Morphine sulfate oral solution concentrated
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral solution containing concentrated morphine sulfate.
Drugs List
Therapeutic Indications
Uses
Pain - severe
Unlicensed Uses
Cough in terminal disease
Treatment of neonatal opioid withdrawal
Dosage
The dosage is dependent on the severity of the pain and the patient's previous history of analgesic requirements. Increasing severity of pain or tolerance to morphine will require increased dosage to achieve the desired relief.
A reduced dose may be appropriate where sedation is undesirable.
The required dose may be added to a soft drink immediately before administration.
Adults
Analgesia
10mg to 20mg every 4 hours or as directed by a physician.
For chronic pain it is recommended 5mg to 10mg every four hours, adjusted according to response.
Increasing severity of pain or tolerance to morphine will require increased dosage to achieve the desired relief. If a patient is still experiencing pain it is recommended that the dose is increased by 30 to 50% per dosage.
Cough in terminal disease (unlicensed)
Initial dose of 5mg every 4 hours.
Elderly
A reduction in the adult dosage may be necessary.
Children
Analgesia
Children aged 12 to 18 years
5mg to 20mg every 4 hours, adjusted according to individual patient response. Maximum daily dose should not exceed 120mg.
Children aged 6 to 12 years
5mg to 10mg every 4 hours, adjusted according to individual patient response. Maximum daily dose should not exceed 60mg.
Children aged 1 to 6 years
5mg every 4 hours, adjusted according to individual patient response. Maximum daily dose should not exceed 30mg.
Children under 1 year
Not recommended - Morphine sulfate concentrated oral solution is not licensed for children under 1 year.
The following unlicensed doses may be suitable:
Children aged 12 to 18 years
Initial dose of 5mg to 10mg every 4 hours, adjusted according to individual patient response.
Children aged 2 to 12 years
Initial dose of 200 micrograms/kg to 300 micrograms/kg every 4 hours, adjusted according to individual patient response. Maximum of 10mg per dose.
Children aged 1 to 2 years
Initial dose of 200 micrograms/kg to 300 micrograms/kg every 4 hours, adjusted according to individual patient response.
Children aged 6 to 12 months
Initial dose of 200 micrograms/kg every 4 hours, adjusted according to individual patient response.
Children aged 3 to 6 months
Initial dose of 100 micrograms/kg to 150 micrograms/kg every 4 hours, adjusted according to individual patient response.
Children aged 1 to 3 months
Initial dose of 50 micrograms/kg to 100 micrograms/kg every 4 hours, adjusted according to individual patient response.
Neonates
Neonatal opioid withdrawal (unlicensed)
Initial dose of 40 micrograms/kg every 4 hours until symptoms controlled. If considered necessary, dose may be increased, but should be reduced gradually to 40 micrograms/kg once a day over a period of 6 to 10 days.
Patients with Renal Impairment
Use with caution in patients with moderate to severe renal impairment, it may be advisable to use a reduced dose as there may be increased cerebral sensitivity.
The Renal Dose Handbook suggests the following dose adjustments:
20 ml/minute to 50 ml/minute GFR: 75% of normal dose
10 ml/minute to 20 ml/minute GFR: use small doses, 2.5mg to 5 mg and extended dosing intervals. Titrate according to response.
Below 10 ml/minute GFR: use small doses, 1.25mg to 2.5 mg and extended dosing intervals. Titrate according to response.
Additional Dosage Information
Transferring Patients from Parenteral to Oral Morphine
Patients should be given a sufficiently increased dosage to compensate for any reduction in analgesic effect associated with oral administration. This increased requirement is of the order of 50 to 100%. A reduced dose should be given in situations where sedation is undesirable.
Contraindications
Acute abdomen
Acute alcohol intoxication
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Acute asthma
Acute hepatic disorder
Cardiac failure secondary to pulmonary disorder
Coma
Delayed gastric emptying
Head trauma
Obstructive pulmonary disease
Paralytic ileus
Phaeochromocytoma
Pregnancy
Raised intracranial pressure
Respiratory depression
Precautions and Warnings
24 hours post-operatively
Children under 1 year
Debilitation
Elderly
Adrenal insufficiency
Asthma
Benign prostatic hyperplasia
Biliary tract disorder
Breastfeeding
Cardiac arrhythmias
Delirium tremens
Drug misuse
Gastrointestinal obstruction
Hepatic impairment
History of alcohol abuse
History of drug misuse
History of opioid abuse
Hypotension
Hypothyroidism
Hypovolaemia
Inflammatory bowel disease
Myasthenia gravis
Myxoedema
Opioid dependence
Pancreatitis
Renal impairment
Respiratory impairment
Seizures
Urethral stricture
Avoid 4 hours before cordotomy/pain relieving surgical procedures
Reduce dose in hypothyroidism
Reduce dose in patients with hepatic impairment
Reduce dose in patients with renal impairment
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
Monitor for constipation; give laxatives as required
Monitor patients with a history of alcoholism and drug abuse
Potential for drug abuse
Tolerance and dependence may occur
Avoid abrupt withdrawal
Discontinue if paralytic ileus is suspected
Discontinue if paralytic ileus occurs
Reduce dose in elderly
Advise patient that the effects of alcohol may be potentiated
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.
Pregnancy and Lactation
Pregnancy
Morphine sulfate concentrated oral solution is contraindicated in pregnancy.
The use of morphine preparations 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 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 morphine sulfate concentrated oral solution with caution in breastfeeding.
Morphine is excreted in breast milk. 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-opioid 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
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
Advise patients that morphine may reduce attention and reaction time and so impair the ability to drive or to operate machines. This should be anticipated particularly at the beginning of treatment, when dosage is increased or when associated with concomitant alcohol or other sedative medicines.
Advise patients to avoid alcohol during treatment.
The required dose may be added to a soft drink immediately before administration.
Side Effects
Abdominal pain
Abnormal thinking
Agitation
Amenorrhoea
Anaphylactoid reaction
Anaphylaxis
Anorexia
Anti-diuretic effect
Asthenia
Biliary spasm
Bradycardia
Bronchospasm
Confusion
Constipation
Cough suppression
Delirium
Dependence
Depression
Disorientation
Dizziness
Drowsiness
Dry mouth
Dyspepsia
Dysphoria
Erectile dysfunction
Euphoria
Excitation
Facial flushing
Fasciculation
Gastro-intestinal disturbances
Hallucinations
Headache
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Hypertonia
Hypotension
Hypothermia
Ileus
Increases in hepatic enzymes
Infertility
Insomnia
Malaise
Micturition disorders
Miosis
Mood changes
Muscle rigidity
Myoclonus
Nausea
Nystagmus
Oedema
Orthostatic hypotension
Palpitations
Pancreatitis
Paraesthesia
Pruritus
Raised intracranial pressure
Rash
Reduced libido
Respiratory depression
Restlessness
Rhabdomyolysis
Seizures
Sexual dysfunction
Sleep disturbances
Somnolence
Syncope
Tachycardia
Taste disturbances
Tolerance
Ureteric spasm
Urinary retention
Urticaria
Vertigo
Visual disturbances
Vomiting
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 ).
Further Information
Last Full Review Date: March 2014
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, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Summary of Product Characteristics: Oramorph oral concentrated solution. Boehringer Ingelheim Limited. Revised October 2012
The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.
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: 16 January 2014
Last accessed: March 05, 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: 08 september 2017
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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