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ZOMORPH is a brand name for Morphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Severe chronic pain and/or pain resistant to other analgesics, in particular pain associated with cancer.
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment goals and discontinuation Before initiating treatment with Zomorph capsules, 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 Zomorph capsules, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4). Posology ZOMORPH capsules 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.
Adults:
Recommended dosage is one capsule twice daily, at 12-hourly intervals. A patient presenting with severe pain, uncontrolled by weaker opioids should normally be started on 30 mg 12 hourly for patient over 70kg, or 20 mg for patients under 70 kg.
Elderly:
As with all narcotics, a reduction in dosage may be advisable in the elderly, as appropriate. Duration of treatment Zomorph capsules should not be used longer than necessary. Increasing severity of pain will require an increased dosage of the capsules by prescribing the 10mg, 30mg, 60mg, 100mg and 200mg capsules in various combinations or alone to obtain the desired relief.
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 previously treated with immediate-release oral morphine should receive the same daily dose of sustained-release capsules, but in two divided doses at 12-hourly intervals. Patients receiving Zomorph capsules in place of parenteral morphine should be given a sufficiently increased dosage to compensate for any reduction of the analgesic effect associated with oral administration.
The most common side effects at usual doses are nausea, vomiting, constipation, and drowsiness. With chronic therapy, nausea and vomiting are unusual with Zomorph capsules but should they occur the capsules can be readily combined with an anti-emetic if required.
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 available data). 4) Eyes 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 Respiratory depression Bronchospasm Pulmonary oedema Cough decreased Central sleep apnoea syndrome Gastrointestinal disorders Nausea Constipation Vomiting Dry mouth Abdominal pain Dyspepsia Ileus Taste perversion Pancreatitis Metabolism and nutrition disorders Anorexia Hepatobiliary disorders Biliary pain Exacerbation of pancreatitis Spasm of sphincter of Oddi Skin and subcutaneous tissue disorders Pruritus Rash Urticaria Acute generalised exanthematous pustulosis (AGEP) Renal and Urinary retention Ureteric spasm System organ class Very common (≥ 1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Not known urinary disorders Reproductive system and breast disorders Amenorrhoea Decreased libido Erectile dysfunction General disorders and administration site conditions Asthenia Fatigue Malaise Peripheral oedema Drug withdrawal syndrome Drug tolerance Drug withdrawal (abstinence) syndrome neonatal Investigations Increased hepatic enzymes Drug dependence Use of opioid analgesics may be associated with the development of physical and/or psychological dependence or tolerance, which may appear after administration of therapeutic doses for periods of 1 to 2 weeks.
5) • Tolerance, physical dependence and withdrawal (see below) • 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 hypovolemia • 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, Zomorph capsules 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 increase the risk of CSA in a dose-dependent manner in some patients.
8). In patients who present with CSA, consider decreasing the total opioid dosage. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Zomorph capsules 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. 2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation.
5). 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.
1 • Severe chronic obstructive pulmonary disease • Severe bronchial asthma • Severe respiratory depression with hypoxia and/or hypercapnia • Paralytic ileus • 'Acute abdomen' • Delayed gastric emptying • Acute hepatic disease • Head injury with raised intracranial pressure • Concurrent treatment with MAO (MAO = monoamine oxidase) inhibitors or within two weeks of discontinuation of their use • Children under six years of age.
Not recommended for pre-operative use or for the first 24 hours post-operatively.
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.
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.
The capsules should not be chewed and should normally be swallowed whole. ). G. with an open distal end or lateral pores. It is sufficient to rinse the tube with 30ml to 50ml of water.
Some cases of dependence have been observed after only 2 to 3 days. 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.
It may occur a few hours after withdrawal and is maximal between the 36th and 72nd hours. 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.
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 vaso-occlusive crisis, close monitoring for ACS symptoms is warranted.
g. surgery, plexus blockade) should not receive Zomorph capsules for 24 hours prior to the intervention. If further treatment with Zomorph capsules is then indicated, the dosage should be adjusted to the new post-operative requirement.
Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as Zomorph capsules. Repeated use of Zomorph capsules 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 Zomorph capsules 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.
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.
If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal […]