Drugs List

Therapeutic Indications

Uses

Relief of severe pain in cancer

Contraindications

Acute abdomen
Acute alcohol intoxication
Cardiopulmonary disorder
Children under 12 years
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Acute respiratory depression
Breastfeeding
Coma
Head trauma
Labour
Phaeochromocytoma
Pulmonary emphysema
Raised intracranial pressure
Severe chronic obstructive pulmonary disease

Precautions and Warnings

24 hours post-operatively
Children aged 12 to 18 years
Debilitation
Hypovolaemic shock
Patients over 75 years
Pre-operative administration
Adrenal insufficiency
Asthma
Benign prostatic hyperplasia
Biliary tract disorder
Central nervous system depression
Chronic obstructive pulmonary disease
Delirium tremens
Gallbladder disease
Gastrointestinal obstruction
Hepatic impairment
History of alcohol abuse
History of drug misuse
Hypotension
Hypothyroidism
Inflammatory bowel disease
Kyphoscoliosis with respiratory compromise
Myasthenia gravis
Pancreatitis
Pregnancy
Reduced respiratory reserve
Renal impairment
Seizures
Toxic psychosis

Reduce dose in patients with hepatic impairment
Reduce dose in patients with renal impairment
Advise patient ability to drive or operate machinery may be impaired
Advise patient drowsiness may affect ability to drive or operate machinery
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Discard any unused portion
Monitor patient closely during titration of dose
Monitor patient for signs and symptoms of respiratory depression
Monitor patients with a history of alcoholism and drug abuse
Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
Potential for drug abuse
Tolerance and dependence may occur
Abstinence syndrome may follow abrupt cessation
Potential for withdrawal symptoms
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 patients over 75 years
Not for long term use
Only recommended for short term use
Advise patient to avoid alcohol during treatment
Hypotensive effects may be potentiated by alcohol

Pregnancy and Lactation

Pregnancy

Hydromorphone is contraindicated in 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.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Hydromorphone is contraindicated in 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.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Addiction
Agitation
Alterations in pancreatic enzymes
Anaphylactic reaction
Anxiety
Asthenia
Biliary spasm
Blurred vision
Bradycardia
Bronchospasm
Cardiac arrest
Changes in mood
Circulatory depression
Cognitive impairment
Confusion
Constipation
Decreased appetite
Dependence
Diarrhoea
Difficulty in micturition
Disturbances of peripheral blood flow
Dizziness
Drowsiness
Dry mouth
Dysgeusia
Dyskinesia
Dyspepsia
Dysphoria
Erectile dysfunction
Euphoria
Fainting
Fatigue
Fear
Flushing
Hallucinations
Headache
Hypersensitivity reactions
Hypotension
Hypothermia
Increases in hepatic enzymes
Induration (injection site)
Insomnia
Irritation (localised)
Lethargy
Local pain (injection site)
Malaise
Miosis
Muscle rigidity
Myoclonus
Nausea
Oedema
Palpitations
Paralytic ileus
Peripheral oedema
Postural hypotension
Pruritus
Rash
Reduced libido
Respiratory depression
Sedation
Seizures
Sexual dysfunction
Sleep disturbances
Somnolence
Sweating
Tachycardia
Tolerance
Tremor
Ureteric spasm
Urinary retention
Urinary urgency
Urticaria
Vertigo
Visual disturbances
Vomiting
Withdrawal symptoms

Presentation

Solution for injection or infusion containing hydromorphone

Drugs List

Therapeutic Indications

Uses

Relief of severe pain in cancer

Dosage

The dosing should be adjusted to the patients severity of pain and to their individual response.

The dose should be carefully titrated until optimum analgesic effect is achieved while keeping the dose as small as possible.

Adults

Elderly

Children

Additional Dosage Information

Contraindications

Acute abdomen
Acute alcohol intoxication
Cardiopulmonary disorder
Children under 12 years
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Acute respiratory depression
Breastfeeding
Coma
Head trauma
Labour
Phaeochromocytoma
Pulmonary emphysema
Raised intracranial pressure
Severe chronic obstructive pulmonary disease

Precautions and Warnings

24 hours post-operatively
Children aged 12 to 18 years
Debilitation
Hypovolaemic shock
Patients over 75 years
Pre-operative administration
Adrenal insufficiency
Asthma
Benign prostatic hyperplasia
Biliary tract disorder
Central nervous system depression
Chronic obstructive pulmonary disease
Delirium tremens
Gallbladder disease
Gastrointestinal obstruction
Hepatic impairment
History of alcohol abuse
History of drug misuse
Hypotension
Hypothyroidism
Inflammatory bowel disease
Kyphoscoliosis with respiratory compromise
Myasthenia gravis
Pancreatitis
Pregnancy
Reduced respiratory reserve
Renal impairment
Seizures
Toxic psychosis

Reduce dose in patients with hepatic impairment
Reduce dose in patients with renal impairment
Advise patient ability to drive or operate machinery may be impaired
Advise patient drowsiness may affect ability to drive or operate machinery
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Discard any unused portion
Monitor patient closely during titration of dose
Monitor patient for signs and symptoms of respiratory depression
Monitor patients with a history of alcoholism and drug abuse
Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
Potential for drug abuse
Tolerance and dependence may occur
Abstinence syndrome may follow abrupt cessation
Potential for withdrawal symptoms
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 patients over 75 years
Not for long term use
Only recommended for short term use
Advise patient to avoid alcohol during treatment
Hypotensive effects may be potentiated by alcohol

Pregnancy and Lactation

Pregnancy

Hydromorphone is contraindicated in 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.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Hydromorphone is contraindicated in 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.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

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

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
Alterations in pancreatic enzymes
Anaphylactic reaction
Anxiety
Asthenia
Biliary spasm
Blurred vision
Bradycardia
Bronchospasm
Cardiac arrest
Changes in mood
Circulatory depression
Cognitive impairment
Confusion
Constipation
Decreased appetite
Dependence
Diarrhoea
Difficulty in micturition
Disturbances of peripheral blood flow
Dizziness
Drowsiness
Dry mouth
Dysgeusia
Dyskinesia
Dyspepsia
Dysphoria
Erectile dysfunction
Euphoria
Fainting
Fatigue
Fear
Flushing
Hallucinations
Headache
Hypersensitivity reactions
Hypotension
Hypothermia
Increases in hepatic enzymes
Induration (injection site)
Insomnia
Irritation (localised)
Lethargy
Local pain (injection site)
Malaise
Miosis
Muscle rigidity
Myoclonus
Nausea
Oedema
Palpitations
Paralytic ileus
Peripheral oedema
Postural hypotension
Pruritus
Rash
Reduced libido
Respiratory depression
Sedation
Seizures
Sexual dysfunction
Sleep disturbances
Somnolence
Sweating
Tachycardia
Tolerance
Tremor
Ureteric spasm
Urinary retention
Urinary urgency
Urticaria
Vertigo
Visual disturbances
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: September 2016

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, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 20 September 2016.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 20 September 2016.

Summary of Product Characteristics: Palladone 2 mg/ml, 10 mg/ml, 20 mg/ml, 50 mg/ml solution for injection or infusion. Napp Pharmaceuticals Ltd. Revised July 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