Repin B6

Active material: Isoniazid + Pyrazinamide + Rifampicin, Ethambutol, Pyridoxine
When ATH: J04AM02
CCF: TB drugs
When CSF: 06.22.05.01
Manufacturer: M.J.BIOPHARM Pvt.Ltd. (India)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Pills, coated dark brown, Oval, lenticular, with Valium, on one side of the risks engraved “RPN”, with another – “MJ”; tablet in cross section a reddish brown color with white patches.

Excipients: colloidal silicon dioxide, Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, corn starch, sodium glycolate.

500 PC. – plastic bags (1) – jars, plastic.
1000 PC. – plastic bags (1) – jars, plastic.

Pharmacological action

The combined anti-TB drugs. Isoniazid has bactericidal activity against actively dividing cells Mycobacterium tuberculosis, It inhibits the synthesis of acid mikolievyh, is a component of the cell wall, It has a moderate effect on the slow and fast-growing atypical mycobacteria. For Mycobacterium tuberculosis is the IPC 0.025-0.05 mg / l. Rifampicin has a bactericidal effect on the inside- and extracellularly located microorganisms, inhibits DNA-dependent RNA polymerase of microorganisms. For Mycobacterium tuberculosis IPC – 2 mg / l. Pyrazinamide has a bactericidal activity, previously transformed into its active form – pyrazine acid. The target gene is pyrazinamide synthetase I mycobacterial fatty acid, involved in the biosynthesis mikolievoy acid. It acts on intracellular mycobacteria located, well into the pockets of tuberculosis. In the acidic environment of the IPC 20 mg / l. Ethambutol – bacteriostatic agent, effective against typical and atypical Mycobacteria tuberculosis. It inhibits cell wall synthesis, blocking the inclusion in her mikolievyh acids. IPC is 0.78-2 mg / l. Pyridoxine – Vitamins; involved in the metabolism. It is necessary for normal functioning of the central and peripheral nervous system. Anti-tuberculosis drugs can reduce the concentration of pyridoxine, in connection with the daily requirement for vitamin increases to 60 mg.

Testimony

Tuberculosis (first identified, any form).

Contraindications

Hypersensitivity, diseases of the liver and digestive tract in the acute phase, CNS disorders (incl. epilepsy, others. disease with a tendency to seizures), diseases of eye (optic neuritis, Cataract, diabeticheskaya retinopathy, inflammatory diseases of the eye), childhood (to 13 years), pregnancy, lactation. Carefully. Gipotireoz, hyperuricemia, gout.

Dosage regimen

Inside, morning, an empty stomach 30-40 minutes before eating. Dosing is carried out by rifampicin – 10 mg / kg body weight, but not more 5 tablets. A course of treatment – 2-4 Months. When body weight more 80 kg isoniazid further in the evening (The total daily dose of isoniazid – 10 mg / kg). If necessary, it can be combined with the / m streptomycin dose 15 mg / kg 1 once a day.

Side effect

Isoniazid.

From the nervous system – headache, dizziness, rarely – fatiguability, weakness, irritability, euphoria, insomnia, paresthesia, numbness, peripheral neuropathy, optic neuritis, polyneuritis, psychoses, emotional lability, depression, increased frequency of seizures in patients with epilepsy.

From the CCC: heartbeat, angina, increased blood pressure. From the digestive system: nausea, vomiting, gastralgia, toxic hepatitis.

Allergic reactions: skin rash, itch, hyperthermia, arthralgia.

Other: rarely – gynecomastia, menorragija, tendency to bleed and hemorrhage.

Rifampicin

From the digestive system – nausea, vomiting, diarrhea, decreased appetite, erosive gastritis, pseudomembranous enterocolitis, activity increase “Hepatic” serum transaminases, giperʙiliruʙinemija, hepatitis.

Allergic reactions: hives, eozinofilija, angioedema, bronchospasm, arthralgia, fever.

From the nervous system: headache, reduced visual acuity, ataxia, disorientation.

From the urinary system: nefronekroz, interstitial nephritis, acute renal failure.

Other: leukopenia, dysmenorrhoea, induction of porphyria, myasthenia, hyperuricemia, worsening of gout, flu-like symptoms, skin reactions, gemoliticheskaya anemia, trombotsitopenicheskaya purpura.

Pyrazinamide

From the digestive system – nausea, vomiting, diarrhea, “metal” taste in the mouth, abnormal liver function (decreased appetite, liver tenderness, gepatomegaliya, jaundice, yellow atrophy of the liver), aggravation of peptic ulcers.

From the nervous system: dizziness, headache, sleep disorders, hypererethism, depression, in some cases – hallucinations, convulsions, confusion.

From the side of hematopoiesis: thrombocytopenia, sideroblastnaya anemia, vacuolation of erythrocytes, porphyria, hypercoagulation, splenomegaly.

On the part of the musculoskeletal system: arthralgia, myalgia.

From the urinary system: dizurija, interstitial nephritis. Allergic reactions: skin rash, hives.

Other: hyperthermia, acne, hyperuricemia, worsening of gout, photosensitivity, increasing the concentration of serum iron.

Ethambutol

From the nervous system – weakness, headache, dizziness, disturbance of consciousness, disorientation, hallucinations, depression, peripheral neuritis (paresthesias in extremities, numbness, paresis, itch).

From the senses: optic neuritis (reduced visual acuity, impaired color perception, mainly green and red colors, daltonism, scotoma).

From the digestive system: decreased appetite, nausea, vomiting, gastralgia, activity increase “Hepatic” transaminases.

Allergic reactions: dermatitis, skin rash, itch, arthralgia, fever, anaphylaxis.

Other: hyperuricemia, worsening of gout. Pyridoxine: allergic reactions, hypersecretion of hydrochloric acid, numbness, the emergence of a sense of compression of the extremities – symptom “stocking” and “Glove”, rarely – rash, itchy skin.

Drug Interactions

Admission isoniazid, rifampicin, and ethambutol, especially, pyrazinamide in combination dosage form significantly increases the antimicrobial activity against Mycobacterium tuberculosis. Rifampicin induces some enzymes of the cytochrome P450, speeding up the metabolism of prednisolone, phenytoin, xinidina, oral anticoagulants, hormonal contraceptives, antifungals, cimetidine, cyclosporine. Isoniazid Rifampicin reduces the connection to plasma proteins, pyrazinamide zamyedlyayet ekskryetsiyu rifampitsina. PAS impairs the absorption of rifampicin. Admission rifampicin lomefloxacin, and ofloxacin reduces the antimicrobial activity of combinations against Mycobacterium tuberculosis. Antacids, opioid analgesics reduce bioavailability rifampitsinaIzoniazid: MAO inhibitors increase the risk of side effects from the CNS, SSS. Pyridoxine, glutamic acid reduces the risk of side effects of isoniazid. Joint cycloserine and isoniazid increases the risk of neurotoxic side effects. Pyrazinamide increases the concentration of isoniazid and rifampicin serum, slowing their excretion. When taken together with rifampicin pyrazinamide increased hepatotoxicity. Aluminium hydroxide reduces absorption of ethambutol. Admission ethambutol with aminoglycosides, ciprofloxacin, imipenem, karʙamazepinom, salts of Li , quinine increases the risk of neurotoxic effects of drugs. Ethambutol enhances antimicrobial activity, etc.. TB drugs. Pyridoxine reduces the effect of levodopa in their joint application, It reduces the risk of toxic action of anti-TB drugs for the central nervous system and peripheral nervous system.