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Morphine sulfate oral standard release

Updated 2 Feb 2023 | Opioid analgesics

Presentation

Standard release oral formulations of morphine sulfate.

Drugs List

  • ACTIMORPH 10mg orodispersible tablet
  • ACTIMORPH 1mg orodispersible tablet
  • ACTIMORPH 2.5mg orodispersible tablet
  • ACTIMORPH 20mg orodispersible tablet
  • ACTIMORPH 30mg orodispersible tablet
  • ACTIMORPH 5mg orodispersible tablet
  • morphine sulfate 10mg orodispersible tablets sugar-free
  • morphine sulfate 10mg tablets
  • morphine sulfate 1mg orodispersible tablets sugar-free
  • morphine sulfate 2.5mg orodispersible tablets sugar-free
  • morphine sulfate 20mg orodispersible tablets sugar-free
  • morphine sulfate 20mg tablets
  • morphine sulfate 30mg orodispersible tablets sugar-free
  • morphine sulfate 50mg tablets
  • morphine sulfate 5mg orodispersible tablets sugar-free
  • SEVREDOL 10mg tablets
  • SEVREDOL 20mg tablets
  • SEVREDOL 50mg tablets
  • Therapeutic Indications

    Uses

    Pain - severe

    Unlicensed Uses

    Cough in terminal disease
    Dyspnoea in terminal disease

    Dosage

    The dosage is dependent on the severity of pain and the patient's previous history of analgesic requirement.

    Patients already receiving opioids may be initiated on higher doses depending on their previous opioid experience.

    If used as breakthrough pain medication, the need for more than two doses daily is usually an indication that the prolonged-release dose requires upward titration.

    Adults

    Tablets
    Acute pain
    10mg to 50mg every four hours, or as directed by the physician.

    Due to enhanced pain severity or tolerance, the dose may be increased using 10mg, 20mg or 50mg alone or in combination to achieve the desired relief.

    Chronic pain
    5mg to 10mg every four hours, or as directed by the physician.

    Due to enhanced pain severity or tolerance, the dose may be increased using 10mg, 20mg or 50mg alone or in combination to achieve the desired relief.

    Cough in terminal disease (unlicensed)
    Initial dose of 5mg every 4 hours.

    Dyspnoea at rest in palliative care (unlicensed)
    Initial dose of 5mg every 4 hours.

    Orodispersible tablets
    Severe pain
    10 to 20mg every four to six hours.
    The dose should then be carefully titrated, every day if necessary, to achieve pain relief.

    Children

    Tablets
    Only the 10mg and 20mg tablets are suitable for children.

    Children aged 12 to 18 years
    (See Dosage; Adult)

    Children aged 6 to 12 years
    5mg to 10mg every 4 hours.

    Children aged 3 to 6 years
    5mg every 4 hours.

    The following unlicensed alternate dosing schedule may be suitable:

    Children aged 12 to 18 years
    Initial dose of 5mg to 10mg every 4 hours, adjusted according to 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 200micrograms/kg to 300micrograms/kg every 4 hours, adjusted according to individual patient response.

    Children aged 6 to 12 months
    Initial dose of 200micrograms/kg every 4 hours, adjusted according to individual patient response.

    Children aged 3 to 6 months
    Initial dose of 100micrograms/kg to 150micrograms/kg every 4 hours, adjusted according to individual patient response.

    Children aged 1 to 3 months
    Initial dose of 50micrograms/kg to 100micrograms/kg every 4 hours, adjusted according to individual patient response.

    Orodispersible tablets
    Orodispersible tablets should not be used for more than seven days in patients less than three years old.
    Children aged 16 to 18 years
    10 to 20mg every four to six hours.

    Children aged 13 to 16 years (40 to 60kg)
    5 to 20mg (about 0.1 to 0.5mg/kg) every 4 to 6 hours.

    Children aged 6 to 13 years (18 to 40kg)
    5 to 10mg (about 0.1 to 0.5mg/kg) every 4 to 6 hours.

    Children aged 1 to 6 years (9 to 18kg)
    2.5 to 5mg (about 0.1 to 0.5mg/kg) every 4 to 6 hours.

    Children over 6 months (6 to 9 kg)
    1mg (about 0.1 to 0.2mg/kg) every 4 to 6 hours.

    Patients with Renal Impairment

    The Renal Dose Handbook suggests the following dose adjustments:

    Glomerular filtration rate 20 to 50ml/min: 75% of normal dose.

    Glomerular filtration 10 to 20ml/min: 50% of normal doses and extended dosing intervals.

    Glomerular filtration less than 10ml/min: 25% of normal dose and extended dosing intervals.

    Additional Dosage Information

    Transferring Patients from Parenteral to Oral Morphine
    Patients should be given an increased dose sufficient to compensate for any reduction in analgesic effect associated with oral administration. This increased requirement is of the order of 100%, individual dose adjustments are advised.

    Correlation between the different routes of administration
    The dose should be divided by 3 when patients are transferred from an oral morphine form to an intravenous form, and halved when transferred to a subcutaneous form.

    Contraindications

    Acute abdomen
    Acute alcohol intoxication
    Children under 6 months
    Risk of paralytic ileus
    Within 2 weeks of discontinuing MAOIs
    Acute asthma
    Acute hepatic disorder
    Breastfeeding
    Cardiac failure secondary to pulmonary disorder
    Coma
    Delayed gastric emptying
    Galactosaemia
    Head trauma
    Labour
    Obstructive pulmonary disease
    Paralytic ileus
    Phaeochromocytoma
    Pregnancy
    Raised intracranial pressure
    Respiratory depression
    Uncontrolled epileptic disorder

    Precautions and Warnings

    24 hours post-operatively
    Children under 3 years
    Constipation
    Debilitation
    Elderly
    Females of childbearing potential
    Impaired consciousness
    Pre-operative administration
    Shock
    Adrenal insufficiency
    Asthma
    Benign prostatic hyperplasia
    Biliary tract disorder
    Delirium tremens
    Drug misuse
    Gastrointestinal obstruction
    Glucose-galactose malabsorption syndrome
    History of alcohol abuse
    History of drug misuse
    History of opioid abuse
    History of psychiatric disorder
    Hypotension
    Hypothyroidism
    Hypovolaemia
    Inflammatory bowel disease
    Lactose intolerance
    Myasthenia gravis
    Opioid dependence
    Pancreatitis
    Psychiatric disorder
    Respiratory impairment
    Seizures
    Severe hepatic disorder
    Severe renal impairment
    Sickle cell disease
    Sleep apnoea
    Urethral stricture

    Avoid 4 hours before cordotomy/pain relieving surgical procedures
    Reduce dose in hypothyroidism
    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
    May reduce seizure threshold
    Not all available brands are licensed for all age groups
    Some formulations contain lactose
    Some preps may contain sulfite; caution hypersensit. in asthma/allergy pts
    Some presentations may contain benzyl alcohol
    If adrenal insufficiency occurs, consider corticosteroid cover
    Monitor for constipation; give laxatives as required
    Monitor patients with a history of alcoholism and drug abuse
    Monitor patients with sickle cell disease for acute chest syndrome symptoms
    Potential for drug abuse
    Tolerance and dependence may occur
    Consider dose reduction if sleep-related breathing disorders occur
    Increased risk of central sleep apnoea and sleep-related hypoxemia
    Prolonged use at high doses may result in hyperalgesia
    Prolonged use may lead to adrenal insufficiency or hypogonadism
    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
    Advise that effects are potentiated by CNS depressants (including alcohol)
    Male & female: Ensure adequate contraception during treatment

    Opioids, such as morphine, may have a pharmacological action on the hypothalamic-pituitary or gonadal axis. Long-term use of opioid analgesics may be associated with decreased levels of sex hormones and increased prolactin levels.

    Pregnancy and Lactation

    Pregnancy

    Morphine sulfate is contraindicated during pregnancy.

    The manufacturer does not recommend using morphine sulfate during pregnancy due to the risk of neonatal respiratory depression. If opioid analgesics are used during pregnancy, the neonate should be monitored for withdrawal signs.

    Lactation

    Morphine sulfate is contraindicated during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst taking morphine sulfate. Morphine is excreted into human breast milk, where it reaches higher concentrations than in maternal plasma.

    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

    For patients with swallowing difficulties, the orodispersible tablet may be placed in a spoon with the addition of a small quantity of water until sufficient dispersion to allow ingestion. This method of administration should be used in patients below the age of 6 years.

    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.

    Advise that effects are potentiated by CNS depressants (including alcohol).

    Side Effects

    Abdominal pain
    Abnormal thinking
    Agitation
    Amenorrhoea
    Anaphylactoid reaction
    Anaphylaxis
    Anorexia
    Asthenia
    Biliary spasm
    Bradycardia
    Bronchospasm
    Confusion
    Constipation
    Convulsions
    Cough suppression
    Decreased appetite
    Delirium
    Dependence
    Depression
    Diplopia
    Disorientation
    Dizziness
    Drowsiness
    Dry mouth
    Dyspepsia
    Dysphoria
    Dyspnoea
    Dysuria
    Erectile dysfunction
    Euphoria
    Excitation
    Facial flushing
    Fasciculation
    Fatigue
    Gastro-intestinal disturbances
    Hallucinations
    Headache
    Hot flushes
    Hyperalgesia
    Hyperhidrosis
    Hypersensitivity reactions
    Hypertension
    Hypertonia
    Hypotension
    Hypothermia
    Hypoxaemia
    Ileus
    Inappropriate secretion of antidiuretic hormone
    Increases in hepatic enzymes
    Insomnia
    Involuntary muscle contractions
    Light-headedness
    Malaise
    Micturition disorders
    Miosis
    Mood changes
    Muscle rigidity
    Myoclonus
    Nausea
    Nightmares
    Nystagmus
    Oedema
    Orthostatic hypotension
    Palpitations
    Pancreatitis
    Paraesthesia
    Pruritus
    Raised intracranial pressure
    Rash
    Reduced libido
    Respiratory depression
    Restlessness
    Sedation
    Seizures
    Sexual dysfunction
    Sleep apnoea
    Sleep disturbances
    Somnolence
    Syncope
    Tachycardia
    Taste disturbances
    Tolerance
    Tremor
    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: November 2019

    Reference Sources

    Summary of Product Characteristics: Actimorph 1mg, 2.5mg, 5mg, 10mg, 20mg & 30mg orodispersible tablets. Ethypharm UK Ltd. Revised July 2021.
    Summary of Product Characteristics: Sevredol tablets. Napp Pharmaceuticals. Revised November 2018.

    The Renal Drug Handbook. 5th Edition (2019) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

    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: 11 November 2019

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 29 March 2022

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