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MORPHINE SULFATE MUNDIPHARMA is a brand name for Morphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the prolonged relief of severe and intractable pain.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Morphine Sulfate Mundipharma tablets should be used at 12-hourly intervals. The dosage is dependent upon the severity of the pain, the patient's age and previous history of analgesic requirements. 4). g. dihydrocodeine) should normally be started on 30 mg 12 hourly for patients over 70kg, or 20 mg for patients under 70 kg.
Patients previously on normal release oral morphine should be given the same total daily dose as Morphine Sulfate Mundipharma tablets but in divided doses at 12-hourly intervals. Increasing severity of pain will require an increased dosage of the tablets.
Higher doses should be made, where possible in 30-50% increments as required. The correct dosage for any individual patient is that which is sufficient to control pain with no, or tolerable, side effects for a full 12 hours. It is recommended that the 200 mg strength is reserved for patients who have already been titrated to a stable analgesic dose using lower strengths of morphine or other opioid preparations.
Patients receiving Morphine Sulfate Mundipharma tablets in place of parenteral morphine should be given a sufficiently increased dosage to compensate for any reduction in analgesic effects associated with oral administration. Usually such increased requirement is of the order of 100%.
In such patients, individual dose adjustments are required. 8 mg morphine per kg bodyweight 12 hourly is recommended. Doses should then be titrated as for adults. Method of administration Route of administration: oral Morphine Sulfate Mundipharma tablets should be swallowed whole and not broken, chewed or crushed.
9, Overdose). Treatment goals and discontinuation Before initiating treatment with Morphine Sulfate Mundipharma tablets, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.
During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with Morphine Sulfate Mundipharma tablets, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4). Duration of treatment Morphine Sulfate Mundipharma tablets should not be used longer than necessary. Discontinuation of therapy An abstinence syndrome may be precipitated if opioid administration is suddenly discontinued. Therefore, the dose should be gradually reduced prior to discontinuation.
In normal doses, the commonest side effects of morphine are nausea, vomiting, constipation and drowsiness. With chronic therapy, nausea and vomiting are unusual with Morphine Sulfate Mundipharma tablets but should they occur the tablets can be readily combined with an anti-emetic if required.
Constipation may be treated with appropriate laxatives. 4) Eye disorders Visual impairment Miosis Ear and labyrinth disorders Vertigo Cardiac disorders Palpitations Bradycardia Tachycardia Vascular disorders Facial flushing Hypotension Hypertension Respiratory thoracic and mediastinal disorders Bronchospasm Pulmonary oedema Respiratory depression Cough decreased Central sleep apnoea syndrome Gastrointestinal disorders Constipation Nausea Abdominal pain Anorexia Dry mouth Vomiting Dyspepsia Ileus Taste perversion Pancreatitis Hepatobiliary disorders Increased hepatic enzymes Biliary pain Exacerbation of pancreatitis Sphincter of Oddi dysfunction Skin and subcutaneous tissue disorders Rash Urticaria Acute generalised exanthematous pustulosis (AGEP) Renal and urinary disorders Urinary retention Ureteric spasm Reproductive system and breast disorders Amenorrhoea Decreased libido Erectile dysfunction General disorders and administration site conditions Asthenia Fatigue Malaise Pruritus Peripheral oedema Drug withdrawal syndrome Drug tolerance Drug withdrawal (abstinence) syndrome neonatal Drug dependence and withdrawal (abstinence) syndrome Repeated use of Morphine Sulfate Mundipharma tablets can lead to drug dependence, even at therapeutic doses.
4). Use of opioid analgesics may be associated with the development of physical and/or psychological dependence or tolerance. An abstinence syndrome may be precipitated when opioid administration is suddenly discontinued or opioid antagonists administered, or can sometimes be experienced between doses.
4.
Physiological withdrawal symptoms include:
5) • Tolerance, physical dependence and withdrawal (see below) • Opioid Use Disorder • Psychological dependence[addiction], abuse profile and history of substance and/or alcohol abuse (see below) • Acute alcoholism • Delirium tremens • Head injury, intracranial lesions or increased intracranial pressure, reduced level of consciousness of uncertain origin.
• hypotension with hypovolaemia • hypothyroidism • adrenocortical insufficiency • convulsive disorders • biliary tract disorders • pancreatitis • prostatic hypertrophy • inflammatory bowel disorders • severely impaired renal function • severely impaired hepatic function • constipation As with all narcotics a reduction in dosage may be advisable in the elderly.
Should paralytic ileus be suspected or occur during use, Morphine Sulfate Mundipharma tablets should be discontinued immediately. Morphine may lower the seizure threshold in patients with a history of epilepsy. Respiratory Depression The major risk of opioid excess is respiratory depression.
Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use may increase the risk of CSA in a dose-dependent fashion. 8). In patients who present with CSA, consider decreasing the total opioid dosage.
Severe cutaneous adverse reactions (SCARs) Acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, has been reported in association with morphine treatment. Most of these reactions occurred within the first 10 days of treatment.
Patients should be informed about the signs and symptoms of AGEP and advised to seek medical care if they experience such symptoms. If signs and symptoms suggestive of these skin reactions appear, morphine should be withdrawn and an alternative treatment considered.
Hepatobiliary disorders Morphine may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Morphine Sulfate Mundipharma tablets and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
1. • severe chronic obstructive pulmonary disease • severe bronchial asthma • severe respiratory depression with hypoxia and/or hypercapnia • paralytic ileus • acute abdomen • head injury • delayed gastric emptying • known morphine sensitivity • acute hepatic disease • concurrent administration of monoamine oxidase inhibitors or within two weeks of discontinuation of their use Children under one year of age.
Not recommended for pre-operative use or for the first 24 hours postoperatively.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Morphine in United Kingdom.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Body aches, tremors, restless legs syndrome, diarrhoea, abdominal colic, nausea, flu-like symptoms, tachycardia and mydriasis. Psychological symptoms include dysphoric mood, anxiety and irritability. In drug dependence, “drug craving” is often involved.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. 2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation.
5). Acute chest syndrome (ACS) in patients with sickle cell disease (SCD) Due to a possible association between ACS and morphine use in SCD patients treated with morphine during a vaso-occlusive crisis, close monitoring for ACS symptoms is warranted.
g. surgery, plexus blockade) should not receive Morphine Sulfate Mundipharma tablets for 24 hours prior to the intervention. If further treatment with Morphine Sulfate Mundipharma tablets is then indicated, the dosage should be adjusted to the new post-operative requirement.
Morphine Sulfate Mundipharma tablets should be used with caution following abdominal surgery as morphine impairs intestinal motility and should not be used until the physician is assured of normal bowel function. Prolonged release opioids should not be used for acute post-operative pain owing to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI).
It is not possible to ensure bio-equivalence between different brands of prolonged release morphine products. Therefore, it should be emphasised that patients, once titrated to an effective dose, should not be changed from Morphine Sulfate Mundipharma preparations to other slow, sustained or prolonged release morphine or other potent narcotic analgesic preparations without retitration and clinical assessment.
Drug dependence, tolerance and potential for abuse For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. g. major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse.
A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions. Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced.
Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death.
It is important that patients only use medicines that are prescribed and do not give this medicine to anyone else. Patients should be closely monitored for […]