LYSTHENON. 10 mg. Ml 5. 25 ampules
LYSTHENON. 10 mg. / Ml 5. 25 ampules
Active substance: 1 ml of solution contains: 10 mg Suxamethonium chloride (as Suxamethonium chloride dihydrate).
Excipients: Sodium chloride, water for injections.
1 ampoule of 5 ml contains 50 mg Suxamethonium chloride as Suxamethonium chloride dihydrate in an isotonic aqueous solution.
And Manufacturer Marketing Authorisation Holder:
Nycomed Austria GmbH, Austria.
1. Lysthenon What is 10 mg / ml and what it is used
Lysthenon 10 mg / ml causes relaxation of skeletal muscle by blocking the transmission of impulses in the final neuromuscular synapses. Operation of Lysthenon 10 mg / ml began almost immediately after its application - 30 sec to 1 min. The duration of the effect is small, approximately 2 min and 8-10 min after the granting of the muscles ceases.
Lysthenon 10 mg / ml is used for skeletal muscle relaxation, endotracheal intubation during surgery, reduction of fractures and dislocations, relieve muscle spasms during electroshock therapy.
2. How apply Lysthenon 10 mg / ml
Method of administration:
Lysthenon 10 mg / ml is administered as an intravenous injection (can also infused), and if necessary, by intramuscular injection.
Ampoules breaking point. No cutting is required.
Turn the ampoule with the point up. Allow the solution to flow down gently shaking the ampoule. Turn ampoule colored point to itself. Break ends.
Lysthenon 10 mg / ml, as well as all other relaxants, peripherally acting can only be administered by physicians experienced in artificial respiration and endo-tracheal intubation. The dosage of Lysthenon 10 mg / ml is determined by a physician and depends on your age and body weight, the desired degree of muscle relaxation, the route of administration, and the individual response of the patient.
For further information see "Information for healthcare professionals" at the end of this leaflet.
3. Before taking Lysthenon 10 mg / ml
Lysthenon 10 mg / ml, and other relaxants, peripherally acting can only be administered by specialist physicians experienced in the use of artificial respiration and endotracheal intubation, which have at their disposal the necessary equipment for ventilation with increased pressure, oxygen and separation of carbon dioxide.
Use in children and adolescents
In children and adolescents in the application of the product has occurred irreversible cardiac damage (cardiac arrest) in patients suffering from neuromuscular disorders, which have not been previously diagnosed. The serious side effects is recommended even in apparently healthy children to apply Lysthenon 10 mg / ml only in emergencies when the need for immediate intubation or maintain a clear airway.
Pregnancy and lactation
Lysthenon 10 mg / ml should be used during pregnancy only when absolutely necessary. Pseudo-cholinesterase levels may be decreased to 25% during pregnancy. This can result in a prolonged effect of Lysthenon 10 mg / ml, particularly in the application of repeated doses. Normal levels of pseudo-cholinesterase activity is reached 6-8 weeks after birth.
Lysthenon excretion of 10 mg / ml in breast milk is unknown, and the consequences for the infant are not known. Lysthenon 10 mg / ml should not be used during breastfeeding.
Effects on ability to drive and use machines
Special care must be taken when driving or operating machinery until 24 hours after Lysthenon 10 mg / ml. This is necessary because co-administration of anesthetics
Lysthenon 10 mg / ml should not be applied in case of:
Hypersensitivity to Lysthenon 10 mg / ml;
Acute liver dysfunction, pulmonary edema, malignant hyperthermia (hyperpyrexia), cholinesterase deficiency, hyperkalemia;
Neuromuscular disorders and neurological disorders, muscle rigidity;
Patients with severe injuries or major burns, penetrating eye injuries;
Be used with caution in patients suffering from heart disease in children and adolescents;
Not recommended Lysthenon of 10 mg / ml in patients with uremia, especially in the presence of high serum potassium levels.
Interactions Lysthenon 10 mg / ml with other drugs
Heart and circulation
Amplification of digitalis-induced ventricular excitability and conduction effects and / or exit of potassium from muscle cells digitized myocardium. Increased cardiac excitability, leading to increased risk of cardiac dysrhythmias.
Aminoglycosides (gentamycin, neomycin, kanamycin, streptomycin)
Additive neuromuscular blocking effect.
Enhancement of neuromuscular blockade and extension of Suxamethonium.
Muscles, joints and bones
Local anesthetics (procaine, lidocaine)
Local anesthetics are hydrolyzed by plasma cholinesterase. Concurrent amplification of action leading to sustained release of Suxamethonium. Neostigmine, physostigmine, tacrine and other cholinesterase inhibitors block plasma cholinesterase and acetylcholinesterase.
Sustained release if the acetylcholinesterase inhibitor is administered in the administration of Suxamethonium.
Central nervous system
Enflurance, desfhirance, isoflurance.
Neuromuscular blockade is potentiated in a dose-dependent inhalation anesthetic desflurance.
Reducing plasma cholinesterase activity, leading to prolongation of the action of Suxamethonium.
Inhibit release of acetylcholine and reduces sensitivity of postsinapsnata membrane. Extension of Suxamethonium. The application of magnesium should be terminated 20-30 min before the administration of a muscle relaxant.
Terbutaline, bambuterol (product terbutaline)
Reversibly inhibits plasma cholinesterase activity. Prolongation of the action of Suxamethonium.
Irreversibly inhibits cholinesterase activity, possibly by alkalizing the enzyme, leading to delayed metabolism Suxamethonium. Sustained release of Suxamethonium.
Parathion and malathion (fosfoorganichni insecticides containing ethiopate)
Ethiopate inhibits acetylcholinesterase and pseudo-cholinesterase. A sustained release due to decreased free Suxamethonium cholinesterase levels.
Previous administration of Suxamethonium enhances the action of non-depolarising relaxants. Previous administration of nondepolarizing relieve or prevent the side effects of Suxamethonium.
Adverse reactions of the heart and circulation are enhanced by halogenated drugs (halothane), and attenuated by thiopental and atropine.
Neuromuscular blocking action of Suxamethonium is amplified by the polypeptide antibiotics, aniphotericin B, cyclopropane, propanidid, quinidine, thiotepa, parasimpanikomimetitsi, including cholinesterase inhibitors, ajmaline, beta-blockers, calcium channel blockers, phenelzine, thiophosphamide, oxytocin, cimetidine, perphenazine , phenothiazine, lithium, and oral contraceptives.
Under the influence of alcohol or drugs that suppress the activity of the central nervous system, the symptoms of an overdose are amplified.
Concomitant administration of volatile anesthetics should be avoided due to increased risk of developing malignant hyperthermia and increase muscle damage caused by Suxamethonium.
Joint infusion of blood or weaken the effect of Suxamethonium.
Lysthenon 10 mg / ml is compatible with isotonic sodium chloride solution, Ringer's solution, 5% fructose solution, 5% dextrose, and 6% dextran solution.
Mixing Lysthenon 10 mg / ml with an alkali (e.g., barbiturates) can neutralize the action of the product
4. Possible side effects
Like any other drug Lysthenon 10 mg / ml can cause side effects. Lysthenon 10 mg / ml is severe and potentially dangerous side effects:
The most frequent non-hazardous side effects include: muscle pain (60%) and muscle fibrillation (90%), non-fatal acute increases in serum potassium (100%), mild bradycardia (50% of children, adults rarely) and myoglobinaemia (20% of children) are very common.
Frequent intraocular pressure and intrastomashno and hypersensitivity reactions such as ecchymosis.
The following adverse reactions are the most dangerous and rarely seen, but must be taken into account when applying Lysthenon 10 mg / ml.
Fatal increases in serum potassium with the development of arrhythmias and cardiac arrest, malignant hyperthermia, anaphylaxis, rhabdomyolysis and myoglobinaemia with renal failure and prolonged paralysis.
Blood and lymphatic system
Very common: non-fatal increase in serum potassium in 100% of cases (slight increase of 0,5 mmol / l most common). Myoglobinaemia (20% of children received Lysthenon 10 mg / ml intravenous develop myoglobinaemia, adults rarely). The reaction was not dose-dependent and can be monitored with or without fibrillation.
Very rare: ventricular fibrillation and cardiac arrest caused by hyperkalemia.
Immune system disorders
Common: hypersensitivity reactions (ecchymosis, urticaria).
Very rare: Anaphylactic shock with ecchymosis, with or without bronchospasm and hypotension flowing in complete shock.
Very rare: Malignant hyperthermia (at 0.002 percent from 0.006 percent adults and children, or once every 15000-150000 anesthesia) with or without muscle hypertonia (persistent spasm of the jaw muscles), cardiovascular complications (hyperventilation, labile blood pressure) and high temperature, severe acidosis, hyperkalemia, hemoglobinuria and myoglobinuria.
Metabolism and nutrition
Very rare: Life-threatening hyperkalemia in patients at increased risk of fatal increase in serum potassium after administration of Lysthenon 10 mg / ml.
Common Increased pressure intraocularly (perhaps due to the contraction of the extra-ocular muscles and increasing the choroid blood volume).
Very common: Arrhythmias (mild bradycardia, nodal rhythm, ectopic) were observed in 50% of children and 20% of adults after the first intravenous injection. The most frequently observed incidence in infants and young children. The incidence is increasing, regardless of age; if applied to a second dose 15 min of the initial dose. Incidents of bradycardia may be reduced in premedication with atropine.
Uncommon: Transient hypertension, tachycardia.
Very rare ventricular arrhythmia, ventricular fibrillation due to hyperkalemia, hypercalcemia (see section 4.8 Blood and lymphatic system). Cardiac arrest induced Lysthenon 10 mg / ml induced hyperkalemia, particularly in children with undiagnosed skeletal muscle myopathies (muscular dystrophy, Duchenne). Severe hypotension due to anaphylactic reactions (see section 4.8 Immune system).
Respiratory, thoracic and mediastinal disorders
Rare: Prolonged apnea in patients with a defect in plasma pseudo-cholinesterase, see section 4.4.
Very rare: Late respiratory failure in muscular dystrophy Duchenne. Secondary bronchospasm as anaphylactoid reactions (see section 4.8 Immune system). Laryngeal and pulmonary edema.
Disorders of the digestive system
Common: Increased intrastomashno pressure (regurgitation in pregnant women, patients with hiatal hernia, stomach or bowel dilatation, ascites and intra-abdominal tumors, see section 4.4).
Uncommon: Increased salivary secretion.
Skin and subcutaneous tissue disorders
Common: Redness of the skin due to histamine release.
Very rare: anaphylactoid reactions.
Disorders of the musculoskeletal system and connective tissue
Very common: Muscle pain from muscle fibrillation observed in 60% of patients. Most often, in the neck, chest, shoulders and back, mostly in women between 20 and 50 years of age. Muscle fibrillation (90%).
Uncommon: A slight increase in facial pressure (60 seconds), after administration of Lysthenon 10 mg / ml. May be decreased by administration of propofol and a smaller dose non-depolarising muscle relaxant.
Rare: muscle contraction instead of the usual relaxation (most often associated with dystrophic myotonia and myotonia congenital). Prolonged paralysis due to the development of double-block may be observed at a neuromuscular disease, or occur with ideosinkreziya (see 5.2 Hereditary embodiments of plasma cholinesterase) to overdosing or under reduced level of plasma cholinesterase.
Very rare: Acute rhabdomyolysis in patients with diagnosed or undiagnosed neuromuscular diseases.
Renal and urinary disorders
Rare: Myoglobinuria or elevated CPK (creatine kinase) levels, most often seen in children treated with Lysthenon 10 mg / ml and halothane.
Very rare: Myoglobinuria causing kidney failure. Most often, patients with the (latent) muscular dystrophy.
Under prolonged relaxation by chance apnea may be caused by: "Atypical" serum cholinesterase, congenital deficiency of serum cholinesterase or temporary reduction of serum cholinesterase in the liver disease, severe anemia after prolonged starvation, cachexia, dehydration, febrile conditions after acute poisoning, chronic exposure or ingestion of insecticides or holinesterata blocking drugs (phospholine, demecarium, neostigmine, physostigmine, distigmine) and concomitant use of drugs competing with enzymatic digestion succinylcholine (eg procaine iv).
Increased duration of the relaxation of muscles at risk of respiratory failure can be caused by:
"Atypical" serum cholinesterase, congenital deficiency of serum cholinesterase;
Temporary reduction in serum cholinesterase: acute liver disease, severe anemia after prolonged fasting, weight loss, dehydration, fever;
After acute poisoning, acceptance or permanent exposure to cholinesterase inhibitors - drugs or insecticides (fosfolin, demecarium, neostigmine, physostigmine, distigmin) and concomitant administration of drugs entering the competition with Listenoi 10 mg / ml of enzyme (such as procaine ), which is decomposed by the plasma cholinesterase.
Ampoules Lysthenon 10 mg / ml of 5 ml. Pack of 5 and 25 ampoules.
5. Storage Lysthenon 10 mg / ml
Store in a dry, dark place at 2 to 8 ° C. Keep out of reach of children.