- chloroprocaine hydrochloride
POM: Prescription only medicine
This information is intended for use by health professionals
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
PosologyPosology must be established on an individual basis in accordance with the characteristics of the specific case. When determining the dose, take into consideration the patient's physical condition and the concomitant administration of other medicinal products. The duration of action is dose-dependent.The indications relating to recommended doses are valid in adults of average height and weight (approximately 70 kg) for obtaining an effective block with one single administration. There are wide individual variations with regard to extent and duration of action. The experience of the anaesthetist and knowledge of the patient's general condition are essential for establishing the dose. With regard to posology the following guidelines are applied:
|Extension of sensory blockade required T10||ml||mg||Average duration of action (minutes)|
|4 5||40 50||80 100|
Special populationIt is advisable to reduce the dose in patients in a compromised general condition.In addition, in patients with established concomitant disorders (e.g. vascular occlusion, arteriosclerosis, diabetic polyneuropathy) a reduced dose is indicated.
Pediatric populationAmpres must not be used in children and adolescents (see section 5.1).
Method of administration
For intrathecal use.
Precautions to be taken before administering the medicinal product.The equipment, drugs and personnel capable of dealing with an emergency, e.g. maintaining the patency of the airways and administering oxygen, must be immediately available, since in rare cases severe reactions, sometimes with a fatal outcome, have been reported after using local anaesthetics, even in the absence of individual hypersensitivity in the patient's case history.Inject Ampres via intrathecal route into the intervertebral space L2/L3, L3/L4 and L4/L5.Slowly inject the entire dose and check the patient's vital functions extremely carefully maintaining continuous verbal contact.In general the following points should be taken into consideration:1. Choose the lowest possible dose!2. Administer the injection slowly, after having aspirated a minimum quantity of CSF to confirm the correct position 3. Do not puncture the skin if there are signs of infection or inflammation4. Spinal anaesthesia = intrathecal anaesthesia should not be performed in patients taking anticoagulants or with congenital or acquired bleeding disorder.For single use. Any unused solution should be discarded.The medicinal product has to be visually inspected prior to use. Only clear solutions practically free from particles should be used. The intact container must not be re-autoclaved.
Hypotension and bradicardia are well known side effects of all local anesthestics.In high risk patients, the recommendation is to improve their general condition prior to the intervention.A rare, but serious, undesirable effect of spinal anaesthesia is high or total spinal block, with consequent cardiovascular and respiratory depression. Cardiovascular depression is induced by an extended block of the sympathetic nervous system, which may induce severe hypotension and bradycardia to the point of cardiac arrest. Respiratory depression is induced by the block of the respiratory musculature and the diaphragm.Especially in elderly patients there is an increased risk of high or total spinal block: consequently it is advisable to reduce the anaesthetic dose.Particularly in the case of elderly patients, an unexpected drop in arterial pressure may occur as a complication of spinal anaesthesia.Rarely, neurological damage may occur after spinal anaesthesia, manifesting as paresthesia, loss of sensitivity, motor weakness, paralysis, cauda equina syndrome and permanent neurological injury.Occasionally these symptoms persist.There is no suspicion that neurological disorders, such as multiple sclerosis, hemiplegia, paraplegia or neuromuscular disorders may be negatively influenced by spinal anaesthesia. Nevertheless, it should be used with care. Careful evaluation of the risk-benefit ratio is recommended prior to treatment.This medicinal product contains less then 1 mmol sodium (23 mg) per dose (maximum dose equal to 5 ml of Ampres), i.e. essentially sodium-free.
Immune system disordersRare: allergic reactions as a result of sensitivity to the local anaesthetic, characterized by signs such as urticaria, pruritus, erythema, angioneurotic edema with possible airway obstruction (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly, anaphylactoid type symptomatology (including severe hypotension).
Nervous system disordersCommon: anxiety, restlessness, paresthesia, dizziness.Uncommon: signs and symptoms of CNS toxicity (backache, headache, tremors possibly proceeding to convulsions, convulsions, circumoral paresthesia, feeling of numbness affecting the tongue, hearing problems, visual problems, blurred vision, shaking, tinnitus, speech problems, loss of consciousness).Rare: neuropathy, drowsiness merging into unconsciousness and respiratory arrest, spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel control, and loss of perineal sensation and sexual function, arachnoiditis, persistent motor, sensory and/or autonomic (sphincter control) deficit of some lower spinal segments with slow recovery (several months), cauda equina syndrome and permanent neurological injury.
Eye disordersRare: diplopia
Cardiac disordersRare: arrhythmia, depression of the myocardium, cardiac arrest (the risk is increased by high doses or unintended intravascular injection).
Vascular disordersVery common: hypotension.Uncommon: bradycardia, hypertension, hypotension raised by high doses.
Respiratory, thoracic and mediastinal disordersRare: respiratory depression
Gastrointestinal disordersVery common: nauseaCommon: vomiting.
Acute systemic toxicitySystemic undesirable effects are of methodological (due to use), pharmacodynamic or pharmacokinetic origin and concern the central nervous system and the cardiocirculatory system.Iatrogenic undesirable effects occur:− after injecting an excessive quantity of solution− from accidental injection into a vessel− from incorrect patient position− from high spinal anaesthesia (marked drop in arterial pressure)In the case of accidental intravenous administration, the toxic effect occurs within 1 minute. In mice, the intravenous LD50 of chloroprocaine HCl is 97 mg/kgSigns of overdose can be classified into two different sets of symptoms which differ in terms of quality and intensity:
a) Symptoms affecting the central nervous systemGenerally, the first symptoms are paresthesia in the mouth area, feeling of numbness of the tongue, feeling dazed, problems with hearing and tinnitus. Visual problems and muscle contractions are more severe and precede a generalized convulsion. These signs must not be erroneously mistaken for neurotic behaviour. Subsequently loss of consciousness and tonic-clonic seizure may occur, generally lasting between a few seconds and a few minutes. The convulsions are immediately followed by hypoxia and increased levels of carbon dioxide in the blood (hypercapnia), attributable to increased muscular activity associated with respiratory problems. In serious cases respiratory arrest may occur. Acidosis and/or hypoxia potentiate the toxic effects of local anaesthetics.The reduction or improvement of symptoms affecting the central nervous system can be attributed to the redistribution of local anaesthetic outside the CNS, with its consequent metabolism and excretion. Regression may be rapid, unless enormous quantities have been used.
b) Cardiovascular symptomsIn serious cases cardiovascular toxicity may occur. Hypotension, bradycardia, arrhythmia and also cardiac arrest may occur in the presence of a high systemic concentration of local anaesthetics.The first signs of toxic symptoms affecting the central nervous system generally precede toxic cardiovascular effects. This statement does not apply if the patient is under general anaesthesia or heavily sedated with medicinal products such as benzodiazepine or barbiturates.
Treatment of acute systemic toxicityThe following measures must be taken immediately:− Stop administration of Ampres.− Ensure an adequate supply of oxygen: keep the airways clear, administer O2, artificial ventilation (intubation) if required.− In case of cardiovascular depression circulation must be stabilized.If convulsions occur and do not resolve spontaneously after 15-20 seconds, the administration of an intravenous anticonvulsant is recommended. Analeptics with a central action are contraindicated in the case of intoxication caused by local anaesthetics!In the event of serious complications, when treating the patient it is advisable to obtain the assistance of a doctor specializing in emergency medicine and resuscitation (e.g. anaesthetist).In patients with genetic deficiency of plasma cholinesterase an intravenous lipid solution could be administered.
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