Sinarta

General characteristics. Structure:

Ampoule And

active ingredient: sulfate glycosamine sodium salt;

1 ml of solution contains a glycosamine of sulfate of sodium salt in terms of 100% substance –

251,25 mg, in terms of a glycosamine sulfate – 200 mg, in terms of sodium chloride –   51,25 mg;

excipients: lidocaine a hydrochloride, water for injections;

ampoule In (solvent)

diethanol amide, water for injections.

Pharmacological properties:

Pharmacodynamics. A glycosamine sulfate stimulates synthesis of glikozaminoglikan and, respectively, joint proteoglycans. Besides, the glycosamine shows antiinflammatory properties, slows down processes of degradation of a joint cartilage mainly due to its metabolic activities, ability to oppress activity interleykina-1 (IL-1), lizosomalny enzymes, a collagenase and a phospholipase of A2.

The effect of treatment of a glycosamine is shown by sulfate in 2-3 weeks from an initiation of treatment.

Pharmacokinetics. After intramuscular introduction of a glycosamine sulfate quickly passes through biological barriers and gets into fabrics, preferential joint cartilage. The elimination half-life − about 60 hours, is removed generally by kidneys.

Pharmaceutical characteristics.

Main physical and chemical properties: ampoule And: transparent colourless or light yellow color liquid; an ampoule In: transparent colourless liquid; A+B ampoule: transparent colourless or light yellow color liquid.

Incompatibility.

Not to mix in one syringe with other drugs. Not to use other solvents besides which is applied.

Indications to use:

Treatment of symptoms of an osteoarthritis: pain and functional restriction.

Route of administration and doses:

Drug is used only intramusculary.

Adult patients and patients of advanced age.

Before use to mix solution In (solvent) with solution A (drug solution) in one syringe. The prepared solution of drug is entered intramusculary on 3 ml (A+B solution) by 3 times a week in 1 day within 4-6 weeks.

Features of use:

Before use it is necessary to carry out skin test on individual sensitivity because of contents as a part of lidocaine drug. It is necessary to appoint carefully drug sick, inclined to a malignant hyperthermia.

Before use of lidocaine at heart diseases it is necessary to normalize potassium level in blood (the hypopotassemia reduces efficiency of lidocaine).

It is necessary to observe extra care at drug use to patients with a circulatory unefficiency, arterial hypotension, abnormal liver functions and/or kidneys. It is also necessary to be careful at Sinarta's appointment to patients of advanced age, patients with epilepsy, at disturbance of conductivity of heart, at respiratory insufficiency.

It is necessary to apply about care to patients with intolerance of glucose. During an initial stage of therapy regular control of level of sugar in blood is necessary for patients with a diabetes mellitus.

With care to use drug at treatment of patients with bronchial asthma.

One dose of medicine contains 40,3 mg of sodium. It should be considered at appointment to patients to whom the rigid electrolyte-deficient diet is shown.

Ability to influence speed of response at control of motor transport or work with other mechanisms.

Researches concerning impact of drug on ability to drive the car and other mechanisms were not conducted.

It is necessary to be careful at control of vehicles and performance of work which require attention, in case of drowsiness or vision disorders.

Side effects:

Criteria for evaluation of frequency of development of side reaction of medicine:

very often –> 1/10, it is frequent – from> 1/100 to <1/10, infrequently – from> 1/1000 to <1/100, is rare – from 1/10000 to <1/1000, is very rare – <1/10000, communication is not proved * – frequency cannot be estimated from available data.

From the alimentary system: often – a stomach ache, a meteorism, diarrhea, a lock, nausea, vomiting.

From a nervous system: often – a headache, drowsiness, the general weakness; numbness of language and lips, a photophobia, a sleep disorder, vision disorders, a diplopia, confusion of consciousness, muscular twitchings, after use of high doses – a sonitus, the excited state, paresthesias, spasms.

From immune system: communication is not proved – allergic reaction in the form of various skin rashes and an itch; hypostasis; very seldom – anaphylactoid reactions, an acute anaphylaxis, generalized exfoliative dermatitis.

From organs of sight: communication is not proved – visual disturbances.

From skin and its structures: infrequently – the erythema, communication is not proved - a hair loss.

From cardiovascular system: arterial hypotension, cross heart block.

From respiratory system: respiratory depression or apnoea, asthma.

Others: feeling of heat, cold or numbness of extremities, malignant hyperthermia, oppression of immune system.

Local reactions: feeling of easy burning (disappears with development of the anesthetizing effect within 1 minute), thrombophlebitis.

Interaction with other medicines:

Drug is compatible to non-steroidal anti-inflammatory drugs and glucocorticosteroids.

At combined use with coumarinic anticoagulants strengthening of their action is possible. In this connection at these patients it is reasonable to carry out control of parameters of coagulation.

Strengthening of gastrointestinal absorption of tetracycline is possible.

Cimetidinum, пептидин, bupivacaine, propranolol, quinidine, Disopyramidum, amitriptyline, нортриптилин, Chlorpromazinum, Imipraminum increase lidocaine level in blood serum, reducing his hepatic metabolism.

Lidocaine can strengthen effect of the drugs blocking neuromuscular transmission as the last reduce conductivity of nervous impulses.

At simultaneous use to antiarrhytmic drugs ІА a class (including to quinidine, procaineamide, Disopyramidum) there is a lengthening of an interval of QT, in isolated cases development of AV blockade or fibrillation of ventricles is possible.

At simultaneous use with sedativny means the soothing effect amplifies. Phenytoinum strengthens cardiodepressive effect of lidocaine.

At simultaneous use with procaineamide the nonsense, hallucinations are possible.

Ethanol strengthens the oppressing effect of lidocaine on respiratory system.

Contraindications:

Individual hypersensitivity to drug components. An allergy on mollusks. Cardiogenic shock. The expressed arterial hypotension. Severe forms of chronic heart failure. Reduced function of a left ventricle. Atrioventricular block ІІ-ІІІ degrees. Heavy bradycardia. Adams-Stokes's syndrome. The spasms in the anamnesis caused by lidocaine use. Sick sinus syndrome. Heavy abnormal liver functions. Hypovolemia. Myasthenia.

Overdose:

Cases of overdose of a glycosamine of sulfate were not noted. In cases of overdose it is necessary to carry out the symptomatic treatment directed to recovery of water and electrolytic balance.

Excipient lidocaine is a part of an injection form of drug. Numbness of language and lips, the excited state, alarm, a sonitus, dizziness, a sight illegibility, a tremor, a depression, drowsiness can be the first symptoms of overdose of lidocaine of a hydrochloride from the central nervous system. The symptomatic treatment is also directed to maintenance of the vital functions of an organism.

Use during pregnancy or feeding by a breast.

It is not recommended to use drug during pregnancy or feeding by a breast.

Children.

Drug is not used for treatment of children.

Storage conditions:

Period of validity. 2 years. Not to apply after the termination of the period of validity specified on packaging. The prepared solution should be applied at once. To store in the place protected from light at a temperature not over 25 ºС. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Ampoule And: on 2 ml of solution in an ampoule from brown transparent glass.

Ampoule In: on 1 ml of solvent in an ampoule from colourless transparent glass.

On 5 ampoules And yes on 5 ampoules In in blisters respectively.

On 1 blister with ampoules And yes on 1 blister with ampoules In in a pack.