Resonisate plus - instructions for use, doses, side effects, contraindications

Active substanceTerizidone + PyridoxineTerizidone + Pyridoxine

Similar drugsTo uncover

Loxidon plus

capsules inwards

FARMSINTEZ, PAO Russia

Resonisate® plus

capsules inwards

VALENTA PHARM, PAO Russia

Resonisate® plus

capsules inwards

VALENTA PHARM, PAO Russia

Terizidone plus

capsules inwards

ArSiAi Synthesis, ZAO

Terizidone + Pyridoxine

capsules inwards

SP.INKOMED, LLC Russia

Terizidone + Pyridoxine-Mack

capsules inwards

McLeodz Pharmaceuticals Co., Ltd. India

Terizidone + Pyridoxine-Mack

capsules inwards

McLeodz Pharmaceuticals Co., Ltd. India

Dosage form: & nbspcapsules

Composition:

One capsule contains:

active substances:

terizidone -0.250 g (250 mg);

Piridoxine hydrochloride - 0.010 g (10 mg);

Excipients: microcrystalline cellulose 0.133 g,

silicon dioxide colloidal - 0,003 g,

magnesium stearate 0.004 g;

hard gelatin capsules (body): titanium dioxide E 171 - 2%, gelatin - up to 100%;

hard gelatin capsules (lid): titanium dioxide E 171-1%, iron dye oxide yellow E 172 0.5%, gelatin - up to 100%.

Description:

gelatin capsules № 00, body white, lid yellow. The contents of the capsules are white to white powder with a yellowish hue of color.

Conglomerates are allowed, which when pressed easily turn into powder.

Pharmacotherapeutic group:anti-tuberculosis drug.

ATX: & nbsp

J.04.A.K.03 Terizidone

A.11.H.A.02 Pyridoxine (vitamin B6)

Pharmacodynamics:

Terizidone is a bacteriostatic broad-spectrum antibiotic, active against Mycobacterium tuberculosis, Mycobacterium bovis, Mycobacterium avium; and Staphylococcus aureus and Staphylococcus epidermidis. To terizidonu also sensitive: Enterococcus faecalis, Escherichia coli, Citrobacter spp., Enterobacter spp., Morganella morganii, Klebsiella pneumoniae and Pseudomonas aeruginosa. Cases of development of secondary resistance are rare. Cross-resistance with other anti-tuberculosis drugs is not observed.

Pyridoxine hydrochloride (vitamin B6) is involved in the metabolism; is necessary for the normal functioning of the central and peripheral nervous system. In organism pyridoxine phosphorylated and converted to pyridoxal-5-phosphate, which is part of the enzymes that carry out decarboxylation, transamination and deamination of amino acids. Participates in lipid metabolism, in the exchange of tryptophan, methionine, cysteine, glutamic and other amino acids, histamine. Reduces the neurotoxic effect of anti-tuberculosis drugs.

Pharmacokinetics:

After oral administration, the drug is almost completely absorbed from the gastrointestinal tract (70-90%). The maximum concentration in plasma is achieved in 2-3 hours. Food intake does not affect the rate of absorption.The level of the minimum effective concentration for mycobacteria tuberculosis is 10-40 mg / l, for staphylococci 8-32 mg / l, for gram-negative bacteria having a clinical value of 20-250 mg / l. It is well distributed in tissues and body fluids (lungs, bile, ascites fluid, pleural effusion, synovial fluid, lymph, sputum). Penetrates into the cerebrospinal fluid - 80-100% of the concentration, in the serum, a higher concentration is created by inflammatory changes in the meninges. In organism terizidone, is metabolized insignificantly. The half-life (T1 / 2) is 21 hours. 60 to 70 % the drug is excreted by the kidneys in the unchanged; a small amount is excreted through the intestine, in unchanged form and in the form of metabolites. �?

Pyridoxine is metabolized in the liver; with the formation of pharmacologically active metabolites (pyridoxal phosphate and pyridoxamino phosphate). Pyridoxal phosphate with plasma proteins binds to 90%. It penetrates well into all tissues; accumulates mainly in the liver, less - in the muscles and central nervous system. Penetrates through the placenta, is secreted; with breast milk.The half-life of T1 / 2 is 15-20 days. It is excreted by the kidneys, as well as during hemodialysis.

Indications:

Tuberculosis (various forms and localizations) in the complex treatment of drug-resistant forms of tuberculosis.

Contraindications:

- hypersensitivity (including cycloserine);

- organic diseases of the central nervous system (including cerebrosclerosis);

- epilepsy;.

- mental disorders;

- alcoholism;

- pregnancy;

- lactation period;

- children's age till 14 years.

Carefully:

- elderly age;

- chronic heart failure;

- chronic renal failure.

Pregnancy and lactation:

Contraindicated in pregnancy.

Penetrates into breast milk, if necessary, use the drug at the time of treatment should stop breastfeeding.

Dosing and Administration:

Inside, regardless of food intake.

The daily dose for adults and adolescents over 14 years is 750-1000 mg (250 mg 3-4 times a day, every 6-8 hours or as directed by a doctor). The highest single dose of terizidone is 250 mg; the maximum daily dose is 1000 mg. Patients weighing up to 50 kg are recommended to use 1 capsule (250 mg) 3 times a day, patients with weight body over 50 kg - 1 capsule (250 mg) 4 times a day.The duration of the course of treatment is 3-4 months or as prescribed by a doctor.

Side effects:

From the central and peripheral nervous system: headache, dizziness, increased excitability, tremor, insomnia, a feeling of intoxication; in isolated cases - epileptiform convulsions, depression, psychosis.

From the side of the digestive system, rarely - abdominal pain, flatulence, diarrhea. Other: very rarely - allergic reactions and exanthema. -

Due to the presence of pyridoxine (optional): hypersecretion of hydrochloric acid, numbness and the appearance of a feeling of compression in the extremities (a symptom of "stocking" and "gloves"), a decrease in lactation.

If any of the side effects listed in the manual are aggravated or any other side effects not indicated in the instructions are noted, the doctor should be informed immediately.

Overdose:

Symptoms: increased neurotoxicity (including epileptiform seizures), a violation of the function of the gastrointestinal tract.

Treatment: symptomatic, Activated carbon, antiepileptic medicines. For the prevention of neurotoxic effects, anticonvulsant and sedative drugs are administered. Hemodialysis is effective.

Interaction:

Ethanol increases the risk of epileptic seizures.

Ethionamide increases the risk of side effects from the central nervous system, especially convulsive syndrome. Isoniazid increases the incidence of dizziness, drowsiness, and negative effects from the nervous system.

Pyridoxine: enhances the action of diuretics; weaken the pharmacological effects of levodopa. Isoniazid, penicillamine, cycloserine and estrogen-containing oral contraceptives weaken the effect of pyridoxine.

Special instructions:

Terizidone can cause a deficiency of cyanocobalamin and / or folic acid. In these cases it is necessary to conduct an appropriate examination and treatment of the patient.

It is necessary to monitor monthly the analysis of blood, urine, indicators of liver function: concentration of alanine aminotransferase, aspartate aminotransferase, bilirubin. The use of the drug against the background of alcohol intake is associated with an increased incidence of side effects, up to the development of seizures, so during the treatment the patient should avoid drinking alcohol.

During the treatment period, it is necessary to monitor the patient's mental status.Medical staff in the hospital, as well as family members of patients receiving Resonisate plus ambulatory, should be informed of the possibility of developing side effects from the central nervous system and are instructed to immediately inform the attending physician if symptoms of depression or changes in the behavior of the patient appear.

With severe liver damage pyridoxine in large doses can cause a deterioration in its function.

When determining urobilinogen using Ehrlich's reagent pyridoxine can distort results.

Effect on the ability to drive transp. cf. and fur:

During the period of treatment, it is necessary to refrain from driving vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Capsules 250 mg + 10 mg.

Packaging:

For 10 capsules in a contour mesh package made of PVC or PVC / PVDC film and aluminum foil printed lacquer.

10 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-000459

Date of registration:01.03.2011 / 15.06.2016

Expiration Date:Unlimited

The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Manufacturer: & nbsp

VALENTA PHARMACEUTICS, JSC Russia

Representation: & nbspVALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Information update date: & nbsp23.09.2015

Illustrated instructions

Instructions

Resonisate® plus (Rezonisate plus)