Laslonvita (Tablets) Instructions for Use

Marketing Authorization Holder

Technology Lekarstv LLC (Russia)

ATC Code

J04AM06 (Rifampicin, Pyrazinamide, Ethambutol and Isoniazid)

Dosage Form

Laslonvita

Film-coated tablets: 100 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (10) – cardboard packs.

Clinical-Pharmacological Group

Antituberculosis drug

Pharmacotherapeutic Group

Combined antitubercular agent

Pharmacological Action

Combined antituberculosis agent.

Isoniazid has a bactericidal effect on actively dividing cells of Mycobacterium tuberculosis, inhibits the synthesis of mycolic acids, which are a component of the cell wall, and has a moderate effect on slowly and rapidly growing atypical mycobacteria. For Mycobacterium tuberculosis, the MIC is 0.025-0.05 mg/L.

Rifampicin has a bactericidal effect on intracellularly and extracellularly located microorganisms, inhibits DNA-dependent RNA polymerase of microorganisms. For Mycobacterium tuberculosis, the MIC is 2 mg/L.

Pyrazinamide has bactericidal activity, being preliminarily converted into an active form – pyrazinoic acid. The target of pyrazinamide is the mycobacterial fatty acid synthase I gene involved in the biosynthesis of mycolic acid. It acts on intracellularly located mycobacteria and penetrates well into tuberculosis foci. In an acidic environment, the MIC is 20 mg/L.

Ethambutol is a bacteriostatic drug effective against typical and atypical Mycobacterium tuberculosis. It inhibits the synthesis of the cell wall by blocking the incorporation of mycolic acids into it. The MIC is 0.78-2 mg/L.

Pyridoxine is a vitamin agent; it is involved in metabolism. It is necessary for the normal functioning of the central and peripheral nervous system. Antituberculosis drugs can reduce the concentration of pyridoxine, therefore the daily requirement for the vitamin increases to 60 mg.

Indications

Tuberculosis (newly diagnosed, any forms).

ICD codes

Dosage Regimen

Administer orally, as a single daily dose in the morning, on an empty stomach 30-40 minutes before a meal.

Calculate the dose based on the patient’s body weight, using rifampicin at 10 mg/kg.

The maximum daily dose is five tablets.

For a patient weighing 30-37 kg, prescribe two tablets.

For a patient weighing 38-54 kg, prescribe three tablets.

For a patient weighing 55-70 kg, prescribe four tablets.

For a patient weighing over 71 kg, prescribe the maximum of five tablets.

Continue the initial intensive phase of treatment for 2-4 months, or as directed by a physician.

Monitor liver function and visual acuity regularly during therapy.

Ensure adequate pyridoxine supplementation to mitigate neuropathic risks.

Adverse Reactions

Isoniazid

Nervous system disorders headache, dizziness, rarely – fatigue, weakness, irritability, euphoria, insomnia, paresthesia, numbness of extremities, peripheral neuropathy, optic neuritis, polyneuritis, psychoses, emotional lability, depression, increased frequency of seizures in patients with epilepsy.

Cardiovascular system disorders palpitations, angina pectoris, increased blood pressure.

Digestive system disorders nausea, vomiting, gastralgia, toxic hepatitis.

Allergic reactions skin rash, itching, hyperthermia, arthralgia.

Other very rarely – gynecomastia, menorrhagia, tendency to bleeding and hemorrhage.

Rifampicin

Digestive system disorders nausea, vomiting, diarrhea, decreased appetite, erosive gastritis, pseudomembranous enterocolitis, increased activity of liver transaminases in blood serum, hyperbilirubinemia, hepatitis.

Allergic reactions urticaria, eosinophilia, angioedema, bronchospasm, arthralgia, fever.

Nervous system disorders headache, decreased visual acuity, ataxia, disorientation.

Urinary system disorders nephronecrosis, interstitial nephritis, acute renal failure.

Other leukopenia, dysmenorrhea, induction of porphyria, myasthenia, hyperuricemia, exacerbation of gout, flu-like syndrome, skin reactions, hemolytic anemia, thrombocytopenic purpura.

Pyrazinamide

Digestive system disorders nausea, vomiting, diarrhea, metallic taste in the mouth, impaired liver function (decreased appetite, liver tenderness, hepatomegaly, jaundice, yellow liver atrophy), exacerbation of peptic ulcer.

Nervous system disorders dizziness, headache, sleep disorders, increased excitability, depression, in some cases – hallucinations, convulsions, confusion.

Hematopoietic system disorders thrombocytopenia, sideroblastic anemia, vacuolization of erythrocytes, porphyria, hypercoagulation, splenomegaly.

Musculoskeletal system disorders arthralgia, myalgia.

Urinary system disorders dysuria, interstitial nephritis.

Allergic reactions skin rash, urticaria.

Other hyperthermia, acne, hyperuricemia, exacerbation of gout, photosensitization, increased serum iron concentration.

Ethambutol

Nervous system disorders weakness, headache, dizziness, impaired consciousness, disorientation, hallucinations, depression, peripheral neuritis (paresthesia in the extremities, numbness, paresis, itching).

Sensory organs disorders optic neuritis (decreased visual acuity, impaired color perception, mainly of green and red colors, color blindness, scotoma).

Digestive system disorders decreased appetite, nausea, vomiting, gastralgia, increased activity of liver transaminases.

Allergic reactions dermatitis, skin rash, itching, arthralgia, fever, anaphylaxis.

Other hyperuricemia, exacerbation of gout.

Pyridoxine

Allergic reactions, hypersecretion of hydrochloric acid, numbness, appearance of a feeling of compression of the extremities – “stocking” and “glove” symptom, rarely – rash, skin itching.

Contraindications

Hypersensitivity to the components of the combination; liver and gastrointestinal diseases in the acute phase; diseases of the central nervous system (including epilepsy, other diseases with a tendency to convulsive seizures); diseases of the organs of vision (optic neuritis, cataract, diabetic retinopathy, inflammatory eye diseases); acute renal failure; children under 13 years of age; pregnancy; breastfeeding period.

With caution

Hypothyroidism, hyperuricemia, gout.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation.

Use in Hepatic Impairment

Contraindication — liver diseases in the acute stage.

Use in Renal Impairment

Contraindicated for use in acute renal failure.

Pediatric Use

Contraindication — children under 13 years of age.

Geriatric Use

Use with caution in elderly patients to avoid the risk of exacerbation of chronic diseases.

Special Precautions

Dosing and administration regimen are determined taking into account the patient’s body weight.

Drug Interactions

Administration of isoniazid, rifampicin, ethambutol and, especially, pyrazinamide in a combined dosage form significantly increases antimicrobial activity against Mycobacterium tuberculosis.

Rifampicin induces some cytochrome P450 system enzymes, accelerating the metabolism of prednisolone, phenytoin, quinidine, oral anticoagulants, hormonal contraceptives, antifungal drugs, cimetidine, cyclosporine.

Isoniazid reduces the binding of rifampicin to plasma proteins, Pyrazinamide slows down the excretion of rifampicin.

PAS (para-aminosalicylic acid) impairs the absorption of rifampicin.

Concomitant use of rifampicin with lomefloxacin and ofloxacin leads to a decrease in the antimicrobial activity of these combinations against Mycobacterium tuberculosis.

Antacids, opioid analgesics reduce the bioavailability of rifampicin.

Isoniazid: MAO inhibitors increase the risk of side effects from the central nervous system and cardiovascular system.

Pyridoxine, glutamic acid reduce the risk of side effects of isoniazid.

Concomitant use of isoniazid and cycloserine increases the risk of neurotoxic side effects.

Pyrazinamide increases the concentration of isoniazid and rifampicin in the blood serum, slowing down their excretion. When rifampicin is taken together with pyrazinamide, hepatotoxicity increases.

Aluminum hydroxide reduces the absorption of ethambutol.

Concomitant use of ethambutol with aminoglycosides, ciprofloxacin, imipenem, carbamazepine, lithium salts, quinine increases the risk of neurotoxic effects of drugs.

Ethambutol enhances the antimicrobial activity of other antituberculosis agents.

Pyridoxine weakens the effect of levodopa when used together and reduces the risk of toxic effects of antituberculosis drugs on the central and peripheral nervous system.

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.