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PALLADONE SR is a brand name for Hydromorphone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the relief of severe pain in cancer. PALLADONE-SR capsules are indicated in adults and children aged 12 years and above.
Verbatim from this product's MHRA label. Tap a section to expand.
4). Transferring patients between oral and parenteral hydromorphone Switching patients from parental hydromorphone to oral hydromorphone should be guided by the sensitivity of the individual patient. 2). Adults and children aged 12 years and above Palladone SR capsules should be used at 12 hourly intervals.
The dosage is dependent upon the severity of the pain and the patient’s previous history of analgesic requirements. 4 mg of hydromorphone has an efficacy approximately equivalent to 30 mg of morphine sulphate given orally. A patient presenting with severe pain should normally be started on a dosage of 4 mg Palladone SR capsules 12 hourly.
Increasing severity of pain may require increased dosage of hydromorphone to achieve the desired relief. Elderly and patients with renal impairment The elderly and patients with renal impairment should be dose titrated with Palladone SR capsules in order to achieve adequate analgesia.
It should be noted, however, that these patients may require a lower dosage to achieve adequate analgesia. Patients with hepatic impairment Contraindicated. Paediatric population. Not recommended. Method of administration For oral use.
The capsules can be swallowed whole or opened and their contents sprinkled on to cold soft food.
Hydromorphone may cause constipation, nausea and vomiting. Constipation may be treated with appropriate laxatives. When nausea and vomiting are troublesome Palladone SR capsules can be readily combined with antiemetics. 4); Central sleep apnoea syndrome Eye disorders Visual impairment Miosis Cardiac disorders Tachycardia Very common Common Uncommon Rare Very rare Not known Vascular disorders Hypotension Flushing Respiratory, thoracic and mediastinal disorders Dyspnoea Respiratory depression Gastrointestinal disorders Constipation; Nausea Abdominal pain; Dry mouth; Vomiting Diarrhoea; Dysgeusia Paralytic ileus Hepatobiliary disorders Hepatic enzymes increased Skin and subcutaneous tissue disorders Pruritus Hyperhidrosis Rash Urticaria Renal and urinary disorders Urinary retention Reproductive system and breast disorders Erectile dysfunction General disorders and administration site conditions Asthenia Drug withdrawal syndrome; Fatigue; Malaise; Peripheral oedema Drug tolerance; Drug withdrawal syndrome neonatal 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.
, Addison’s disease) • Severely impaired renal function • Severely impaired hepatic function • Alcoholism • Delirium tremens • Convulsive disorders • Constipation • Shock or reduced respiratory reserve. Respiratory depression The major risk of opioid excess is respiratory depression.
Opioids may 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 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 (and other CNS depressants): Concomitant use of Palladone SR 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. If a decision is made to prescribe Palladone SR capsules 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 sleeprelated hypoxemia.
8). In patients who present with CSA, consider decreasing the total opioid dosage Tolerance and Opioid Use Disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids.
Abuse or intentional misuse of Palladone SR may result in overdose and/or death. g. major depression, anxiety and personality disorders). g. too early requests for refills). This includes the review of concomitant opioids and psycho- active drugs (like benzodiazepines).
Hydromorphone is contra-indicated in patients with: • Known hypersensitivity to hydromorphone or any of the excipients • Severe respiratory depression with hypoxia and/or hypercapnia • Severe chronic obstructive lung disease • Severe bronchial asthma • Paralytic ileus • Acute abdomen • Coma • Hepatic impairment • Concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Hydromorphone in United Kingdom.
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Palladone SR capsules are not recommended for pre-operative use or in the first 24 hours post-operatively. After this time they should be used with caution, particularly following abdominal surgery. Palladone SR capsules should not be used where there is the possibility of paralytic ileus occurring.
Should paralytic ileus be suspected or occur during use, Palladone SR capsules should be discontinued. Patients about to undergo cordotomy or other pain relieving surgical procedures should not receive Palladone SR capsules for 24 hours prior to surgery.
If further treatment with Palladone SR capsules is indicated then the dosage should be adjusted to the new post-operative requirement. 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 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 hydromorphone.
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, […]