Oxycodone hydrochloride oral 12 hour modified release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral 12 hour modified release formulations of oxycodone hydrochloride.
Drugs List
Therapeutic Indications
Uses
Pain - moderate to severe
Dosage
The dosage is dependent on the severity of pain and the patient's previous history of analgesic requirements.
The correct dosage for any individual patient is that which controls the pain and is well tolerated for a full 12 hours. Doses should be titrated to pain relief in 25% to 50% increments unless unmanageable adverse drug reactions prevent this. The need for additional pain relief more than twice a day indicates that the dosage of oxycodone tablets should be increased.
Adults
Initial dose for opioid naive patients is 10mg every 12 hours.
Some patients may benefit from an initial dose of 5mg every 12 hours, to minimise incidence of side effects.
The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief. For non-malignant pain a daily dose of 20mg every 12 hours is usually sufficient. For cancer related pain, doses of 40mg to 60mg every 12 hours may be needed although higher doses have been recorded.
Children
Moderate to severe pain in palliative care in children 12 to 18 years
Initially 10mg every 12 hours, adjusted individually according to the severity of pain.
Moderate to severe pain in palliative care in children 8 to 12 years (unlicensed)
Initially 5mg every 12 hours, adjusted individually according to the severity of pain.
Additional Dosage Information
Patients previously receiving oral morphine:
10mg to 13mg of oral oxycodone is equivalent to approximately 20mg of oral morphine, both in the prolonged release formulation.
Patients transferring between oral and parenteral oxycodone:
2mg of oral oxycodone is equivalent to approximately 1mg of parenteral oxycodone, the dose should be carefully titrated.
Contraindications
12 hours prior to pain relieving surgical procedure
24 hours post-operatively
Acute abdomen
Children under 8 years
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Cardiac failure secondary to pulmonary disorder
Chronic constipation
Chronic obstructive pulmonary disease
Delayed gastric emptying
Head trauma
Hypercapnia
Hypoxia
Labour
Moderate hepatic impairment
Paralytic ileus
Pregnancy
Raised intracranial pressure
Renal impairment - creatinine clearance below 10ml/minute
Respiratory depression
Severe asthma
Precautions and Warnings
Acute alcohol intoxication
Children aged 8 to 18 years
Debilitation
Elderly
Impaired consciousness
Opioid-naive patients
Pre-operative administration
Predisposition to seizures
Addison's disease
Adrenal insufficiency
Alcoholism
Biliary colic
Biliary tract disorder
Delirium tremens
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of alcohol abuse
History of drug misuse
Hypotension
Hypothyroidism
Hypovolaemia
Inflammatory bowel disease
Lactose intolerance
Mild hepatic impairment
Myxoedema
Opioid dependence
Pancreatitis
Prostate disorder
Renal colic
Renal impairment
Severe pulmonary disease
Sleep apnoea
Toxic psychosis
Before administration after abdominal surgery ensure normal bowel function
Not suitable for acute pain relief
Reduce dose in patients with hepatic impairment
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
Not all available brands are licensed for all age groups
Some brands contain sucrose. Consult specific brand literature
Some formulations contain lactose
May cause adrenal suppression
Monitor at regular intervals as withdrawal symptoms & dependence may occur
Monitor patient for signs and symptoms of respiratory depression
Monitor patients with a history of alcoholism and drug abuse
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
May increase risk of seizure
Neonate exposed in labour: Risk of respiratory depression
Potential for withdrawal symptoms
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)
Advise patient grapefruit products may increase plasma level
Advise patients that empty tablet/capsule may be observed in stools
Use caution in patients with low body weight or slow metabolism, reduced doses may be required.
Opioid naive patients should not be initiated on high doses of oxycodone (60mg and above) due to risk of adverse effects including respiratory depression.
Oxycodone should be used with caution in patients receiving concomitant treatment with serotonin agents. The dosage may need to be reduced in patients using these medications.
All patients require careful monitoring for signs of abuse and addiction.
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.
Central sleep apnoea and sleep-related hypoxemia has been reported with opioid use in a dose-dependent fashion. Consider dose reduction in patients presenting with central sleep apnoea.
Pregnancy and Lactation
Pregnancy
Oxycodone hydrochloride is contraindicated in pregnancy.
There is limited information regarding the use of oxycodone hydrochloride in pregnant women.
Oxycodone hydrochloride should not be used during labour due to the potential for gastric stasis and inhalation pneumonia in the mother as well as a risk of respiratory depression and withdrawal symptoms in the neonate. Infants born to mothers who have received oxycodone hydrochloride should be monitored for respiratory depression.
Schaefer (2015) states that oxycodone can be used during pregnancy but only under strict indication and long term use only ever under special situations.
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 may cause respiratory depression in the newborn, it should therefore not be used in breast feeding mothers.
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
Abnormal thoughts
Accidental injury
Agitation
Amenorrhoea
Amnesia
Anaphylactic reaction
Anaphylactoid reaction
Anorexia
Anxiety
Asthenia
Biliary colic
Bradycardia
Bronchospasm
Cellulitis
Chills
Cholestasis
Cognitive impairment
Confusion
Constipation
Convulsions
Cough increased
Cough suppression
Dehydration
Dependence
Depersonalisation
Depression
Discolouration of stools
Disorientation
Disturbances of appetite
Dizziness
Dream abnormalities
Dry mouth
Dysphagia
Dysphoria
Dyspnoea
Erectile dysfunction
Euphoria
Facial flushing
Gastrointestinal disorder
Gingivitis
Haematuria
Hallucinations
Headache
Hiccups
Hypalgesia
Hyperacusis
Hyperhidrosis
Hypersensitivity reactions
Hypertonia
Hypoaesthesia
Hypotension
Hypotonia
Ileus
Impaired co-ordination
Inappropriate secretion of antidiuretic hormone
Increase in dental caries
Increases in hepatic enzymes
Insomnia
Lability of affect
Lacrimation disorder
Lethargy
Lymphadenopathy
Micturition disorders
Migraine
Miosis
Mood changes
Muscle contraction
Muscle rigidity
Nausea
Nervousness
Oedema
Orthostatic hypotension
Pain
Palpitations
Paraesthesia
Pharyngitis
Pyrexia
Reduced libido
Respiratory depression
Restlessness
Rhinitis
Sedation
Serotonin syndrome
Skin disorder
Somnolence
Speech disturbances
Stomatitis
Supraventricular tachycardia
Syncope
Taste disturbances
Thirst
Tolerance
Tooth disorder
Tremor
Urinary retention
Vasodilatation
Vertigo
Visual disturbances
Voice 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: August 2018
Reference Sources
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Oxycodone Last revised: 01 March 2018
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