1. Name Of The Medicinal Product
Codeine Phosphate Syrup BPC 1973
2. Qualitative And Quantitative Composition
Codeine Phosphate 25mg per 5ml
For excipients – see 6.1
3. Pharmaceutical Form
Oral Solution
A clear almost colourless syrupy liquid.
4. Clinical Particulars
4.1 Therapeutic Indications
1. For the relief of the symptoms of diarrhoea in adults and children over 12 years.
2. For the relief of mild to moderate pain in adults and children over 1 year.
Label states “For use as directed by the practitioner”.
4.2 Posology And Method Of Administration
Oral
Recommended doses:
1. For the relief of the symptoms of diarrhoea:
Adults and children over 12 years: One or two 5ml spoonfuls every 4 to 6 hours.
The elderly: Should be used with caution, doses as for adults may be given at the doctor's discretion.
Children under 12 years: Not recommended.
2. For the relief of mild to moderate pain:
Adults and children over 12 years: One or two 5ml spoonfuls to be taken every four hours but not more than eight 5ml spoonfuls in any 24 hours.
Elderly: Should be used with caution, doses as for adults may be given at the doctor's discretion.
Children aged 1 – 12 years: 3mg/kg daily in 4 – 6 divided doses.
Children under 1 year: Not recommended.
Label states “For use as directed by the practitioner”.
4.3 Contraindications
Hypersensitivity to codeine or to any of the other ingredients.
Contraindicated during an acute asthmatic attack, in cases of respiratory depression and liver disease.
Avoid use in children under 1 year.
In patients with raised intracranial pressure or head injury.
Contraindicated in patients at risk of paralytic ileus and in those with acute ulcerative colitis or antibiotic associated colitis.
Concurrent use with monoamine oxidase inhibitors or within 2 weeks discontinuation of their use.
Acute alcoholism
4.4 Special Warnings And Precautions For Use
Use with caution in patients with renal impairment and a history of asthma.
Prolonged use could aggravate irritable bowel syndrome.
Use with caution in the elderly as codeine may induce faecal impaction, producing incontinence, spurious diarrhoea, abdominal pain, and rarely, colonic obstruction.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
If symptoms persist consult your doctor
Use is seldom necessary for the treatment of diarrhoea in children, where fluid and electrolyte replacement in gastro-enteritis and the specific treatment of other diseases causing diarrhoea, is usually more appropriate.
It is potentially harmful if used to treat infective diarrhoeas as it may delay the passage of liquid faeces, encourage proliferation of pathogens and cause the severity of the diarrhoea to be underestimated.
Caution should be exercised in hepatic impairment (reduce dose).
Convulsive disorders
The risk-benefit of continued use should be assessed regularly by the prescriber.
The leaflet will state in a prominent position in the 'before taking' section:
• Do not take for longer than directed by your prescriber.
• Taking codeine regularly for a long time can lead to addition, which might cause you to feel restless and irritable when you stop the syrup.
• Taking a painkiller for headaches too often or for too long can make them worse
The label will state (To be displayed prominently on outer pack – not boxed):
• Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can lead to addiction.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Codeine phosphate causes antagonism of the effects of metoclopramide as they have opposing effects on gastro-intestinal activity.
Opioid analgesics can antagonise the gastrointestinal effects of domperidone.
May enhance the effects of alcohol and cause potentiation of the effects of hypnotics and anxiolytics.
Opioid analgesics may potentiate the depressant effects of anaesthetics, tricyclic antidepressants and antipsychotics.
May cause delayed absorption of flecainide and mexiletine.
CNS excitation and hypertension may occur when taken in conjunction with monoamine oxidase inhibitors – these effects can occur up to two weeks after stopping MAOI's.
4.6 Pregnancy And Lactation
Opioid administration near term may cause respiratory depression in the newborn.
The product should be avoided during pregnancy.
4.7 Effects On Ability To Drive And Use Machines
The use of codeine phosphate may cause sedation, dizziness and nausea, if affected do not drive or operate machinery.
4.8 Undesirable Effects
Use may result in tolerance and dependence, sedation, dizziness, nausea and constipation. Due to the histamine – releasing effect, reactions such as urticaria and pruritis occur in some individuals.
• Regular prolonged use of codeine/DHC 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.
4.9 Overdose
The effects in overdose will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
Symptoms
Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.
Management
This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.
Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC Code – NO2A A59
Codeine phosphate is an opioid analgesic.
5.2 Pharmacokinetic Properties
Codeine phosphate is absorbed from the gastro-intestinal tract, it is metabolised by 0- and N-demethylation in the liver to morphine and norcodeine.
Codeine and its metabolites are excreted almost entirely by the kidney, mainly as conjugates with glucuronic acid.
Ingestion of codeine phosphate produces peak plasma codeine concentration in about 1 hour. The plasma half-life has been reported to be between 2½ and 4 hours after ingestion.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Purified Water
Chloroform
Ethanol (96%)
Syrup
6.2 Incompatibilities
None
6.3 Shelf Life
500ml : 24 months unopened.
2000ml: 24 months unopened.
6.4 Special Precautions For Storage
None.
6.5 Nature And Contents Of Container
500ml: Amber glass bottle with lined plastic cap.
2000ml: Amber glass bottle with lined plastic cap.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Thornton & Ross Ltd
Linthwaite Laboratories
Huddersfield
HD7 5QH
8. Marketing Authorisation Number(S)
PL 00240/6213R
9. Date Of First Authorisation/Renewal Of The Authorisation
12/05/82, 09/12/83
10. Date Of Revision Of The Text
31st August 2007
11. DOSIMETRY (IF APPLICABLE)
Not applicable
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)
Not applicable
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