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Drug Details

PALLADONE Capsules

• Drug Class Description
  Opiates (opioids).
• Generic Name
  Hydromorphone Hydrochloride
• Presentation
  PALLADONE capsules 1.3 mg are orange/clear capsules marked HNR 1.3. PALLADONE capsules 2.6 mg are red/clear capsules marked HNR 2.6.
• Description
  PALLADONE capsules contain Hydromorphone Hydrochloride USP 1.3 mg or 2.6 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 capsules should be used at 4-hourly intervals. The dosage is dependent upon the severity of the pain and the patient's previous history of analgesic requirements. 1.3 mg of hydromorphone has an efficacy approximately equivalent to 10 mg of morphine given orally. A patient presenting with severe pain should normally be started on a dosage of one PALLADONE capsule 4-hourly. Increasing severity of pain will require increased dosage of hydromorphone to achieve the desired relief.

  Patients with hepatic impairment

  Contra-indicated.

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

  Elderly and patients with renal impairment

  The elderly and patients with renal impairment should be dose titrated with PALLADONE 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. Hydromorphone should be avoided in patients with raised intracranial pressure or head injury, and also in patients with convulsive disorders or acute alcoholism.

• 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 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 capsules should not be used where there is the possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, PALLADONE capsules should be discontinued immediately.

  Patients about to undergo cordotomy or other pain-relieving surgical procedures should not receive PALLADONE capsules for 4 hours prior to surgery. If further treatment with PALLADONE capsules is indicated, 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.

  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, alcohol, 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.

• Adverse Drug Reactions
  

  Hydromorphone may cause constipation, nausea and vomiting. Constipation may be treated with appropriate laxatives. When nausea and vomiting are troublesome, PALLADONE 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 Dysphori Euphoria Hallucination
  Renal and urinary disorders	Urinary retention
  Respiratory, thoracic and mediastinal disorders		Respiratory depression
  Skin and subcutaneous tissue disorders	Pruritus Rash Sweating	Urticaria