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Morphine sulfate oral solution

Updated 2 Feb 2023 | Opioid analgesics

Presentation

Oral solution containing morphine sulfate.

Drugs List

  • morphine sulfate 10mg/5ml oral solution
  • ORAMORPH 10mg/5ml oral solution
  • Therapeutic Indications

    Uses

    Treatment of severe pain

    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.

    Adults

    Analgesia
    10mg to 20 mg every 4 hours or as directed by a physician. Maximum daily dose should not exceed 120mg.
    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
    Initial dose of 5mg to 20mg every 4 hours. Maximum daily dose should not exceed 120mg.

    Children aged 6 to 12 years
    Initial dose of 5mg to 10 mg every 4 hours. Maximum daily dose should not exceed 60mg.

    Children aged 1 to 6 years
    Initial dose of 5mg every 4 hours. Maximum daily dose should not exceed 30mg.

    Children under 1 year
    Not recommended - Morphine sulfate oral solution is not licensed for children under 1 year.

    The following unlicensed doses may also 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, e.g. 2.5mg to 5mg and extended dosing intervals. Titrate according to response.

    Below 10 ml/minute GFR: use small doses, e.g. 1.25mg to 2.5mg 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
    Hereditary fructose intolerance
    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
    Glucose-galactose malabsorption syndrome
    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
    Contains alcohol
    Contains hydroxybenzoate
    Preparation contains sucrose
    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 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 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.

    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 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

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