Diamorphine hydrochloride parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Powder for solution for injection of diamorphine hydrochloride.
Drugs List
Therapeutic Indications
Uses
Pain - severe
Pain in acute myocardial infarction
Pain in acute pulmonary oedema
For the use of severe pain such as that associated with myocardial infarction, cancer, acute pulmonary oedema and in palliative care.
Dosage
Adults
Acute myocardial infarction
5mg administered by slow intravenous injection at a rate of 1mg per minute. If necessary a further dose of 2.5mg to 5mg may be administered.
Acute pulmonary oedema
2.5mg to 5mg administered by slow intravenous injection at a rate of 1mg per minute.
Pain requiring parenteral opioid
Acute to chronic
5mg to 10mg every 4 hours based on individual response, administered by intramuscular or subcutaneous injection.
If administered by slow intravenous injection, the dose should be one quarter to one half of the corresponding intramuscular dose.
Children
Starting dose should be determined based on individual patients age, size, symptoms and previous analgesic requirements. If treatment continues for more than 24 hours it may be appropriate to use a syringe driver.
The following dosing schedule may be suitable:
Acute or chronic pain
Administered by intravenous injection
Children aged 12 to 18 years
2.5mg to 5mg every 4 hours.
Children aged 1 to 12 years
75mg/kg to 100microgram/kg every 4 hours. Maximum dose is 5mg every 4 hours.
Children aged 6 months to 1 year
75micrograms/kg every 4 hours.
Children aged 3 to 6 months
25micrograms/kg to 50micrograms/kg every 6 hours.
Children aged 1 to 3 months
20micrograms/kg every 6 hours.
Administered by continuous intravenous infusion
Children aged 1 month to 12 years
12.5micrograms/kg/hour to 25 microgram/kg/hour.
Administered by intramuscular or subcutaneous injection
Children aged 12 to 18 years
5mg every 4 hours.
Neonates
The following dosing schedule may be suitable:
Ventilated
Initial dose: 50micrograms/kg administered by slow intravenous injection over a period of 30 minutes.
Followed by a further continuous intravenous infusion of 15micrograms/kg per hour.
Non-Ventilated
2.5micrograms/kg/hour to 7micrograms/kg/hour administered by continuous intravenous infusion.
Additional Dosage Information
In cancer pain parenteral administration of diamorphine is appropriate when oral administration is no longer possible due to the dosage required or where impaired absorption, intestinal disorders, nausea, vomiting or difficulty in swallowing is experienced.
Transfer of patients from oral opioid to parenteral treatment should be carried out under close medical supervision. Tables of equivalent doses are readily available in standard text books.
Contraindications
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Alcoholism
Biliary colic
Breastfeeding
Coma
Head trauma
Obstructive pulmonary disease
Paralytic ileus
Phaeochromocytoma
Pregnancy
Raised intracranial pressure
Respiratory depression
Precautions and Warnings
Children under 18 years
Debilitation
Elderly
Severe obesity
Shock
Adrenal insufficiency
Asthma
Benign prostatic hyperplasia
Biliary tract disorder
Central nervous system depression
Delirium tremens
Drug misuse
Epileptic disorder
Gastrointestinal obstruction
Hepatic impairment
History of alcohol abuse
History of drug misuse
Hypotension
Hypothyroidism
Kyphoscoliosis with respiratory compromise
Myxoedema
Pulmonary emphysema
Reduced respiratory reserve
Renal impairment
Respiratory impairment
Severe diarrhoea
Severe inflammatory bowel disease
Toxic psychosis
Urethral stricture
Asthma: avoid use during acute exacerbations
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 this medicine is subject to driving restrictions
Not all available strengths are licensed for all indications
Not all routes are licensed for all indications
Respiratory monitoring required in neonates and children under 1 year
Tolerance and dependence may occur
Avoid abrupt withdrawal
Tolerance and physical dependence may occur after a few weeks of therapy. This does not prevent reduction and discontinuation when medically appropriate, and drug abuse does not generally occur when used for relief of pain.
Neonates and children under one are particularly susceptible to respiratory depression Respiratory monitoring is recommended and respiratory support should be available for non ventilated children.
In the control of pain in terminal illness, the precautions should not necessarily be a deterrent to the use of diamorphine hydrochloride.
Diamorphine should be used with caution in patients with head injuries due to the increased risk of respiratory depression which may lead to elevations in intracranial pressure. The sedative and pupillary effects of diamorphine may interfere with monitoring of the patient.
Pregnancy and Lactation
Pregnancy
Diamorphine is contraindicated in pregnancy.
Use in the third trimester is not advisable due to the risk of respiratory depression in the new born. Use during labour may cause gastric stasis and inhalation pneumonia in the mother.
Withdrawal symptoms may occur in neonates of dependent mothers.
Acute opiate withdrawal should be avoided during pregnancy, substitution with methadone is recommended.
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
Diamorphine is contraindicated during breastfeeding.
Diamorphine is able to transfer into human breast milk in sufficient quantities to cause addiction in the infant.
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). This medicine may be subject to police testing and has specified maximum blood levels for driving.
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.
It is an offence to drive while under the influence of this medicine. However, a patient is not committing an offence (called 'statutory defence') if: 1. The medicine has been prescribed to treat a medical or dental problem and 2. The medicine has been taken according to the instructions given by the prescriber and/or in the information provided with the medicine, and 3. The medicine was not affecting the ability to drive safely. For further guidance see https://www.gov.uk
Side Effects
Anorexia
Biliary spasm
Bradycardia
Cardiac arrest
Confusion
Constipation
Dependence
Difficulty in micturition
Dizziness
Dry mouth
Dysphoria
Euphoria
Facial flushing
Faintness
Hallucinations
Headache
Hypotension
Hypothermia
Impotence
Miosis
Mood changes
Nausea
Palpitations
Postural hypotension
Pruritus
Raised intracranial pressure
Rash
Reduced libido
Respiratory depression
Sedation
Sexual dysfunction
Shock
Sweating
Syncope
Tachycardia
Taste disturbances
Ureteric spasm
Urinary retention
Urticaria
Vertigo
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: June 2017
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.
Summary of Product Characteristics: Diamorphine Hydrochloride BP 5mg Lyophilisate for solution for injection. Actavis UK Ltd. Revised February 2016.
Summary of Product Characteristics: Diamorphine Hydrochloride BP 10mg Lyophilisate for solution for injection. Actavis UK Ltd. Revised February 2016.
Summary of Product Characteristics: Diamorphine Hydrochloride BP 30mg Lyophilisate for solution for injection. Actavis UK Ltd. Revised February 2016.
Summary of Product Characteristics: Diamorphine Hydrochloride BP 100mg Lyophilisate for solution for injection. Actavis UK Ltd. Revised February 2016.
Summary of Product Characteristics: Diamorphine Hydrochloride BP 500mg Lyophilisate for solution for injection. Actavis UK Ltd. Revised July 2017.
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 5mg. Auralis. Revised January 2010.
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 10mg. Auralis. Revised January 2010.
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 30mg. Auralis. Revised January 2010.
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 100mg. Auralis. Revised January 2010.
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 500mg. Auralis. Revised September 2008.
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 5mg.Teva UK Ltd. Revised August 2014.
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 10mg.Teva UK Ltd. Revised August 2014.
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 30mg. Teva UK Ltd. Revised August 2014.
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 100mg. Teva UK Ltd. Revised August 2014.
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 500mg. Teva UK Ltd. Revised August 2014.
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 5mg. ViroPharma Ltd. Revised August 2013.
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 10mg. ViroPharma Ltd. Revised August 2013.
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 30mg. ViroPharma Ltd. Revised August 2013.
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 100mg.ViroPharma Ltd. Revised August 2013.
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 500mg. ViroPharma Ltd Revised August 2013.
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 5mg. Wockhardt UK Ltd. Revised June 2014
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 10mg. Wockhardt UK Ltd. Revised June 2014
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 30mg. Wockhardt UK Ltd. Revised June 2014
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 100mg. Wockhardt UK Ltd. Revised June 2014
Summary of Product Characteristics: Diamorphine Hydrochloride for injection 500mg. Wockhardt UK Ltd. Revised June 2014
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
NICE - Evidence Services Available at: www.nice.org.uk Last accessed: 27 June 2017.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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