Tubavit^® (Tablets) Instructions for Use

Marketing Authorization Holder

Technology Lekarstv LLC (Russia)

Manufactured By

Valenta Pharm, JSC (Russia)

ATC Code

J04AM02 (Rifampicin and Isoniazid)

Active Substances

Pyridoxine (Rec.INN registered by WHO)

Rifampicin (Rec.INN registered by WHO)

Isoniazid (Rec.INN registered by WHO)

Dosage Form

Tubavit®

Film-coated tablets, 100 mg+150 mg+10 mg: 30 or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets, round, biconvex; the cross-section shows two layers: a red-brown coating and a brownish-red core with white specks.

* calculated as the active substance.

Excipients: microcrystalline cellulose, copovidone, colloidal silicon dioxide (aerosil), magnesium stearate, croscarmellose sodium (primellose).

Film coating composition: hypromellose (hydroxypropyl methylcellulose), copovidone, Opadry II (series 85) [partially hydrolyzed polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, iron oxide red dye (E172), aluminum lake based on sunset yellow FCF dye (E110), ponceau 4R dye [Ponso 4R] (E124)].

10 pcs. – blister packs (3) – cardboard cartons.
10 pcs. – blister packs (10) – cardboard cartons.

Clinical-Pharmacological Group

Antituberculosis drug

Pharmacotherapeutic Group

Combined antitubercular agent

Pharmacological Action

Combined drug.

Isoniazid is an antituberculosis agent with specific activity against Mycobacterium tuberculosis, including strains resistant to other antituberculosis antibiotics.

Rifampicin is a broad-spectrum antibiotic; it suppresses DNA-dependent RNA polymerase. It has high activity against mycobacteria, including Mycobacterium tuberculosis, and some gram-positive pathogens; activity against gram-negative organisms is lower. It does not exhibit cross-resistance with other antibiotics.

Pyridoxine plays an important role in metabolism and is necessary for the normal functioning of the nervous system. In its phosphorylated form, pyridoxine is a coenzyme for a large number of enzymes acting on the non-oxidative metabolism of amino acids. It is involved in the metabolism of tryptophan, methionine, cysteine, glutamic acid, and other amino acids. It plays an important role in histamine metabolism. It helps normalize lipid metabolism.

Indications

• Tuberculosis of the lungs and other organs;
• Leprosy;
• Infectious and inflammatory diseases of the lungs and respiratory tract caused by multidrug-resistant staphylococci;
• Osteomyelitis;
• Infections of the urinary and biliary tracts;
• Acute gonorrhea.

ICD codes

Dosage Regimen

Determine the daily dose individually based on the patient’s body weight.

For pulmonary and extrapulmonary tuberculosis, administer the drug in a single daily dose on an empty stomach, at least 30 minutes before a meal.

For adults and children with a body weight over 50 kg, the standard daily dose is 4 tablets.

For adults and children with a body weight of 40-49 kg, the daily dose is 3 tablets.

For adults and children with a body weight of 30-39 kg, the daily dose is 2 tablets.

For the initial phase of tuberculosis treatment, use the drug daily for 2-3 months.

For the continuation phase, the same daily dose may be administered daily or as an intermittent regimen three times per week.

For the treatment of leprosy, administer 450-600 mg of rifampicin once monthly under medical supervision, combined with other antileprosy drugs.

For other infections, the daily dose for adults is typically 600 mg of rifampicin and 300 mg of isoniazid in a single dose.

For the treatment of acute gonorrhea, administer a single dose of 900 mg of rifampicin and 600 mg of isoniazid.

Adjust the dose carefully in patients with hepatic impairment or elderly patients.

Do not use in children under 1 year of age.

Swallow the tablets whole with a sufficient amount of water.

Adverse Reactions

Isoniazid

From the nervous system: headache, dizziness, rarely – excessive fatigue or weakness, irritability, euphoria, insomnia, paresthesia, numbness of extremities, peripheral neuropathy, optic neuritis, polyneuritis, psychoses, mood changes, depression. In patients with epilepsy, seizures may become more frequent.

From the cardiovascular system: palpitations, angina pectoris, increased blood pressure.

From the digestive system: nausea, vomiting, epigastric pain, toxic hepatitis.

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

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

Rifampicin

From the digestive system: nausea, vomiting, diarrhea, decreased appetite, erosive gastritis, pseudomembranous colitis; increased activity of liver transaminases in blood serum, hyperbilirubinemia, hepatitis.

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

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

From the urinary system: nephron necrosis, interstitial nephritis.

Other: leukopenia, dysmenorrhea, induction of porphyria, myasthenia, hyperuricemia, exacerbation of gout.

With irregular intake or upon resumption of treatment after a break, flu-like syndrome (fever, chills, headache, dizziness, myalgia), skin reactions, hemolytic anemia, thrombocytopenic purpura, acute renal failure are possible.

Pyridoxine

Allergic reactions.

Contraindications

Hypersensitivity to the active substances; first trimester of pregnancy; lactation period; children under 1 year of age; acute liver diseases, jaundice; chronic renal failure.

With caution

Second and third trimesters of pregnancy, liver and kidney diseases, diabetes mellitus, elderly age, debilitated patients.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy and during lactation. With caution: second and third trimesters of pregnancy.

Use in Hepatic Impairment

Contraindicated: liver diseases. With caution liver diseases.

Use in Renal Impairment

Contraindicated: chronic renal failure. With caution kidney diseases.

Pediatric Use

Contraindication: children under 1 year of age.

Geriatric Use

With caution: elderly age.

Special Precautions

It is used as part of complex therapy, usually at the initial stage of the tuberculous process.

During treatment, monitoring of liver transaminase activity and plasma uric acid is necessary.

If signs of liver dysfunction appear, it is necessary to discontinue the drug.

After interrupting the course of treatment, resumption of the drug should be done with caution due to the risk of developing hepatotoxicity and nephrotoxicity.

When using this agent, staining of saliva, sputum, urine, and tear fluid in an orange-red color is possible.

During treatment, vitamin D should be additionally prescribed to prevent disorders of calcium and phosphorus metabolism.

Drug Interactions

Concomitant use of isoniazid and phenytoin leads to an increase in the concentration of the latter in the blood, which may require a reduction in the phenytoin dose.

With simultaneous use of isoniazid and cycloserine, a weakening of the pyridoxine effect may be observed.

Rifampicin is an inducer of microsomal oxidation; with simultaneous administration of glucocorticosteroids, hormonal contraceptives, dapsone, phenytoin, cardiac glycosides, and quinidine, an acceleration of the metabolism of these drugs may be observed, so their dose must be increased, and upon discontinuation of rifampicin, reduced.

Storage Conditions

Store at 2°C (36°F) to 15°C (59°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.