Fentanyl injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection containing fentanyl.
Drugs List
Therapeutic Indications
Uses
Analgesia and suppression of respiratory activity in ventilated patients
Analgesia during surgery
Neuroleptanalgesia (in combination with a neuroleptic)
Treatment of severe pain
Fentanyl is an opioid analgesic used for the following:
Analgesia during short surgical procedures.
Analgesia and respiratory depression in patients requiring assisted ventilation.
In combination with a neuroleptic in the technique of neuroleptanalgesia.
Treatment of severe pain (e.g. the pain of myocardial infarction).
Dosage
Dose should be adjusted to each individual patient depending on age, bodyweight, physical status, underlying conditions, concurrent drugs, and type of surgery and anaesthesia.
Fentanyl should only be administered by experienced personnel in an environment where the airway can be controlled. Resuscitation equipment and opioid antagonists must be readily available.
Adults
In unpremedicated adult patients, 100 micrograms intravenous fentanyl is expected to provide sufficient analgesia for 10 to 20 minutes in surgical procedures involving a low pain intensity.
Fentanyl 500 micrograms injected as a bolus is expected to provide sufficient analgesia for 1 hour in surgical procedures involving a moderate pain intensity.
Fentanyl 50 micrograms/kg bodyweight will provide intense analgesia for approximately 4 to 6 hours, for intensely stimulating surgery.
Doses exceeding 200 micrograms are for use in anaesthesia only.
Intravenous injection
Patients with spontaneous respiration
Initial dose: 50 micrograms to 200 micrograms, based on individual patient.
Supplemental doses: 25 micrograms to 50 micrograms
Patients with assisted ventilation
Initial dose: 300 micrograms to 3500 micrograms
Supplemental doses: 100 micrograms to 200 micrograms
Intramuscular injection
Premedication
50 micrograms to 100 micrograms may be given 45 minutes before anaesthesia is induced.
Intravenous infusion
Patients with spontaneous respiration
Lower infusion rates of 0.05 microgram/kg to 0.08 microgram/kg bodyweight per minute (3 to 4.8 microgram/kg/hour) are required if spontaneous ventilation is to be maintained.
Patients with assisted ventilation
Loading dose of 1 microgram/kg bodyweight per minute for the first 10 minutes followed by an infusion of approximately 0.1 microgram/kg bodyweight per minute (6 microgram/kg/hour).
The loading dose may be administered as a bolus injection.
Infusion rates should be titrated according to the response of the patient.
If post-operative ventilation is not planned, the infusion should be stopped 40 minutes before the end of the surgical procedure.
Higher infusion rates have been used in cardiac surgery (e.g. up to 3 micrograms/kg bodyweight per minute)
Elderly
Dosage should be reduced in elderly patients. The effect of the initial dose should be considered when determining subsequent doses (See Dosage; Adult).
Children
Children aged 12 to 18 years
(See Dosage; Adult)
The following alternate doses may also be suitable:
Patients with assisted ventilation
Initial dose: 1 microgram/kg to 5 microgram/kg by intravenous injection over at least 30 seconds,
Supplemental dose: 50 micrograms to 200 micrograms, as required.
Patients with assisted ventilation in intensive care
Initial dose: 1 microgram/kg to 5 micrograms/kg by intravenous injection.
Supplemental dose: 1 to 6 microgram/kg/hour by intravenous infusion, adjusted according to individual patient response.
Infusion rates should be titrated according to the response of the patient.
If post-operative ventilation is not planned, the infusion should be stopped 40 minutes before the end of the surgical procedure.
Children aged 2 to 12 years
Patients with spontaneous respiration
Initial dose: 1 micrograms/kg to 3 micrograms/kg by intravenous injection, adjusted based on individual patient.
Supplemental dose: 1 micrograms/kg to 1.25 microgram/kg, as required.
Patients with assisted ventilation
Initial dose: 1 micrograms/kg to 3 micrograms/kg by intravenous injection, adjusted based on individual patient.
Supplemental dose: 1 micrograms/kg to 1.25 microgram/kg, as required.
The following alternate doses may be suitable (unlicensed in children under 2 years):
Children aged 1 month to 12 years
Patients with spontaneous respiration
Initial dose: 1 micrograms/kg to 3 micrograms/kg by intravenous injection over at least 30 seconds.
Supplemental dose: 1 microgram/kg, as required.
Patients with assisted ventilation
Initial dose: 1 micrograms/kg to 5 micrograms/kg by intravenous injection over at least 30 seconds.
Supplemental dose: 1 micrograms/kg to 3 micrograms/kg, as required.
The following dose may be suitable (administered by intravenous infusion is unlicensed in children under 12 years):
Children aged 1 month to 18 years
Patients with assisted ventilation in intensive care
Initial dose: 1 microgram/kg to 5 micrograms/kg by intravenous injection.
Supplemental dose: 1 to 6 microgram/kg/hour by intravenous infusion, adjusted according to individual patient response.
Infusion rates should be titrated according to the response of the patient.
If post-operative ventilation is not planned, the infusion should be stopped 40 minutes before the end of the surgical procedure.
Neonates
Patients with assisted ventilation (unlicensed)
Initial dose: 1 microgram/kg to 5 micrograms/kg by intravenous injection over at least 30 seconds.
Supplemental dose: 1 microgram/kg to 3 micrograms/kg, as required.
Patients with assisted ventilation in intensive care (unlicensed)
Initial dose: 1 microgram/kg to 5micrograms/kg by intravenous injection.
Supplemental dose: 1.5 microgram/kg/hour by intravenous infusion, adjusted according to individual patient response.
Infusion rates should be titrated according to the response of the patient.
If post-operative ventilation is not planned, the infusion should be stopped 40 minutes before the end of the surgical procedure.
Patients with Renal Impairment
Dosage should be titrated with care and prolonged monitoring may be required. The effect of analgesia may be prolonged and increased, and there is increased cerebral sensitivity.
Patients with Hepatic Impairment
Dosage should be titrated with care and prolonged monitoring may be required. May precipitate coma.
Administration
For intramuscular injection, intravenous injection or intravenous infusion only.
Contraindications
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Acute asthma
Acute respiratory depression
Chronic obstructive pulmonary disease
Coma
Head trauma
Raised intracranial pressure
Precautions and Warnings
Children under 2 years
Debilitation
Elderly
Obesity
Restricted sodium intake
Adrenal insufficiency
Alcoholism
Asthma
Benign prostatic hyperplasia
Biliary tract disorder
Breastfeeding
Cardiogenic shock
Epileptic disorder
Gastrointestinal obstruction
Hepatic impairment
Hypothyroidism
Hypovolaemia
Inflammatory bowel disease
Myasthenia gravis
Opioid dependence
Pregnancy
Pulmonary disease
Reduced intracerebral compliance
Reduced respiratory reserve
Renal impairment
Seizures
Uncontrolled hypothyroidism
Urethral stricture
Reduce dose in hypothyroidism
Sodium content of formulation may be significant
Advise patient ability to drive or operate machinery may be impaired
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
Not all presentations are licensed for all indications
Treatment to be initiated and supervised by a specialist
Avoid rapid bolus injection if intracerebral compliance is reduced
Resuscitation facilities must be immediately available
May cause respiratory depression
Monitor blood pressure
Monitor patients with a history of alcoholism and drug abuse
Monitor patients with hepatic impairment
Monitor patients with pulmonary insufficiency
Monitor patients with renal impairment
Monitor post operative patients for respiratory and other side effects
Monitor the elderly for optimum dosing
Tolerance and dependence may occur
Reduce dose +/or add antiparkinsonian drug if extrapyramidal symptoms occur
Consider dose reduction in renal impairment
In obese patients dosing should be based on ideal weight
Reduce dose in debilitated patients
Reduce dose in elderly
Advise patient not to take St John's wort concurrently
Intravenous administration may cause a transient fall in blood pressure, especially in hypovolaemic patients. A stable arterial pressure should be maintained.
Fentanyl should only be administered by experienced personnel in an environment where the airway can be controlled. Resuscitation equipment and opioid antagonists must be readily available.
Hyperventilation during anaesthesia may alter the patient's response to carbon dioxide and affect respiration after the procedure.
Doses exceeding 200 micrograms will cause significant respiratory depression. Effects can be reversed by administering specific narcotic antagonists (e.g. naloxone).
Respiratory depression may persist into or recur in the postoperative period. Before the patient is discharged from the recovery area, adequate spontaneous breathing must be established and maintained in the absence of stimulation.
Patients who have not been given atropine may develop bradycardia and possible asystole. However, these effects may be antagonised by atropine.
Fentanyl may cause muscle rigidity. This can be avoided by administering fentanyl by slow intravenous injection, by administering benzodiazepine premedication, and by using muscle relaxants.
Non epileptic (myo)clonic movements may occur.
Higher doses may be required in patients on chronic opioid therapy or those with a history of opioid abuse.
Rapid bolus injections should be avoided in patients with compromised intracerebral compliance. A transient decrease in the mean arterial pressure with a transient reduction of the cerebral perfusion pressure may be experienced in these patients.
There is a higher incidence of hypotension when fentanyl is used with a neuroleptic. Extrapyramidal symptoms may occur, and can be controlled with anti-Parkinson agents.
Due to anticholinergic effects, fentanyl administration may lead to increased bile duct pressure and Sphincter of Oddi spasms.
Pregnancy and Lactation
Pregnancy
Use fentanyl with caution in pregnancy.
Placental transfer of fentanyl has been demonstrated in the first and second trimesters, and at term, and is detectable in foetal blood. The potential risk for humans is unknown, but there are no reports of teratogenic effects or congenital defects. Animal studies have found that fentanyl is not teratogenic in rats, but impaired fertility and embryotoxic effects were seen at intravenous doses only 0.3 times the human dose.
The manufacturer does not recommend the use of fentanyl during labour and delivery due to the risk of respiratory depression in the foetus or neonate. However, studies have shown that the risk of neonatal respiratory depression is small, and fentanyl seems to be less frequently associated with maternal nausea, vomiting or prolonged sedation. Studies comparing intravenous fentanyl with no analgesia during labour found no statistical differences in the neonates in terms of changes in respiratory rate, heart rate, blood pressure, adaptive capacity, neurologic evaluation and overall assessment.
There is some concern, as with any opioid analgesic, that long-term use during pregnancy may cause withdrawal symptoms in the neonate. Mild withdrawal symptoms, without apparent long-term effects were observed in an infant after long-term high-dose maternal treatment with a transdermal fentanyl patch. The neonate should be observed closely for withdrawal syndrome. Schaefer concludes that fentanyl can be used during every phase of pregnancy.
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 to 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 fentanyl with caution in breastfeeding.
Fentanyl is excreted into breast milk, and the manufacturer warns this may cause respiratory depression and sedation in the infant. However, studies have shown that, due to the low oral bioavailability of fentanyl, the amounts the infant is exposed to are so small they are not expected to cause clinically significant adverse effects. No toxic effects have been described following exposure.
LactMed states that when fentanyl is used during labour or for a short time postpartum, it is not necessary to discard milk or enforce a waiting period before resuming breastfeeding; it can resume as soon as the mother is sufficiently recovered to nurse her child. There is no published experience with repeated doses of fentanyl during breastfeeding - in these cases other agents may be preferred, especially in newborn or premature infants.
After repeated exposure, infants should be monitored for drowsiness, adequate weight gain and developmental milestones, especially in younger, exclusively breastfed infants. Consider limiting maternal intake of fentanyl and supplementing with a non-narcotic analgesic if necessary. A physician should be contacted immediately if the infant experiences difficulty in breastfeeding, breathing difficulties or limpness. As with any opiate analgesic, fentanyl should only be used for short periods during breastfeeding, and particular care should be taken with infants with a tendency towards apnoea because of the risk of respiratory depression.
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
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.
Counselling
Patients should be advised not to drive or operate machinery for 24 hours following fentanyl administration.
Side Effects
Abdominal pain
Agitation
Airway obstruction
Allergic dermatitis
Allergic reaction
Amnesia
Anaphylactic shock
Anaphylaxis
Anorexia
Apnoea
Arrhythmias
Asystole
Ataxia
Bladder pain
Blood disorders
Bradycardia
Bronchospasm
Cardiac arrest
Changes of blood pressure
Chills
Confusion
Constipation
Convulsions
Cough increased
Delusions
Dependence
Diarrhoea
Dizziness
Dysarthria
Dyskinesia
Dyspepsia
Dyspnoea
Euphoria
Flatulence
Gastroesophageal reflux
Haemoptysis
Hallucinations
Headache
Hiccups
Hypersensitivity reactions
Hypertension
Hyperventilation
Hypotension
Hypothermia
Hypoventilation
Impaired concentration
Impaired consciousness
Inco-ordination
Insomnia
Laryngospasm
Malaise
Muscle rigidity
Myoclonic movements
Nausea
Paraesthesia
Paralytic ileus
Phlebitis
Pruritus
Pyrexia
Respiratory depression
Sedation
Seizures
Shock
Stomatitis
Sweating
Tachycardia
Thirst
Thrombocytopenia
Urinary retention
Urticaria
Vasodilatation
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 2015
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Summary of Product Characteristics: Fentanyl citrate injection. Martindale Pharmaceuticals Ltd. Revised September 2010.
Summary of Product Characteristics: Fentanyl Injection. Mercury Pharma group. Revised August 2012.
Summary of Product Characteristics: Fentanyl 50 microgram/ml Injection. Hameln pharmaceuticals Ltd. Revised May 2011.
Summary of Product Characteristics: Sublimaze injection. Janssen-Cilag Ltd. Revised June 2017.
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
Fentanyl Last revised: 02 June 2015
Last accessed: 08 September 2015
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: 6 January 2015
New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: https://www.mhra.gov.uk Last accessed: 6 January 2015
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 August 2017
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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