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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 adults as an analgesic, an anti-tussive, and for the symptomatic treatment of chronic diarrhoea. Codeine is indicated in patients older than 12 years for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen alone.
Verbatim from this product's MHRA label. Tap a section to expand.
4).
Posology As an analgesic:
Adults: 30-60mg every four hours, when necessary to a maximum 240mg daily.
Elderly:
Dosage should be reduced in the elderly where there is impairment of hepatic or renal function.
As an anti-tussive:
Adults: 15-30mg three or four times daily.
Elderly:
Dosage should be reduced in the elderly where there is impairment of hepatic or renal function.
For the symptomatic treatment of chronic diarrhoea:
Adults: 15-60mg every four to six hours.
Elderly:
Dosage should be reduced in the elderly where there is impairment of hepatic or renal function. Codeine should be used at the lowest effective dose for the shortest period of time. This 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. Codeine Phosphate tablets should not be used longer than necessary.
Paediatric population Children over 12 years 30-60mg every four hours, when necessary to a maximum 240mg daily. 4). Method of Administration For oral use Treatment goals and discontinuation Before initiating treatment with Codeine Phosphate tablets, 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.
Immune system disorders: (may be caused by histamine release) – including rash, urticaria, pruritus, difficulty breathing, increased sweating, redness or flushed face. 4). Nervous system disorders: confusion, drowsiness, malaise, tiredness, vertigo, dizziness, changes in mood, hallucinations, CNS excitation (restlessness/excitement), convulsions, mental depression, headache or nightmare, raised intracranial pressure, tolerance or dependence, dysphoria, hypothermia.
Eye disorders: - miosis, blurred or double vision. Cardiac disorders: bradycardia, palpitations, hypotension, orthostatic hypotension, tachycardia. Respiratory, thoracic and mediastinal disorders: respiratory depression with larger doses.
Gastrointestinal disorders: constipation (too constipating for long-term use), biliary spasm, nausea, vomiting, dry mouth, pancreatitis. Muscoskeletal, connective tissue and bone density: muscle rigidity. Hepatobiliary disorders: sphincter of Oddi dysfunction.
Renal and urinary disorders: ureteral spasm, antidiuretic effect, urinary retention. Reproductive system and breast disorders: decrease in libido and potency. General disorders and administration site conditions: uncommon: drug withdrawal syndrome.
Withdrawal effects: abrupt withdrawal precipitates a withdrawal syndrome. Symptoms may include tremor, insomnia, restlessness, irritability, anxiety, depression, anorexia, nausea, vomiting, diarrhoea, sweating, lacrimation, rhinorrhoea, sneezing, yawning, piloerection, mydriasis, weakness, pyrexia, muscle cramps, dehydration, and increase in heart rate, respiratory rate and blood pressure.
Drug dependence: repeated use of Codeine Phosphate tablets can lead to drug dependence, even at therapeutic doses. 4). NOTE – tolerance diminishes rapidly after withdrawal so a previously tolerated dose may prove fatal. - Regular prolonged use of codeine is known to lead to addiction and tolerance.
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 tablets. Repeated use of Codeine Phosphate tablets 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 tablets 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. Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia.
g. emphysema; - Asthma – Opioids should not be administered during an asthma attack, hepatic failure; - Head injuries or conditions where intracranial pressure is raised; - Acute alcoholism; - Diarrhoea associated with either pseudomembranous colitis or poisoning; - Risk of paralytic ileus.
4). - In children below the age of 12 years for the symptomatic treatment of cough and/or cold due to an increased risk of developing serious and life-threatening adverse reactions. 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.
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4).
Symptoms of restlessness and irritability may result when treatment is then stopped. - Prolonged use of a painkiller for headaches can make them worse. 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.
Opioid use increases the risk of CSA in a dose- dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Hyperalgesia Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.
This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality.
Symptoms of hyperalgesia may resolve with a reduction of opioid dose. 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. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Codeine Phosphate Tablets and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Codeine Phosphate Tablets concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Hepatobiliary disorders Codeine may cause dysfunction and spasm of the sphincter of Oddi, thus increasing the risk of biliary tract symptoms and pancreatitis.
Therefore, codeine has to be administered with caution in patients with pancreatitis and diseases of the biliary tract. 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 therapeutic 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 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. 9% Northern European 1% to 2% Post-operative use in children There have been reports in the published literature that codeine given post-operatively in children after tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, led to rare, but […]