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Strong opioid Pregnancy: VERBATIM (§4.6): 'There are no well-controlled studies of hydromorphone in pregnant women. Hydromorphone should not be used in pregnancy unless clearly necessary. Palladone capsules are not recommended during pregnancy and labour due to impaired uterine contractility. Regular use in pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate. If opioid use is required for a prolonged period in pregnant women, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available.' Breast-feeding: 'Administration to nursing women is not recommended as hydromorphone is excreted into breast milk in low amounts and may cause respiratory depression in the infant.' Fertility: non-clinical toxicology studies in rats showed no effects on male or female fertility or sperm parameters.

Hydromorphone hydrochloride

Brand names: Palladone

Hydromorphone hydrochloride is a potent opioid analgesic used for the management of moderate to severe pain, including cancer pain.

Adult dose

Dose: Severe pain: one Palladone capsule = 1.3 mg hydromorphone hydrochloride, the SPC's normal starting dose for a patient presenting with severe pain (the strength is pinned by the source product name, 'Palladone 1.3 mg capsules')
Route: Oral — immediate-release capsules, swallowed whole or opened and their contents sprinkled onto cold soft food
Frequency: Every 4 hours (4-hourly intervals)
SCOPE — READ FIRST: this covers the ORAL IMMEDIATE-RELEASE capsule only, which is the page's primary route and product. The page also lists a modified-release 4 mg 12-hourly regimen and a subcutaneous route: NEITHER is in this bundle (the modified-release product has a separate SPC and there is no parenteral SPC here), so no MR or SC figure is published. VERBATIM (§4.2, 'Adults and children aged 12 years and above'): '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 may require increased dosage of hydromorphone to achieve the desired relief.' The SPC states NO maximum dose, so maxDose is left empty — titrate to effect within the safety constraints below. SWITCHING FROM PARENTERAL: 'Switching patients from parenteral hydromorphone to oral hydromorphone should be guided by the sensitivity of the individual patient. The oral starting dose should not be overestimated.' ELDERLY AND RENAL IMPAIRMENT: dose-titrate to achieve adequate analgesia, noting these patients may require a lower dosage. PAEDIATRIC: §4.2 states 'Paediatric population Not recommended.' — note the same section heads its adult posology 'Adults and children aged 12 years and above', so the SPC carries both statements; the US label states safety and effectiveness in paediatric patients have not been established. Verify any under-18 use against a children's formulary and specialist palliative care advice. BEFORE STARTING AND STOPPING: 'Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with hydromorphone in order to minimise the risk of addiction and drug withdrawal syndrome'; agree treatment duration and goals in advance, keep frequent physician-patient contact to review the need for continued treatment, taper gradually when no longer required, and consider hyperalgesia, tolerance and progression of underlying disease if pain control is inadequate. 'Hydromorphone should not be used longer than necessary.' Some sections of the product information we used were incomplete — check the full SPC.

Dose adjustments

Renal

VERBATIM (§4.2): '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.' Severely impaired renal function is additionally listed in §4.4 as requiring caution. No numeric reduction is given. The US label notes hydromorphone is substantially excreted by the kidney and the risk of adverse reactions may be greater in renal impairment.

Hepatic

CONTRAINDICATED. VERBATIM (§4.2): 'Patients with hepatic impairment Contraindicated.' Hepatic impairment is also listed in §4.3 Contraindications. (§4.4 separately lists severely impaired hepatic function among the cautions.)

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • 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 of their use

Side effects

  • Respiratory depression — 'The major risk of opioid excess is respiratory depression'; opioids may cause sleep-related breathing disorders including central sleep apnoea and sleep-related hypoxaemia, increasing central sleep apnoea risk in a dose-dependent manner and worsening pre-existing sleep apnoea (§4.4, §4.8)
  • Gastrointestinal: constipation, nausea, vomiting, abdominal pain, dry mouth, diarrhoea, dysgeusia; paralytic ileus. Constipation may be treated with appropriate laxatives and antiemetics can be combined with the capsules
  • Nervous system: dizziness, somnolence, headache, myoclonus, paraesthesia, tremor, sedation, lethargy, convulsions, dyskinesia, hyperalgesia
  • Psychiatric: anxiety, confusional state, insomnia, agitation, depression, euphoric mood, hallucination, nightmares, dysphoria, drug dependence
  • Drug dependence, drug tolerance, drug withdrawal syndrome and neonatal drug withdrawal syndrome — repeated use can lead to dependence even at therapeutic doses, and to Opioid Use Disorder
  • Cardiovascular: hypotension, tachycardia, flushing
  • Skin: pruritus, hyperhidrosis, rash, urticaria
  • Renal and reproductive: urinary retention, erectile dysfunction
  • Immune: hypersensitivity including oropharyngeal swelling, anaphylactic reactions
  • Other: decreased appetite, asthenia, fatigue, malaise, peripheral oedema, visual impairment, miosis, dyspnoea, raised hepatic enzymes

Monitoring

  • Respiratory rate and level of sedation, particularly where a sedative medicine such as a benzodiazepine is co-prescribed — patients and caregivers should be told to watch for these symptoms (§4.4)
  • Pain control and analgesic response during titration; if control is inadequate consider hyperalgesia, tolerance and progression of underlying disease (§4.2, §4.4)
  • Frequent physician-patient contact to evaluate the need for continued treatment, consider discontinuation and adjust dosage (§4.2)
  • Signs of tolerance, physical or psychological dependence and Opioid Use Disorder, especially with a personal or family history of substance use disorder or current tobacco use (§4.4)
  • Sleep-related breathing disorders — in patients who present with central sleep apnoea, consider decreasing the total opioid dosage (§4.4)
  • Bowel function — constipation is a listed very common class effect requiring appropriate laxatives (§4.8)
  • Withdrawal symptoms when stopping — taper the dose gradually (§4.2)

Clinical monograph

How it works

It is a full agonist at mu-opioid receptors in the central nervous system, producing analgesia and other opioid effects.

Prescribing in practice

  • Respiratory depression is the most serious risk, especially on initiation, dose increase, in opioid-naive patients or with other CNS depressants, and the modified-release and immediate-release products are not interchangeable milligram for milligram.
  • It is a controlled drug with potential for dependence, misuse and diversion, requiring appropriate prescribing and storage.
  • Use reduced exposure and extra caution in the elderly and in renal or hepatic impairment, and anticipate and manage constipation.

Monitoring

Monitor pain control, sedation, respiratory rate and bowel function, particularly during initiation and dose titration.

Counselling the patient

  • It can cause drowsiness; do not drive or operate machinery if affected and avoid alcohol.
  • Take regular laxatives for constipation and never exceed the prescribed dose.

Evidence & guidelines

Use of strong opioids for pain, including titration and safety monitoring, is supported by NICE guidance on opioids in palliative care and MHRA opioid safety advice.

Reference: Palliative care formulary; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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