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ACTIMORPH is a brand name for Morphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Severe pain which can be adequately managed only with opioids.
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment goals and discontinuation Before initiating treatment with Actimorph, a treatment strategy including treatment duration and treatment goals, and a plan for end of 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 Actimorph, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. 4).
Posology Actimorph Orodispersible tablets should be administered as follows:
Population Starting dose Adults and adolescents over 16 years 10-20 mg of morphine sulfate every 4-6 hours The dose should then be carefully titrated, every day if necessary, to achieve pain relief. Patients already receiving opioids may be initiated on higher doses depending on their previous opioid experience.
If used for dose titration Actimorph Orodispersible tablets should be taken in a fixed time schedule (every 4 to 6 hours). The correct dose for any individual patient is that which will maintain adequate analgesia with acceptable undesirable effects.
The dose can be increased under medical supervision according to the intensity of the pain the sensitivity and the previous history of analgesic requirements of the individual patient. Duration of treatment This medicinal product should not be used longer than necessary.
If the need for long-term pain treatment is anticipated in view of the nature and severity of the illness, the patient should be switched to prolonged-release analgesics. The total daily dose should be the same. If used as breakthrough pain medication, the need for more than two occasions per day is usually an indication that the prolonged-release dose requires upward titration.
Actimorph Orodispersible tablets can be taken with or without food. Correspondence between the different routes of administration The posology of morphine varies depending on the route of administration. Switching from a morphine pharmaceutical form to another must take conversion factors into account in order to maintain the same amount of morphine available.
The dose should be divided by 3 when patients are transferred from an oral morphine form to an intravenous form, and halved when transferred to a subcutaneous form. 5-5 mg every 4-6 hours). Patients with hepatic or renal impairment In patients with hepatic or renal impairment, Actimorph Orodispersible tablets should be administered with particular care.
In normal doses, the commonest undesirable effects of morphine are nausea, vomiting, confusion, constipation and drowsiness. With chronic therapy, nausea and vomiting are unusual with morphine but should they occur the orodispersible tablets can be readily combined with an anti-emetic if required.
Constipation however does not stop while continuing the treatment. All these effects are predictable and need to be treated Constipation may be treated with appropriate laxatives.
The following frequencies are the basis for assessing undesirable effects:
Very common (≥1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). g. 4) Light- headedness Eye disorders Miosis Nystagmus Blurred vision Double vision (diplopia) Ear and labyrinth disorders Vertigo Cardiac disorders Palpitations Bradycardia Tachycardia Heart failure Vascular disorders Facial flushing Hypotension Hypertension Hot flushes Respiratory thoracic and mediastinal disorders Bronchospasm Pulmonary oedema Respiratory depression (with apnoea at most) Dyspnoea Cough reflex decreased Non- cardiogenic pulmonary oedema after rapid dose increase Central sleep apnoea syndrome Gastrointestinal disorders Constipation Nausea Abdominal pain Dry mouth Vomiting (notably at treatment initiation) Dyspepsia Paralytic ileus Pancreatitis (including exacerbation of pancreatitis) Intestinal obstruction Dental disease, but a causal relationship to morphine treatment cannot be established.
Hepatobiliary disorders Biliary colic Spasm of sphincter of Oddi Skin and subcutaneous tissue disorders Rash Hyperhidrosis Urticaria Pruritus Acute generalised exanthematous pustulosis (AGEP) Musculoskeletal, connective tissue and bone diseases Muscle spasms Muscle rigidity Renal and urinary disorders Urinary retention (notably in case of prostatic adenoma or urethral stenosis) Renal colic Ureteric spasm Dysuria Reproductive system and breast disorders Amenorrhoea Erectile dysfunction General disorders and administration site conditions Asthenia Fatigue Malaise Peripheral oedema Shivers Drug tolerance Drug withdrawal (abstinence) syndrome Drug withdrawal (abstinence) syndrome neonatal Investigations Hepatic enzymes increased Description of selected adverse reactions Drug dependence Repeated sue of Actimorph can lead to drug dependence, even at therapeutic doses.
A particularly careful medical supervision and if necessary dose reduction is recommended in the following cases: - Dependence on opioids, patients with a history of substance abuse, - Impaired respiratory function, - Respiratory depression (see below), - Sleep apnoea, - Cor pulmonale, - Head injury, intracranial lesions or conditions with increased intracranial pressure, if ventilation is not performed, - Impaired consciousness, - Hypotension with hypovolemia, - Prostatic hyperplasia with residual urine formation (risk of bladder rupture due to urinary retention), - Urinary tract narrowing or colic of the urinary tract, - Biliary tract disorders, - Obstructive and inflammatory bowel disease, - Constipation, - Pheochromocytoma, - Adrenocortical insufficiency, - Pancreatitis, - Severely impaired renal function, - Severely impaired hepatic function, - Hypothyroidism, - Epileptic seizure disorders or increased susceptibility to seizures, - Elderly patients.
Respiratory depression The major risk of opioid overdose 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 increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Risk from concomitant use of sedative medicinal products such as benzodiazepines or related medicinal products Concomitant use of Actimorph Orodispersible tablets and sedative medicinal products, such as benzodiazepines or related medicinal products, may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicinal products should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Actimorph Orodispersible tablets concomitantly with sedative medicinal products, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
g. g. naltrexone, nalmefene), sodium oxybate, - Concurrent administration of mono-amine oxidase inhibitors or within two weeks of discontinuation of their use.
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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Patients with suspected delayed gastrointestinal passage In patients with suspected delayed gastrointestinal passage, Actimorph Orodispersible tablets should be administered with particular care. 3). Method of administration Actimorph Orodispersible tablets are for oral use.
The tablet disperses rapidly in the mouth and is then swallowed. Alternatively, for special population such as children or patients with difficulties in swallowing, the tablet may be placed in a spoon with the addition of a small quantity of water until sufficient dispersion to allow ingestion.
This method of administration should be used in children below the age of 6 years.
4).
Withdrawal (abstinence) syndrome:
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: 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.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Morphine has an abuse potential similar to other strong agonist opioids and should be used with particular caution in patients with a history of alcohol and drug abuse.
Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as Actimorph. Repeated use of Actimorph 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 Actimorph may result in overdose and/or death. The risk of developing OUD is increased in patients with a personal or a family history (parents or siblings) of substance use disorders (including alcohol use disorder), in current tobacco users or in patients with a personal history of other mental health disorders (eg.
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. 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.
Abuse of oral pharmaceutical forms by parenteral administration can be expected to result in serious adverse events, which may be fatal. 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.
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 vasoocclusive crisis, close monitoring for ACS symptoms is warranted.
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. Pre- and postoperative use Actimorph Orodispersible tablets should be used with caution, pre- and postoperatively, due to the increased risk of ileus or respiratory depression in the postoperative period compared to patients who are not having surgery.
Due to the analgesic effect of morphine serious intra-abdominal complications such as bowel perforation can be masked. Patients who are going to undergo additional procedures to relieve pain (eg plexus block surgery) should not receive Actimorph Orodispersible tablets within 4 hours prior to the intervention.
If treatment with Actimorph Orodispersible tablets is indicated, a dose adjustment should be made based on the new post-operative requirements. Hyperalgesia Hyperalgesia that does not respond to a further dose increase of morphine may occur in particular in high doses.
A morphine dose reduction or change in opioid may be required. Adrenal insufficiency Opioid analgesics may cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement […]