Drugs List

Therapeutic Indications

Uses

Acute pain management - parenteral
Anaesthetic for field blocks
Epidural/perineural block in surgical anaesthesia
Local anaesthetic for nerve blocks

Surgical anaesthesia in adults and children aged 12 years and above (10mg/ml and 7.5mg/ml preparations only).
Epidural blocks for surgery, including Caesarean section.
Major nerve blocks.
Field blocks.

Acute pain management in adults and children aged 12 years and above (2mg/ml preparations only).
Continuous epidural infusion or intermittent bolus administration during postoperative or labour pain.
Continuous peripheral nerve block via continuous infusion or intermittent bolus, e.g. postoperative pain management.
Field blocks.

Acute pain management in children up to 12 years of age (2mg/ml preparations only).
Caudal epidural block for peri- and post- operative pain management.
Continuous epidural infusion for peri- and post- operative pain management.

Post operative pain management in adults (administration system only)
Continuous wound infiltration.

Acute pain management in children aged 1 to 12 years
Single and continuous peripheral nerve block.

Dosage

Due to the complexity and specialist nature of using anaesthesia, specific dosing information on this agent is not included.

When using this agent, specialist literature, national guidelines and Trust policies should be consulted to ensure appropriate dosage and assessment of all relevant patient factors.

Surgical anaesthesia generally requires higher doses and concentrations than those recommended for analgesia.

Administration

For perineural or epidural injection or infusion only.

For wound infiltration (administration system only).

Careful aspiration before and during injection is recommended to prevent intravascular administration. Inadvertent intravascular injection may be recognised by a temporary increase in heart rate and accidental intrathecal injection by signs of a spinal block.

Contraindications

Administration site infection
Conditions where epidural anaesthesia is contra-indicated
Inflammation of injection site
Hypovolaemia
Obstetric paracervical anaesthesia
Third degree atrioventricular block

Precautions and Warnings

Children under 18 years
Debilitation
Elderly
Neonates
Obesity
Restricted sodium intake
Shock
Acute porphyria
Breastfeeding
Cardiac conduction defects
Cardiovascular disorder
Chronic renal failure
Epileptic disorder
Myasthenia gravis
Pregnancy
Respiratory impairment
Severe hepatic impairment
Severe renal impairment

Sodium content of formulation may be significant
Advise patient ability to drive or operate machinery may be impaired
Not all available products are licensed for all age groups
Not all available strengths are licensed for all indications
Treatment to be initiated and supervised by a specialist
Aspirate prior to injection to avoid intravascular administration
Discontinue immediately if toxic symptoms occur, especially in epidural use
Effect may be reduced if injected into an inflamed or infected area
Resuscitation facilities must be immediately available
In obese patients dosing should be based on ideal weight

Cardiac arrest has been reported rarely especially following accidental intravascular administration in elderly patients and patients with cardiac disease. In some cases, resuscitation has been difficult. If cardiac arrest occurs, prolonged resuscitation may be required. 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.

Neonates should be treated with caution. Due to immaturity of their metabolic pathways, there may be an increased risk of systemic toxicity, especially during continuous epidural infusion. Regular monitoring for systemic toxicity (e.g. CNS toxicity, ECG and saturation of peripheral oxygen) and local neurotoxicity (e.g. prolonged recovery) are required, and should continue after the infusion has ceased.

There is an increased risk of inadvertent intravascular injection and / or rapid systemic absorption, leading to high plasma concentrations with major peripheral nerve blocks as a large volume of anaesthetic may be administered in highly vascularised areas, often close to large vessels. Accidental intravascular injection may be recognised by a temporary increase in heart rate. Accidental intrathecal injection may be recognised by spinal block.

In chronic renal failure, acidosis and reduced plasma protein concentration frequently seen in these patients may increase the risk of systemic toxicity.

Prolonged blocks, either through continuous epidural infusion or repeated bolus administration, may increase the risks of reaching toxic plasma concentrations or inducing local neural injury. Manufacturers report that cumulative doses up to 675mg over 24 hours have been well tolerated in adults, as were postoperative continuous epidural infusions at rates of up to 28mg/hour for 72 hours. In a limited number of patients, 800mg/day has been administered with relatively few adverse effects.

Pregnancy and Lactation

Pregnancy

Use ropivacaine with caution in pregnancy.

Ropivacaine is widely used during labour, and for caesarian section, but experience in other uses is limited. Human and animal data indicate the risk to a human foetus from the use of ropivacaine in pregnancy is very low. There is limited experience of ropivacaine use in the 1st trimester of pregnancy, but the available data indicate a low risk of teratogenicity. Low amounts of ropivacaine can be measured in the maternal circulation, but this is not thought to represent a significant risk to the foetus.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use ropivacaine with caution in breastfeeding.

At the time of writing there is limited published information regarding the use of ropivacaine during breastfeeding. Only small amounts of ropivacaine can be detected in the maternal circulation after epidural use; the drug passes poorly into breast milk and is not absorbed by exposed infants. Available data indicates no adverse effects on the breastfed infant. Some manufacturers advise temporarily discontinuing breastfeeding during treatment as it is short term. Milk should be pumped and discarded during this period.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Allergic reaction
Anaphylactic shock
Angioedema
Anxiety
Back pain
Bradycardia
Cardiac arrest
Cardiac arrhythmias
CNS toxicity
Dizziness
Dysarthria
Dyspnoea
Headache
Hyperacusis
Hypertension
Hypoaesthesia
Hypotension
Hypothermia
Light-headedness
Muscle twitch
Nausea
Neuropathy
Paraesthesia
Respiratory depression
Rigors
Rise in body temperature
Seizures
Spinal cord dysfunction
Syncope
Tachycardia
Tinnitus
Tongue numbness
Tremor
Urinary retention
Urticaria
Visual disturbances
Vomiting

Presentation

Parenteral formulations of ropivacaine hydrochloride.

Drugs List

Therapeutic Indications

Uses

Acute pain management - parenteral
Anaesthetic for field blocks
Epidural/perineural block in surgical anaesthesia
Local anaesthetic for nerve blocks

Surgical anaesthesia in adults and children aged 12 years and above (10mg/ml and 7.5mg/ml preparations only).
Epidural blocks for surgery, including Caesarean section.
Major nerve blocks.
Field blocks.

Acute pain management in adults and children aged 12 years and above (2mg/ml preparations only).
Continuous epidural infusion or intermittent bolus administration during postoperative or labour pain.
Continuous peripheral nerve block via continuous infusion or intermittent bolus, e.g. postoperative pain management.
Field blocks.

Acute pain management in children up to 12 years of age (2mg/ml preparations only).
Caudal epidural block for peri- and post- operative pain management.
Continuous epidural infusion for peri- and post- operative pain management.

Post operative pain management in adults (administration system only)
Continuous wound infiltration.

Acute pain management in children aged 1 to 12 years
Single and continuous peripheral nerve block.

Dosage

Due to the complexity and specialist nature of using anaesthesia, specific dosing information on this agent is not included.

When using this agent, specialist literature, national guidelines and Trust policies should be consulted to ensure appropriate dosage and assessment of all relevant patient factors.

Surgical anaesthesia generally requires higher doses and concentrations than those recommended for analgesia.

Administration

For perineural or epidural injection or infusion only.

For wound infiltration (administration system only).

Careful aspiration before and during injection is recommended to prevent intravascular administration. Inadvertent intravascular injection may be recognised by a temporary increase in heart rate and accidental intrathecal injection by signs of a spinal block.

Contraindications

Administration site infection
Conditions where epidural anaesthesia is contra-indicated
Inflammation of injection site
Hypovolaemia
Obstetric paracervical anaesthesia
Third degree atrioventricular block

Precautions and Warnings

Children under 18 years
Debilitation
Elderly
Neonates
Obesity
Restricted sodium intake
Shock
Acute porphyria
Breastfeeding
Cardiac conduction defects
Cardiovascular disorder
Chronic renal failure
Epileptic disorder
Myasthenia gravis
Pregnancy
Respiratory impairment
Severe hepatic impairment
Severe renal impairment

Sodium content of formulation may be significant
Advise patient ability to drive or operate machinery may be impaired
Not all available products are licensed for all age groups
Not all available strengths are licensed for all indications
Treatment to be initiated and supervised by a specialist
Aspirate prior to injection to avoid intravascular administration
Discontinue immediately if toxic symptoms occur, especially in epidural use
Effect may be reduced if injected into an inflamed or infected area
Resuscitation facilities must be immediately available
In obese patients dosing should be based on ideal weight

Cardiac arrest has been reported rarely especially following accidental intravascular administration in elderly patients and patients with cardiac disease. In some cases, resuscitation has been difficult. If cardiac arrest occurs, prolonged resuscitation may be required. 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.

Neonates should be treated with caution. Due to immaturity of their metabolic pathways, there may be an increased risk of systemic toxicity, especially during continuous epidural infusion. Regular monitoring for systemic toxicity (e.g. CNS toxicity, ECG and saturation of peripheral oxygen) and local neurotoxicity (e.g. prolonged recovery) are required, and should continue after the infusion has ceased.

There is an increased risk of inadvertent intravascular injection and / or rapid systemic absorption, leading to high plasma concentrations with major peripheral nerve blocks as a large volume of anaesthetic may be administered in highly vascularised areas, often close to large vessels. Accidental intravascular injection may be recognised by a temporary increase in heart rate. Accidental intrathecal injection may be recognised by spinal block.

In chronic renal failure, acidosis and reduced plasma protein concentration frequently seen in these patients may increase the risk of systemic toxicity.

Prolonged blocks, either through continuous epidural infusion or repeated bolus administration, may increase the risks of reaching toxic plasma concentrations or inducing local neural injury. Manufacturers report that cumulative doses up to 675mg over 24 hours have been well tolerated in adults, as were postoperative continuous epidural infusions at rates of up to 28mg/hour for 72 hours. In a limited number of patients, 800mg/day has been administered with relatively few adverse effects.

Pregnancy and Lactation

Pregnancy

Use ropivacaine with caution in pregnancy.

Ropivacaine is widely used during labour, and for caesarian section, but experience in other uses is limited. Human and animal data indicate the risk to a human foetus from the use of ropivacaine in pregnancy is very low. There is limited experience of ropivacaine use in the 1st trimester of pregnancy, but the available data indicate a low risk of teratogenicity. Low amounts of ropivacaine can be measured in the maternal circulation, but this is not thought to represent a significant risk to the foetus.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use ropivacaine with caution in breastfeeding.

At the time of writing there is limited published information regarding the use of ropivacaine during breastfeeding. Only small amounts of ropivacaine can be detected in the maternal circulation after epidural use; the drug passes poorly into breast milk and is not absorbed by exposed infants. Available data indicates no adverse effects on the breastfed infant. Some manufacturers advise temporarily discontinuing breastfeeding during treatment as it is short term. Milk should be pumped and discarded during this period.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Allergic reaction
Anaphylactic shock
Angioedema
Anxiety
Back pain
Bradycardia
Cardiac arrest
Cardiac arrhythmias
CNS toxicity
Dizziness
Dysarthria
Dyspnoea
Headache
Hyperacusis
Hypertension
Hypoaesthesia
Hypotension
Hypothermia
Light-headedness
Muscle twitch
Nausea
Neuropathy
Paraesthesia
Respiratory depression
Rigors
Rise in body temperature
Seizures
Spinal cord dysfunction
Syncope
Tachycardia
Tinnitus
Tongue numbness
Tremor
Urinary retention
Urticaria
Visual disturbances
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: April 2018

Reference Sources

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 17 April 2018

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Ropivacaine Last revised: 11 October 2016
Last accessed: 16 April 2018

Summary of Product Characteristics: Naropin 2mg / ml solution for injection. AstraZeneca UK Limited. Revised February 2018.
Summary of Product Characteristics: Naropin 7.5mg / ml solution for injection. AstraZeneca UK Limited. Revised February 2018.
Summary of Product Characteristics: Naropin 10mg / ml solution for injection. AstraZeneca UK Limited. Revised February 2018.
Summary of Product Characteristics: Naropin 2mg / ml solution for infusion. AstraZeneca UK Limited. Revised February 2018.
Summary of Product Characteristics: Ropivacaine 2mg / ml solution for infusion. Mercury Pharma Group. Revised May 2016.
Summary of Product Characteristics: Ropivacaine 2mg / ml solution for injection. Mercury Pharma Group. Revised May 2016.
Summary of Product Characteristics: Ropivacaine 7.5mg / ml solution for injection. Mercury Pharma Group. Revised May 2016.
Summary of Product Characteristics: Ropivacaine 10mg / ml solution for injection. Mercury Pharma Group. Revised May 2016.
Summary of Product Characteristics: Ropivacaine 500mg/250ml solution for infusion in administration system. Galen limited. Revised December 2017.