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CODEINE PHOSPHATE is a brand name for Codeine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone) Dry or painful cough Diarrhoea
Verbatim from this product's MHRA label. Tap a section to expand.
4). Posology For Mild to Moderate Pain Adults Codeine should be used at the lowest effective dose for the shortest period of time. The dose may be taken, up to 4 times a day at intervals of not less than 6 hours. Maximum daily dose of codeine should not exceed 240mg.
The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician. Elderly Dosage should be reduced in elderly patients.
Paediatric population Children aged 12 years to 18 years:
The recommended codeine dose for children 12 years and older should be 30-60mg every 6 hours when necessary up to a maximum dose of codeine of 240mg daily. 5-1mg/kg). 4). For dry or painful cough Adults: 15-30mg 3-4 times daily. Elderly Dosage should be reduced in elderly patients Paediatric Population Children aged less than 12 years: Codeine is contraindicated in children below the age of 12 years for the symptomatic treatment of cough see section
Regular prolonged use of codeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is then stopped. Prolonged use of a painkiller for headaches can make them worse. Tolerance and some of the most common side effects – drowsiness, nausea, and vomiting, and confusion – generally develops with long term use.
Immune system disorders: maculopapular rash has been seen as part of a hypersensitivity syndrome associated with oral codeine phosphate; fever, splenomegaly and lymphadenopathy also occurred. Endocrine disorders: hyperglycaemia. Metabolism and nutrition disorders: anorexia.
Psychiatric disorders: mental depression, hallucinations and nightmares, restlessness, confusion, mood changes, euphoria and dysphoria. 4). Nervous system disorders: convulsions (especially in infants and children), dizziness, drowsiness, headache (prolonged use of a painkiller for headaches can make them worse).
Raised intracranial pressure may occur in some patients. Eye disorders: blurred or double vision or other changes in vision. Miosis. Ear and labyrinth disorders: vertigo. Cardiac disorders: tachycardia, palpitations and bradycardia. Vascular disorders: postural hypotension, facial flushing.
Large doses produce hypotension.
Respiratory, thoracic and mediastinal disorders:
Dyspnoea. Large doses produce respiratory depression. Gastrointestinal disorders: nausea, vomiting, constipation, dry mouth, stomach cramps.
Hepatobiliary disorders:
Biliary spasm (may be associated with altered liver enzyme values). Skin and subcutaneous tissue disorders: allergic reactions such as skin rashes, urticaria, pruritus, sweating and facial oedema.
3 Contraindications). It should only be used with caution or in reduced dose in elderly patients or debilitated patients, or in patients with hypotension, hypothyroidism, prostatic hypertrophy, adrenocortical insufficiency, inflammatory or obstructive bowel disorders, urethral stricture, shock, convulsive disorders, myasthenia gravis.
3 Contraindications, liver disease). Use with caution in those with a history of drug abuse. CYP2D6 metabolism Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained.
Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses.
These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels. General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite.
In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal. 3). All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid or extensive metabolisers in their ability to metabolise codeine to morphine.
Children with compromised respiratory function Codeine is not recommended for use in children in whom respiratory function might be compromised including 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. Opioid analgesics should be avoided in patients with biliary tract disorders or used in conjunction with an antispasmodic. Administration of pethidine and possibly other opioid analgesics to patients taking a monoamine oxidase inhibitor (MAOI) has been associated with very severe and sometimes fatal reactions.
3. 4). Diarrhoea Adults: 30mg three to four times daily (range 15-60mg) Elderly Dosage should be reduced in elderly patients Paediatric Population Not recommended. Method of administration Oral route Treatment goals and discontinuation Before initiating treatment with Codeine Phosphate, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.
During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with codeine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4). Duration of treatment Codeine Phosphate should not be used longer than necessary. 3 Contraindications Acute respiratory depression, hypersensitivity to codeine or other opioid analgesics or to any of the excipients obstructive airways disease, liver disease, severe hepatic dysfunction, acute alcoholism.
Use should be avoided in patients with raised intracranial pressure or head injury (in addition to the risk of respiratory depression and increased intracranial pressure, may affect pupillary and other responses vital for neurological assessment).
Codeine should not be given to comatose patients. g. pseudomembranous colitis) or diarrhoea caused by poisoning. 6). • In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Codeine in United Kingdom.
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Musculoskeletal and connective tissue disorders:
Uncontrolled muscle movements. Muscle rigidity may occur after high doses. Renal and urinary disorders: difficulty with micturation, urinary retention, ureteric spasm, dysuria. An antidiuretic effect may also occur with codeine. Reproductive system and breast disorders: sexual dysfunction, erectile dysfunction, decreased potency.
Decreased libido. General disorders and administration site conditions: malaise, tiredness, hypothermia. Uncommon: drug withdrawal syndrome. Drug dependence Repeated use of Codeine Phosphate can lead to drug dependence, even at therapeutic doses.
4).
Other possible side effects:
Not known (frequency cannot be estimated from the available data): Gastrointestinal disorders: pancreatitis Hepatobiliary disorders: sphincter of Oddi dysfunction Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
5). The risk-benefit of continued use should be assessed regularly by the prescriber. Tolerance and opioid use disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as Codeine Phosphate.
Repeated use of Codeine Phosphate can lead to OUD. A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Codeine Phosphate may result in overdose and/or death. g.
major depression, anxiety and personality disorders). 2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should contact their physician. g. too early requests for refills).
This includes the review of concomitant opioids and psycho- active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered. Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with Codeine Phosphate.
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.
The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.
If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Hyperalgesia As with other opioids, in case of insufficient pain control in response to an increased dose of codeine, the possibility of opioid-induced hyperalgesia should be considered.
A dose reduction or treatment review may be indicated. Sleep-related breathing disorders Opioids can cause […]