1. Name Of The Medicinal Product
Rhotard Morphine SR 60 mg Tablets
Morphgesic SR 60 mg Tablets
2. Qualitative And Quantitative Composition
Rhotard Morphine SR 60 mg Tablets/ Morphgesic SR 60 mg Tablets contain 60mg Morphine Sulphate.
Each 60mg tablet is an orange coloured biconvex round film coated tablet.
3. Pharmaceutical Form
Controlled release tablets
4. Clinical Particulars
4.1 Therapeutic Indications
For the prolonged relief of severe pain.
4.2 Posology And Method Of Administration
Route of administration: Oral
Rhotard Morphine SR/ Morphgesic SR tablets should be swallowed whole and not chewed.
Adults:
The dosage is dependent upon the severity of the pain and the patient's previous history of analgesic requirements. The tablets should normally be administered twice daily at 12 hourly intervals. One or two 10 mg tablets (10mg) twice daily is the recommended starting dosage for a patient presenting with severe pain. With increasing severity of pain it is recommended that the dosage of morphine be increased to achieve the desired relief. The dosage may be varied by choosing combinations of available strengths (10, 30, 60, and 100 mg) or by using higher strength tablets alone.
It is recommended that a patient transferred from another oral morphine preparation, having similar bioavailability to oral morphine liquid, should receive the same total morphine dose in one 24-hour period. This total dose should be divided between the morning and evening administration. Dosage titration and clinical assessment may be appropriate.
Where a patient had previously received parenteral morphine prior to being transferred to Rhotard Morphine SR/ Morphgesic SR tablets, a higher dosage of morphine may be required. Individual dosage adjustment will be necessary to compensate for any reduction in analgesic effect associated with oral administration.
When Rhotard Morphine SR/ Morphgesic SR is to be given for the relief of post-operative pain, it is not advisable to administer it during the first 24 hours. Following this initial period, the dosage should be at the physician's discretion.
Some patients may require supplemental parenteral morphine which is perfectly acceptable. Careful attention should be paid to the total morphine dosage however, and the prolonged effects of morphine in the Rhotard Morphine SR/ Morphgesic SR formulation should also be borne in mind.
Rhotard Morphine SR/ Morphgesic SR tablets should be used with caution post-operatively (as with all morphine preparations) but especially in cases of 'acute abdomen' and following abdominal surgery.
Gastric motility should have returned and be maintained.
Children:
Rhotard Morphine SR/ Morphgesic SR tablets are not recommended for paediatric use.
4.3 Contraindications
Respiratory depression, paralytic ileus, delayed gastric emptying, obstructive airways disease, known morphine sensitivity or acute hepatic disease. It is also contra-indicated in the presence of hypersensitivity to any of the constituents, acute alcoholism, head injuries and conditions in which intracranial pressure is raised. Neither should it be given during an attack of bronchial asthma nor heart failure secondary to chronic lung disease.
Not recommended for pre-operative use or for the first 24 hours post-operatively.
Not recommended during pregnancy and lactation.
Concurrent administration of monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuation of their use.
4.4 Special Warnings And Precautions For Use
Rhotard Morphine SR/ Morphgesic SR tablets should be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy or shock. It should be used with caution in patients with either obstructive bowel disorders or myasthenia gravis.
Caution in patients with convulsive disorders, hypotension with hypovolaemia, the elderly, opioid dependent patients, diseases of the biliary tract, pancreatitis and inflammatory bowel disorders.
Should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected to occur during use, treatment should be discontinued immediately.
As with all morphine preparations, patients who are to undergo cordotomy or other pain relieving surgical procedures should not receive Rhotard Morphine SR/ Morphgesic SR tablets for 24 hours prior to surgery. If further treatment is then indicated, the dosage should be adjusted to the new post-operative requirement.
It is not possible to ensure bio-equivalence between different brands of controlled release morphine products. Therefore, it should be emphasised that patients, once titrated to an effective dose should not be changed from Rhotard Morphine SR/ Morphgesic SR tablets to other slow, sustained or controlled release morphine or other potent narcotic analgesic preparations without retitration and clinical assessment.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Rhotard Morphine SR/ Morphgesic SR should not be concurrently administered with monoamine oxidase inhibitors (MAOI's) or used within two weeks of discontinuation of MAOI use. The depressant effects of morphine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, tricyclic antidepressants and phenothiazines. The action of morphine may in turn affect the activities of other compounds, for example its gastro-intestinal effects may delay absorption as with mexilitine or may be counteractive as with metoclopramide.
Cimetidine inhibits the metabolism of morphine.
Morphine potentiates the effects of tranquillisers, muscle relaxants and anti-hypertensives.
Mixed agonist/antagonist opioid analgesics (e.g. Buprenorphine, nalbuphine, pentazocine) should not be administered to a patient who has received a course of therapy with a pure opioid agonist analgesic.
4.6 Pregnancy And Lactation
Rhotard Morphine SR/ Morphgesic SR tablets are contraindicated during pregnancy and lactation.
4.7 Effects On Ability To Drive And Use Machines
Patients taking Rhotard Morphine SR/ Morphgesic SR should not operate machines.
4.8 Undesirable Effects
The commonest side-effects of morphine when administered at normal doses are nausea, vomiting, constipation, drowsiness and confusion. Micturition may be difficult and there may be ureteric or biliary spasm. There is also an antidiuretic effect. Dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypothermia, restlessness, changes of mood and miosis also occur. These effects occur more commonly in ambulant patients than in those at rest in bed. Raised intracranial pressure occurs in some patients. Larger doses of morphine produce respiratory depression and hypotension with circulatory failure and deepening coma. Death may occur from respiratory failure. Toxic doses vary considerably with the individual. Tolerance and dependence may occur.
Paralytic ileus may be associated with opioid usage. Other effects include bronchospasm, headache, disorientation, hallucinations, rash, myoclonus, decreased libido and colic.
Morphine has histamine releasing effects which may be responsible in part for reactions such as urticaria and pruritus.
4.9 Overdose
In acute poisoning by Rhotard Morphine SR/ Morphgesic SR tablets, the stomach should be emptied by aspiration and lavage. A laxative may be given to aid peristalsis. Signs of morphine toxicity and overdose are likely to consist of pin-point pupils, respiratory depression and hypotension. Circulatory failure and deepening coma may occur in more severe cases.
Treatment of respiratory failure and shock may require intensive supportive therapy. In addition to this the specific antagonist naloxone hydrochloride should be administered at a dose of 0.4 to 2 mg iv. This dose should be repeated at intervals of 2 to 3 minutes if required, up to a total dose of 10mg.
The physician should be aware that Rhotard Morphine SR/ Morphgesic SR tablets remaining in the intestine will continue to release morphine sulphate for a period of hours.
Rhabdomyolysis progressing to renal failure has been reported in opioid overdosage.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Morphine is an opioid analgesic. It acts mainly on the central nervous system and on smooth muscle. Although morphine is predominantly a central nervous system depressant it has some central stimulant actions which results in nausea and vomiting and miosis. Morphine generally increases smooth muscle tone, especially the sphincters of the gastro-intestinal tract.
Morphine and related analgesics may produce both physical and psychological dependence and should therefore be used with discrimination. Tolerance may also develop.
Morphine is an analgesic used for the symptomatic relief of moderate to severe pain, especially that associated with neoplastic disease, myocardial infarction and surgery. When pain is likely to be short of duration, a short-acting analgesic is usually preferred in addition to relieving pain, morphine also alleviates the anxiety associated with severe pain. It is useful as a hypnotic where sleeplessness is due to pain and may also relieve the pain of biliary or renal colic, although an antispasmodic may also be required since morphine may increase smooth muscle tone.
Morphine reduces intestinal motility and is used in the symptomatic treatment of diarrhoea. It also relieves the dyspnoea of left ventricular failure and of pulmonary oedema. It is effective for the suppression of cough, but codeine is usually preferred as there is less risk of dependence. Morphine has been used pre-operatively as an adjunct to anaesthesia for pain relief and to allay anxiety. It has also been used in high doses as a general anaesthetic in specialised procedures. Morphine is usually administered as the sulphate, although the hydrochloride and the tartrate are used in similar doses; the acetate has also been used. Routes of administration include the oral, subcutaneous, intramuscular, intravenous, intraspinal and rectal routes. Parenteral doses may be intermittent injections or continuous or intermittent infusions adjusted according to individual analgesic requirements.
5.2 Pharmacokinetic Properties
Morphine has a plasma half life of about 2 to 3 hours and if given IV must be administered frequently. Rhotard Morphine SR/ Morphgesic SR, being a sustained release preparation of morphine, has the advantage that it is only administered twice daily.
A summary of the morphine pharmacokinetic parameters is given below:
(a) Half life; plasma half life; about 2-3 hours
(b) Volume of distribution; about 3-5 litres/KG
(c) Clearance; plasma clearance; about 15 to 20 ml/min/kg
(d) Protein binding; in plasma 20-35%
Pharmacokinetic parameters pertinent to Rhotard Morphine SR/ Morphgesic SR are summarised in the following table:
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5.3 Preclinical Safety Data
No preclinical safety data are available which are additional to the experience gained in man with morphine over many years.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lactose, Hydroxyethylcellulose, Hypromellose (E464), Povidone, Talc, Magnesium Stearate, Macrogol and Industrial Methylated Spirits 99% BP.
Rhotard Morphine SR 60 mg Tablets/ Morphgesic SR 60 mg Tablets contain the colourants listed below:
Titanium Dioxide (E171)
FD&C Yellow #6/Sunset Yellow FCF Lake (E110)
6.2 Incompatibilities
None.
6.3 Shelf Life
36 Months
6.4 Special Precautions For Storage
1Do not store above 25°C. Store in the original package.
6.5 Nature And Contents Of Container
Each pack contains either 10 or 60 tablets in PVC blister packs with aluminium foil lidding.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Waymade plc
Trading as : Sovereign Medical
Sovereign House
Miles Gray Road
Basildon
Essex.
SS14 3FR
United Kingdom
And trading as Amdipharm
Regency House
Miles Gray Road
Basildon
Essex
SS14 3AF
United Kingdom
8. Marketing Authorisation Number(S)
PL 06464/1653
9. Date Of First Authorisation/Renewal Of The Authorisation
28 June 2002
10. Date Of Revision Of The Text
April 2003
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