drowsiness. dosage adjustments may be necessary and patients should be monitored closely for signs of cns toxicity. 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.

Pregnancy section pregnancy category c a study in 2 generations of rats given doses up to 100 mg/kg/day demonstrated no teratogenic effect in offspring. it is not known whether cycloserine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. cycloserine should be given to a pregnant woman only if clearly needed.

Pediatric use section safety and effectiveness in pediatric patients have not been established.

Overdosage section acute toxicity from cycloserine can occur if more than 1 g is ingested by an adult. chronic toxicity from cycloserine is dose related and can occur if more than 500 mg is administered daily. patients with renal impairment will accumulate cycloserine and may develop toxicity if the dosing regimen is not modified. patients with severe renal impairment should not receive the drug. the central nervous system is the most common organ system involved with toxicity. toxic effects may include headache, vertigo, confusion, drowsiness, hyperirritability, paresthesias, dysarthria, and psychosis. following larger ingestions, paresis, convulsions, and coma often occur. ethyl alcohol may increase the risk of seizures in patients receiving cycloserine. the oral median lethal dose in mice is 5290 mg/kg. treatment to obtain up–to–date information about the treatment of overdose, a good resource is your certified regional poison control center. telephone numbers of certified poison control centers are listed in the physicians’ desk reference (pdr). in managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. overdoses of cycloserine have been reported rarely. the following is provided to serve as a guide should such an overdose be ecountered. protect the patient’s airway and support ventilation and perfusion. meticulously monitor and maintain, within acceptable limits, the patient’s vital signs, blood gases, serum electrolytes, etc. absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. safeguard the patient’s airway when employing gastric emptying or charcoal. in adults, many of the neurotoxic effects of cycloserine can be both treated and prevented with the administration of 200 to 300 mg of pyridoxine daily. the use of hemodialysis has been shown to remove cycloserine from the bloodstream. this procedure should be reserved for patients with life-threatening toxicity that is unresponsive to less invasive therapy

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.

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.

How supplied section 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].

Package label principal display panel cycloserine capsules, usp 250mg the chao center ndc 13845-1201-3 40 capsules rx only usual initial adult dose: one capsule (250 mg) twice a day at 12 hour intervals. see accompanying literature. dispense in a tight container. warning: potent drug. may cause serious reactions in some individuals. use in patients under close medical supervision. read accompanying literature before using. 13845-1201-3 lm000264.00 keep tightly closed. store at controlled room temperature, 20 degrees to 25 degrees c (68 degrees to 77 degrees f). [see usp] maunfacture the chao center for industrial pharmacy and contract manufacturing, west lafayette, in 47906, usa expiration date batch no. purdue gmp cycloserine label