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ROPIVACAINE HYDROCHLORIDE is a brand name for Ropivacaine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ropivacaine 7.5 mg/ml is indicated in adults and adolescents aged above 12 years of age for: Surgical anaesthesia: - Epidural blocks for surgery, including Caesarean section. - Major nerve blocks. - Field blocks. Ropivacaine 10 mg/ml is indicated in adults and adolescents aged above 12 years of age for: Surgical…
Verbatim from this product's MHRA label. Tap a section to expand.
Ropivacaine should only be used by, or under the supervision of, clinicians experienced in regional anaesthesia.
Posology Adults and adolescents above 12 years of age:
The following table is a guide to dosage for the more commonly used blocks. The smallest dose required to produce an effective block should be used. The clinician’s experience and knowledge of the patient’s physical status are of importance when deciding the dose.
Table 1 Adults and adolescents above 12 years of age Conc. Volume Dose Onset Duratio n mg/m l ml mg minute s hours Conc. g. g. g. 0 6–14 ml/h 12–28 mg/h n/a(2) n/a(2) Field Block Conc. g. g. 0 5–10 ml/h 10–20 mg/h n/a n/a The doses in the table are those considered to be necessary to produce a successful block and should be regarded as guidelines for use in adults.
Individual variations in onset and duration occur. The figures in the column ‘Dose’ reflect the expected average dose range needed. Standard textbooks should be consulted for both factors affecting specific block techniques and individual patient requirements.
* With regard to major nerve block, only for brachial plexus block a dose recommendation can be given. For other major nerve blocks lower doses may be required. However, there is presently no experience of specific dose recommendations for other blocks.
5 mg = 13 ml; 105 mg = 14 ml) to be given over 3–5 minutes. Two extra doses, in total an additional 50mg, may be administered as needed. (2) n/a = not applicable. (3) The dose for a major nerve block must be adjusted according to site of administration and patient status.
4). g. epidural administration) requires the use of the higher concentrations and doses. The Ropivacaine 10 mg/ml formulation is recommended for epidural anaesthesia in which a complete motor block is essential for the surgery. g. epidural administration for acute pain management) the lower concentrations and doses are recommended.
Method of administration Careful aspiration before and during injection is recommended to prevent intravascular injection. When a large dose is to be injected, a test dose of 3–5 ml lidocaine (lignocaine) with adrenaline (epinephrine) is recommended.
An inadvertent intravascular injection may be recognised by a temporary increase in heart rate and an accidental intrathecal injection by signs of a spinal block. Aspiration should be performed prior to and during administration of the main dose, which should be injected slowly or in incremental doses, at a rate of 25– 50 mg/min, while closely observing the patient’s vital functions and maintaining verbal contact.
General The adverse reaction profile for ropivacaine is similar to those for other long- acting local anaesthetics of the amide type. g. a decrease in blood pressure and bradycardia during spinal/epidural block. 8 are: 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 Frequen cy Undesirable Effect Immune system disorders Rare Allergic reactions (anaphylactic reactions, anaphylactic shock, angioneurotic oedema and urticaria) Psychiatric disorders Uncomm on Anxiety Common Paraesthesia, Dizziness, Headache Uncomm on 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 Nervous System disorders Not known Dyskinesia, Horner’s syndrome Common Bradycardia, TachycardiaCardiac disorders Rare Cardiac arrest, Cardiac arrhythmias Very common Hypotensiona Vascular disorders Common Hypertension System Organ Class Frequen cy Undesirable Effect Uncomm on Syncope Respiratory, Thoracic and Mediastinal disorders Uncomm on Dyspnoea Very common NauseaGastrointestin al disorders Common Vomitingb Musculoskele tal and connective tissue disorders Common Back pain Renal and Urinary disorders Common Urinary retention Common Temperature elevation, ChillsGeneral disorders and Administrativ e site conditions Uncomm on Hypothermia a Hypotension is less frequent in children (>1/100).
b Vomiting is more frequent in children (>1/10). * These symptoms usually occur because of inadvertent intravascular injection, overdose or rapid absorption, see section
Regional anaesthetic procedures should always be performed in a properly equipped and staffed area. Equipment and drugs necessary for monitoring and emergency resuscitation should be immediately available. Patients receiving major blocks should be in an optimal condition and have an intravenous line inserted before the blocking procedure.
9) such as inadvertent subarachnoid injection, which may produce a high spinal block with apnoea and hypotension. Convulsions have occurred most often after brachial plexus block and epidural block. This is likely to be the result of either accidental intravascular injection or rapid absorption from the injection site.
Caution is required to prevent injections in inflamed areas. Cardiovascular Epidural and intrathecal anaesthesia may lead to hypotension and bradycardia. Hypotension should be treated promptly with a vasopressor intravenously, and with an adequate vascular filling.
g. amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive. There have been rare reports of cardiac arrest during the use of Naropin for epidural anaesthesia or peripheral nerve blockade, especially after unintentional accidental intravascular administration in elderly patients and in patients with concomitant heart disease.
In some instances, resuscitation has been difficult. Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the possibility of a successful outcome. Head and neck blocks Certain local anaesthetic procedures, such as injections in the head and neck regions, may be associated with a higher frequency of serious adverse reactions, regardless of the local anaesthetic used.
Major peripheral nerve blocks Major peripheral nerve blocks may imply the administration of a large volume of local anaesthetic in highly vascularised areas, often close to large vessels where there is an increased risk of intravascular injection and/or rapid systemic absorption, which can lead to high plasma concentrations.
Hypersensitivity to ropivacaine or to other local anaesthetics of the amide type. General contra-indications related to epidural anesthesia, regardless of the local anaesthetic used, should be taken into account. Intravenous regional anaesthesia.
Obstetric paracervical anaesthesia Hypovolaemia
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If toxic symptoms occur, the injection should be stopped immediately. In epidural block for surgery, single doses of up to 250 mg ropivacaine have been used and well tolerated. In brachial plexus block a single dose of 300 mg has been used in a limited number of patients and was well tolerated.
When prolonged blocks are used, either through continuous infusion or through repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered. Cumulative doses up to 675 mg ropivacaine for surgery and postoperative analgesia administered over 24 hours were well tolerated in adults, as were postoperative continuous epidural infusions at rates up to 28 mg/hour for 72 hours.
In a limited number of patients, higher doses of up to 800 mg/day have been administered with relatively few adverse reactions. 5 mg/ml is induced via an epidural catheter. Analgesia is maintained with Ropivacaine 2 mg/ml infusion. Infusion rates of 6–14 ml (12– 28 mg) per hour provide adequate analgesia with only slight and non- progressive motor block in most cases of moderate to severe postoperative pain.
The maximum duration of epidural block is 3 days. However, close monitoring of analgesic effect should be performed in order to remove the catheter as soon as the pain condition allows it. With this technique a significant reduction in the need for opioids has been observed.
In clinical studies an epidural infusion of Ropivacaine 2 mg/ml alone or mixed with fentanyl 1-4 μg/ml has been given for postoperative pain management for up to 72 hours. The combination of ropivacaine and fentanyl provided improved pain relief but caused opioid side effects.
The combination of […]
Hypersensitivity A possible cross–hypersensitivity with other amide–type local anaesthetics should be taken into account. Hypovolaemia Patients with hypovolaemia due to any cause can develop sudden and severe hypotension during epidural anaesthesia, regardless of the local anaesthetic used.
Patients in poor general health Patients in poor general condition due to ageing or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention, although regional anaesthesia is frequently indicated in these patients.
Patients with hepatic and renal impairment Ropivacaine is metabolised in the liver and should therefore be used with caution in patients with severe liver disease; repeated doses may need to be reduced due to delayed elimination. Normally there is no need to modify the dose in patients with impaired renal function when used for single dose or short-term treatment.
Acidosis and reduced plasma protein concentration, frequently seen in patients with chronic renal failure, may increase the risk of systemic toxicity. Acute porphyria Naropin solution for injection and infusion is possibly porphyrinogenic and should only be prescribed to patients with acute porphyria when no safer alternative is available.
Appropriate precautions should be taken in the case of vulnerable patients, according to standard textbooks and/or in consultation with disease area experts. Chondrolysis There have been post-marketing reports of chondrolysis in patients receiving post-operative intra-articular continuous infusion of local anaesthetics, including ropivacaine.
The majority of reported cases of chondrolysis have involved the shoulder joint. Intra-articular continuous infusion is not an approved indication for Naropin. Intra-articular continuous infusion with Naropin should be avoided, as the efficacy and safety has not been established.
40% of the WHO recommended maximum daily intake of 2g sodium for an adult. 80% of the WHO recommended maximum daily intake of 2g sodium for an adult. 5). Paediatric population Neonates may need special attention due to immaturity of metabolic pathways.
The larger variations in plasma concentrations of ropivacaine observed in clinical trials in neonates suggest that there may be an increased risk of systemic toxicity in this age group, especially during continuous epidural infusion.
The recommended doses in neonates are based on limited clinical data. g. g. prolonged recovery) is required, which should be continued after ending infusion, due to a slow elimination in neonates. 5 mg/ml and 10 mg/ml in children up to and including 12 years has not been established.
- The safety and efficacy of ropivacaine 2 mg/ml for field block in children up to and including 12 years has not been established. - The safety and efficacy of ropivacaine 2 mg/ml for peripheral nerve blocks in infants below 1 year has not been established.