Hlorsuccillin

1. What is Chlorsuccillin and what is it used for

Suxamethonium chloride is a depolarizing agent with a very short duration of action. It causes skeletal muscle relaxation by depolarizing the neuromuscular plate. Immediately after administration, there is a brief muscle twitch, which subsides after a few seconds, followed by muscle relaxation. After intravenous administration, the action of suxamethonium chloride begins after 30 seconds and lasts for about 5 minutes.

Indications

Short-term muscle relaxation necessary for endotracheal intubation during short surgical procedures. As an aid in the treatment of seizures caused by electroshock or overdose of certain medications.

2. Important information before using Chlorsuccillin

When not to use Chlorsuccillin

If the patient has:

• hypersensitivity to suxamethonium chloride;
• myasthenia gravis;
• myopathies (with increased creatine kinase activity);
• a history of malignant hyperthermia (malignant fever);
• severe liver or kidney disease;
• increased intracranial pressure;
• open eye injuries;
• extensive tissue damage (in severe burns and large injuries);
• hyperkalemia (elevated potassium levels in the blood);
• genetically determined reduced cholinesterase activity.

Warnings and precautions

The medicine is intended for hospital use and may only be used by qualified medical personnel, provided that equipment for controlled respiration is available. Inform your doctor if you have:

• genetically determined disorders of cholinesterase activity;
• severe generalized tetanus;
• tuberculosis and other severe chronic infections;
• severe burns;
• disease with exhaustion;
• cancer;
• chronic anemia and malnutrition;
• end-stage liver failure;
• acute or chronic kidney failure;
• autoimmune disease;
• myxedema (hypothyroidism);
• collagenosis. Also, inform your doctor:
• about recent plasmapheresis, exchange transfusion, or extracorporeal circulation;
• about contact with insecticides.

Other medicines and Chlorsuccillin

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. In particular, tell your doctor about taking the following medicines:

• anesthetics and analgesics;
• eye drops used for increased intraocular pressure;
• medicines used for cough, colds, and allergies;
• medicines used to treat malaria;
• oral contraceptives;
• medicines used to treat asthma and other respiratory disorders;
• medicines used to treat cancer (cytotoxic drugs);
• medicines used to treat mental disorders;
• medicines containing magnesium salts;
• medicines containing steroids;
• medicines containing estrogens;
• antibiotics;
• medicines used to treat heart rhythm disorders;
• medicines used to treat myasthenia gravis;
• immunosuppressants. Also, inform your doctor about possible contact with insecticides.

Pregnancy, breastfeeding, and fertility

In pregnancy, during breastfeeding, or if you suspect you are pregnant or plan to become pregnant, consult your doctor before using this medicine. Use during pregnancy The medicine may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus. When considering the use of suxamethonium chloride for muscle relaxation during delivery, the possibility of the medicine passing to the fetus and causing apnea in the newborn must be taken into account. This effect may occur after administration of suxamethonium chloride to the mother in a dose greater than 1 mg/kg body weight. Breastfeeding Due to the short half-life and lack of effect on lactation, there are no contraindications to the use of suxamethonium chloride during breastfeeding.

Driving and using machines

Suxamethonium chloride severely impairs psychophysical fitness. For 24 hours after administration of the medicine, there is an absolute ban on driving and operating machines.

3. How to use Chlorsuccillin

The medicine can be administered by intravenous injection or infusion. The medicine can only be used by medical personnel. During administration of the medicine, respiratory function must be monitored or controlled respiration used. The doctor will decide how and in what dose to administer the medicine, depending on:

• the patient's weight;
• the level of muscle relaxation required in a given case;
• the expected response to the administered medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Heart disorders:High doses, especially repeated ones, can cause dangerous bradycardia and a sudden drop in blood pressure. Bradycardia can be prevented by administering atropine beforehand. The depolarizing mechanism of action of suxamethonium chloride causes a sudden and significant shift of potassium ions (K+) from muscle cells to blood serum. This is particularly dangerous in conditions of existing hyperkalemia (burns, extensive muscle damage, severe infections). Musculoskeletal and connective tissue disorders:Repeated injections of high doses of suxamethonium chloride can also cause the occurrence of phase II block, which is usually accompanied by brief muscle twitching, especially in the face, neck, and limbs. Immediately after administration of the medicine, generalized muscle tension may occur, which can cause malignant hyperthermia. These phenomena can be prevented by administering a small dose of a non-depolarizing relaxant, such as tubocurarine, before injecting suxamethonium chloride. Eye disorders:Brief increase in intraocular pressure. Respiratory, thoracic, and mediastinal disorders:Bronchospasm. Gastrointestinal disorders:Increased salivation. Skin and subcutaneous tissue disorders:Rash. Immune system disorders:Anaphylactic reactions.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Chlorsuccillin

Store at a temperature below 25°C. Store in the original packaging to protect from light. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Chlorsuccillin contains:

The active substance of the medicine is suxamethonium chloride. 1 vial contains 200 mg of suxamethonium chloride.

What Chlorsuccillin looks like and contents of the pack

White or almost white solid mass (lyophilisate) in a solid or partially fragmented form. The product may take the form of a more or less compact mass adhering to the bottom and walls of the vial or a so-called tablet stuck to the walls of the vial at different heights. The surface of the product may be matte or glossy. The packaging contains 10 vials made of colorless glass, closed with a rubber stopper and a red aluminum cap, in a cardboard box.

Marketing authorization holder:

Bausch Health Ireland Limited 3013 Lake Drive Citywest Business Campus, Dublin 24, D24PPT3 Ireland

Manufacturer:

Przedsiębiorstwo Farmaceutyczne Jelfa SA 58-500 Jelenia Góra, ul. Wincentego Pola 21

Date of last revision of the leaflet:

The following information is intended for medical personnel or healthcare professionals only.

Warnings and precautions

The medicine should not be used in patients in whom an increase in potassium ion (K+) concentration in blood serum (3.6-5.4 mmol/l in healthy individuals) may reach life-threatening values, e.g., severely burned patients (especially within 2-6 weeks after the burn), after large injuries, with paraplegia, spinal cord injury, and muscle damage. In healthy individuals, after administration of suxamethonium chloride, a transient increase in potassium levels in blood serum rarely occurs. In some pathological conditions, such an increase in potassium levels may be significant and may cause severe cardiac arrhythmias up to cardiac arrest. In patients with neurological damage with accompanying muscle relaxation (disease of the upper and lower motor neuron), the tendency to increased potassium levels occurs in the first 6 months after the onset of neurological disorders and is related to the degree and extent of muscle paralysis. Such risk is faced by patients who require immobilization. In adults, suxamethonium chloride can cause transient bradycardia at the beginning of administration. Bradycardia is more frequently observed in children, and with repeated doses, both in children and adults. Administration of atropine intravenously before the procedure significantly reduces the risk of severe bradycardia caused by suxamethonium chloride. After too frequent repetition of suxamethonium chloride doses, tachyphylaxis may develop. Suxamethonium chloride can cause cardiac arrhythmias. The risk of arrhythmias increases when glycosides are used concurrently. Particular caution should be exercised when using local anesthetics and in patients with elevated or decreased body temperature.

• Prolonged and severe neuromuscular blockade (when a dose of 1 to 1.5 mg/kg body weight acts for 3-6 hours, resulting from very slow metabolism) may occur secondarily due to reduced cholinesterase activity in the following pathological conditions: physiological changes during pregnancy and postpartum, genetically determined disorders of cholinesterase activity, severe generalized tetanus, tuberculosis, other severe chronic infections, severe burns, disease with exhaustion, cancer, chronic anemia and malnutrition, end-stage liver failure, acute or chronic kidney failure, autoimmune diseases, myxedema, collagenosis, and iatrogenic effects such as exchange transfusion, plasmapheresis, extracorporeal circulation, and concurrent use of other medicines. Prolonged depolarizing block and muscle relaxation may also occur in individuals occupationally exposed to esterase inhibitors (e.g., those in contact with organophosphorus insecticides). The patient should be given controlled respiration until the medicine is completely eliminated. Before using muscle relaxants, the patient's cholinesterase type should be tested. Suxamethonium chloride may act as a triggering factor for prolonged skeletal muscle contraction in sensitive individuals and is also contraindicated in patients with a family history of malignant hyperthermia. If such a condition develops unexpectedly, administration of all anesthetic agents (including suxamethonium chloride) that may be related to it should be discontinued, and all possible corrective measures should be taken immediately. The recommended first-line treatment involves rapid intravenous infusion of sodium dantrolene.

Interactions with other medicines

Certain medicines or chemical compounds may reduce the activity of serum cholinesterase and may cause prolonged neuromuscular blockade after administration of suxamethonium chloride. These include: organophosphorus insecticides; eye drops containing ecotiopate iodide; trimetaphan; compounds acting as cholinesterase antagonists: neostigmine, pyridostigmine, physostigmine, edrophonium; cytotoxic drugs: cyclophosphamide and thiotepa; psychotropic drugs: phenelzine, promazine, chlorpromazine; anesthetic agents: ketamine, morphine, and morphine antagonists, pethidine, pankuronium. Medicines that may potentially reduce cholinesterase activity include: aprotinin, diphenhydramine, promethazine, estrogens, oxytocin, steroids in high doses, and oral contraceptives. Certain medicines or substances may enhance or prolong the neuromuscular action of suxamethonium chloride through a mechanism unrelated to cholinesterase activity. These include: magnesium salts, lithium carbonate, azathioprine, quinine, and chloroquine; antibiotics such as aminoglycosides, clindamycin, and polymyxins; antiarrhythmic drugs such as quinine, procainamide, verapamil, beta-adrenergic receptor blockers, lignocaine, and procaine; inhalation anesthetics: halothane, enflurane, isoflurane, ether for anesthesia have a minimal effect on phase I block induced by suxamethonium, but may accelerate or enhance the intensity of phase II block induced by suxamethonium. In the case of a change from depolarizing block to phase II block (non-depolarizing), which may occur after repeated doses of suxamethonium chloride, esterase inhibitors may partially reverse it. Solutions of suxamethonium chloride should not be mixed in the same syringe with thiopental.

How to use Chlorsuccillin

Method of preparation of the medicine before intravenous injection or infusion.

Immediately before injection, a solution is prepared by dissolving the contents of the vial in water for injection or in a 0.9% sodium chloride solution for injection. The prepared solution should not be mixed in the same syringe with other medicinal products, including thiopental. For intravenous injections, solutions containing 2% suxamethonium chloride are prepared by dissolving the contents of 1 vial in 10 ml of water for injection or in 10 ml of a 0.9% sodium chloride solution for injection. For drop infusions, solutions containing 0.1% or 0.2% suxamethonium chloride are prepared by dissolving and diluting the contents of 1 vial in 200 ml or 100 ml of the solvent: water for injection or a 0.9% sodium chloride solution for injection. Shelf-life after reconstitution From a microbiological point of view, the solution should be used immediately after preparation. If it is not used immediately, the user is responsible for the storage time and conditions before administration. This time should not exceed 24 hours, at a temperature of 2-8°C, unless the reconstitution was performed under controlled and validated aseptic conditions.

Dosage

The dosage is determined individually by the doctor, depending on the type of procedure, the patient's body weight, and their sensitivity to suxamethonium chloride. It is recommended to perform a test to determine the individual sensitivity, speed, and duration of action of the medicine. For this purpose, 10 mg of the medicine is administered intravenously. Adults Depending on the desired degree of muscle relaxation and the expected duration of the procedure, the following doses are used: in short surgical procedures intravenously The average muscle-relaxing dose for a short period is 40 mg (2 ml of a 2% solution). The optimal dose may be 20 mg to 80 mg (1 ml to 4 ml of a 2% solution) (0.5 mg to 1.5 mg/kg body weight). Muscle relaxation occurs within about 1 minute, and maximum relaxation usually lasts about 2 minutes. Return to the pre-administration state occurs after 8-10 minutes. in longer surgical procedures intravenously or by drop infusion 0.1 mg to 0.5 mg and even 1 mg/kg body weight. The dosage of the medicine administered by drop infusion depends on the duration of the procedure and the degree of muscle relaxation required. Usually, the dose administered in a continuous intravenous infusion is 2.5 mg to 4 mg/minute. The total dose administered in multiple injections or by infusion should not exceed 500 mg/hour.

• Children: 1 mg to 2 mg/kg body weight.
• Older children should be given a smaller dose.
• Newborns and infants: 2 mg to 3 mg/kg body weight.
• The total dose used in pediatrics should not exceed 150 mg.

Use of a higher than recommended dose of Chlorsuccillin

In the event of an overdose (e.g., after too frequent repetition of suxamethonium chloride doses during general anesthesia), a so-called double block occurs, i.e., a change from depolarizing block to non-depolarizing (competitive) block. Overdose leads to muscle relaxation, prolonged apnea, and cardiac arrhythmias. Treatment involves controlled respiration, oxygen therapy, and blood transfusion.