Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Sintetica Limited, 30<sup>th</sup> Floor, 40 Bank Street, Canary Wharf, London, E14 5NR, United Kingdom
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.
Caution is required to prevent injections in inflamed areas.
In case of unintentional intravascular injection severe systemic toxicity may occur immediately (see sections 4.8 and 4.9)
In high risk patients, the recommendation is to improve their general condition prior to the intervention.
A rare, but serious, undesirable effect of loco-regional anaesthesia (PNBs) is the peripheral nerve injury caused by an inadvertent damage to anatomic structures by the advancing needle. Most injuries are transient and often subclinical, or present as mild mononeuropathies. Rarely, injuries can result in permanent nerve damage.
Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions.
Use in Ophthalmic Surgery: when local anesthetic injections are employed for retrobulbar block, lack of corneal sensation should not be relied upon to determine whether or not the patient is ready for surgery. This is because complete lack of corneal sensation usually precedes clinically acceptable external ocular muscle akinesia.
Chloroprocaine and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.
This medicinal product contains 37 mg sodium per 20 ml vial, equivalent to 1.85% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Concurrent administration of vasopressors (e.g. for the treatment of hypotension related to obstetric blocks) and ergot-type oxytocic medicinal products 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 medicinal product 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.
Concurrent use of cholinesterase inhibitors such as antimyasthenics, cyclophosphamide, echotiophate may inhibit the metabolism of chloroprocaine leading to increased risk of toxicity.
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 regional anaesthesia from the ester group. These undesirables effects are generally dose related and may result from rapid absorption from the injection site, diminished tolerance, or from unintentional intravascular injection of the local anaesthetic solution. In addition to systemic dose-related toxicity, unintentional subarachnoid injection of drug during the intended performance of nerve blocks near the vertebral column (especially in the head and neck region) may result in underventilation or apnea (“Total Spinal”). 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), from direct effects (e.g. nerve injury) or the indirect effects (e.g. nerve inflammation) of the needle puncture.
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: anesthetic complication.
Common: anxiety, restlessness, paresthesia, dizziness.
Uncommon: signs and symptoms of CNS toxicity (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, loss of bladder and bowel control, and loss of perineal sensation and sexual function and permanent neurological injury.
Rare: diplopia.
Uncommon: bradycardia.
Rare: arrhythmia, depression of the myocardium, cardiac arrest (the risk is increased by high doses or unintended intravascular injection).
Very common: hypotension.
Uncommon: hypertension, hypotension raised by high doses.
Rare: dyspnoea.
Very common: nausea.
Common: vomiting.
Reporting suspected adverse reactions after authorization 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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