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

Excipients - lactose monohydrate 100.00 mg, copovidone 5.00 mg, talc 37.50 mg, magnesium stearate 7.50 mg, shell capsules: gelatin 81.33 mg, titanium dioxide E-171 2.29 mg, indigocarmine E-132 (indigotine) 0.03 mg, iron (III) oxide E-172 0.14 mg, purified water 14.21 mg.

Description:

Solid opaque gelatin capsules of light green color, size 0, with contents in powder form from white to slightly yellowish color.

Pharmacotherapeutic group:Anti-tuberculosis drug.

ATX: & nbsp

J.04.A.K Other antituberculous drugs

Pharmacodynamics:

Terizidone is a chemotherapeutic agent for oral administration, which has a bacteriostatic effect and a wide spectrum of action.

Terizidone is effective against Mycobacterium tuberculosis, Mycobacterium bovis, Mycobacterium avium, and Staphylococcus aureus and Staphylococcus epidermis. To this preparation are also sensitive Enterococcus faecalis, Escherichia coli, Citrobacter, Enterobacter, Morganella morganii, Klebsiella pneumonia and Pseudomonas aeruginosa.

The level of the minimal effect of the initial concentration for mycobacteria is 10-40 mg / l, for staphylococci 8 - 32 mg / l, and for gramogens bacteria of clinical significance 50 - 250 mg / l.

The sensitivity of mycobacteria exceeds 90 %. The sensitivity of other bacteria in some cases varies considerably and is established only for staphylococci (more than 90%) and Streptococcus faecalis (81 %),

The development of secondary resistance is rare. Between trisidone and other anti-tuberculosis drugs there is no cross-resistance.

Pharmacokinetics:

After oral administration, the drug is almost completely absorbed from the gastrointestinal tract. The maximum concentration in plasma is achieved in 2-3 hours. Food intake does not affect the rate of absorption. The half-life period (T1 / 2) is 21 hours.

In organism terizidone Metabol is slightly reduced, mainly, excreted by the kidneys. by glomerular filtration and only in small amounts with feces.

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

Contraindications:

- hypersensitivity to terizidone or cycloserine;

- hypersensitivity,

- organic diseases of the central nervous system, - epilepsy, epileptic seizures (including in the anamnesis),

- chronic heart failure,

- chronic renal failure (creatinine clearance less than 50 ml / min); |

- severe cerebral sclerosis;

- alcoholism;

- children under 14 years old

Carefully:

- pregnancy;

- lactation period.

Pregnancy and lactation:

Use during pregnancy is possible if the expected benefit for the mother exceeds the potential risk to the fetus.

Terizidone is excreted in breast milk, during breastfeeding it is necessary to stop breastfeeding.

Dosing and Administration:

Inside.

The recommended daily intake for adults and adolescents over 14 years is 750-1000 mg (patients with a body weight of up to 60 kg are recommended to use 250 mg (1 capsule)

3 times a day, patients with a body weight of more than 60 kg - but 250 mg (1 capsule) 4 times a day).

Capsules are best swallowed whole during meals, washed down with a small amount of liquid, at regular intervals during the day (one capsule every 6-8 hours). Intolerance to the drug can be prevented by gradually increasing the dose to the optimum value.

Side effects:

From the central nervous system (CNS): headache, dizziness, increased excitability, tremor, insomnia and a sense of intoxication. In isolated cases - epileptiform cramps, depression, psychosis.

From the gastrointestinal tract: pain in the abdomen, flatulence and diarrhea - are rarely seen or in isolated cases. Most often they are weakly expressed and usually quickly pass after discontinuation of therapy.

Very rarely: allergic reactions and exanthema.

Overdose:

Data on the overdose was not published.

In case of an overdose, stop taking the drug. Treatment: symptomatic, Activated carbon. For the prevention of neurotoxic effects, pyridoxip is administered, in the event of seizures - proprioepilspitschskis preparations, Terizidone can be eliminated by hemodialysis.

Interaction:

It should avoid the appointment of fluoroquinolones and other drugs that have an adverse effect on the central nervous system.

In the case of concomitant administration with isoniazid, the tendency to develop seizures is likely to increase.

No use together with cycloserine, as the risk of side effects increases.

Special instructions:

During the treatment period, do not drink alcohol.

Effect on the ability to drive transp. cf. and fur:Patients taking the drug should refrain from potentially dangerous activities associated with the need for concentration and increased speed of psychomotor reactions.

Form release / dosage:

Capsules 250 mg.

Packaging:

10 capsules in a blister of white PVC and aluminum foil, shiny or matte. For 50 blisters with instructions for use in a pack of cardboard (for inpatient), a label is attached to the pack.

For 50 capsules in a white container made of polypropylene, with a white lid of low density polyethylene with a ring of the first opening, the empty space is filled with foam rubber sealant, a label is attached to the container. A container of 50 capsules together with the instruction for use will be placed in a cardboard box.

When the drug is packaged in JSC AKRIKHIN.

For 5 blisters together with the instruction for use are put in a pack of cardboard for consumer packaging subgroups chrome or chrome-ersatz according to GOST 7933-89, a stick on the packet label. Group packing and shipping containers in accordance with GOST.

Storage conditions:

Store at a temperature of no higher than 25 ° C in a dry and dark place. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-009584/09

Date of registration:25.11.2009

The owner of the registration certificate:Rimzer Artsynaimitel, AGRimzer Artsynaimitel, AG Germany

Manufacturer: & nbsp

RIMZER ARTSNAYMMITEL, AG Germany

Representation: & nbspRimzer Artsynaimitel AGRimzer Artsynaimitel AG

Information update date: & nbsp23.09.2015

Illustrated instructions

Instructions

Terizidone (Terizidon)