1. Name Of The Medicinal Product
Codeine Linctus BP
2. Qualitative And Quantitative Composition
Codeine Phosphate BP 15mg/5ml dose.
3. Pharmaceutical Form
Linctus.
4. Clinical Particulars
4.1 Therapeutic Indications
Codeine is indicated in adults for relief of the symptoms of dry or irritating coughs.
4.2 Posology And Method Of Administration
Oral.
Recommended doses
Adults: one 5ml spoonful
The elderly: Use with caution, not exceeding the recommended adult dose.
Paediatric population
Codeine should not be used for the treatment of children under the age of 18 years.
Dosage schedule
The dose may be repeated after four hours if required, but not more than 4 doses in any 24 hours.
4.3 Contraindications
Contraindicated:
In cases of liver disease and respiratory depression.
In patients with raised intracranial pressure or head injury.
During an acute asthmatic attack
Hypersensitivity to codeine or to any of the other ingredients.
Concurrent use of monoamine oxidase inhibitors or within 2 weeks discontinuation of their use.
4.4 Special Warnings And Precautions For Use
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Use with caution in patients with large bowel disease, renal impairment or 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.
Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. Estimates indicate that up to 7% of the caucasian population may have this deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression. Estimates indicate that up to 1 to 2% of the caucasian population may be ultra-rapid metabolisers.
Precautions/warnings to be declared on labels:
Do not exceed the stated dose.
Keep all medicines away from children.
Use with caution if elderly.
Do not take during pregnancy except on a doctor's advice.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Antagonism of the effects of metoclopramide; codeine phosphate has the opposing effect on gastro-intestinal activity. Opioid analgesics can antagonise the gastrointestinal effects of domperidone
May cause delayed absorption of flecainide and mexiletine, and potentiation of the effects of hypnotics and anxiolytics.
When used with monoamine-oxidase inhibitors this may cause CNS excitation and hypertension, the effects can occur up to two weeks after stopping MAOI'S.
The effects of alcohol may be enhanced and codeine phosphate can be absorbed by light kaolin.
Opioid analgesics may potentiate the depressant effects of anaesthetics, tricyclic antidepressants and antipsychotics.
4.6 Pregnancy And Lactation
The product should not be used during pregnancy unless considered necessary by the physician.
Opioid administration near term may cause respiratory depression in the newborn.
At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.
However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolites may be present in breast milk and on very rare occasions 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 codine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.
4.7 Effects On Ability To Drive And Use Machines
Using the dose recommended, codeine linctus is not considered to be a hazard, however the use of codeine phosphate may cause sedation, dizziness and nausea. If affected driving or operating of machinery would not be advised.
4.8 Undesirable Effects
Use may result in tolerance and dependence, sedation, dizziness, nausea and constipation.
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.
Due to the histamine releasing effect, reactions such as urticaria and pruritus occur in some individuals.
4.9 Overdose
Following large doses of codeine, respiratory depression, hypotension with circulatory failure and deepening coma, excitement, and in children convulsions may occur.
Death may occur due to respiratory failure.
Toxic doses vary considerably with the individual addicts may tolerate large doses.
Treatment of overdose should consist of aspiration and gastric lavage together with supportive therapy such as replacement of fluids and electrolytes.
Naloxone may be given to counteract respiratory depression.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Codeine depresses the cough reflex, partly by a direct effect on a cough centre in the medulla; the exact mechanism is not entirely clear. It has been suggested that the usual doses of opioids produce their major effect on the patients subjective reactions to the cough, rather than on the frequency and intensity of coughing.
5.2 Pharmacokinetic Properties
Codeine phosphate is absorbed from the gastro-intestinal tract, it is metabolised by O- 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 concentrations in about one hour. The plasma half-life has been reported to be between 2½ and 4 hours after ingestion.
5.3 Preclinical Safety Data
None.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Citric Acid Monohydrate BP, Purified Water BP, Lemon Oil Terpeneless BP, Chloroform BP, Ethanol (96%) BP, Benzoic Acid Solution BP, Invert Syrup BP, Quinoline Yellow Solution Compound, Syrup BP.
6.2 Incompatibilities
Codeine phosphate is incompatible with bromides, iodides and salts of heavy metals.
It is incompatible with phenobarbitone sodium, forming a codeine-phenobarbitone complex.
6.3 Shelf Life
100ml: 24 months unopened
200ml: 24 months unopened
500ml: 24 months unopened
2000 ml: 24 months unopened
6.4 Special Precautions For Storage
Protect from light.
Store below 25°C.
6.5 Nature And Contents Of Container
100ml: Amber glass bottle with polypropylene cap or white 28mm child-resistant cap with tamper evident band and EPE/Saranex liner.
200ml: Amber glass bottle with polypropylene cap or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.
500ml: Amber glass bottle with plastic cap and saranex/epe liner or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.
2000ml: Amber glass bottle with plastic cap and saranex/epe liner or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
L.C.M. LIMITED
Linthwaite Laboratories
Huddersfield
HD7 5QH
8. Marketing Authorisation Number(S)
PL 12965/0009
9. Date Of First Authorisation/Renewal Of The Authorisation
21.7.1993
10. Date Of Revision Of The Text
09/12/2010
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