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Drug Details

Palladone SR capsules

• Drug Class Description
  Natural opium alkaloid - ATC code: NO2A A03
• Generic Name
  Hydromorphone Hydrochloride
• Presentation
  Prolonged release capsule. Hard gelatin capsule containing spherical prolonged release pellets. PALLADONE SR capsules 2 mg are yellow/white capsules marked HCR 2. PALLADONE SR capsules 4 mg are pale blue/clear capsules marked HCR 4. PALLADONE SR capsules 8 mg are pink/clear capsules marked HCR 8. PALLADONE SR capsules 16 mg are brown/clear capsules marked HCR 16. PALLADONE SR capsules 24 mg are dark blue/clear capsules marked HCR 24.
• Description
  The capsules contain Hydromorphone Hydrochloride USP 2 mg, 4 mg, 8 mg, 16 mg, 24 mg.
• Indications
  

  For the relief of severe pain in cancer.

• Adult Dosage
  

  Route of administration

  The capsules can be swallowed whole or opened and their contents sprinkled on to cold soft food.

  Dosage and administration

  Adults and children over 12 years

  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 will 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

  Contra-indicated.

• Child Dosage
  Children under 12 years - Not recommended.
• Elderly Dosage
  

  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.

• Contra Indications
  

  Hydromorphone is contra-indicated in patients with known hypersensitivity to hydromorphone or other ingredients in the formulation.

  It is also contra-indicated in respiratory depression with hypoxia or elevated carbon dioxide levels in the blood, pregnancy, coma, acute abdomen, hepatic impairment, paralytic ileus, concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use. Use of PALLADONE SR capsules should be avoided in patients with raised intracranial pressure or head injury, and also in patients with convulsive disorders or acute alcoholism.

  Pre-operative administration of PALLADONE SR capsules is not recommended and is not an approved indication.

• Special Precautions
  

  The major risk of opioid excess is respiratory depression. As with all narcotics, a reduction in dosage may be advised in the elderly or infirm patients with severely impaired pulmonary function, toxic pyschosis, delirium tremens, pancreatitis, hypothyroidism, hypotension with hypovolaemia, chronic obstructive airways disease, renal or adrenocortical insufficiency, prostatic hypertrophy, shock or reduced respiratory reserve. PALLADONE SR capsules are not recommended 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.

  The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. The patient may develop physical dependence; an abstinence syndrome may be seen following abrupt cessation.

  When a patient no longer requires therapy with hydromorphone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

  Hydromorphone has a morphine-like abuse profile and may be sought and abused by people with latent or manifest addiction disorders. Hydromorphone should be used with particular care in patients with a history of alcohol and drug abuse.

  The prolonged release capsules may be opened and their contents sprinkled on to soft cold food. However the capsule contents should not be chewed or crushed. The administration of chewed or crushed hydromorphone pellets may lead to a rapid release and absorption of a potentially fatal dose of hydromorphone.

  Concomitant use of alcohol and Palladone SR capsules may increase the undesirable effects of Palladone SR capsules; concomitant use should be avoided.

  Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal.

• Interactions
  

  Centrally acting drugs such as major and minor tranquillisers, anaesthetics, barbiturates, antiemetics, antidepressants, neuroleptics, hypnotics, other opioids, monoamine oxidase inhibitors and sedatives may interact with hydromorphone, and potentiate the effects of either drug, e.g. sedation, respiratory depression, etc.

  Alcohol may enhance the pharmacodynamic effects of Palladone SR capsules; concomitant use should be avoided.

• Adverse Drug Reactions
  

  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 anti-emetics

  Common (incidence of 1%) and uncommon ( 1%) adverse drug reactions are listed in the table below:

  	Common	Uncommon
  Cardiac and vascular disorders	Hypotension
  Eye disorders		Blurred vision Miosis
  Gastrointestinal and hepatobiliary disorders	Constipation Dry mouth Nausea Vomiting	Biliary colic Paralytic ileus
  General disorders	Asthenic conditions	Drug withdrawal syndrome Drug tolerance Peripheral oedema
  Immune system disorders		Hypersensitivity reactions (including oropharyngeal swelling)
  Nervous system disorders	Dizziness Somnolence	Convulsions Dyskinesia Headache Sedation Tremor In particular in high doses hyperalgesia that will not respond to a further dose of hydromorphone (possibly dose reduction or change in opioid required).
  Psychiatric disorders	Confusion	Drug addiction Agitation Dysphoria Euphoria Hallucination
  Renal and urinary disorders	Urinary retention
  Respiratory, thoracic and mediastinal disorders		Respiratory depression
  Skin and subcutaneous tissue disorders	Pruritus Rash Sweating	Urticaria