Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Sintetica Limited, 30th Floor, 40 Bank Street, Canary Wharf, London, E14 5NR, United Kingdom
Spinal anaesthesia in adults where the planned surgical procedure should not exceed 40 minutes.
Posology 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 | 40 | 80 |
| 5 | 50 | 100 |
The maximum recommended dose is 50mg (=5ml) of chloroprocaine hydrochloride.
It 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.
Ampres must not be used in children and adolescents (see section 5.1).
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:
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.
It is unlikely that Ampres, at the recommended posology by intrathecal administration, will induce plasma levels capable of inducing systemic toxicity.
Systemic 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:
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/kg.
Signs 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 system
Generally, 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 symptoms
In 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.
The following measures must be taken immediately:
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.
24 months.
The medicinal product has to be used immediately after first opening.
Do not refrigerate or freeze. Please do not store above 25°C. Store in original package in order to protect from light.
Type I clear colourless glass ampoule.
Box of 10 ampoules each containing 5 ml of solution for injection.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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