ORAMORPH CONCENTRATED is a brand name for Morphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the relief of severe pain in adults, adolescents (aged 13-18 years) and children (aged 1-12 years).
Verbatim from this product's MHRA label. Tap a section to expand.
0 ml) every 4 hours. Maximum daily dose: 120 mg per day. 25 ml) every 4 hours.
Maximum daily dose: 30 mg per day Children under 1 year:
Not recommended. Dosage can be increased under medical supervision according to the severity of the pain and the patient's previous history of analgesic requirements. 3), renal impairment, severe hypothyroidism, adrenocortical insufficiency, prostatic hypertrophy, shock or where sedation is undesirable.
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. Method of Administration For oral use A calibrated oral dosing pipette is supplied with this dosage form for accurate and convenient dose adjustment.
The required dose may be added to a soft drink immediately prior to administration. When patients are transferred from other morphine preparations to Oramorph Oral preparations dosage titration may be appropriate. Morphine sulfate is readily absorbed from the gastro-intestinal tract following oral administration.
However, when oral Oramorph preparations are used in place of parenteral morphine, a 50 % to 100 % increase in dosage is usually required in order to achieve the same level of analgesia.
8. Abuse Morphine sulfate is an opioid agonist and controlled drug. Such drugs are sought by drug abusers and people with addiction disorders. Morphine sulfate can be abused in a manner similar to other opioid agonists, legal or illicit.
This should be considered when prescribing or dispensing morphine in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Morphine should be used with particular care in patients with a history of alcohol and drug abuse.
Morphine sulfate may be abused by inhaling or injecting the product. These practices pose a significant risk to the abuser that could result in overdose and death. Hypersensitivity Hypersensitivity and anaphylactic reactions have both occurred with the use of Oramorph.
Care should be taken to elicit any history of allergic reactions to opiates. 3). Adrenal insufficiency Opioid analgesics may cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy. g. nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, or low blood pressure.
Decreased sex hormones and increased prolactin Long-term use of opioid analgesics may be associated with decreased sex hormone levels and increased prolactin. Symptoms include decreased libido, impotence or amenorrhoea. 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. Risk in special populations Morphine is metabolised by the liver and should be used with caution in patients with hepatic disease as oral bioavailability may be increased.
2). The active metabolite Morphine-6-glucuronide may accumulate in patients with renal failure, leading to CNS and respiratory depression. 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.
2), • and where there is reduced respiratory function, such as kyphoscoliosis, emphysema, cor pulmonale and severe obesity. Asthma It has been suggested that opioids can be used with caution in controlled asthma. 3). 3). The capacity of morphine to elevate cerebrospinal fluid pressure may be greatly increased in the presence of already elevated intracranial pressure produced by trauma.
Also, morphine may produce confusion, miosis, vomiting and other adverse reactions which may obscure the clinical course of patients with head injury. 3), or if the patient has bowel or obstructive biliary disease. Should paralytic ileus be suspected or occur during use, Oramorph should be discontinued immediately.
Caution should be exercised where there is an obstructive bowel disorder, biliary colic, operations on the biliary tract, acute pancreatitis or prostatic hyperplasia. If constipation occurs this may be treated with the appropriate laxatives.
Care should be exercised in patients with inflammatory bowel disease. Morphine may obscure the diagnosis or clinical course of patients with acute abdominal conditions and complications following abdominal surgery. 5). Dependence and withdrawal (abstinence) syndrome Use of opioid analgesics may be associated with the development of physical and/or psychological dependence or tolerance.
The risk increases with the time the drug is used, and with higher doses. Symptoms can be minimised with adjustments of dose or dosage form, and gradual withdrawal of morphine. 8. Abuse Morphine sulfate is an opioid agonist and controlled drug.
Such drugs are sought by drug abusers and people with addiction disorders. Morphine sulfate can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing morphine in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.
5) • patients with phaeochromocytoma. 4 for information relating to use in controlled asthma)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Oramorph Concentrated Oral Solution and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
Because of these risks, co-prescription of Oramorph Concentrated Oral Solution and sedative medicines should be reserved for patients for whom alternative treatment options are not possible. Oramorph Concentrated Oral Solution particularly when prescribed concomitantly with sedative medicines, should be used at the lowest effective dose for the shortest period of time.
Patients should be monitored closely for signs and symptoms of respiratory depression and sedation. 5). Use with rifampicin Plasma concentrations of morphine may be reduced by rifampicin. The analgesic effect of morphine should be monitored and doses of morphine adjusted during and after treatment with rifampicin.
Excipient related warnings Oramorph Concentrated Oral Solution contains the excipient Amaranth (E123), which may cause allergic reactions. 3). Gabapentin Interactions have been reported in those taking morphine and gabapentin. Reported interactions suggest an increase in opioid adverse events when co-prescribed, the mechanism of which is not known.
Caution should be taken where these medicines are co-prescribed. In a study involving healthy volunteers (N=12), when a 60 mg controlled-release morphine capsule was administered 2 hours prior to a 600 mg gabapentin capsule, mean gabapentin AUC increased by 44% compared to gabapentin administered without morphine.
Therefore, patients should be carefully observed for signs of CNS depression, such as somnolence, and the dose of gabapentin or morphine should be reduced appropriately. Ritonavir Although there are no pharmacokinetic data available for concomitant use of ritonavir with morphine, ritonavir may increase the activity of glucuronyl transferases.
Consequently, co-administration of ritonavir and morphine may result in decreased serum concentrations of morphine with possible loss of analgesic effectiveness. Rifampicin Rifampicin can reduce the plasma concentration of morphine and decrease its analgesic effect, the mechanism of which is not known.
Cimetidine Cimetidine inhibits the metabolism of morphine. Sedative medicines such as benzodiazepines or related drugs The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect.
4). 4), hypnotics, sedatives, antipsychotics, tricyclic antidepressants and alcohol. Esmolol Morphine may increase plasma concentrations of esmolol. Domperidone/metoclopramide Opioid analgesics including morphine may antagonise the actions of domperidone and metoclopramide on gastro-intestinal activity.
Mexiletine […]
Morphine should be used with particular care in patients with a history of alcohol and drug abuse. Morphine sulfate may be abused by inhaling or injecting the product. These practices pose a significant risk to the abuser that could result in overdose and death.
Hypersensitivity Hypersensitivity and anaphylactic reactions have both occurred with the use of Oramorph. Care should be taken to elicit any history of allergic reactions to opiates. 3). Adrenal insufficiency Opioid analgesics may cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy.
g. nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, or low blood pressure. Decreased sex hormones and increased prolactin Long-term use of opioid analgesics may be associated with decreased sex hormone levels and increased prolactin.
Symptoms include decreased libido, impotence or amenorrhoea. 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.
Risk in special populations Morphine is metabolised by the liver and should be used with caution in patients with hepatic disease as oral bioavailability may be increased. 2). The active metabolite Morphine-6-glucuronide may accumulate in patients with renal failure, leading to CNS and respiratory depression.
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.
Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Oramorph Concentrated Oral Solution and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
Because of these risks, co-prescription of Oramorph Concentrated Oral Solution and sedative medicines should be reserved for patients for whom alternative treatment options are not possible. Oramorph Concentrated Oral Solution particularly when prescribed concomitantly with sedative medicines, should be used at the lowest effective dose for the shortest period of time.
Patients should be monitored closely for signs and symptoms of respiratory depression and sedation. 5). Use with rifampicin Plasma concentrations of morphine may be reduced by rifampicin. The analgesic effect of morphine should be monitored and doses of morphine adjusted during and after treatment with rifampicin.
Excipient related warnings Oramorph Concentrated Oral Solution contains the excipient Amaranth (E123), which may cause allergic reactions.