Adverse reactions : תופעות לוואי

4.8 Undesirable effects
General
The adverse reaction profile for Ropivacaine is similar to those for other long acting local anaesthetics of the amide type. Adverse reactions should be distinguished from the physiological effects of the nerve block itself e.g. Hypotension (a decrease in blood pressure), bradycardia during spinal/ epidural block.

Table of adverse reactions
The following frequencies are used for the description of the occurrence of adverse reactions: 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) and not known (cannot be estimated from the available data).


System organ class              Frequency                       Undesirable effects Immune system                  Rare                            Allergic reactions (anaphylactic reactions, disorders                                                      angioneurotic oedema and urticaria) Psychiatric Disorders           Uncommon                        Anxiety Nervous System Disorders        Common                          Paraesthesia, dizziness, headache Uncommon                        Symptoms of CNS toxicity (convulsions, grand mal convulsions, seizures, light headedness, circumoral paraesthesia,
numbness of the tongue, hyperacusis,
tinnitus, visual disturbances, dysarthria,
muscular twitching, tremor)*,
hypoaesthesia
Not known                      Dyskinesia
Cardiac Disorders               Common                          Bradycardia, tachycardia 
Rare                            Cardiac arrest, cardiac arrhythmias
Vascular Disorders              Very common                     Hypotension Common                          Hypertension
Uncommon                        Syncope
Respiratory, Thoracic and       Uncommon                        Dyspnoea Mediastinal Disorders
Gastrointestinal Disorders      Very common                     Nausea Common                          Vomiting
Musculoskeletal and             Common                          back pain connective tissue disorders
Renal and Urinary           Common                              Urinary retention Disorders
General Disorders and       Common                              Temperature elevation, Administration Site                                             Chills Conditions
Uncommon                            Hypothermia


*      These symptoms usually occur because of inadvertent intravascular injection, overdose or rapid absorption, see section 4.9.


Class-related adverse drug reactions
Neurological complications
Neuropathy and spinal cord dysfunction (e.g. anterior spinal artery syndrome, arachnoiditis, cauda equina), which may result in rare cases of permanent sequelae, have been associated with regional anaesthesia, regardless of the local anaesthetic used.

Total spinal block
Total spinal block may occur if an epidural dose is inadvertently administered intrathecally.

Acute systemic toxicity
Systemic toxic reactions primarily involve the central nervous system (CNS) and the cardiovascular system (CVS). Such reactions are caused by high blood concentration of a local anaesthetic, which may appear due to (accidental) intravascular injection, overdose or exceptionally rapid absorption from highly vascularized areas, see also section 4.4. CNS reactions are similar for all amide local anaesthetics, while cardiac reactions are more dependent on the drugs, both quantitatively and qualitatively.

Central nervous system toxicity
Central nervous system toxicity is a graded response with symptoms and signs of escalating severity.
Initially symptoms such as visual or hearing disturbances, perioral numbness, dizziness, light-headedness, tingaling and paraesthesia are seen. Dysarthria, muscular rigidity and muscular twitching are more serious and may precede the onset of generalised convulsions. These signs must not be mistaken for neurotic behaviour. Unconsciousness and grand mal convulsions may follow, which may last from a few seconds to several minutes. Hypoxia and hypercarbia occur rapidly during convulsions due to the increased muscular activity, together with the interference with respiration. In severe cases even apnoea may occur. The respiratory and metabolic acidosis increases and extends the toxic effects of local anaesthetics.

Recovery follows the redistribution of the local anaesthetic drug from the central nervous system and subsequent metabolism and excretion. Recovery may be rapid unless large amounts of the drug have been injected.

Cardiovascular system toxicity
Cardiovascular toxicity indicates a more severe situation. Hypotension, bradycardia, arrhythmia and even cardiac arrest may occur as a result of high systemic concentrations of local anaesthetics. In volunteers the intravenous infusion of ropivacaine resulted in signs of depression of conductivity and contractility.
Cardiovascular toxic effects are generally preceded by signs of toxicity in the central nervous system, unless the patient is receiving a general anaesthetic or is heavily sedated with drugs such as benzodiazepines or barbiturates.

Treatment of acute systemic toxicity
(See section 4.9)

Reporting of suspected adverse reactions
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. Any suspected adverse event should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/