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
It is also necessary to take into consideration general and specific contraindications for the technique of spinal anaesthesia = intrathecal anaesthesia.
Spinal anaesthesia must only be administered by anaesthetists with the necessary knowledge and experience in the intrathecal anesthesia domain. The doctor in charge is responsible for taking the measures needed to avoid an intravascular injection and should be fully trained in emergency medicine and resuscitation to be ready to prevent and treat the side effects and complication of the procedure.
In addition, it is essential for the doctor to know how to recognize and treat undesirable effects, systemic toxicity and other complications. If signs of acute systemic toxicity or total spinal block are observed, the injection of the local anaesthetic must be stopped immediately (see section 4.9).
Some patients require special attention in order to reduce the risk of serious undesirable effects, even when locoregional anaesthesia constitutes the optimum choice for the surgical intervention:
Ensuring the presence of reliable venous access is mandatory.
Hypotension and bradycardia 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”.
Concurrent administration of vasopressor drugs (e.g. for the treatment of hypotension related to obstetric blocks) and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.
The para-aminobenzoic acid metabolite of chloroprocaine inhibits the action of sulfonamides. Therefore, chloroprocaine should not be used in any condition in which a sulfonamide drug is being employed.
No studies have been performed on interactions between chloroprocaine and class III antiarrhythmics (e.g. amiodarone), but care must also be taken in this case (also see section 4.4).
The combination of various local anaesthetics induces additional effects which affect the cardiovascular system and the CNS.
Animal studies are insufficient with respect to effects on pregnancy and foetal development (see 5.3). Therefore, Ampres is not recommended during pregnancy and in women of childbearing potential not using contraception. The use of Ampres in pregnancy should only be considered if the expected benefit to the mother outweighs any potential risk to the foetus. This does not preclude the use of Ampres at term for obstetrical anaesthesia.
It is not known whether chloroprocaine/metabolites are excreted in human milk.
No fertility studies the have been performed.
Ampres has major influence on the ability to drive and use machines.
The doctor is responsible for deciding in each individual case if the patient can drive or use machines.
The possible undesirable effects due to the use of Ampres are generally similar to the undesirable effects of other local anaesthetics for spinal anaesthesia from the ester group. The undesirable effects induced by the medicinal product are difficult to distinguish from the physiological effects of the nerve block (e.g. reduction in arterial pressure, bradycardia, temporary urine retention), from direct effects (e.g. spinal hematoma) or the indirect effects (e.g. meningitis) of the injection or from the effects due to the loss of cerebrospinal liquid (e.g. post-spinal headache).
The frequency of undesirable effects listed below is defined using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Rare: 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).
Common: 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.
Rare: diplopia
Rare: arrhythmia, depression of the myocardium, cardiac arrest (the risk is increased by high doses or unintended intravascular injection).
Very common: hypotension.
Uncommon: bradycardia, hypertension, hypotension raised by high doses.
Rare: respiratory depression
Very common: nausea
Common: vomiting.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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