CLOSERIN Capsule

Susceptible microorganisms: Mycobacterium tuberculosis

Indication: in the treatment of active pulmonary and extra-pulmonary tuberculosis.

Dosage& Administration

Adults: The initial dosage is 250mg twice daily.

The dosage may vary according to the patient’s age and symptom.

In principle, Cycloserine is used in conjunction with other antituberculous agents.

1. Patients with hypersensitivity to Cycloserine

2. Patients with depression, epilepsy, severe anxiety of psychosis

3. Patients with severe renal insufficiency

4. Patients with excessive concurrent use of alcohol.

1. Nervous system: headache, vertigo, drowsiness, tremor, depression, abalienatio, hallucination, coma, psychosis (possibly with suicidal tendencies), hyperreflexia, arthralgia, confusion, peripheral neuritis, paresis, dysarthria, hyposomnia, characteristic change, hyperirritability, aggression, paresthesia, major and minor (localized) clonic seizures, confusion and disorientation with loss of memory may occur. If the patient develops these symptoms, the administration should be discontinued.

2. Hypersensitivity: skin rash may occur. The administration should be discontinued of the dosage reduced if the patients develop allergic dermatitis.

3. Digestive system: occasionally, nausea, anorexia, abdominal pain, constipation, diarrhea may occur.

4. Cardiovascular: sudden development of congestive heart failure in patients receiving 1-1.5g of Cycloserine daily has been reported.

5. Hematologic: Vitamin B12 deficiency, folic acid deficiency, megaloblastic, anemia, and sideroblastic anemia may occur rarely in patients receiving Cycloserine in conjunction with other antituberculous agents. If anemia occurs, the patients should be sufficiency monitored and appropriate therapy should be initiated.

6. Other: elevated serum aminotransferase (transaminase) concentrations, especially in patients with preexisting liver disease, have been reported.

1. Concurrent administration of Ethionamide may potentiate neurotoxic side-effects, therefore the administration should be carried on the caution.

2. Alcohol increases the possibility and risk of epileptic episodes, therefore it should be avoided during treatment.

3. 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.

1. Safety in use in pregnancy has not been established. Therefore, it should only be used in pregnant women or women with potential to become pregnant only if the expected benefits to the mother exceed the potential risk to the fetus.

2. It has been reported that the drug was excreted in the milk. Therefore, mothers who are under treatment should not breast-feed.

The drug should be cautiously administered in the following patients

1. Patients with renal impairment

2. Patients with a family history of psychosis or epilepsy

3. Alcoholics

4. Patients with allergic skin infections, confusion, hyperrflexia, headache, chills, dizziness, incomplete paralysis, dysphemia, etc… symptoms of central nerve toxicity.

5. This pharmaceutical product contains yellow no.5 (sunset yellow FCF), therefore it should be administered with caution to patients who are sensitive to it, or who have allergic medical history to yellow no.5.

General precautions

1. Prior to the administration of Cycloserine, susceptibility to the drug should be tested to prevent manifestation of resistant bacteria and the duration therapy should be the minimum of needed for the treatment.

2. Cycloserine is used after failure of adequate treatment with the primary medications (streptomycin, isoniazid, refampicin and ethambutol).

3. The toxicity of Cycloserine is closely relate to excessive blood levels (above 30µg/mL), as determined by high dosage or inadequate renal cleance. The ratio of toxic dose to effective dose in tuberculosis is low.

4. Patients with hepatic, renal impairment should be monitored by hematologic, renal excretion, blood level, and liver function studies.