Prothionamide-Acry® (Protionamid-Akri®)

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Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspcoated tablets
Composition:

1 tablet contains:

active substance: protionamide 250 mg;

Excipients: cellulose microcrystalline, potato starch, povidone, hypromellose, silicon dioxide colloid, magnesium stearate, sodium carboxymethyl starch, talc, macrogol, hydroxypropylcellulose, titanium dioxide, dye yellow orange (orange S).

Description:

The tablets covered with a film cover, round, biconcave, from light orange to dark orange color. Roughness is allowed.

Pharmacotherapeutic group:anti-tuberculosis drug
Pharmacodynamics:

Second-line anti-tuberculosis drug. It acts bacteriostatically, blocks the synthesis of mycolic acids, which are the most important structural component of the cell wall of mycobacterium tuberculosis. Has the properties of a nicotinic acid antagonist. In high concentrations, it breaks the synthesis of the protein of the microbial cell and acts bactericidal.

Effective against mycobacteria tuberculosis, resistant to drugs of the I series.

The use in combination with other anti-tuberculosis drugs reduces the likelihood of resistance of the causative agent of tuberculosis.

Pharmacokinetics:

Prothionamide is rapidly absorbed in the gastrointestinal tract, creating a maximum concentration of the drug in the blood plasma 2-4 hours after ingestion, penetrates into healthy and pathologically altered tissue types (tuberculous foci and caverns in the lungs, serous and purulent pleural effusion, cerebrospinal fluid at meningitis). In the body it is partially converted into sulfoxide, which has tuberculostatic activity. Partially excreted unchanged (up to 15-20% of the dose) with urine and feces.

Indications:

Prothionamide is used to treat all forms of tuberculosis, including with resistance of the pathogen to other anti-tuberculosis drugs (I series) or their intolerance.

Contraindications:

Prothionamide should not be used with individual hypersensitivity to the components of the drug, during pregnancy and lactation, acute gastritis, peptic ulcer and duodenal ulcer, erosive ulcerative colitis, acute hepatitis, cirrhosis, chronic alcoholism.

Children under 3 years (for this dosage form).

Carefully:

Diabetes mellitus, severe hepatic insufficiency.

Dosing and Administration:

Take the drug inside after eating.

Adults appoint 0.25 g 3 times a day, with good tolerance - 0.5 g 2 times a day.

In patients older than 60 years and with a body weight of less than 50 kg the daily dose should not exceed 0.75 g (more often prescribed 0.25 g 2 times a day).

Children designate at the rate of 10-20 mg / kg of body weight per day.

Side effects:

From the side of the cardiovascular system: tachycardia, weakness, orthostatic hypotension.

From the gastrointestinal tract: loss of appetite, nausea, vomiting, dry mouth or hypersalivation, a "metallic" taste. After the withdrawal of the drug, these phenomena tend to quickly pass.

Often during the treatment there is a rise in the blood level of transaminases. Rare violations of liver function with signs of hepatitis and jaundice are rare. Hepatotoxicity of the drug depends on the existing violations of liver function, such as liver damage due to alcoholism or after surgery. These side effects are noted especially in combination therapy with isoniazid, rifampicin and pyrazinamide.

Skin Reactions are rare, in some cases described pellagrope-like reactions, respectively, with a combination of skin manifestations and disorders from the central nervous system.

Sometimes violations are noted from the endocrine system. Along with the development of hypoglycemia (a decrease in blood sugar of less than 50 mg /%) in patients with diabetes, described the development of gynecomastia (an increase in mammary glands in men). Rarely there is a violation of the menstrual cycle and impotence, as well as hypothyroidism (a decrease in thyroid function).

In rare cases, protionamide disorders of the peripheral and central nervous system: insomnia, agitation, depression, anxiety, rarely - dizziness, drowsiness.

In a combination with isoniazid cases of polyneuropathy are described. Taking protionamide can cause dizziness, headaches, weakness, impaired concentration, mental disorders. Rarely, optic neuritis, tachycardia. Simultaneous reception of other antituberculosis drugs acting on the central nervous system, such as isoniazid and cycloserine, can lead to an increase in side effects from the central nervous system. The same effect can have a simultaneous reception of alcohol. In some cases, allergic reactions and disorders of the bone marrow are described.

Interaction:

With combined therapy of tuberculosis, the additive hepatotoxic effect of individual drugs should be taken into account. This is especially true for the combination of a protionamide with isoniazid, rifampicin and pyrazinamide. The active effect on the central nervous system is noted when isoniazid and cycloserine are combined.

Simultaneous reception of alcohol leads to depression of the central nervous system. In certain cases, when taking protionamide, it is necessary to reduce the dose of insulin or oral antidiabetic drugs.

Special instructions:

It is necessary to avoid the joint use of protionamide and alcohol because of the danger of CNS depression (associated with increased toxic effect of alcohol).

In the combined use of protionamide with isoniazid and cycloserine, special attention should be paid to the possibility of mental disturbance.

Since the drug is constantly used in combination with other antituberculous drugs, regular monitoring of serum transaminases, gamma-glutamate transferase and alkaline phosphatase is necessary.

In patients with diabetes, blood glucose levels need to be monitored at least once a month.

Skin reactions may be the first signs of pellagruide-like side effects. This should be regarded as the reason for the necessary withdrawal of the drug.

Form release / dosage:

The tablets covered with a cover, 250 mg.

Packaging:

10 tablets per contour cell pack.

For 50 or 100 tablets in a jar of orange glass or a can of polypropylene (polyethylene).

Each jar or 5 or 10 contour squares, together with the instruction for use, is placed in a pack of cardboard.

Storage conditions:

In a dry, 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.

Terms of leave from pharmacies:On prescription
Registration number:P N000104 / 01
Date of registration:10.05.2007
Date of cancellation:2018-02-06
The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia
Manufacturer: & nbsp
Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
Information update date: & nbsp06.02.2018
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