Drugs List

Therapeutic Indications

Uses

Pain - moderate to severe

Administration

For subcutaneous and intravenous administration.

The solution may be given directly as a subcutaneous bolus dose. After dilution, it may be administered by subcutaneous infusion, intravenous injection or infusion or included in a device for patient-controlled analgesia.

Contraindications

Acute abdomen
Children under 18 years
Predisposition to paralytic ileus
Acute asthma
Breastfeeding
Cardiac failure secondary to pulmonary disorder
Chronic constipation
Chronic obstructive pulmonary disease
Head trauma
Hypercapnia
Moderate hepatic impairment
Paralytic ileus
Pregnancy
Raised intracranial pressure
Respiratory depression

Precautions and Warnings

24 hours post-operatively
Acute alcohol intoxication
Debilitation
During surgery
Elderly
Impaired consciousness
Pre-operative administration
Within 2 weeks of discontinuing MAOIs
Addison's disease
Adrenal insufficiency
Asthma
Biliary tract disorder
Delirium tremens
History of alcohol abuse
History of drug misuse
Hypotension
Hypothyroidism
Hypovolaemia
Inflammatory bowel disease
Mild hepatic impairment
Mild renal impairment
Myxoedema
Opioid dependence
Pancreatitis
Prostate disorder
Psychiatric disorder
Pulmonary disease
Sleep apnoea
Toxic psychosis

Reduce dose in hypothyroidism
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 not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Monitor patient for signs and symptoms of respiratory depression
Neonate exposed in utero: Monitor for respiratory depression
Patients on long-term therapy should be regularly reviewed
Potential for drug abuse
Tolerance and dependence may occur
When used with SSRIs, risk of Serotonin syndrome
Consider dose reduction if sleep-related breathing disorders occur
Increased risk of central sleep apnoea and sleep-related hypoxemia
Prolonged use at high doses may result in hyperalgesia
Progressive withdrawal recommended
Discontinue if paralytic ileus is suspected
Consider dose reduction or alternative opioid in cases of hyperalgesia
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
Alcohol may enhance side effects
Advise patient grapefruit products may increase plasma level

Adrenal insufficiency has been reported with opioid use, as opioid may influence the gonadal or the hypothalamic-pituitary-adrenal axes. Changes in serum prolactin, plasma cortisol and testosterone levels have been shown with the use of opioids. If adrenal insufficiency is suspected, gradually wean patient off opioid treatment until adrenal function is recovered. Continue with corticosteroid treatment until adrenal function has recovered and opioid treatment can commence.

Pregnancy and Lactation

Pregnancy

The manufacturer does not recommend oxycodone in pregnancy or during labour.

No studies on the effects on fertility or post-natal development have been carried out in humans. Studies in rats and rabbits with oral doses of oxycodone equivalent to 3 and 47 times the adult dose of 160 mg a day, did not reveal evidence of harm to the foetus due to oxycodone. Briggs (2011) reports no evidence to suggest a relationship between maternal use of oxycodone for analgesia and malformations in the foetus.

Infants born to opioid dependant mothers or mothers treated with opioids, including oxycodone, during pregnancy may show withdrawal symptoms at birth and should be monitored for respiratory depression.

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

Oxycodone is contraindicated in breastfeeding.

Oxycodone is secreted in breast milk and could cause respiratory depression in infants.

Briggs (2011) suggests that occasional maternal doses for analgesia present minimal risk for adverse effects during nursing. The infant should be monitored for gastrointestinal effects, sedation, and changes in feeding patterns.

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
Abnormal thinking
Agitation
Allergic reaction
Amenorrhoea
Amnesia
Anaphylactic reaction
Anaphylactoid reaction
Anorexia
Anxiety
Asthenia
Belching
Biliary spasm
Bronchospasm
Chills
Confusion
Constipation
Convulsions
Cough suppression
Dehydration
Dependence
Depression
Diarrhoea
Disorientation
Dizziness
Dream abnormalities
Drowsiness
Dry mouth
Dry skin
Dyspepsia
Dysphagia
Dysphoria
Dyspnoea
Epistaxis
Eructation
Euphoria
Exfoliative dermatitis
Facial flushing
Faintness
Fever
Flatulence
Gait abnormality
Gastritis
Hallucinations
Headache
Hiccups
Hyperkinesia
Hypersensitivity reactions
Hypertonia
Hypoaesthesia
Hypotension
Hypotonia
Ileus
Impotence
Inappropriate secretion of antidiuretic hormone
Increases in hepatic enzymes
Insomnia
Involuntary muscle contractions
Lability of affect
Lacrimation disorder
Malaise
Miosis
Mood changes
Muscle rigidity
Nausea
Nervousness
Oedema
Oral ulceration
Orthostatic hypotension
Palpitations
Paraesthesia
Peripheral oedema
Pruritus
Rash
Reduced libido
Respiratory depression
Restlessness
Rhinitis
Sedation
Sleep apnoea
Speech disturbances
Supraventricular tachycardia
Sweating
Syncope
Tachycardia
Taste disturbances
Thirst
Tinnitus
Tolerance
Tremor
Twitching
Ureteric spasm
Urinary retention
Urticaria
Vasodilatation
Vertigo
Visual disturbances
Vomiting
Weight changes
Withdrawal symptoms

Presentation

Solutions for injection or infusion of oxycodone hydrochloride

Drugs List

Therapeutic Indications

Uses

Pain - moderate to severe

Dosage

Dosage should be based on the level of pain, condition of the patient and previous or concurrent medication.

Adults

Elderly

Additional Dosage Information

Administration

For subcutaneous and intravenous administration.

The solution may be given directly as a subcutaneous bolus dose. After dilution, it may be administered by subcutaneous infusion, intravenous injection or infusion or included in a device for patient-controlled analgesia.

Contraindications

Acute abdomen
Children under 18 years
Predisposition to paralytic ileus
Acute asthma
Breastfeeding
Cardiac failure secondary to pulmonary disorder
Chronic constipation
Chronic obstructive pulmonary disease
Head trauma
Hypercapnia
Moderate hepatic impairment
Paralytic ileus
Pregnancy
Raised intracranial pressure
Respiratory depression

Precautions and Warnings

24 hours post-operatively
Acute alcohol intoxication
Debilitation
During surgery
Elderly
Impaired consciousness
Pre-operative administration
Within 2 weeks of discontinuing MAOIs
Addison's disease
Adrenal insufficiency
Asthma
Biliary tract disorder
Delirium tremens
History of alcohol abuse
History of drug misuse
Hypotension
Hypothyroidism
Hypovolaemia
Inflammatory bowel disease
Mild hepatic impairment
Mild renal impairment
Myxoedema
Opioid dependence
Pancreatitis
Prostate disorder
Psychiatric disorder
Pulmonary disease
Sleep apnoea
Toxic psychosis

Reduce dose in hypothyroidism
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 not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Monitor patient for signs and symptoms of respiratory depression
Neonate exposed in utero: Monitor for respiratory depression
Patients on long-term therapy should be regularly reviewed
Potential for drug abuse
Tolerance and dependence may occur
When used with SSRIs, risk of Serotonin syndrome
Consider dose reduction if sleep-related breathing disorders occur
Increased risk of central sleep apnoea and sleep-related hypoxemia
Prolonged use at high doses may result in hyperalgesia
Progressive withdrawal recommended
Discontinue if paralytic ileus is suspected
Consider dose reduction or alternative opioid in cases of hyperalgesia
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
Alcohol may enhance side effects
Advise patient grapefruit products may increase plasma level

Adrenal insufficiency has been reported with opioid use, as opioid may influence the gonadal or the hypothalamic-pituitary-adrenal axes. Changes in serum prolactin, plasma cortisol and testosterone levels have been shown with the use of opioids. If adrenal insufficiency is suspected, gradually wean patient off opioid treatment until adrenal function is recovered. Continue with corticosteroid treatment until adrenal function has recovered and opioid treatment can commence.

Pregnancy and Lactation

Pregnancy

The manufacturer does not recommend oxycodone in pregnancy or during labour.

No studies on the effects on fertility or post-natal development have been carried out in humans. Studies in rats and rabbits with oral doses of oxycodone equivalent to 3 and 47 times the adult dose of 160 mg a day, did not reveal evidence of harm to the foetus due to oxycodone. Briggs (2011) reports no evidence to suggest a relationship between maternal use of oxycodone for analgesia and malformations in the foetus.

Infants born to opioid dependant mothers or mothers treated with opioids, including oxycodone, during pregnancy may show withdrawal symptoms at birth and should be monitored for respiratory depression.

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

Oxycodone is contraindicated in breastfeeding.

Oxycodone is secreted in breast milk and could cause respiratory depression in infants.

Briggs (2011) suggests that occasional maternal doses for analgesia present minimal risk for adverse effects during nursing. The infant should be monitored for gastrointestinal effects, sedation, and changes in feeding patterns.

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.

Side Effects

Abdominal pain
Abnormal thinking
Agitation
Allergic reaction
Amenorrhoea
Amnesia
Anaphylactic reaction
Anaphylactoid reaction
Anorexia
Anxiety
Asthenia
Belching
Biliary spasm
Bronchospasm
Chills
Confusion
Constipation
Convulsions
Cough suppression
Dehydration
Dependence
Depression
Diarrhoea
Disorientation
Dizziness
Dream abnormalities
Drowsiness
Dry mouth
Dry skin
Dyspepsia
Dysphagia
Dysphoria
Dyspnoea
Epistaxis
Eructation
Euphoria
Exfoliative dermatitis
Facial flushing
Faintness
Fever
Flatulence
Gait abnormality
Gastritis
Hallucinations
Headache
Hiccups
Hyperkinesia
Hypersensitivity reactions
Hypertonia
Hypoaesthesia
Hypotension
Hypotonia
Ileus
Impotence
Inappropriate secretion of antidiuretic hormone
Increases in hepatic enzymes
Insomnia
Involuntary muscle contractions
Lability of affect
Lacrimation disorder
Malaise
Miosis
Mood changes
Muscle rigidity
Nausea
Nervousness
Oedema
Oral ulceration
Orthostatic hypotension
Palpitations
Paraesthesia
Peripheral oedema
Pruritus
Rash
Reduced libido
Respiratory depression
Restlessness
Rhinitis
Sedation
Sleep apnoea
Speech disturbances
Supraventricular tachycardia
Sweating
Syncope
Tachycardia
Taste disturbances
Thirst
Tinnitus
Tolerance
Tremor
Twitching
Ureteric spasm
Urinary retention
Urticaria
Vasodilatation
Vertigo
Visual disturbances
Vomiting
Weight changes
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 2013

Reference Sources

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.

Summary of Product Characteristics: Oxycodone 10mg/ml solution for injection or infusion. Wockhardt UK Ltd. Revised May 2010.
Summary of Product Characteristics: Oxycodone 50mg/ml solution for injection or infusion. Wockhardt UK Ltd. Revised July 2013.
Summary of Product Characteristics: OxyNorm 10mg/ml solution for injection or infusion. Napp Pharmaceuticals Limited. Revised October 2020.
Summary of Product Characteristics: OxyNorm 50mg/ml solution for injection or infusion. Napp Pharmaceuticals Limited. Revised October 2020.
Summary of Product Characteristics: Shortec 10mg/ml solution for injection or infusion. Qdem Pharmaceuticals Limited. Revised October 2016.
Summary of Product Characteristics: Shortec 50mg/ml solution for injection or infusion. Qdem Pharmaceuticals Limited. Revised October 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

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 February 2021