Kansamin (Capsules) Instructions for Use
ATC Code
J04AB01 (Cycloserine)
Active Substance
Cycloserine (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Antituberculosis drug
Pharmacotherapeutic Group
Agents active against mycobacteria; antituberculosis agents; antibiotics
Pharmacological Action
Antituberculosis antibiotic. It acts bacteriostatically or bactericidally depending on the concentration at the site of infection and the sensitivity of the microorganisms. It is an analog of the amino acid D-alanine. It competitively inhibits the activity of the enzymes L-alanine racemase, which converts L-alanine into D-alanine, and D-alanyl-D-alanine synthetase, which incorporates D-alanine into the pentapeptide necessary for building the bacterial cell wall.
It is active against Mycobacterium tuberculosis, Mycobacterium avium.
Indications
Use only as a component of combination therapy to prevent the rapid development of microbial resistance.
- Treatment of pulmonary and extrapulmonary tuberculosis caused by susceptible strains of Mycobacterium tuberculosis.
- Management of atypical mycobacterial infections, particularly those caused by the Mycobacterium avium complex (MAC).
ICD codes
| ICD-10 code | Indication |
| A15 | Respiratory tuberculosis, bacteriologically and histologically confirmed |
| A17 | Tuberculosis of nervous system |
| A18 | Tuberculosis of other organs |
| A31.0 | Pulmonary infection due to Mycobacterium |
| ICD-11 code | Indication |
| 1B10.0 | Respiratory tuberculosis, bacteriologically or histologically confirmed |
| 1B11.Z | Tuberculosis of nervous system, unspecified |
| 1B12 | Tuberculosis of other systems and organs |
| 1B21.0 | Pulmonary infection due to nontuberculous mycobacterium |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer orally in divided doses. Initiate therapy at lower doses and titrate upward based on patient tolerance and blood level monitoring to minimize CNS toxicity.
For adults, the typical daily dosage range is 0.25 to 1 gram. The maximum recommended daily dose is 1 gram. For children, the recommended dosage is 10 to 20 mg per kg of body weight per day, administered in divided doses.
Adverse Reactions
Adverse reactions primarily involve the central nervous system. Monitor patients closely, especially at doses exceeding 500 mg daily.
Reported reactions include headache, dizziness, drowsiness, anxiety, confusion, depression, dysarthria, nightmares, myoclonus, tremor, hyperreflexia, peripheral neuropathy, and convulsive seizures. Allergic reactions such as skin rash may also occur.
Contraindications
Do not administer to patients with known hypersensitivity to cycloserine or any component of the formulation.
- Contraindicated in patients with depression, psychosis, severe anxiety, or alcoholism.
- Do not use in patients with epilepsy, a history of seizures, or significant organic diseases of the central nervous system.
- Contraindicated in patients with impaired renal function and during pregnancy.
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy.
Cycloserine is excreted in breast milk, so if it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.
Use in Renal Impairment
Contraindicated in impaired renal function.
Pediatric Use
Use is possible according to the dosage regimen.
Special Precautions
With monotherapy with cycloserine, rapid development of mycobacterial resistance is possible, so only combination therapy should be used.
Careful monitoring of patients receiving Cycloserine at a dose of more than 500 mg/day is necessary to identify signs of toxic effects on the CNS.
Do not consume alcohol during treatment.
Drug Interactions
Concomitant use requires caution due to increased risk of adverse effects. Concurrent use with ethanol significantly increases the risk of convulsive seizures.
Simultaneous administration with other antituberculosis drugs such as ethionamide or isoniazid may potentiate CNS toxicity, including dizziness or drowsiness. Monitor patients for enhanced neurotoxic effects.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Capsules 125 mg: 10, 20, 30, 50, 60 or 100 pcs.
Marketing Authorization Holder
Pharmasintez, JSC (Russia)
Dosage Form
 |
Kansamin | Capsules 125 mg: 10, 20, 30, 50, 60 or 100 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin size No. 2, blue in color; the contents of the capsules are a white or white with a yellowish tint powder.
| 1 caps. | |
| Cycloserine | 125 mg |
Excipients : pregelatinized starch – 6 mg, lactose – 5 mg, talc – 4 mg.
Composition of hard gelatin capsules: brilliant blue – 0.15%, titanium dioxide – 1.8817%, gelatin – up to 100%.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
Capsules 250 mg: 10, 20, 30, 50, 60, or 100 pcs.
Marketing Authorization Holder
Pharmasintez, JSC (Russia)
Dosage Form
|
Kansamin | Capsules 250 mg: 10, 20, 30, 50, 60, or 100 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin size No. 1, dark brown in color; the contents of the capsules are a white or white with a yellowish tint powder.
| 1 caps. | |
| Cycloserine | 250 mg |
Excipients : pregelatinized starch – 12 mg, lactose – 10 mg, talc – 8 mg.
Composition of hard gelatin capsules: indigo carmine – 0.0632%, ponceau 4R – cochineal red A – 1.2637%, titanium dioxide – 0.7362%, gelatin – up to 100%.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
Capsules 500 mg: 10, 20, 30, 50, 60, or 100 pcs.
Marketing Authorization Holder
Pharmasintez, JSC (Russia)
Dosage Form
|
Kansamin | Capsules 500 mg: 10, 20, 30, 50, 60, or 100 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin size No. 00, white body, yellow cap; the contents of the capsules are a white or white with a yellowish tint powder.
| 1 caps. | |
| Cycloserine | 500 mg |
Excipients : pregelatinized starch – 24 mg, lactose – 20 mg, talc – 16 mg.
Composition of hard gelatin capsules
Cap quinoline yellow – 0.4343%, titanium dioxide – 2.6%, sunset yellow FCF dye – 0.0057%; gelatin – up to 100%.
Body titanium dioxide – 2%, gelatin – up to 100%.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
![Kansamin [Capsules] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Kansamin [Capsules] 2")