Sustagard Arthro - instructions for use, dose, side effects, contraindications

active substance: glucosamine sodium sulfate chloride (in terms of dry matter) - 502.5 mg (contains glucosamine sulfate - 400 mg, sodium chloride - 102.5 mg)

Excipients: lidocaine hydrochloride 10.0 mg, sodium disulfite 2.0 mg, hydrochloric acid concentrated to pH 2.0-3.0, water for injection up to 2 ml.

Ampoule B (solvent). One ampoule (1 ml) contains: diethanolamine - 24.0 mg, water for injection - up to 1 ml.

Description:

Ampule A - colorless or light yellow transparent liquid.

Ampoule B (solvent) - colorless transparent liquid.

Solution: Ampoule A + Ampoule B (solvent) - colorless or light yellow transparent liquid without suspended particles.

Pharmacotherapeutic group:Reparation of tissue stimulant

ATX: & nbsp

M.01.A.X.05 Glucosamine

Pharmacodynamics:

The drug has a stimulating regeneration of cartilaginous tissue, anabolic, anti-catabolic, chondroprotective, anti-inflammatory, analgesic actions.

Glucosamine sulfate, an active component of the drug Sustagard® ARTHRO, is a salt of natural aminomonosaccharide glucosamine, which is physiologically contained in the body. Glucosamine stimulates the synthesis of chondrocytes proteoglycans (glucosaminoglycans and hyaluronic acid) synovial fluid; inhibits enzymes (collagenase, phospholipase A2, etc.) that cause 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 andthe synthesis of glycosaminoglycans induced by non-steroidal 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:

After intramuscular administration of glucosamine, sulfate rapidly passes through biological barriers and penetrates into tissues, mainly of the articular cartilage. The half-life of T1 / 2 is about 60 hours, excreted mainly by the kidneys.

Indications:

Primary and secondary osteoarthritis, osteochondrosis, spondylarthrosis.

Contraindications:

Hypersensitivity to glucosamine, lidocaine and other components of the drug Sustagard® ARTHRO.

Due to the content of lidocaine: cardiac conduction disorders, acute heart failure, epileptiform convulsions in the anamnesis, severe violations of the liver and kidneys; period of pregnancy and breastfeeding, children and adolescence under 18 years.

Carefully:

Patients with chronic heart failure, arterial hypotension, the drug should be used with caution.

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 in patients prone 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 function and / or nights. Caution should be exercised when prescribing lidocaine to elderly patients with epilepsy, if cardiac conduction is impaired, with respiratory failure.

Dosing and Administration:

Only for intramuscular application! The drug is 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 administered intramuscularly 3 times a week for 4-6 weeks.

Injection of the drug can be combined with the intake of glucosamine inside.

Side effects:

From the digestive system: flatulence, diarrhea, constipation.

Allergic reactions: hives, itching.

Local reactions: sensation of slight burning (disappears with the development of anesthetic effect for 1 min), thrombophlebitis.

Due to the lidocaine included in the formulation, there are possible side reactions typical for this component from the digestive system: nausea, vomiting; from the side of the nervous system, numbness of tongue and mucous membrane of the mouth, drowsiness, diplopia, headache, dizziness, tremor, euphoria, disorientation; from the side of the cardiovascular system, violation of cardiac conduction; allergic reactions: edema, anaphylactic shock.

The disulfite included in the preparation of sodium is able in rare cases to cause severe hypersensitivity reactions and bronchospasm.

Overdose:

Cases of an overdose have not been revealed.

The composition of the drug includes a lidocaine hydrochloride. The first symptoms of an overdose of lidocaine hydrochloride from the side of the CNS can be: numbness of the tongue and lips, nervous state, anxiety, tinnitus, dizziness, blurred vision, tremor, depression, drowsiness. It is necessary to monitor the cardiovascular and respiratory functions of the patient. Changing these parameters may indicate an overdose of the drug, so the patient should immediately provide access to oxygen. All complications require symptomatic treatment.

Interaction:

Glucosamine sulfate is compatible with non-steroidal anti-inflammatory drugs, paracetamol and glucocorticosteroids.

The preparation contains an auxiliary substance lidocaine. Cimetidine, pentidine, bupivacaine, propranolol, quinidine, disopyramide, amitriptyline, nortriptyline, chlorpromazine, imipramine increase the level of lidocaine in the blood plasma, reducing its hepatic metabolism. With simultaneous use with antiarrhythmic drugs IA class (including quinidine, procainamide, disopyramide), the interval Q-T, In very rare cases, it is possible to develop AV-blockades or ventricular fibrillation. When used simultaneously with sedatives, the sedative effect is enhanced. Phenytoin strengthens cardiodepressant action of lidocaine. With concomitant use with procainamide, delusions and hallucinations are possible. Lidocaine can strengthen the action of drugs that predetermine the blockade of neuromuscular transmission, since the latter reduce the conductivity of nerve impulses. Ethanol enhances the inhibitory effect of lidocaine on breathing.

Special instructions:

Sustagard® ARTHRO should be administered with caution to patients with impaired glucose tolerance. Use with caution in the treatment of patients with bronchial asthma.

One dose of the drug 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 injecting form of the drug contains an auxiliary substance lidocaine, before using it, a skin test should be performed on the individual sensitivity to the drug, which may be indicated by edema and redness of the injection site.

Effect on the ability to drive transp. cf. and fur:

The effect of glucosamine on the ability to drive vehicles and mechanisms was not considered. It should be borne in mind that the composition includes 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.

Form release / dosage:

Solution for intramuscular injection 200 mg / ml complete with a solvent.

Packaging:

Ampoule A: 2 ml each in ampoules of light-protective glass with a color fracture ring or with a colored dot and a notch. One, two or three color rings and / or a two-dimensional bar code, and / or alphanumeric coding or without additional color rings, a two-dimensional bar code, and alphanumeric coding are additionally applied to the ampoules.

By 5 ampoules in a contour cell box made of a polyvinylchloride film and aluminum foil or a polymer film, or without a foil and film.

Ampoule B: 1 ml per ampoule of colorless glass with a color fracture ring or with a colored dot and a notch.One, two or three color rings and / or a two-dimensional bar code, and / or alphanumeric coding or without additional color rings, a two-dimensional bar code, and alphanumeric coding are additionally applied to the ampoules.

By 5 ampoules in a contour cell box made of a polyvinylchloride film and aluminum foil or a polymer film, or without a foil and film.

1 contour mesh package with ampoules A and 1 contour pack with ampoules B together with instructions for use in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003149

Date of registration:20.08.2015

The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia

Manufacturer: & nbsp

FarmSirma Soteks, ZAO Russia

Information update date: & nbsp19.11.2015

Illustrated instructions

Instructions

Sustagard® Artro (Susragard® Arthro)