Drugs List

Therapeutic Indications

Uses

For the relief of chronic and acute severe pain

Administration

For rectal administration

Contraindications

Children under 1 month

Acute respiratory depression

Obstructive pulmonary disease

Within 2 weeks of discontinuing treatment with an MAOI

Acute hepatic disorder

Raised intracranial pressure

Acute abdomen

Head trauma

Convulsive disorders

Acute alcohol intoxication

Acute asthma

Risk of paralytic ileus
Paralytic ileus

Phaeochromocytoma

Coma

Delayed gastric emptying

Heart failure secondary to chronic lung disease

Pregnancy ( see Pregnancy )

Precautions and Warnings

Children aged 1 month to 12 years

Reduced respiratory reserve

Asthma

Elderly (see Dosage - Elderly )

Debilitation - reduce dose

Hypothyroidism - reduce dose

Renal impairment (see Dosage - Renal impairment )

Hepatic impairment (see Dosage - Hepatic impairment )

Breastfeeding ( see Lactation )

Hypotension

Prostatic hypertrophy

Adrenocortical insufficiency - reduce dose

Biliary tract disorder

Obstructive or inflammatory bowel disease

Pancreatitis

Shock

Myasthenia gravis

Cardiac arrhythmias

Opioid dependent patients

Morphine should be discontinued at least 4 hours before cordotomy or other pain relieving procedures

Morphine should be used with caution post-operatively, in particular following abdominal surgery as morphine impairs intestinal motility. If paralytic ileus is suspected, or occurs, morphine should be discontinued immediately

Due to the effects of morphine, it has the potential for abuse. Use with caution in patients with a history of drug or alcohol abuse. Tolerance and dependence may occur.

Abrupt withdrawal should be avoided after long term treatment

Morphine may cause sedation, and so patients should be advised not to drive or operate machinery if they experience drowsiness.

Pregnancy and Lactation

Pregnancy

The use of morphine suppositories is not recommended by the manufacturer for use during pregnancy and labour. Teratogenic effects have been observed in animal studies, but there are currently no reports linking use at therapeutic doses with major congenital defects, and there is not thought to be any increased incidence of birth defects in humans. Use for prolonged periods of time or at term should be avoided due to increased risk of neonatal respiratory depression and withdrawal following maternal use, particularly if used during labour. Use in the third trimester and during labour should therefore be avoided. Maternal addiction can also increase the risk of neonatal withdrawal syndrome. Effects on the neonate include tremors, irritability, diarrhoea, vomiting and seizures. There is a possibility of long-term or late-developing behavioural abnormalities, but the link is unclear at the time of writing.

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 ).

Recommended for use in pregnancy? - No.

Known human teratogen? - Unknown.

Animal data - Teratogenic effects observed in some studies.

Crosses placenta? - Yes, rapidly.

Other information - Not recommended due to risk of effects on neonate, but may be used if compellingly indicated.

Lactation

Morphine is not recommended for use during lactation. However, no toxic symptoms were observed in an infant exposed to up to 12% of the maternal dose, and the levels are not thought to be clinically relevant. Morphine is considered an opiate analgesic of choice during breastfeeding due to its relatively poor oral bioavailability of 26%. The infant should be monitored for drowsiness, adequate weight gain and developmental milestones, particularly younger, exclusively breastfed infants. Medical advice should be sought immediately if the infant suffers from increased sleepiness, has difficulty breastfeeding, breathing difficulties or limpness. Particular care should be taken with children with a tendency for apnoea, due to the risk of respiratory depression, and infants should be monitored for somnolence and respiratory problems in the case of repeated doses. Opiate analgesics should only be used for short periods of time during breastfeeding; consider limiting the mother's parenteral morphine dosage by supplementing analgesia with a non-narcotic analgesic. The long-term effects on neurobehaviour and development are unknown at the time of writing, but warrant further study.

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

Drug excreted in breast milk? - Yes, in amounts unlikely to be harmful to the infant.

Considered suitable or recommended by manufacturer? - No.

UK Drugs in Lactation Advisory Service Classification - May be administered to breastfeeding mothers.

Drug substance licensed in infants? - Yes.

Side Effects

Constipation
Nausea
Respiratory depression
Urinary retention
Dry mouth
Sweating
Facial flushing
Bradycardia
Palpitations
Restlessness
Mood changes
Hallucinations
Vomiting
Confusion
Drowsiness
Hypotension
Muscle rigidity
Difficulty in micturition
Ureteric spasm
Biliary spasm
Headache
Vertigo
Tachycardia
Postural hypotension
Hypothermia
Dysphoria
Dependence
Miosis
Reduced libido
Reduction of male potency
Rash
Urticaria
Pruritus
Abdominal pain
Agitation
Amenorrhoea
Anorexia
Bronchospasm
Cough suppression
Delirium
Depression
Disorientation
Dizziness
Dyspepsia
Euphoria
Excitation
Hypertension
Malaise
Myoclonus
Nystagmus
Pancreatitis
Paraesthesia
Paralytic ileus
Oedema
Raised intracranial pressure
Rhabdomyolysis
Seizures
Sleep disturbances
Syncope
Taste disturbances
Visual disturbances
Withdrawal symptoms

Presentation

Suppositories containing 10mg morphine sulfate
Suppositories containing 15mg morphine sulfate
Suppositories containing 20mg morphine sulfate
Suppositories containing 30mg morphine sulfate

Drugs List

Therapeutic Indications

Uses

For the relief of chronic and acute severe pain

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Administration

For rectal administration

Contraindications

Children under 1 month

Acute respiratory depression

Obstructive pulmonary disease

Within 2 weeks of discontinuing treatment with an MAOI

Acute hepatic disorder

Raised intracranial pressure

Acute abdomen

Head trauma

Convulsive disorders

Acute alcohol intoxication

Acute asthma

Risk of paralytic ileus
Paralytic ileus

Phaeochromocytoma

Coma

Delayed gastric emptying

Heart failure secondary to chronic lung disease

Pregnancy ( see Pregnancy )

Precautions and Warnings

Children aged 1 month to 12 years

Reduced respiratory reserve

Asthma

Elderly (see Dosage - Elderly )

Debilitation - reduce dose

Hypothyroidism - reduce dose

Renal impairment (see Dosage - Renal impairment )

Hepatic impairment (see Dosage - Hepatic impairment )

Breastfeeding ( see Lactation )

Hypotension

Prostatic hypertrophy

Adrenocortical insufficiency - reduce dose

Biliary tract disorder

Obstructive or inflammatory bowel disease

Pancreatitis

Shock

Myasthenia gravis

Cardiac arrhythmias

Opioid dependent patients

Morphine should be discontinued at least 4 hours before cordotomy or other pain relieving procedures

Morphine should be used with caution post-operatively, in particular following abdominal surgery as morphine impairs intestinal motility. If paralytic ileus is suspected, or occurs, morphine should be discontinued immediately

Due to the effects of morphine, it has the potential for abuse. Use with caution in patients with a history of drug or alcohol abuse. Tolerance and dependence may occur.

Abrupt withdrawal should be avoided after long term treatment

Morphine may cause sedation, and so patients should be advised not to drive or operate machinery if they experience drowsiness.

Pregnancy and Lactation

Pregnancy

The use of morphine suppositories is not recommended by the manufacturer for use during pregnancy and labour. Teratogenic effects have been observed in animal studies, but there are currently no reports linking use at therapeutic doses with major congenital defects, and there is not thought to be any increased incidence of birth defects in humans. Use for prolonged periods of time or at term should be avoided due to increased risk of neonatal respiratory depression and withdrawal following maternal use, particularly if used during labour. Use in the third trimester and during labour should therefore be avoided. Maternal addiction can also increase the risk of neonatal withdrawal syndrome. Effects on the neonate include tremors, irritability, diarrhoea, vomiting and seizures. There is a possibility of long-term or late-developing behavioural abnormalities, but the link is unclear at the time of writing.

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 ).

Recommended for use in pregnancy? - No.

Known human teratogen? - Unknown.

Animal data - Teratogenic effects observed in some studies.

Crosses placenta? - Yes, rapidly.

Other information - Not recommended due to risk of effects on neonate, but may be used if compellingly indicated.

Lactation

Morphine is not recommended for use during lactation. However, no toxic symptoms were observed in an infant exposed to up to 12% of the maternal dose, and the levels are not thought to be clinically relevant. Morphine is considered an opiate analgesic of choice during breastfeeding due to its relatively poor oral bioavailability of 26%. The infant should be monitored for drowsiness, adequate weight gain and developmental milestones, particularly younger, exclusively breastfed infants. Medical advice should be sought immediately if the infant suffers from increased sleepiness, has difficulty breastfeeding, breathing difficulties or limpness. Particular care should be taken with children with a tendency for apnoea, due to the risk of respiratory depression, and infants should be monitored for somnolence and respiratory problems in the case of repeated doses. Opiate analgesics should only be used for short periods of time during breastfeeding; consider limiting the mother's parenteral morphine dosage by supplementing analgesia with a non-narcotic analgesic. The long-term effects on neurobehaviour and development are unknown at the time of writing, but warrant further study.

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

Drug excreted in breast milk? - Yes, in amounts unlikely to be harmful to the infant.

Considered suitable or recommended by manufacturer? - No.

UK Drugs in Lactation Advisory Service Classification - May be administered to breastfeeding mothers.

Drug substance licensed in infants? - Yes.

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

Counselling

Morphine may cause sedation, and so patients should be advised not to drive or operate machinery if they experience drowsiness.

Advise patients to avoid alcohol during treatment

Side Effects

Constipation
Nausea
Respiratory depression
Urinary retention
Dry mouth
Sweating
Facial flushing
Bradycardia
Palpitations
Restlessness
Mood changes
Hallucinations
Vomiting
Confusion
Drowsiness
Hypotension
Muscle rigidity
Difficulty in micturition
Ureteric spasm
Biliary spasm
Headache
Vertigo
Tachycardia
Postural hypotension
Hypothermia
Dysphoria
Dependence
Miosis
Reduced libido
Reduction of male potency
Rash
Urticaria
Pruritus
Abdominal pain
Agitation
Amenorrhoea
Anorexia
Bronchospasm
Cough suppression
Delirium
Depression
Disorientation
Dizziness
Dyspepsia
Euphoria
Excitation
Hypertension
Malaise
Myoclonus
Nystagmus
Pancreatitis
Paraesthesia
Paralytic ileus
Oedema
Raised intracranial pressure
Rhabdomyolysis
Seizures
Sleep disturbances
Syncope
Taste disturbances
Visual disturbances
Withdrawal symptoms

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 ).

Shelf Life and Storage

At or below 25 degrees C

Further Information

Last Full Review Date: August 2011

Reference Sources

Summary of Product Characteristics: Morphine Sulfate suppositories 10mg. Aurum Pharmaceuticals Ltd. Revised March 2005
Summary of Product Characteristics: Morphine Sulfate suppositories 15mg. Aurum Pharmaceuticals Ltd. Revised March 2009
Summary of Product Characteristics: Morphine Sulfate suppositories 20mg. Aurum Pharmaceuticals Ltd. Revised March 2009

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

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, 8th edition (2008) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Medications and Mother's Milk, 12th edition (2006) Hale, T.W. Hale Publishing, Amarillo, Texas.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed). Record 370 - Morphine
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Last revised: 5 February 2008
Last accessed: 19 April 2011

UK Drugs in Lactation Advisory Service.
Available at: https://www.ukmicentral.nhs.uk/drugpreg/qrg_p1.asp
Last accessed: 19 April 2011

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: 08 September 2017