Composition, form of production and packaging
Solution for the / m introduction (ampoule A) as a clear liquid of a colorless or light yellow color; solvent (ampoule B) - colorless transparent liquid; the prepared solution (ampoule A + ampoule B) is colorless or light yellow, transparent, without suspended particles.
Ampoule A:
1 amp. (2 ml)
glucosamine sodium sulfate chloride * 502.5 mg
contains glucosamine sulfate 400 mg
Sodium chloride 102.5 mg
[PRING] lidocaine hydrochloride - 10 mg, sodium disulfite - 2 mg, hydrochloric acid concentrated - to pH 2.0-3.0, water d / and - up to 2 ml.
Solvent (ampoule B): diethanolamine - 24 mg, water d / u - up to 1 ml.
2 ml (ampoule A) - ampoules of dark glass (5) complete with a solvent 1 ml (ampoule B) 5 pcs. - packings contour mesh (2) - packs cardboard.
* in terms of dry matter
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Stimulator of tissue regeneration. The drug has a stimulating regeneration of cartilaginous tissue, anabolic, anti-catabolic, chondroprotective, anti-inflammatory, analgesic actions.
Glucosamine sulfate, the active ingredient of the drug SustagardВ® Arthro, is a salt of natural ammonomonosaccharide glucosamine, which is physiologically contained in the body. Glucosamine stimulates the synthesis of chondrocytes of proteoglycans (glucosaminoglycans and hyaluronic acid) synovial fluid; inhibits enzymes (including collagenase, phospholipase A 2 ), causing the destruction of cartilaginous tissue; prevents the formation of superoxide radicals, inhibits the activity of lysosomal enzymes; initiates the process of fixing sulfur in the synthesis of chondroitinsulfuric acid and promotes the normal deposition of calcium in bone tissue;prevents the damaging effect of corticosteroids on chondrocytes and the disruption of glycosaminoglycan synthesis induced by nonsteroidal anti-inflammatory drugs.
The sulfo groups also participate in the synthesis of glycosaminoglycans and the metabolism of cartilaginous tissue, and the side chain sulphoesters in proteoglycans, promoting water retention, in maintaining the elasticity of the cartilage matrix.
Glucosamine sulfate stops the destruction of cartilage and reduces symptoms in osteoarthritis. Reduction of clinical symptoms is usually manifested after 2 weeks from the beginning of treatment with preservation of clinical improvement within 8 weeks after discontinuation of the drug.
PHARMACOKINETICS
Suction and distribution
After the / m introduction of glucosamine sulfate quickly passes through biological barriers and penetrates into tissues, mainly articular cartilage.
Excretion
T 1/2 - about 60 hours. It is excreted mainly by the kidneys.
INDICATIONS
- primary and secondary osteoarthritis;
- osteochondrosis;
- spondylarthrosis.
DOSING MODE
The drug is administered only in / m. Not intended for intravenous administration.
Immediately prior to administration, mix the contents of ampoule A with ampoule B (solvent) in a single syringe. The prepared solution (3 ml) is injected / m 3 times a week for 4-6 weeks.
In / m injections of the drug can be combined with the intake of glucosamine inside.
SIDE EFFECT
From the digestive system: flatulence, diarrhea, constipation.
Allergic reactions: hives, itching.
Local reactions: sensation of light burning (disappears with the development of anesthetic effect for 1 min), thrombophlebitis.
Adverse reactions due to lidocaine, which is part of the drug
From the digestive system: nausea, vomiting.
From the nervous system: numbness of the tongue and mucous membrane of the mouth, drowsiness, diplopia, headache, dizziness, tremor, euphoria, disorientation.
From the cardiovascular system: a violation of cardiac conduction.
Allergic reactions: edema, anaphylactic shock.
Included in the solution for the / m introduction of sodium disulfite is able in rare cases to cause severe hypersensitivity reactions and bronchospasm.
CONTRAINDICATIONS
- hypersensitivity to the components of the drug;
- Pregnancy;
- the period of lactation (breastfeeding);
- children and adolescence under 18;
- Due to the content of lidocaine - a violation of cardiac conduction, acute heart failure, epileptiform cramps in history, severe violations of the liver and kidneys.
Caution should be used in patients with chronic heart failure, arterial hypotension.
When seafood intolerance (shrimp, shellfish) increases the likelihood of allergic reactions to the drug.
The safety of the use of anesthetics in the lidocaine group is questionable with a tendency to malignant hyperthermia, therefore, in such cases, their use should be avoided. Special care should be taken when using the drug in patients with circulatory failure, arterial hypotension, impaired liver and / or kidney function. Caution should be exercised when prescribing lidocaine to elderly patients, with epilepsy, with conduction disorders in the heart, with respiratory failure.
SPECIAL INSTRUCTIONS
Sustagard В® Arthro should be administered with caution to patients with impaired glucose tolerance, patients with bronchial asthma.
One dose of the drug in the form of a solution for the / m administration contains 40.8 mg of sodium. This should be considered when appointing patients who are shown a strict salt-free diet.
Due to the fact that the lidocaine is included in the injectable form of the drug, before using it, it is necessary to conduct a skin test for individual sensitivity to the drug, which may be indicated by edema and reddening of the injection site.
Impact on the ability to drive vehicles and manage mechanisms
The effect of glucosamine on the ability to drive vehicles and mechanisms was not considered. It should be noted that the preparation contains lidocaine, which can have a temporary effect on motor ability and coordination. During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities.
OVERDOSE
Cases of an overdose have not been revealed.
Symptoms: the preparation contains an auxiliary substance lidocaine hydrochloride. The first symptoms of an overdose of lidocaine hydrochloride from the side of the central nervous system can be numbness of the tongue and lips, nervous state, anxiety, tinnitus, dizziness, blurred vision, tremor, depression, drowsiness.
Treatment: it is necessary to monitor the functions of the cardiovascular and respiratory system. Changing the appropriate parameters may indicate an overdose of the drug, so the patient should immediately provide access to oxygen. With the development of any complications, symptomatic therapy is performed.
DRUG INTERACTION
Glucosamine sulfate is compatible with NSAIDs, paracetamol and GCS.
Drug interaction caused by the presence of lidocaine in the drug
Cimetidine, peptidine, bupivacaine, propranolol, quinidine, disopyramide, amitriptyline, nortriptyline, chlorpromazine, imipramine increase the concentration of lidocaine in the blood plasma, reducing its hepatic metabolism.
With simultaneous use with antiarrhythmic drugs IA class (including with quinidine, procainamide, disopyramide), the QT interval is prolonged, in very rare cases, AV blockade or ventricular fibrillation may develop.
When used simultaneously with sedatives, the soothing effect is enhanced.
Phenytoin increases the cardio-depressant effect of lidocaine.
With concomitant use with procainamide, delusions and hallucinations are possible.
Lidocaine can enhance the action of drugs that predetermine the blockade of neuromuscular transmission, as the latter reduce the conductivity of nerve impulses.
Ethanol enhances the inhibitory effect of lidocaine on breathing.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, protected from light at a temperature of no higher than 25 В° C. Shelf life - 2 years.
