Pro-tube-2

General characteristics. Structure:

Active ingredients: 100,0 mg of an isoniazid, 150,0 mg of rifampicin, 10,0 mg of a pyridoxine of a hydrochloride; 100,0 mg of an isoniazid, 150,0 mg of rifampicin, 20,0 mg of a pyridoxine of a hydrochloride; 300,0 mg of an isoniazid, 450,0 mg of rifampicin, 20,0 mg of a pyridoxine of a hydrochloride.

The combined antituberculous remedy.

Pharmacological properties:

Pharmacodynamics. The combined drug. The isoniazid – an antituberculous remedy, has specific activity concerning Micobacterium tuberculosis, including strains, resistant to other antitubercular antibiotics. Rifampicin - an antibiotic of a broad spectrum of activity; suppresses a DNA-dependent polymerase. Has high activity concerning mycobacteria, including Micobacterium tuberculosis, and some gram-positive activators; activity concerning gram-negative organisms is lower. Has no cross resistance with other antibiotics. The pyridoxine plays an important role in a metabolism, is necessary for normal functioning of a nervous system. In a fosforilirovanny form the pyridoxine is coenzyme of a large number of the enzymes operating on not oxidizing exchange of amino acids. Participates in exchange of tryptophane, methionine, cysteine, glutaminic, etc. Amino acids. Plays an important role in exchange of a histamine. Contributes to normalization of lipidic exchange.

Pharmacokinetics. The isoniazid is well soaked up in a GIT. Meal slows down absorption and reduces bioavailability. Cmax in 1-2 hours after reception, semi-removal time – of 30 minutes till 5 o'clock, depending on the acetylation speed (specific features of an organism). Well gets into various fabrics and liquids of an organism. It is metabolized in a liver. At the same time the active metabolite (pirazinoyevy acid) is formed. It is removed by kidneys generally in the form of inactive metabolites. Rifampicin is soaked up well and quickly. Meal reduces drug absorption. Cmax in 2-2.5 hours. It is quickly distributed on bodies and fabrics, gets into a bone tissue. Gets through a placenta and it is allocated with breast milk. It is metabolized in a liver. T1/2 depends on the accepted dose and makes 2.5-5 h. It is removed with bile and kidneys. At patients with abnormal liver functions increase in concentration of rifampicin in plasma and lengthening of T1/2 is noted. The pyridoxine is soaked up quickly throughout a small intestine. It is metabolized in a liver with formation pharmacological of active metabolites. Well gets into all fabrics; collects preferential in a liver, it is less - in muscles and TsNS. Gets through a placenta, cosecretes with breast milk. T1/2 - 15-20 days. It is removed by kidneys (at in introduction - with bile of 2%), and also during a hemodialysis.

Indications to use:

Pulmonary tuberculosis and other bodies. As a part of a combination therapy in an intensive phase and/or in a phase of continuation of treatment at an out-patient stage.

Route of administration and doses:

The dose is established individually, depending on character and a form of a disease. A way of introduction — inside. It is recommended to appoint drug in 30 minutes prior to food of 1 times in days. To wash down with water (from 0.5 to 1 glasses). No more than 0.6 g in days are dosed on rifampicin of 10-20 mg/kg of body weight, but. It is recommended to accept all daily dose in 1 reception on an empty stomach.

Features of use:

Appoint as a part of complex therapy, as a rule, at an initial stage of tubercular process. In the course of treatment control of activity of "hepatic" transaminases, uric acid in plasma is necessary.

At emergence of signs of an abnormal liver function it is necessary to stop administration of drug. After interruption of a course of treatment it is necessary to resume administration of drug with care, because of risk of development gepato-and nephrotoxicity.

At use of drug coloring of saliva, a phlegm, urine and the lacrimal liquid in orange-red color is possible. During treatment it is necessary to appoint in addition vitamin D for prevention of disturbances of exchange of Ca2 + and phosphorus.

With care. Pregnancy (the II-III trimesters), diseases of a liver and kidneys, a diabetes mellitus, advanced age, the exhausted patients.

Side effects:

Isoniazid. From a nervous system: a headache, dizziness, it is rare - excessive fatigue or weakness, irritability, euphoria, sleeplessness, paresthesias, numbness of extremities, a peripheral neuropathy, an optic neuritis, a polyneuritis, psychoses, change of mood, a depression. At patients with epilepsy attacks can become frequent.

From CCC: heartbeat, stenocardia, increase in the ABP.

From the alimentary system: nausea, vomiting, gastralgia, toxic hepatitis.

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

Others: very seldom – a gynecomastia, a menorrhagia, tendency to bleedings and hemorrhages.

 

Rifampicin. From the alimentary system: nausea, vomiting, diarrhea, loss of appetite, erosive gastritis, pseudomembranous coloenteritis; increase in activity of "hepatic" transaminases in blood serum, a hyperbilirubinemia, hepatitis.

Allergic reactions: urticaria, eosinophilia, Quincke's disease, bronchospasm, arthralgia, fever.

From a nervous system: headache, decrease in visual acuity, ataxy, disorientation.

From an urinary system: нефронекроз, intersticial nephrite.

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

At irregular reception or when resuming treatment after a break the grippopodobny syndrome (fever, a fever, a headache, dizziness, a mialgiya), skin reactions, hemolitic anemia, a Werlhof's disease, an acute renal failure are possible.

Pyridoxine. Allergic reactions.

Interaction with other medicines:

Simultaneous use of an isoniazid and Phenytoinum leads to increase in concentration of the last in blood in this connection Phenytoinum dose decline can be required. At simultaneous use of an isoniazid and Cycloserinum easing of effect of a pyridoxine can be observed. Rifampicin - the inductor of a microsomal oxidation; at a concomitant use of GKS, hormonal contraceptives, dapsone, Phenytoinum, cardiac glycosides and quinidine acceleration of metabolism of these HP therefore the dose them needs to be increased can be observed, and at cancellation of rifampicin to reduce.

Contraindications:

Hypersensitivity, pregnancy (the I trimester), the lactation period, children's age (till 1 year), acute diseases of a liver, jaundice, HPN.

Overdose:

Isoniazid. Symptoms: dizziness, a dysarthtia, slackness, a disorientation, a hyperreflexia, a peripheral polyneuropathy, an abnormal liver function, a metabolic acidosis, a hyperglycemia, a glucosuria, a ketonuria, spasms (in 1-3 h after drug use), a coma. Treatment: see the Isoniazid.
Rifampicin. Symptoms: fluid lungs, lethargy, confusion of consciousness, spasm. Treatment: see rifampicin.

Storage conditions:

List B. In the dry, protected from light place at a temperature not over 25 ºС.

Issue conditions:

According to the recipe

Packaging:

Tablets, coated, on 100 or 500 tablets in bank of polymeric.