Sinarta (glucosamine sulfate sodium salt) solution for injections 200 mg/ml. 2 ml. vials №5 + solvent 1 ml.

Description

Sinarta (glucosamine sulfate sodium salt) solution for injections 200 mg/ml. 2 ml. vials №5 + solvent 1 ml.

Composition

ampoule A

active ingredient: glucosamine sulfate sodium salt;

1 ml of solution contains sodium salt glucosamine sulfate in terms of 100% substance – 251.25 mg, in terms of glucosamine sulfate – 200 mg, in terms of sodium chloride – 51.25 mg;

excipients: lidocaine hydrochloride, water for injection;

ampoule B (solvent)

diethanolamine, water for injection.

Dosage form

Injection.

Basic physical and chemical properties:

Ampoule A: clear, colorless or light yellow liquid (at the time of issue). Clear, colorless or light yellow to yellow liquid (during the expiration date); ampoule B: clear, colorless liquid; and ampule A + B: a clear, colorless or light yellow liquid (at the time of issue). Clear, colorless or light yellow to yellow liquid (during the expiration date).

Pharmacological group

Nonsteroidal anti-inflammatory and antirheumatic drugs.
ATX code M01A X05.

Pharmacological properties
The active substance, glucosamine sulfate, is a salt of the amino monosaccharide glucosamine, which is present in the human body under physiological conditions and is used together with sulfates for the biosynthesis of hyaluronic acid in the synovial fluid and glycosaminoglycans of the main substance of the articular cartilage.
Thus, the mechanism of action of glucosamine sulfate is to stimulate the synthesis of glycosaminoglycans and, accordingly, articular proteoglycans. In addition, glucosamine has an anti-inflammatory effect and inhibits the process of destruction of articular cartilage mainly due to possible manifestations of its own metabolic properties, the ability to suppress the activity of interleukin 1 (IL-1), which, on the one hand, affects the symptoms of osteoarthritis, and on the other hand, potentially delays structural joint damage, as evidenced by data from long-term clinical studies.
Indications
Treatment of osteoarthritis symptoms: pain and functional limitation.
Contraindications
Individual hypersensitivity to the active substance or to any of the excipients, a tendency to bleeding.
Sinarta should not be used in patients with shellfish allergy, since the active ingredient is obtained from shellfish shells, such patients may be more prone to developing allergic reactions to glucosamine with possible exacerbation of symptoms of their disease.
The injectable form of the drug includes the auxiliary substance lidocaine, which has the following contraindications: cardiogenic shock, severe arterial hypotension, severe forms of chronic heart failure, reduced left ventricular function, atrioventricular block II-III degree, severe bradycardia, blood coagulation disorders, Wolf’s syndrome Parkinson-White, Adams-Stokes syndrome; a history of convulsions caused by the use of lidocaine; sick sinus syndrome, severe liver dysfunction, hypovolemia, myasthenia gravis, infection at the injection site, hypersensitivity to other amide-type anesthetics (since there is an increased risk of hypersensitivity cross-reactions).
Application during pregnancy or lactation
There are no data on the use of the drug during pregnancy or lactation, so the use of the drug is contraindicated in this category of patients.
Method of administration and dosage
For intramuscular use! The drug is not intended for intravenous administration.
Adult patients and elderly patients.
Before use, mix solution B (solvent 1 ml) with solution A (drug solution 2 ml) in one syringe.
The prepared solution of the drug is injected intramuscularly in 3 ml or 6 ml (solution A + B) 3 times a week, for 4-6 weeks.
The presence of a yellowish color of the solution in ampoule A does not affect the effectiveness and tolerability of the drug.
Injections of the drug can be combined with oral administration of the drug in powder form to prepare a solution.
Glucosamine is not indicated for the treatment of acute pain.
Symptom relief (especially pain relief) may only occur after several weeks of treatment, and in some cases even after a longer time.
Patients with impaired renal and / or liver function are not provided with recommendations for dose adjustment, since no relevant studies have been performed.
Children
Do not use in children and adolescents, since the safety and efficacy of the drug for such patients have not been established.

Overdose
Overdose cases were not observed. In cases of overdose, symptomatic treatment should be carried out aimed at restoring the water-electrolyte balance.
The injectable form of the drug contains the excipient lidocaine. The first symptoms of an overdose of lidocaine hydrochloride from the central nervous system may be numbness of the tongue and lips, agitation, euphoria, anxiety, tinnitus, dizziness, blurred vision, nystagmus, tremor, depression, drowsiness, loss of consciousness, up to coma, tonic clonic seizures. As indicated in the literature, symptoms of an overdose associated with lidocaine hydrochloride on the part of the cardiovascular system and respiratory function can be a decrease in blood pressure, collapse, AV blockade and respiratory depression. It is necessary to monitor the cardiovascular and respiratory functions of the patient.
Changes in these parameters may indicate an overdose of the drug, therefore, the patient should be provided with oxygen immediately. All complications require symptomatic treatment.
Side effects:

• From the digestive system: abdominal pain, flatulence, dyspepsia, diarrhea, constipation, nausea, vomiting; hyperglycemia in patients with impaired glucose tolerance;
• From the nervous system: headache, drowsiness, increased fatigue, dizziness;
• From the immune system: hypersensitivity reactions, including allergic reactions, exacerbation of bronchial asthma;
• From the side of the organs of vision: visual impairment;
• On the part of the skin and its structures: erythema, itching, rash, angioedema, urticaria, hair loss, abscess;
• Local reactions: reactions at the injection site.
  The injectable form of the drug contains lidocaine. In exceptional cases, side reactions characteristic of this component are possible:
• From the digestive system: nausea, vomiting;
• From the nervous system: numbness of the tongue and lips, photophobia, diplopia, headache, confusion, muscle twitching, when used in high doses – tinnitus, agitation, anxiety, paresthesia, convulsions, loss of consciousness, coma, hyperacusis;
• From the side of the organs of vision: visual impairment, conjunctivitis; when used in high doses – nystagmus;
  mental disorders: sleep disturbance;
• From the side of the cardiovascular system: arterial hypotension, transverse heart block, increased blood pressure; when used in high doses – arrhythmia, bradycardia, slowing of cardiac conduction, cardiac arrest, peripheral vasodilation, collapse, tachycardia, pain in the region of the heart;
• From the immune system: suppression of the immune system, allergic reactions including edema, skin reactions, itching; urticaria, hypersensitivity reactions, including anaphylactoid reactions (including anaphylactic shock), generalized exfoliative dermatitis;
• From the respiratory system: respiratory depression or respiratory arrest, shortness of breath;
• Оthers: feeling of heat, cold or numbness of the extremities, malignant hyperthermia; when used in high doses – rhinitis;
• Local reactions: tingling of the skin at the injection site, abscess, a slight burning sensation (disappears with the development of the anesthetic effect within 1 minute), thrombophlebitis.