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Codeine phosphate oral


Oral formulations of codeine phosphate.

Drugs List

  • codeine phosphate 15mg tablets
  • codeine phosphate 25mg/5ml oral solution
  • codeine phosphate 30mg tablets
  • codeine phosphate 60mg tablets
  • Therapeutic Indications


    Cough (dry or painful)
    Diarrhoea - functional
    Pain - mild to moderate


    Administer the lowest effective dose over the shortest period of time.

    The duration of treatment should be limited to 3 days.


    Mild to moderate pain
    30mg to 60mg to be taken up to 4 times a day, with at least 4 hours between each dose.
    Maximum dose should not exceed 240mg a day.

    Acute diarrhoea
    15mg to 60mg to be taken three to four times a day. The usual recommended dose is 30mg.
    Maximum dose should not exceed 240mg a day.

    Dry or painful cough
    15mg to 30mg to be taken three to four times a day.
    Maximum dose should not exceed 240mg a day.


    (See Dosage; Adult)


    Children aged 12 to 18 years
    Mild to moderate pain
    30mg to 60mg to be given every 6 hours, or when necessary based on individual response. 0.5mg/kg to 1mg/kg of bodyweight is also recommended as a suitable dose.
    Maximum dose should not exceed 240mg a day.

    Acute diarrhoea
    15mg to 60mg to be taken three to four times a day.
    Maximum dose should not exceed 240mg a day

    15mg to 30mg to be taken three to four times a day.
    Maximum dose should not exceed 240mg a day.

    Codeine is not recommended for symptomatic treatment of cough in children aged 12 to 18 years with compromised respiratory function.

    Patients with Renal Impairment

    The Renal Drug Handbook suggests the following doses

    GFR 20ml/minute to 50ml/minute: Dose as normal.

    GFR 10ml/minute to 20ml/minute: 30mg administered every 4 hours. Doses may be increased if tolerated, based on individual patient response.

    GFR less than 10 ml/minute: 30mg administered every 6 hours. Doses may be increased if tolerated, based on individual patient response.


    Acute alcohol intoxication
    Children under 12 years
    Predisposition to paralytic ileus
    Acute asthma
    Acute respiratory depression
    CYP2D6 ultra-rapid metaboliser genotype
    Head trauma
    Obstructive pulmonary disease
    Paralytic ileus
    Raised intracranial pressure
    Severe hepatic impairment
    Severe renal impairment

    Precautions and Warnings

    Acute abdomen
    Children aged 12 to 18 years
    Within 2 weeks of discontinuing MAOIs
    Adrenal insufficiency
    Benign prostatic hyperplasia
    Biliary tract disorder
    Cardiac arrhythmias
    Gall bladder disorder
    Gastrointestinal obstruction
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    History of drug misuse
    Inflammatory bowel disease
    Lactose intolerance
    Myasthenia gravis
    Opioid dependence
    Recent gastrointestinal surgery
    Recent surgery of the urinary tract
    Reduced respiratory reserve
    Renal impairment
    Urethral stricture

    Children under 18 years: Increased risk of rare and severe adverse effects
    Reduce dose in patients with hepatic impairment
    Reduce dose in patients with renal impairment
    Advise ability to drive/operate machinery may be affected by side effects
    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 may be subject to driving restrictions
    Not all available brands are licensed for all age groups
    Some formulations contain lactose
    Potential for drug abuse
    Tolerance and dependence may occur
    Advise patient to stop medication & contact GP if signs of opioid toxicity
    Avoid abrupt withdrawal
    Reduce dose in elderly
    Avoid long term continuous therapy

    Codeine use should be avoided in patients with infective diarrhoea as it may delay the passage of faeces and encourage proliferation of pathogens, consequently masking the severity of the condition.

    Codeine should not be used in paediatric patients who are undergoing tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to the increased risk of adverse reactions.

    Codeine is not recommended for use in children in whom respiratory function might be compromised (for example in neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures). These factors may worsen symptoms of morphine toxicity.

    The long term use of codeine phosphate should be assessed regularly, considering the risks and benefits.

    Following recent urinary tract surgery, patients will be more prone to urinary retention caused by spasm of the urethral sphincter, and via constipation caused by codeine.

    Patients with the CYP2D6 ultra-rapid metaboliser genotype may have an increased risk of developing side effects of opioid toxicity at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.

    Signs of opioid toxicity Patients, parents and caregivers who notice any of the following symptoms when taking, or in a patient given codeine, should stop the medicine and seek medical attention immediately: Slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation and lack of appetite.

    Pregnancy and Lactation


    Use codeine phosphate with caution in pregnancy. Codeine phosphate is contraindicated during labour.

    The risks and benefits should be considered before administering codeine phosphate to a pregnant woman because opioid analgesics cross the placenta. Studies in animals have shown opioids to cause delayed ossification in mice and increased resorption in rats. Regular opioid use during pregnancy may cause physical dependence in the foetus, consequently leading to withdrawal symptoms in the neonate. Neonates exposed to codeine phosphate in pregnancy may experience respiratory malformations.

    During labour, opioids enter the foetal circulation and may cause respiratory depression in the neonate. Gastric stasis and a risk of inhalation pneumonia could occur in the mother during labour. Administration should be avoided during the late stages of labour and during the delivery of a premature infant.
    There have been reports describing association between first trimester exposure to opioid analgesics and congenital defects such as respiratory malformation. When used in late pregnancy, there is a risk of neonatal withdrawal symptoms or respiratory depression. There is also evidence that foetal and newborn toxicity may occur if the mother is addicted to codeine or opioids or consumes high doses of these agents during the latter half of pregnancy or close to delivery. In all cases evaluate whether the benefit to the mother out weighs the risk to the foetus (Briggs, 2015).

    Codeine has been prescribed as a heroin substitute for patients suffering from drug addiction. Due to its addictive properties, codeine has be abused by pregnant women in the past and its administration to patients with a history of drug misuse or who may be currently receiving codeine as a heroin substitute should be deliberated (Schaefer, 2007).

    Schaefer (2007) concludes that codeine may be considered as an analgesic for pregnant women if paracetamol is not sufficiently effective. The potential for dependency must always be kept in mind.

    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 ( ) or if this is unavailable at the backup site ( ).


    Codeine is contraindicated in breastfeeding.

    At normal therapeutic doses codeine phosphate (and its active metabolites) may be present in breast milk at very low doses and is unlikely to adversely affect the nursing infant. However, if the mother has a CYP2D6 ultra-rapid metaboliser genotype, higher levels of the active metabolite, morphine, may be present in breast milk. In very rare occasions, this may result in symptoms of opioid toxicity in the infant. If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be discontinued and replaced with non-opioid analgesics. In severe cases consideration should be given to prescribing naloxone to reverse these adverse effects.
    LactMed suggests neonate infants (particularly in the first week) of life can be sensitive to even small doses of narcotic analgesics which can cause infant drowsiness, asymptomatic bradycardia, apnoea or cyanosis and may contribute to neuroblastoma. Hale (2014), however, indicates that codeine taken in moderation for short durations is suitable for breastfeeding women and has limited adverse effects on their nursing infant. Hale (2014) continues, any report of overt somnolence, apnoea, poor feeding or grey skin should be reported immediately.

    Briggs (2015) indicates that long term use of codeine phosphate should be avoided during breastfeeding, but short term therapy (1 to 2 days) may be compatible with close monitoring of 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

    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.

    Side Effects

    Abdominal pain
    Anti-diuretic effect
    Biliary spasm
    Blurred vision
    Breathing difficulties
    CNS excitation
    Difficulty in micturition
    Double vision
    Dry mouth
    Erectile dysfunction
    Facial flushing
    Faecal impaction
    Maculopapular rash
    Mood changes
    Muscle rigidity
    Orthostatic hypotension
    Postural hypotension
    Raised intracranial pressure
    Reduced libido
    Reduction of male potency
    Respiratory depression
    Sexual dysfunction
    Sleep disturbances
    Slight redness of the skin
    Ureteric spasm
    Urinary retention
    Visual disturbances


    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 ( ) or if this is unavailable at the backup site ( ).

    The MHRA have produced 'generic' overdose sections for the top ten drugs for which the NPIS received the greatest number of queries about management of overdose in 2002. This information is attached below:

    The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

    Further Information

    Last Full Review: November 2016

    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, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    Summary of Product Characteristics: Codeine Phosphate Tablets 15mg . Actavis UK Ltd. Revised October 2016.
    Summary of Product Characteristics: Codeine Phosphate Tablets 30mg. Actavis UK Ltd. Revised October 2016.
    Summary of Product Characteristics: Codeine Phosphate Tablets 60mg. Actavis UK Ltd. Revised October 2016.

    Summary of Product Characteristics: Codeine Phosphate 15mg Tablets. Wockhardt UK Ltd. Revised April 2017.
    Summary of Product Characteristics: Codeine Phosphate 30mg Tablets. Wockhardt UK Ltd. Revised April 2017.
    Summary of Product Characteristics: Codeine Phosphate 60mg Tablets. Wockhardt UK Ltd. Revised April 2017.

    New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: Last accessed: 22 September 2016.

    NICE - Evidence Services
    Available at:
    Last accessed: 23 June 2017.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Codeine. Last revised: 04 February 2016
    Last accessed: 22 September 2016.

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