Loxidone - instructions for use, dose, side effects, contraindications

purified water - 14-15 mg, sodium lauryl sulfate - 0.24 mg, methyl parahydroxybenzoate - 0.8 mg, propyl parahydroxybenzoate 0.2 mg, floxin B 0.1537 mg, dye sunset yellow 0.4888 mg, titanium dioxide 1.1522 mg, gelatin 100 mg.

For a dosage of 250 mg:

Capsule body:

purified water - 14-15 mg, sodium lauryl sulfate - 0.24 mg, methyl parahydroxybenzoate - 0.8 mg, propyl parahydroxybenzoate 0.2 mg, titanium dioxide 2.05 mg, gelatin up to 100 mg;

capsule cap:

purified water - 14-15 mg, sodium lauryl sulfate - 0.24 mg, methyl parahydroxybenzoate - 0.8 mg, propyl parahydroxybenzoate 0.2 mg, titanium dioxide 1.1522 mg, brilliant blue dye 0.1500 mg, gelatin up to 100 mg.

For a dosage of 300 mg:

Capsule body:

purified water - 14-15 mg, sodium lauryl sulfate 0.24 mg, methyl parahydroxybenzoate 0.8 mg, propyl parahydroxybenzoate 0.2 mg, titanium dioxide 2.05 mg, gelatin up to 100 mg;

capsule cap:

purified water - 14-15 mg, sodium lauryl sulfate - 0.24 mg, methyl parahydroxybenzoate - 0.8 mg, propyl parahydroxybenzoate 0.2 mg, titanium dioxide 1.1627 mg; dye quinoline yellow - 0.1500 mg, gelatin - up to 100 mg.

Description:

For a dosage of 150 mg: hard gelatin capsules white body, orange cover No. 1.

For a dosage of 250 mg: hard gelatin capsules white body, blue cover No. "0",

For a dosage of 300 mg: hard gelatin capsules white body, yellow cover No. 00.

The contents of the capsules are white or white with a yellowish tinge powder.

Pharmacotherapeutic group:Other synthetic antibacterial agents

ATX: & nbsp

J.04.A.K Other antituberculous drugs

Pharmacodynamics:

Terizidone is a bacteriostatic broad-spectrum antibiotic, active against Mycobacterium tuberculosis, Mycobacterium bovis, Mycobacterium avium, and Staphylococcus aureus and Staphylococcus epidermidis.

Also sensitive: Enterococcus faecalis, Escherichia coli, Citrobacter spp., Enterobacter spp., Morganella morganii, Klebsiella pneumoniae and Pseudomonas aeruginosa.

Development of secondary resistance is rare. Cross-resistance with other anti-TB drugs is not observed.

Pharmacokinetics:

Absorption from the gastrointestinal tract - 70-90% (eating does not affect the rate of absorption). Time to reach the maximum concentration in the blood (TCam) - 2-3 hours. Effective minimum concentration: for Mycobacterium tuberculosis - 10-40 mg / l, for Staphylococcus spp. - 8-32 mg / l, for gram-negative bacteria (of clinical significance) - 20-250 mg / l.

It is well distributed in tissues and body fluids (lungs, bile, ascites fluid, pleural effusion, synovial fluid, lymph, sputum).It penetrates the hemato-encephalic barrier (the concentration in the cerebrospinal fluid reaches 80-100% of that in the blood serum). Higher concentrations in the cerebrospinal fluid are created by inflammatory changes in the meninges.

Metabolized slightly. The half-life period (T1 / 2) is 21 hours. It is excreted by the kidneys (in unchanged form - 60-70%), intestine (insignificant quantity in unaltered form and in the form of metabolites).

Indications:

Tuberculosis of various forms and localizations in the complex therapy of resistant forms of the disease.

Contraindications:

Hypersensitivity (including cycloserine), organic diseases of the central nervous system (including atherosclerosis of cerebral vessels), epilepsy, mental disorders, alcoholism, pregnancy, lactation, children (up to 14 years), lactase deficiency and glucose-galactose malabsorption syndrome.

Carefully:

Elderly age, chronic heart failure, chronic renal failure.

Pregnancy and lactation:

The drug is contraindicated for use in pregnancy and lactation.

Dosing and Administration:

Inside, regardless of the reception of the poor: adults and children over 14 years old and weighing less than 60 kg - 300 mg twice a day (600 mg / day); with a body weight of 60-80 kg - 300 mg three times a day (900 mg / day).

Adults with a body weight of more than 80 kg - 600 mg twice a day (1200 mg / day). Accept for 3-4 months.

If there is a violation of kidney function (creatinine clearance less than 30 ml / min), the dose of the drug and the frequency of intake are reduced.

Side effects:

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

From the digestive system: abdominal pain, flatulence, diarrhea.

Other: allergic reactions.

Overdose:

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

Treatment: symptomatic, reception of activated charcoal, anticonvulsant, sedatives. Hemodialysis is effective.

Interaction:

Ethanol increases the risk of seizures.

When used simultaneously with ethionamide, the risk of side effects from the central nervous system increases (especially seizures).Simultaneous use with isoniazid increases the incidence of dizziness, drowsiness.

Special instructions:

Terizidone can cause deficiency of cyanocobalamin and / or folic acid, it is necessary to conduct appropriate examination and treatment.

It should be monitored monthly blood and urine indicators, liver function (alanine aminotransferase, aspartate aminotransferase, bilirubin).

It is necessary to avoid the use of ethanol, t. simultaneous administration with terizidone increases the incidence of side effects (up to the development of seizures).

In connection with the possibility of developing adverse reactions from the nervous system (depression, behavior change), it is necessary to monitor the patient's mental status.

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.

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

During the treatment period, care must be taken when operating vehicles and mechanisms.

Form release / dosage:

Capsules of 150 mg, 250 mg and 300 mg.

Packaging:

Primary packaging of medicinal product. 10 capsules per contour cell packaging made of polyvinylchloride film and aluminum foil printed lacquered. For 30, 50 or 100 capsules in a can of polymer with a lid pulled with the control of the first opening. Free space is filled with cotton wool. On the banks are glued labels from paper label or writing or from polymeric materials, self-adhesive.

Secondary packaging of medicinal product.

By 1, 2, 3, 5, 6, 10 contour mesh packages together with the instruction for use are placed in a pack of cardboard for consumer containers.

On 1 bank together with the instruction on application place in a pack from a cardboard for consumer tare.

Storage conditions:

In the original packaging of the manufacturer at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002373

Date of registration:14.02.2014 / 24.03.2016

Expiration Date:14.02.2019

The owner of the registration certificate:FARMSINTEZ, PAO FARMSINTEZ, PAO Russia

Manufacturer: & nbsp

FARMASINTEZ, JSC (Irkutsk) Russia

Information update date: & nbsp03.04.2018

Illustrated instructions

Instructions

Loxidone (Loxidon)