Cycloserine Meiji

One capsule of CYCLOSERINE Capsules MEIJI contains the following ingredients. (See Table 1.)

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Product description: See Table 2.

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PHYSICOCHEMISTRY: Nonproprietary name: Cycloserine.
Abbreviation: CS.
Chemical name: (R)-4-amino-3-isoxazolidinone.
Molecular formula: C₃H₆N₂O₂.
Molecular weight: 102.09.
Cycloserine, JP (The Japanese Pharmacopoeia) is a white to faint yellowish-white odorless crystals or a crystalline powder. The substance is soluble in water, sparingly soluble in ethanol and slightly soluble in ether.

PHARMACOLOGY: In vitro antibacterial activity: The minimum inhibitory concentrations (MICs) of cycloserine against human-type tubercle bacilli H₃₇R_V range from 6.25 to 12.5 μg/mL. (See Table 3.)

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PHARMACOKINETICS: Blood concentration: The mean blood concentration two hours after oral administration of 250 mg (potency) of the product to human (n=15) was 16.9 μg/mL (range: 6.0 to 26 μg/mL).
Excretion: After an oral single administration of 500 mg* of the product to human (n=9), a mean of 41% (19 to 92%) of the given dose was excreted within the first 24 hours. (Foreign data).
* The approved single dose of this product is 250 mg.

Pulmonary tuberculosis.

For adults, an oral single dose of 250 mg (potency) of cycloserine is usually administered twice a day. The dose should be adjusted according to the patient's age and body weight. As a general rule, the product should be used in combination with other anti-M. tuberculosis agents.

CYCLOSERINE CAPSULES MEIJI are contraindicated in the following patients: Patients with mental disorders such as epilepsy: Mental disorders such as epileptic seizure may further worsen.

As a general rule, the duration of administration of this product should be limited to the minimum period required for the treatment of the patient's condition, after susceptibility of the microorganism to the product has been confirmed, in order to prevent the emergence of drug-resistant microorganisms.
Careful Administration: CYCLOSERINE Capsules MEIJI should be administered with care in the following patients.
Patients with renal impairment: Elevated blood concentration of this product may cause adverse reactions on CNS, etc.
Use in Pregnancy & Lactation: The product should only be used in pregnant women and women suspected of being pregnant, only when it is considered that the expected therapeutic benefits outweigh the potential risks of treatment. [The safety of the product in pregnant women has not been established.]
It is recommended that breast feeding is avoided during the administration of cycloserine. [This product transfers to human breast milk.]
Use in the Elderly: Since physiological functions are generally depressed in the elderly, care should be taken including dose reduction.

Use during Pregnancy, Delivery or Lactation: The product should only be used in pregnant women and women suspected of being pregnant, only when it is considered that the expected therapeutic benefits outweigh the potential risks of treatment. [The safety of the product in pregnant women has not been established.]
It is recommended that breast feeding is avoided during the administration of cycloserine. [This product transfers to human breast milk.]

Adverse reactions have been reported in 606 (34.7%) of a total 1,745 patients. (Results of reevaluation).
1) Clinically significant adverse reactions: Since insanity, epilepsy-like seizure and spasms (0.1 to <5%) may appear, patients should be thoroughly monitored. Administration should be discontinued and suitable measures should be taken if these symptoms appear.
2) Other adverse reactions: See Table 4.

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Precautions for co-administration: CYCLOSERINE Capsules MEIJI should be administered with care when co-administered with the following drugs.
Alcohol (drinking): The product may intensify the action of alcohol.
Isoniazid: CNS adverse reactions such as vertigo and drowsiness may reportedly be intensified.
Ethionamide: Nervous system adverse reactions may be intensified.

Precautions concerning Use When handling out this product to patients: In case of this product supplied in PTP sheets, the patients should be advised to swallow the tablet ONLY after taking it out from the PTP sheets. (There have been several reports of patients who have swallowed by mistake the medicine together with the piece of PTP sheets, and in whom the hard and sharp corner of the PTP sheets has injured the esophagus resulting in the development of severe complications such as mediastinitis due to perforation.)
PRECAUTIONS FOR HANDLING: Seal hermetically because the product is hygroscopic.

Store below 30 °C. (See PRECAUTIONS FOR HANDLING under Cautions for Usage.)

Anti-TB Agents

J04AB01 - cycloserine ; Belongs to the class of antibiotics. Used in the systemic treatment of tuberculosis.

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