REZONIZAT PLUS

Active material: Pyridoxine, Terizidon
When ATH: J04AK03
CCF: TB drugs
When CSF: 06.22.04
Manufacturer: OAO Valenta PHARMACEUTICS {Russia}

Pharmaceutical form, composition and packaging

Capsules hard gelatin, size №00, and the housing lid yellow; contents of capsules – white or white with a yellowish tinge powder.

Excipients: ludipress LTSE (lactose monohydrate, povidone (Kollidon 30)), talc, magnesium stearate.

The composition of hard gelatin capsules: Titanium dioxide (E171), dye iron oxide yellow (E172), gelatin.

10 PC. – packings Valium planimetric (10) – packs cardboard.

Pharmacological action

Pharmacological action – TB.

Pharmacokinetics

Terizidon. After oral administration almost completely absorbed from the gastrointestinal tract (70–90%). Cmax in plasma achieved in 2-3 hours. Eating does not affect the rate of absorption. The level of effective Cmin for Mycobacterium tuberculosis is 10-40 mg / l, for staphylococci - 8-32 mg / l, for Gram-negative bacteria, have clinical significance - 20-250 mg / l. T1/2 — 21 no. Distributed in the tissues and body fluids, light, bile, ascites, pleural fluid and synovial fluid, lymph and sputum. It penetrates into the cerebrospinal fluid (80-100% Of the concentration in serum), a higher concentration in the cerebrospinal fluid is created in the inflammatory changes of the meninges. In the body it is metabolized slightly terizidone. From 60 to 70% the drug is excreted by the kidneys unchanged; a small amount of output through the intestine and a small part - in the form of metabolites. Pyridoxine hydrochloride. Upon receiving rapidly absorbed throughout the small intestine, greater amount absorbed in the jejunum. It is metabolized in the liver with the formation of the pharmacologically active metabolite (pyridoxal phosphate and piridoksaminofosfat). Pyridoxal plasma protein binds to 90%. It penetrates into all tissues; accumulates predominantly in the liver, less - in muscles and CNS. It penetrates through the placenta, excreted in breast milk. T1 / 2 - 5-20 days. Report the news (with a / in the introduction - the bile 2%), as well as during hemodialysis.

Farmakodinamika

Terizidon. It is a bacteriostatic antibacterial agent with a broad spectrum of activity. It is active against tuberculosis Musobacterium, Мусоbacterium bovis, Мусоbacterium avium, а также Staphylococcus aureus и Staphylococcus epidermidis. This drug is also sensitive Enterococcus faecalis, Escherichia coli, Citrobacter, Enterobacter, Morganella morganii, Klebsiella pneumoniae и Pseudomonas aeruginosa. The cases of secondary resistance are rare. Between terizidone and other anti-TB drugs is not observed cross-resistance. Pyridoxine hydrochloride - Vitamins. Participates in metabolism. It is necessary for normal functioning of the central and peripheral nervous system. It provides neuroprotection.

Testimony

Tuberculosis (Various shapes and localization) in the treatment of drug-resistant tuberculosis.

Contraindications

Hypersensitivity, incl. to cycloserine; organic diseases of the central nervous system, incl. I degree; epilepsy; mental disorders; alcoholism; pregnancy; lactation; Children up to age 14 years. Carefully: advanced age; congestive heart failure; chronic renal failure.

Side effects

CNS: headache, dizziness, hypererethism, tremor, insomnia and feeling of intoxication. In rare cases - epileptiform convulsions, depression, psychosis. From the digestive system: rare - abdominal pain, flatulence, diarrhea. Other: rarely - allergic reactions.

Cooperation

Ethanol increases the risk of seizures. Ethionamide increases the risk of side effects from the CNS, especially seizures. Isoniazid increases the incidence of dizziness, drowsiness.

Overdose

Symptoms: increased neurotoxicity, incl. epileptimorfnye seizures, dysfunction of the gastrointestinal tract. Treatment: symptomatic, appointment of activated carbon, anticonvulsant drugs. To prevent neurotoxic effects - the appointment of anticonvulsants and sedative drugs. Hemodialysis is effective.

Dosing and Administration

Inside, daily, regardless of the meal. Adults and children (senior 14 years): weighing up 60 kg - daily dose 620 mg (by 1 caps. 2 once a day); weighing 60-80 kg - 930 mg (by 1 caps. W times a day); adults weighing more 80 kg - 1240 mg (by 2 caps. 2 once a day). The duration of treatment ranged from Z to 4 Months. When Cl creatinine below 30 ml / min, the dose and frequency of dosing is recommended to reduce.

Cautions

Terizidone can cause the development of vitamin B12 and / or folic acid. In these cases it is necessary to conduct an appropriate examination and treatment of the patient. Monthly control of blood and urine tests, liver function tests (GOLD, IS, bilirubin). Use of the drug on a background of alcohol intake is associated with an increased rate of side effects, until the development of seizures, so while taking the drug should avoid alcohol. It is necessary to monitor the condition of the patient: health care workers, watching the sick in hospital, same, as well as family members of outpatients, taking terizidone, They should be informed of the possibility of adverse reactions from the central nervous system and instructed to immediately inform the treating physician with the appearance of depression or changes in the behavior of the patient. Effect on ability to drive or operate machinery. During the period of treatment should refrain from driving vehicles and Occupation potentially hazardous activities, require high concentration and speed of psychomotor reactions.

Storage conditions

Dry, protected from light, at a temperature not higher 25 °C.