MORPHINE SULFATE is a brand name for Morphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Morphine Sulfate 1 mg/ml solution for injection is indicated for the relief of moderate to severe pain. Morphine sulfate 1 mg/ml solution for injection is used especially in pain associated with cancer, myocardial infarction and surgery. Morphine also helps to relieve the anxiety and insomnia which may be associated…
Verbatim from this product's MHRA label. Tap a section to expand.
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Posology Adults and children over 12 years:
Morphine Sulfate 1 mg/ml solution for injection is formulated for use by the intravenous route in Patient Controlled Analgesia (PCA) systems. PCA, which permits adjustment of dosage according to the patient’s individual needs, must only be carried out in departments and by staff who are trained and have experience of the system.
Patient selection for the use of PCA must ensure that the patient is capable of understanding and following the instructions of the medical/nursing staff. The specific department or unit protocols must be covered to ensure aseptic transfer of the contents of the vial to the PCA system.
There is a considerable variation in analgesic requirements among patients and therefore individualised treatment strategies are required. Dosage should be based on the severity of the pain and the response and opiate tolerance of the patient.
Loading dose Loading doses of typically between 1 mg and 10 mg (maximum 15 mg) of morphine sulfate may be given by intravenous infusion over four or five minutes. The loading dose used will depend upon the patient’s diagnosis and condition.
PCA demand dose An initial demand dose of 1 mg Morphine Sulfate 1 mg/ml solution for injection with a lockout period of 5 to 10 minutes is recommended. Dosages may vary depending on the loading dose, the tolerance and condition of the patient, and whether a background infusion of morphine is being given.
The patient should be specifically monitored for pain, sedation and respiratory rate during the first few hours of treatment to ensure that the dosage regimen is suitable. The duration of treatment should be kept to a minimum, although dependence and tolerance are not generally a problem when morphine is used legitimately in patients with opioid-sensitive pain.
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.
Use in children:
Not recommended for children under 12 years.
The side-effects most commonly seen with morphine and other opioids are respiratory depression, nausea, vomiting, constipation, drowsiness and confusion. With long term use these symptoms generally lessen, although constipation frequently persists.
The following adverse events are from published literature and frequencies are not known. Immune system disorders Anaphylactic reactions and anaphylactoid reactions to morphine have been reported rarely. Endocrine disorders Long term use of opioid analgesics can cause adrenal insufficiency.
Exacerbation of pancreatitis. 4), restlessness, mood changes, hallucinations, delirium, disorientation, excitation, agitation, sleep disturbance. Nervous system disorders Headache, vertigo, euphoria, dysphoria, dizziness, taste disturbances, seizures, paraesthesia, raised intracranial pressure, hyperhidrosis.
4).. Eye disorders Visual disturbances, nystagmus, miosis. Ear and labyrinth disorders Vertigo. Cardiac disorders Bradycardia, tachycardia, palpitations, syncope. Vascular disorders Orthostatic hypotension, hypotension, hypertension, facial flushing, oedema.
Respiratory, thoracic and mediastinal disorders Bronchospasm (in association with anaphylaxis), inhibition of cough reflex. Central sleep apnoea syndrome. Gastrointestinal disorders Dyspepsia, paralytic ileus, abdominal pain, anorexia, dry mouth, pancreatitis.
Hepatobiliary disorders Biliary spasm, spasm of sphincter of Oddi. Skin and subcutaneous tissue disorders Rashes, urticaria, pruritus. Acute generalised exanthematous pustulosis (AGEP). Musculoskeletal and connective tissue disorders Muscle fasciculation, myoclonus, rhabdomyolysis, muscle rigidity.
Renal and urinary disorders Difficult micturition, ureteric spasm, urinary retention. Reproductive system and breast disorders Long term use of opioid analgesics can cause hypogonadism in both men and women. This can lead to amenorrhoea, reduced libido, infertility, depression and erectile dysfunction.
As with other narcotics, a dose reduction may be appropriate in elderly patients, in patients with hypothyroidism, renal and chronic hepatic disease. Morphine Sulfate 1 mg/ml solution for injection should be used with caution in debilitated patients and those with adrenocortical insufficiency (see below); hypopituitarism; prostatic hypertrophy; shock; diabetes mellitus; diseases of the biliary tract; myasthenia gravis; cardiac arrhythmias; excessive obesity; hypotension and severe cardiac failure.
It should also be used with caution post-operatively following total joint arthroplasty (colonic pseudo- obstruction). 5 – Interaction with other medicinal products and other forms of interaction). Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of morphine and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe morphine concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia.
Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as Morphine Sulfate 1 mg/ml solution for injection.
1 - respiratory depression; obstructive airways disease; excessive bronchial secretions; during a bronchial asthma attack or in heart failure secondary to chronic lung disease - head injury; raised intra-cranial pressure - coma - convulsion disorders - ulcerative colitis - presence of a risk of paralytic ileus - biliary and renal tract spasm - acute alcoholism - phaeochromocytoma - moderate to severe renal impairment (glomerular filtration rate <20ml/min) - severe or acute liver failure - patients receiving monoamine oxidase inhibitors or within two weeks of discontinuing such treatment Use of Morphine Sulfate 1 mg/ml solution for injection during pregnancy or lactation is not recommended.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Use in the elderly:
Morphine doses need to be reduced in elderly patients. Method of administration For intravenous injection. The product should not be diluted before use. The medicinal product is to be visually inspected prior to use. Only clear solutions practically free from particles should be used.
Treatment goals and discontinuation Before initiating treatment with Morphine Sulfate 1 mg/ml solution for injection, 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 1 mg/ml solution for injection, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4). Duration of treatment Morphine Sulfate 1 mg/ml solution for injection should not be used longer than necessary.
General disorders and administration site conditions Hypothermia, malaise, asthenia, pain and irritation at the injection site. The side effect uncommonly seen with morphine and other opioids is drug withdrawal syndrome – see Drug dependence and withdrawal syndrome below for further information.
Long Term Use Long term use of opioid analgesics has been associated with a state of abnormal pain sensitivity (hyperalgesia). Tolerance and psychological and physical dependence may occur (see below). Decreased potency may be experienced.
High doses may produce respiratory depression and hypotension, with deepening coma. Convulsions may occur particularly in infants. Drug dependence and withdrawal syndrome Repeated use of Morphine Sulfate 1 mg/ml solution for injection 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 restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.
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.
Repeated use of Morphine Sulfate 1 mg/ml solution for injection can lead to Opioid Use Disorder (OUD). A higher dose and longer duration of opioid treatment, can increase the risk of developing OUD. Abuse or intentional misuse of Morphine Sulfate 1 mg/ml solution for injection may result in overdose and/or death.
g. major depression, anxiety and personality disorders). 2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact their physician.
Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse. g. too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines).
For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered. 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. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.
Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for analgesic treatment should be reviewed regularly. Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with morphine.
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.
The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.
However, when doses of morphine are carefully titrated against pain, clinically significant respiratory depression, dependence, rapid tolerance and euphoria rarely develop. Clinically significant tolerance to morphine is unusual in cancer patients with severe pain.
If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Acute chest syndrome (ACS) in patients with sickle cell disease (SCD) Due to possible association between ACS and morphine use in SCD […]