1. Name Of The Medicinal Product
Terpin and Codeine Linctus
2. Qualitative And Quantitative Composition
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For a full list of excipients, see section 6.1
3. Pharmaceutical Form
Linctus
4. Clinical Particulars
4.1 Therapeutic Indications
Codeine is indicated in adults for symptomatic relief of troublesome coughs
4.2 Posology And Method Of Administration
Oral.
Recommended doses
Adults: 5ml, diluted with water.
The elderly: as adult dose with caution.
Dosage schedule
The dose may be repeated after 6 hours, but not more than 3 doses in any 24 hours.
If symptoms persist for more than 7 days consult your doctor.
Paediatric population
Codeine should not be used for the treatment of children under the age of 18 years.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
In the use of monoamine oxidase inhibitors or within 2 weeks discontinuation of their use.
During an acute asthmatic attack.
In cases of acute colitis.
Contraindicated in cases of liver disease and respiratory depression. Avoid use in children under 12 years. Avoid use in patients with raised intracranial pressure or head injury.
4.4 Special Warnings And Precautions For Use
Take after food.
Shake the bottle.
Do not exceed the stated dose.
Keep all medicines out of the reach and sight of children
Avoid alcoholic drinks.
Use with caution in renal impairment or in a history of asthma
Use with caution in the elderly as codeine may contribute to faecal impaction, producing incontinence, spurious diarrhoea, abdominal pain and rarely colonic obstruction.
Prolonged use could aggravate irritable bowl syndrome.
If symptoms persist consult your doctor.
Avoid driving and operating machinery.
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.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Antagonism of the effects of metoclopramide; codeine phosphate has the opposing effects on gastro-intestinal activity. Codeine may delay/reduce the absorption (of eg. mexiletine, flecainide), cause 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. May enhance the effects of alcohol.
Opioid analgesics may potentiate the depressant effects of anaesthetics, tricyclic antidepressants and antipsychotics.
The gastrointestinal effects of domperidone (as well as metoclopramide) can be antagonised.
4.6 Pregnancy And Lactation
There is no, or inadequate, evidence of safety in human pregnancy. The drugs have been widely used for many years without apparent ill consequence, but use in pregnant women should be avoided unless considered necessary.
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 codeine 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, terpin and 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 operation 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. Use may result in hypersensitivity reactions to menthol, terpin and codeine. Epigastric pain may follow administration on an empty stomach.
4.9 Overdose
The effects in overdosage 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 adults presents within one hour of ingestion of more than 350mg or a child more than 5mg/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, or eight hours if a sustained release presentation has been taken.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
R05F B 02- Cough suppressants and expectorants
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.
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.
Menthol acts to ventilate the bronchial passages and is excreted in the urine and bile as a glucuronide.
Terpin hydrate is stated to increase bronchial secretions and assist expectoration.
5.2 Pharmacokinetic Properties
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.
Menthol - no information available.
Terpin hydrate - no information available.
5.3 Preclinical Safety Data
No data of relevance, which is additional to that on other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Cineole BPC 1973, ethanol BP, glycerol BP, pumilio pine oil BP, syrup BP and purified water BP.
6.2 Incompatibilities
No major incompatibilities known.
6.3 Shelf Life
200m1: 36 months unopened.
6.4 Special Precautions For Storage
Store below 25°C.
Protect from light
6.5 Nature And Contents Of Container
200ml: amber glass bottle with white 28mm child resistant tamper evident cap with EPE /Saranex liner.
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 00240/5026R
9. Date Of First Authorisation/Renewal Of The Authorisation
14/09/2007
10. Date Of Revision Of The Text
23/11/2010
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