1. Name Of The Medicinal Product
Ipecacuanha and Morphine Mixture BP 1980
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Mixture
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of coughs.
4.2 Posology And Method Of Administration
Oral.
Recommended doses and dosage schedule
Adults, the elderly and children over 12 years: 10ml.
This dose can he repeated up to 4 times in any 24 hours.
Children under 12 years: Not recommended.
4.3 Contraindications
Due to the presence of morphine this product is contraindicated in respiratory depression. It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.
4.4 Special Warnings And Precautions For Use
Caution is advised in patients with asthma, hepatic and renal disease, and a history of drug abuse.
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4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Concomitant administration of other central nervous system depressants eg. alcohol, hypnotics, sedatives, may result in an enhancement of effects.
It may antagonise the effect of metoclopramide.
4.6 Pregnancy And Lactation
As with all medicines use should be avoided during pregnancy, especially in the first trimester, and in lactation unless recommended by a doctor.
4.7 Effects On Ability To Drive And Use Machines
Although morphine may cause drowsiness, it is not expected that the quantities present in this product will have an effect on the ability to drive etc.
4.8 Undesirable Effects
Adverse effects would not be expected to occur when this preparation is taken at the recommended dose. However, a number of effects are known to arise from administration of morphine, the commonest of these being nausea, vomiting, constipation, drowsiness and confusion.
4.9 Overdose
Overdose with this preparation is unlikely to occur due to the low concentrations of the active ingredients present.
Large doses of ipecacuanha irritate the gastro-intestinal tract and may give rise to bloody vomiting and diarrhoea. Absorption of emetine may have adverse effects on the heart, such as conduction abnormalities or myocardial infarction.
Respiratory depression, nausea and vomiting may occur due to the morphine.
After acute overdosage of ipecacuanha, activated charcoal should be given to delay absorption, followed by gastric lavage if necessary. Excessive vomiting should be controlled by administration of an ant-emetic, and fluid and electrolyte imbalance corrected if necessary.
In acute opiold poisoning the stomach should be emptied by aspiration and lavage, intensive supportive therapy may be required to correct respiratory failure and shock.
Severe respiratory depression and coma produced by excessive doses of opioids can be counteracted by the administration of naloxone given intravenously at a dose of 0.4 to 2mg, repeated at 2-3 minute intervals if necessary, up to 10mg.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Ipecacuanha is an expectorant, and in larger doses an emetic.
Morphine is an opioid analgesic acting mainly on the central nervous system and smooth muscle. It is used for relief of moderate to severe pain and is also effective as a cough suppressant.
5.2 Pharmacokinetic Properties
Emetine one of the major alkaloids of ipecacuanha is excreted or metabolised slowly, it has been detected in urine 40-60 days after discontinuation of treatment.
Morphine salts are absorbed from the gastro-intestinal tract. Morphine is distributed throughout the body. It crosses the placenta and traces have been found in milk and sweat.
Conjugation to morphine 3- and 6- glucuronides occurs in the liver. About 10% of a dose is excreted through the bile into the faeces, the remainder being excreted in the urine in the form of conjugates. About 90% of total morphine is excreted in 24 hours with traces up to 48 hours.
5.3 Preclinical Safety Data
None.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Treacle Black Commercial, Peppermint Oil BP, Ethanol (96%) BP, Diethyl Ether (Peroxide Free), Chloroform BP, Syrup BP and Purified Water BP.
6.2 Incompatibilities
None known.
6.3 Shelf Life
18 months unopened, 8 weeks after first opening.
6.4 Special Precautions For Storage
Store below 25°C.
6.5 Nature And Contents Of Container
200ml: Amber glass bottle with plastic screw cap and 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
Thornton & Ross Limited
Linthwaith Laboratories
Huddersfield
HD7 5QH
8. Marketing Authorisation Number(S)
PL 00240/6491R
9. Date Of First Authorisation/Renewal Of The Authorisation
05/03/2009
10. Date Of Revision Of The Text
30/10/2009
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