Hydromorphone hydrochloride oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Standard release oral formulations of hydromorphone.
Drugs List
Therapeutic Indications
Uses
Relief of severe pain in cancer
Dosage
Dosage is dependent on severity of pain and patients previous history of analgesic requirements.
1.3mg of hydromorphone has an efficacy approximately equivalent to 10mg of morphine given orally.
Adults
Initially 1.3mg every 4 hours.
Monitor and assess analgesic effect. Increasing severity of pain will require increased dosage.
Elderly
Initially 1.3mg every 4 hours.
Monitor and assess analgesic effect. Increasing severity of pain will require increased dosage.
Dosage should be individually determined, titrate dose to achieve adequate analgesia.
Dosage reduction may be necessary, monitor closely.
Children
12 years and above
Initially 1.3mg every 4 hours.
Monitor and assess analgesic effect. Increasing severity of pain will require increased dosage.
Contraindications
Acute abdomen
Acute alcohol intoxication
Children under 12 years
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Coma
Galactosaemia
Head trauma
Hepatic impairment
Hypercapnia
Hypoxia
Paralytic ileus
Pregnancy
Raised intracranial pressure
Severe asthma
Severe chronic obstructive pulmonary disease
Severe respiratory depression
Precautions and Warnings
24 hours post-operatively
Constipation
Debilitation
Elderly
Pre-operative administration
Shock
Adrenal insufficiency
Benign prostatic hyperplasia
Delirium tremens
Glucose-galactose malabsorption syndrome
History of alcohol abuse
History of drug misuse
Hypotension
Hypothyroidism
Hypovolaemia
Lactose intolerance
Pancreatitis
Psychiatric disorder
Reduced respiratory reserve
Renal impairment
Respiratory impairment
Seizures
Sleep apnoea
Toxic psychosis
Avoid 4 hours before cordotomy/pain relieving surgical procedures
Reduce dose in patients with renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Contains lactose
Monitor at regular intervals as withdrawal symptoms & dependence may occur
Monitor for signs of tolerance and dependence
Monitor patient for signs and symptoms of respiratory depression
Monitor patients with a history of alcoholism and drug abuse
Monitor post operative patients for respiratory and other side effects
Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
Potential for drug abuse
Tolerance and dependence may occur
Abstinence syndrome may follow abrupt cessation
Consider dose reduction if sleep-related breathing disorders occur
Increased risk of central sleep apnoea and sleep-related hypoxemia
May cause dependence
Neonate exposed in labour: Risk of respiratory depression
Potential for withdrawal symptoms
Prolonged use at high doses may result in hyperalgesia
Avoid abrupt withdrawal
Discontinue if paralytic ileus is suspected
Consider dose reduction or alternative opioid in cases of hyperalgesia
Maintain treatment at the lowest effective dose
Reduce dose in elderly
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
Hypotensive effects may be potentiated by alcohol
Pregnancy and Lactation
Pregnancy
Hydromorphone is contraindicated during pregnancy.
The manufacturer does not recommend the use of hydromorphone during pregnancy. There is insufficient information on the use of hydromorphone in humans or animals to justify use, but no reports linking use with congenital defects have been located.
Withdrawal in infants is possible following exposure to prolonged maternal ingestion in utero. Neonatal respiratory depression should be expected similar to that produced by morphine.
Lactation
Hydromorphone is contraindicated during breastfeeding.
The manufacturer does not recommend use during breastfeeding. There are insufficient data on use in humans or animals. Hydromorphone is excreted in breast milk in small amounts. If used, it should only be for short periods of time. It may cause infant drowsiness, as neonates are particularly sensitive to the effects of even small doses, especially during the first week of life. Take particular care with children with a tendency to apnoea due to the depressive effect on respiration. Maternal intake should be limited, and analgesia supplemented with non-opioids if necessary. If the infant exhibits increased sleepiness, difficulty breastfeeding, breathing difficulties or limpness a physician should be contacted immediately.
Effects on Ability to Drive and Operate Machinery
This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them.
Counselling
Advise patient to swallow the capsules whole or, alternatively, open the capsule and sprinkle the contents on to cold soft food.
Patients should be advised that their ability to drive and operate machinery may be impaired by treatment.
Advise patients to avoid alcohol during treatment.
Side Effects
Abdominal pain
Addiction
Agitation
Anaphylactic reaction
Anorexia
Anxiety
Asthenia
Biliary colic
Blurred vision
Confusion
Constipation
Convulsions
Decreased appetite
Dependence
Depression
Diarrhoea
Dizziness
Drowsiness
Dry mouth
Dysgeusia
Dyskinesia
Dysphoria
Dyspnoea
Erectile dysfunction
Euphoria
Fatigue
Flushing
Hallucinations
Headache
Hypalgesia
Hypersensitivity reactions
Hypotension
Increases in hepatic enzymes
Insomnia
Lethargy
Malaise
Miosis
Muscle rigidity
Myoclonus
Nausea
Nightmares
Oropharyngeal swelling
Paraesthesia
Paralytic ileus
Peripheral oedema
Pruritus
Rash
Respiratory depression
Sedation
Sleep apnoea
Somnolence
Sweating
Tachycardia
Tolerance
Tremor
Urinary retention
Urticaria
Vomiting
Withdrawal symptoms
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: April 2014
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 07 November 2016.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 07 November 2016.
Summary of Product Characteristics: Palladone Capsules. Napp Pharmaceuticals Ltd. Revised October 2021.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Hydromorphone Last revised: 16 January 2014.
Last accessed:07 November 2016
Gov.uk. Government departments. Department for Transport. Publications. Drug driving and medicine: advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: https://www.gov.uk Last accessed: 6 January 2015 New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: https://www.mhra.gov.uk Last accessed: 6 January 2015
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.