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Characteristics of the substance Trecator-SC

Ethionamide, a derivative of isonicotinic acid. Series II antituberculosis drug. A yellow crystalline powder with a mild to moderate sulphur odour. Non-hygroscopic. Practically insoluble in water and ether; difficult to dissolve in ethyl and methyl alcohol, propylene glycol; soluble in acetone, dichloroethane; freely soluble in pyridine. Molecular weight 166.25.

Pharmacology

Pharmacological effect

Nicotinic acid antagonist. Suppresses peptide and mycolic acid synthesis in mycobacteria. Has a bacteriostatic effect. More active in an acidic environment. Acts on Mycobacterium tuberculosis outside and inside cells (including isoniazid and streptomycin resistant strains). In high concentrations, acts on Mycobacterium leprae and some atypical avium-like mycobacteria. It increases phagocytosis at the site of TB inflammation, which promotes its resorption. It inhibits the development of resistance to other anti-TB agents. During treatment, resistance of microorganisms appears rapidly, bacteriostatic activity is reduced. There is complete cross-resistance to prothionamide, partial resistance to thioacetasone. It is rapidly and completely absorbed from the gastrointestinal tract.

Bioavailability is approximately 100%. The Cmax after a single dose of 500 mg is 2.2 µg/ml and is reached after 1.8 hours. Plasma protein binding is low (10%). Widely distributed to most tissues and body fluids, including liver, kidney, spleen and cerebrospinal fluid. Volume of distribution is 2.8 l/kg. Concentrations in organs and cerebrospinal fluid are almost equal to those in plasma. It is metabolized in the liver to pharmacologically active sulfoxide and inactive metabolites. T1/2 is 2-3 hours. 1% of unchanged etionamide is excreted in the urine, up to 5% in active form and the remainder as inactive metabolites.

Use of the substance Trecator-SC

Tuberculosis (pulmonary and extrapulmonary, in cases of intolerance or ineffectiveness of first-line anti-tuberculosis drugs, including complex static tuberculosis therapy).

Contraindications

Hypersensitivity, including isoniazid, pyrazinamide, nicotinic acid and other chemical-type drugs, acute gastritis, gastric and duodenal ulcers, ulcerative colitis, cirrhosis of the liver and other acute liver diseases, chronic alcoholism, renal failure, age under 14 years.

Restrictions on use

Diabetes mellitus, epilepsy, liver disease by exacerbation (increased risk of hepatotoxicity).

Application during pregnancy and lactation

It is contraindicated for pregnancy. Ethionamide passes through the placenta. Experimental studies on animals (rabbits, rats) have shown teratogenic effects at doses higher than those recommended for humans. It is recommended not to breast-feed during treatment (it is not known whether etionamide passes into breast milk).

Side effects of etionamide

Nervous system and sensory organs: neurological and mental disorders - headaches, paresthesia, convulsions, decreased concentration, confusion, drowsiness or insomnia, weakness, depression, hallucinations, agitation, psychosis, peripheral neuritis, optic neuritis.

Gastrointestinal organs: anorexia, metallic taste in the mouth, stomatitis, hypersalivation, burping with rotten odor, nausea, vomiting, epigastrium pain, diarrhea, flatulence, liver dysfunction (hepatotoxicity to hepatitis). Of the cardiovascular system and blood (hematopoiesis, hemostasis): tachycardia, orthostatic hypotension, hematopoiesis disorder (thrombocytopenia).

Allergic reactions: rash, urticaria, exfoliative dermatitis. Other: gynecomastia, dysmenorrhea, impotence, hypothyroidism, hypoglycemic episodes in diabetic patients, hypovitaminosis B6, weight loss, arthralgia, photosensitization.

Interaction

When used concomitantly with other tuberculosis drugs, there is synergy with the main action. Simultaneous use with cycloserine increases the risk of neurotoxic effects, especially seizures (especially in patients with a history of neurological disease), isoniazid, rifampicin and pyrazinamide - risk of hepatotoxicity. It reinforces the toxic effect of alcohol.

Methods of administration

Inside.

Precautions regarding the substance Trecator-SC

Prior to treatment, it is necessary to examine the gastrointestinal tract and liver function and to determine the susceptibility of the isolated strain of mycobacteria. During treatment, liver transaminase activity levels should be monitored every 2 to 4 weeks, ophthalmologic examination should be performed and blood glucose levels should be determined regularly in diabetic patients.

When used with pyrazinamide, more frequent monitoring of liver function is required. Concomitant use with protionamide is not recommended due to cross-resistance of tuberculosis mycobacteria to these drugs. Concomitant use with drugs having a hepatotoxic effect should be avoided.

To prevent side effects, etionamides should be combined with nicotinamide (0.1 g 2-3 times daily) and vitamin B6 (1-2 ml of 5% w/w solution). During the treatment, you must abstain from alcohol. Use with caution for drivers of vehicles and people whose activities require increased concentration.

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