Brands of Codeine in Kenya:
Codeine Phosphate, Cosmos Limited
Codeine is indicated in adults for the relief of an unproductive dry cough.
Codeine sulfate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses reserve codeine for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated.
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
DOSAGE AND ADMINISTRATION
Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with Codeine Phosphate in order to minimise the risk of addiction and drug withdrawal syndrome.
For Mild to Moderate Pain
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.
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. The dose is based on the body weight (0.5-1mg/kg).
Children aged less than 12 years:
Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine.
Dosage should be reduced in elderly patients.
For dry or painful cough
15-30mg 3-4 times daily.
Children aged less than 12 years:
Codeine is contraindicated in children below the age of 12 years for the symptomatic treatment of cough.
Children aged 12 years to 18 years
Codeine is not recommended for use in children aged 12 years to 18 years with compromised respiratory function for the symptomatic treatment of cough.
Dosage should be reduced in elderly patients
30mg three to four times daily (range 15-60mg)
Dosage should be reduced in elderly patients
Suspected opiate abuse, known hypersensitivity to codeine or any of the other ingredients.
Liver or respiratory failure or patients at risk of paralytic ileus.
In patients with raised intracranial pressure or head injury.
In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.
During an acute asthma attack.
Children under 18 years of age.
In women during breastfeeding.
Antimuscarinics: codeine phosphate may increase the risk of antimuscarinic side effects such as dry mouth, urine retention and constipation (but this does not generally apply to antimuscarinics taken by inhalation).
Metabolism of codeine is accelerated by rifampicin leading to reduced effect.
As an opioid analgesic, codeine phosphate may potentiate the effects of tranquillisers such as barbiturates, general anaesthetics, anxiolytics and hypnotics, sedatives and alcohol.
Possible CNS excitation or depression (hypertension or hypotension) can occur when opioid analgesics are given with antidepressants such as moclobemide (a reversible MAO-A inhibitor). The sedative effects of codeine can possibly be increased when given with tricyclic antidepressants, with anxiolytics or hypnotics, or with sedating antihistamines. Antipsychotic medicines can enhance hypotensive and sedative effects when opioid analgesics are given with antipsychotics.
Monoamine oxidase inhibitors: MAOIs taken with pethidine have been associated with severe CNS excitation or depression (including hypertension or hypotension). Although this has not been documented with codeine, it is possible that a similar interaction may occur and therefore the use of codeine should be avoided while the patient is taking MAOIs and for 2 weeks after MAOI discontinuation, including MAO-B inhibitor selegiline. This may also apply to the antibacterial linezolid, which is a reversible, non-selective MAO inhibitor.
Anti-emetics: The reduction in intestinal motility caused by codeine may delay the absorption or antagonise the gastrointestinal effects of other drugs e.g. metoclopramide and domperidone.
Metabolism of opioid analgesics is inhibited by cimetidine leading to increased plasma concentration.
Anti-arrhythmics: May delay the gastro-intestinal absorption of mexiletine or quinidine (which may also reduce the efficacy of codeine).
The opioid analgesics enhance effects of sodium oxybate, used to treat symptoms of narcolepsy and concomitant use should be avoided.
Psychiatric disorders: hallucinations, dysphoria, euphoria, mood changes, restlessness, confusion.
Nervous system disorders: dizziness, drowsiness, seizures, addiction, tolerance, dependence, headache, vertigo, malaise, sleep disturbances.
Eye disorders: miosis, visual disturbances.
Cardiac disorders: palpitations, bradychardia, tachycardia.
Vascular disorders: postural hypotension, hypothermia, facial flushing, oedema.
Respiratory, thoracic and mediastinal disorders: respiratory depression.
Gastrointestinal disorders: nausea, vomiting, constipation, abdominal pain, anorexia, pancreatitis, dry mouth.
Hepatobiliary disorders: biliary spasm.
Skin and subcutaneous tissue disorders: rashes, urticaria, pruritis, sweating.
Musculoskeletal and connective tissue disorders: muscle fasciculation or rigidity.
Renal and urinary disorders: difficulty with micturition, ureteric spasm or retention.
Reproductive system and breast disorders: decreased libido or potency.
Reporting of suspected adverse reactions
The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
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. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, email@example.com or clicking below button:
Clinical | Pharmacokinetic data
Pregnancy Category: C
Routes of Administration: By mouth, rectal, subcutaneous injection, intramuscular injection
Bioavailability: Oral: ~90%
Protein Binding: Not Available
Metabolosim: Liver: CYP2D6 (to morphine), CYP3A4 (to norcodeine), UGT2B7 (to 3- and 6-glucuronides of codeine, norcodeine, and morphine)
Onset of Action: 15–30 minutes
Elimination Half life: 2.5–3 hours
Excretion: Urinary excretion accounts for 4 to 11 per cent of the administered drug as free codeine, 42 to 58 per cent as conjugated codeine, and 46 to 69 per cent as total codeine
Legal Status | Dosage forms & Strengths
Prescription only Medicine (POM) , ℞-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This is a controlled Schedule 1 Drug ,Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:
|CompTox Dashboard (EPA)|
- Williams, D. G., D. J. Hatch, and R. F. Howard. “Codeine phosphate in paediatric medicine.” British Journal of Anaesthesia 86.3 (2001): 413-421.
- Shah, Jaymin C., and William D. Mason. “Plasma codeine and morphine concentrations after a single oral dose of codeine phosphate.” The Journal of Clinical Pharmacology 30.8 (1990): 764-766.
- Band, Christian J., et al. “Human pharmacokinetic study of immediate‐release (codeine phosphate) and sustained‐release (codeine Contin) codeine.” The Journal of Clinical Pharmacology 34.9 (1994): 938-943.