Drugs List

Therapeutic Indications

Uses

Analgesia for painful procedures
Analgesic agent during induction and/or maintenance of general anaesthesia

Analgesic supplement before and during anaesthesia in:
Short procedures and outpatient surgery.
Procedures of medium to long duration when given as a bolus injection followed by supplemental doses or infusion.

Neonates, infants and children in:
association with a hypnotic to induce anaesthesia
association with general anaesthesia and for both short and long surgical procedures.

It may be used for anaesthetic induction agent in ventilated patients (at very high doses).

Administration

For intravenous administration by injection or infusion.

Induction doses should be infused slowly over 3 minutes. An increased incidence of hypotension has been associated with rates of less than one minute.

Contraindications

Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Coma
Head trauma
Labour
Non-ventilated obstructive pulmonary disease
Non-ventilated respiratory depression
Raised intracranial pressure

Precautions and Warnings

Children under 18 years
Debilitation
Elderly
Obesity
Shock
Adrenal insufficiency
Alcoholism
Asthma
Benign prostatic hyperplasia
Biliary tract disorder
Drug misuse
Gastrointestinal obstruction
Hepatic impairment
History of drug misuse
Hypotension
Hypothyroidism
Hypovolaemia
Inflammatory bowel disease
Myasthenia gravis
Opioid dependence
Pregnancy
Psychiatric disorder
Pulmonary disease
Reduced intracerebral compliance
Reduced respiratory reserve
Renal impairment
Seizures
Severe burn
Urethral stricture

Reduce dose in hypothyroidism
Reduce dose in patients with hepatic impairment
Reduce dose in patients with renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Advise patient not to drive until they know how the medicine affects them
Advise patient not to drive/operate machinery within 24 hours of treatment
Advise patient this medicine may be subject to driving restrictions
Avoid within 2 weeks of discontinuing a MAOI
Excess muscle rigidity: Administer neuromuscular blocker and/or hypnotic.
Resuscitation facilities must be immediately available
Treatment to be administered by or under supervision of specialist
Always administer by slow intravenous injection or infusion
May cause respiratory depression
Monitor at regular intervals as withdrawal symptoms & dependence may occur
Monitor patient for signs and symptoms of respiratory depression
Monitor patients on prolonged therapy
Monitor patients with a history of alcoholism and drug abuse
Monitor post operative patients for respiratory and other side effects
Monitor vital signs, respiration & cardiac function
Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
Reduce dose if bradycardia develops
Tolerance and dependence may occur
When used with SSRIs, risk of Serotonin syndrome
Discontinue or reduce rate in muscle rigidity
Neonate exposed in labour: Risk of respiratory depression
Prolonged use at high doses may result in hyperalgesia
Progressive withdrawal recommended
Interrupt infusion if hypotension occurs
Consider dose reduction or alternative opioid in cases of hyperalgesia
In obese patients dosing should be based on ideal weight
Not licensed for all indications in all age groups
Reduce dose in debilitated patients
Reduce dose in elderly
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)

A fall in blood pressure may occur which may exaggerated in the hypovolaemic patient or in the presence of concomitant sedative medication. Appropriate measures to maintain a stable arterial pressure should be taken.

Significant respiratory depression and loss of consciousness will occur following doses of alfentanil exceeding 1mg, and this effect is dose related. This effect is usually short in duration and can be reversed by specific opioid antagonists, such as naloxone. The duration of respiratory depression may last for longer than the opioid antagonist action, therefore additional doses of the antagonist may be required.

Alfentanil may cause bradycardia, an effect that may be marked and rapid in onset but which can be antagonised by atropine. Particular care must be taken following treatment with drugs which may depress the heart or increase vagal tone, such as anaesthetic agents or beta-blockers.

Cardiac arrest following bradycardia has been reported on very rare occasions in non-atropinised patients. Therefore it is advisable to be prepared to administer an anticholinergic drug.

Patients on chronic opioid therapy or with a history of opioid abuse may require higher doses.

Rapid bolus injections should be avoided in patients with compromised intracerebral compliance. A transient decrease in the mean arterial pressure, occasionally with a transient reduction of the cerebral perfusion pressure, may be experienced in these patients.

Hyperventilation during anaesthesia may alter the patient's response to carbon dioxide and affect respiration after the procedure.

Non-epileptic (myo)clonic movements may occur.

There maybe a higher risk of respiratory complications when alfentanil is administered to neonates and very young children than when it is used in older children and adults. Young paediatric subjects should be monitored immediately after administration of alfentanil is commenced.

Risk of muscle rigidity in neonates and young infants. All children should be monitored for a sufficient period of time following cessation of treatment with alfentanil to ensure the return of spontaneous respiration has been achieved.

Pregnancy and Lactation

Pregnancy

Use alfentanil with caution during pregnancy.

The manufacturer advises caution when prescribing alfentanil during pregnancy.

At the time of writing there is limited published information regarding the use of alfentanil during pregnancy. Alfentanil crosses the placenta, and regular use during pregnancy may result in drug dependence in the foetus and withdrawal symptoms in the neonate. Use of alfentanil during labour may result in respiratory depression in the neonate. Animal studies have not shown teratogenic or acute embryotoxic effects.

Lactation

The use of alfentanil is contraindicated during breastfeeding.

The manufacturer does not recommend the use of alfentanil during breastfeeding. Alfentanil is secreted into breast milk, and may cause respiratory depression in the breastfeed infant.

LactMed (2018) states that there is limited data regarding intravenous use thus alternative agents are preferred. If alfentanil is used during breastfeeding and the infant shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately.

Side Effects

Agitation
Allergic dermatitis
Anaphylaxis
Apnoea
Arrhythmias
Asystole
Biliary spasm
Bradycardia
Bradypnoea
Bronchospasm
Cardiac arrest
Circulatory failure
Coma
Confusion
Constipation
Convulsions
Cough
Decrease in heart rate
Dependence
Difficulty in micturition
Disorientation
Dizziness
Drowsiness
Dry mouth
Dyskinesia
Dysphoria
Elevation of liver enzymes
Epistaxis
Erythema
Euphoria
Excitation
Fatigue
Fever
Flushing
Hallucinations
Headache
Hiccups
Hypercapnia
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Hypotension
Hypothermia
Hypoxia
Laryngospasm
Local pain (injection site)
Miosis
Mood changes
Movement disturbances
Muscle rigidity
Myoclonic movements
Nausea
Oedema
Pain
Palpitations
Postural hypotension
Pruritus
Raised intracranial pressure
Rash
Respiratory arrest
Respiratory depression
Restlessness
Sedation
Sensation of cold
Sexual dysfunction
Shivering
Sleep disturbances
Somnolence
Tachycardia
Unconsciousness
Ureteric spasm
Urinary retention
Urticaria
Vertigo
Visual disturbances
Vomiting

Presentation

Injections of alfentanil hydrochloride containing 500micrograms per ml.

Drugs List

Therapeutic Indications

Uses

Analgesia for painful procedures
Analgesic agent during induction and/or maintenance of general anaesthesia

Analgesic supplement before and during anaesthesia in:
Short procedures and outpatient surgery.
Procedures of medium to long duration when given as a bolus injection followed by supplemental doses or infusion.

Neonates, infants and children in:
association with a hypnotic to induce anaesthesia
association with general anaesthesia and for both short and long surgical procedures.

It may be used for anaesthetic induction agent in ventilated patients (at very high doses).

Dosage

Should be used as bolus injections (short procedures) or bolus supplemented by increments or by infusion (long painful surgical procedures).

Dose should be adjusted according to each individual patient.

Adults

Children

Neonates

Additional Dosage Information

Administration

For intravenous administration by injection or infusion.

Induction doses should be infused slowly over 3 minutes. An increased incidence of hypotension has been associated with rates of less than one minute.

Contraindications

Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Coma
Head trauma
Labour
Non-ventilated obstructive pulmonary disease
Non-ventilated respiratory depression
Raised intracranial pressure

Precautions and Warnings

Children under 18 years
Debilitation
Elderly
Obesity
Shock
Adrenal insufficiency
Alcoholism
Asthma
Benign prostatic hyperplasia
Biliary tract disorder
Drug misuse
Gastrointestinal obstruction
Hepatic impairment
History of drug misuse
Hypotension
Hypothyroidism
Hypovolaemia
Inflammatory bowel disease
Myasthenia gravis
Opioid dependence
Pregnancy
Psychiatric disorder
Pulmonary disease
Reduced intracerebral compliance
Reduced respiratory reserve
Renal impairment
Seizures
Severe burn
Urethral stricture

Reduce dose in hypothyroidism
Reduce dose in patients with hepatic impairment
Reduce dose in patients with renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Advise patient not to drive until they know how the medicine affects them
Advise patient not to drive/operate machinery within 24 hours of treatment
Advise patient this medicine may be subject to driving restrictions
Avoid within 2 weeks of discontinuing a MAOI
Excess muscle rigidity: Administer neuromuscular blocker and/or hypnotic.
Resuscitation facilities must be immediately available
Treatment to be administered by or under supervision of specialist
Always administer by slow intravenous injection or infusion
May cause respiratory depression
Monitor at regular intervals as withdrawal symptoms & dependence may occur
Monitor patient for signs and symptoms of respiratory depression
Monitor patients on prolonged therapy
Monitor patients with a history of alcoholism and drug abuse
Monitor post operative patients for respiratory and other side effects
Monitor vital signs, respiration & cardiac function
Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
Reduce dose if bradycardia develops
Tolerance and dependence may occur
When used with SSRIs, risk of Serotonin syndrome
Discontinue or reduce rate in muscle rigidity
Neonate exposed in labour: Risk of respiratory depression
Prolonged use at high doses may result in hyperalgesia
Progressive withdrawal recommended
Interrupt infusion if hypotension occurs
Consider dose reduction or alternative opioid in cases of hyperalgesia
In obese patients dosing should be based on ideal weight
Not licensed for all indications in all age groups
Reduce dose in debilitated patients
Reduce dose in elderly
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)

A fall in blood pressure may occur which may exaggerated in the hypovolaemic patient or in the presence of concomitant sedative medication. Appropriate measures to maintain a stable arterial pressure should be taken.

Significant respiratory depression and loss of consciousness will occur following doses of alfentanil exceeding 1mg, and this effect is dose related. This effect is usually short in duration and can be reversed by specific opioid antagonists, such as naloxone. The duration of respiratory depression may last for longer than the opioid antagonist action, therefore additional doses of the antagonist may be required.

Alfentanil may cause bradycardia, an effect that may be marked and rapid in onset but which can be antagonised by atropine. Particular care must be taken following treatment with drugs which may depress the heart or increase vagal tone, such as anaesthetic agents or beta-blockers.

Cardiac arrest following bradycardia has been reported on very rare occasions in non-atropinised patients. Therefore it is advisable to be prepared to administer an anticholinergic drug.

Patients on chronic opioid therapy or with a history of opioid abuse may require higher doses.

Rapid bolus injections should be avoided in patients with compromised intracerebral compliance. A transient decrease in the mean arterial pressure, occasionally with a transient reduction of the cerebral perfusion pressure, may be experienced in these patients.

Hyperventilation during anaesthesia may alter the patient's response to carbon dioxide and affect respiration after the procedure.

Non-epileptic (myo)clonic movements may occur.

There maybe a higher risk of respiratory complications when alfentanil is administered to neonates and very young children than when it is used in older children and adults. Young paediatric subjects should be monitored immediately after administration of alfentanil is commenced.

Risk of muscle rigidity in neonates and young infants. All children should be monitored for a sufficient period of time following cessation of treatment with alfentanil to ensure the return of spontaneous respiration has been achieved.

Pregnancy and Lactation

Pregnancy

Use alfentanil with caution during pregnancy.

The manufacturer advises caution when prescribing alfentanil during pregnancy.

At the time of writing there is limited published information regarding the use of alfentanil during pregnancy. Alfentanil crosses the placenta, and regular use during pregnancy may result in drug dependence in the foetus and withdrawal symptoms in the neonate. Use of alfentanil during labour may result in respiratory depression in the neonate. Animal studies have not shown teratogenic or acute embryotoxic effects.

Lactation

The use of alfentanil is contraindicated during breastfeeding.

The manufacturer does not recommend the use of alfentanil during breastfeeding. Alfentanil is secreted into breast milk, and may cause respiratory depression in the breastfeed infant.

LactMed (2018) states that there is limited data regarding intravenous use thus alternative agents are preferred. If alfentanil is used during breastfeeding and the infant shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately.

Effects on Ability to Drive and Operate Machinery

This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them.

Side Effects

Agitation
Allergic dermatitis
Anaphylaxis
Apnoea
Arrhythmias
Asystole
Biliary spasm
Bradycardia
Bradypnoea
Bronchospasm
Cardiac arrest
Circulatory failure
Coma
Confusion
Constipation
Convulsions
Cough
Decrease in heart rate
Dependence
Difficulty in micturition
Disorientation
Dizziness
Drowsiness
Dry mouth
Dyskinesia
Dysphoria
Elevation of liver enzymes
Epistaxis
Erythema
Euphoria
Excitation
Fatigue
Fever
Flushing
Hallucinations
Headache
Hiccups
Hypercapnia
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Hypotension
Hypothermia
Hypoxia
Laryngospasm
Local pain (injection site)
Miosis
Mood changes
Movement disturbances
Muscle rigidity
Myoclonic movements
Nausea
Oedema
Pain
Palpitations
Postural hypotension
Pruritus
Raised intracranial pressure
Rash
Respiratory arrest
Respiratory depression
Restlessness
Sedation
Sensation of cold
Sexual dysfunction
Shivering
Sleep disturbances
Somnolence
Tachycardia
Unconsciousness
Ureteric spasm
Urinary retention
Urticaria
Vertigo
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: September 2018

Reference Sources

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

Summary of Product Characteristics. Alfentanil 500microgram/ml solution for injection. Hameln Pharmaceuticals Ltd. Revised July 2018.

Summary of Product Characteristics. Rapifen 500micrograms/ml solution for injection or infusion. Piramal Critical Care Ltd. Revised August 2020.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Alfentanil Last revised: 31 October 2018
Last accessed: 20 May 2021

Gov.uk. Government departments. Department for Transport. Publications. Drug driving and medicine: Advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: https://www.gov.uk/ Last accessed: 07 September 2018
New drug driving offence. Implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: https://www.mhra.gov.uk Last accessed: 07 September 2018

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 September 2018