Oxycodone hydrochloride oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral 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 need for continued treatment should be assessed at regular intervals.
The correct dosage for any individual patient is that which controls the pain and is well tolerated throughout the dosing period. Doses should be titrated to pain relief unless unmanageable adverse drug reactions prevent this.
Adults
Initial dose of 5mg every 4 to 6 hours. If considered necessary, dose may be increased by careful titration once a day.
Patients already receiving opioids may start treatment with higher doses taking into consideration previous experience with other opioid therapies.
Maximum daily dose of 400mg. Some patients may require a higher dose than the recommended maximum.
Children
Children aged 12 to 18 years (unlicensed)
Initial dose of 5mg every 4 to 6 hours. If considered necessary, dose may be increased. Maximum daily dose of 400mg.
Children aged 1 month to 12 years (unlicensed)
Initial dose of 200micrograms/kg every 4 to 6 hours. If considered necessary, dose may be increased. Maximum of 5mg per dose.
Patients with Renal Impairment
The dose initiation should follow a conservative approach in these patients.
Adults
The manufacturers recommended starting dose should be reduced by 50%, and each patient should be titrated to adequate pain control according to their clinical situation.
Children
Some sources suggest a maximum initial dose of 2.5mg every 6 hours in opioid naive children.
The Renal Drug Handbook suggests the following doses adjustments:
Glomerular filtration rate 20 to 50ml/minute: Reduce dose by 75%.
Glomerular filtration rate 10 to 20ml/minute: Reduce dose by 75%.
Glomerular filtration rate below 10ml/minute: Reduce dose by 50%.
Patients with Hepatic Impairment
The dose initiation should follow a conservative approach in these patients.
Adults
The manufacturers recommended starting dose should be reduced by 50%, and each patient should be titrated to adequate pain control according to their clinical situation.
Children
Some sources recommend a maximum initial dose of 2.5mg every 6 hours in opioid naive children.
Additional Dosage Information
Patients previously receiving oral morphine:
A guide to daily dose should be based on the following ratio: 10mg of oral oxycodone hydrochloride is equivalent to 20mg of oral morphine sulphate.
It must be emphasised that this is a guide to the dose of oxycodone hydrochloride required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.
Contraindications
24 hours post-operatively
Acute abdomen
Neonates under 1 month
Pre-operative administration
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Acute asthma
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
Renal impairment - creatinine clearance below 10ml/minute
Respiratory depression
Precautions and Warnings
Acute alcohol intoxication
Children 1 month to 18 years
Debilitation
Elderly
Opioid-naive patients
Predisposition to seizures
Adrenal insufficiency
Alcoholism
Asthma
Biliary colic
Biliary tract disorder
Chronic hepatic disorder
Chronic renal disorder
Delirium tremens
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of alcohol abuse
History of drug misuse
History of seizures
Hypotension
Hypothyroidism
Hypovolaemia
Inflammatory bowel disease
Lactose intolerance
Myasthenia gravis
Myxoedema
Opioid dependence
Pancreatitis
Prostate disorder
Raised intracranial pressure
Renal impairment
Respiratory impairment
Toxic psychosis
Before administration after abdominal surgery ensure normal bowel function
Consider dose modification in hypothyroidism
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
May reduce seizure threshold
Not all available products are licensed for all age groups
Some brands contain Sunset Yellow (E110) - can trigger allergic reactions
Some formulations contain lactose
Some products may contain soya or soya derivative
Monitor patients on prolonged therapy
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
May increase risk of seizure
Potential for withdrawal symptoms
May affect results of some laboratory tests
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
Increases in serum prolactin and decreases in plasma cortisol and testosterone may occur with use of oxycodone hydrochloride, as opioids may affect the hypothalamic-pituitary-adrenal or gonadal axes.
Pregnancy and Lactation
Pregnancy
Oxycodone hydrochloride is contraindicated during pregnancy.
The manufacturer does not recommend the use of oxycodone hydrochloride during pregnancy.
Oxycodone hydrochloride should not be used during labour. Infants born to mothers who have received opioids during pregnancy should be monitored for respiratory depression. Infants born to dependent mothers may exhibit withdrawal symptoms and may have respiratory depression at birth (Briggs 2015).
Lactation
Oxycodone hydrochloride is contraindicated during breastfeeding.
The manufacturer does not recommend the use of oxycodone hydrochloride during breastfeeding. Oxycodone hydrochloride is secreted in breast milk (Briggs 2015) and may cause respiratory depression in the newborn, and should therefore not be used in breastfeeding mothers.
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 thoughts
Agitation
Amenorrhoea
Amnesia
Anaphylactic reaction
Anaphylactoid reaction
Anorexia
Anxiety
Asthenia
Biliary colic
Bronchospasm
Chills
Confusion
Constipation
Convulsions
Cough suppression
Dehydration
Dependence
Depersonalisation
Depression
Diarrhoea
Disorientation
Dizziness
Dream abnormalities
Dry mouth
Dry skin
Dyspepsia
Dysphagia
Dysphoria
Dyspnoea
Erectile dysfunction
Eructation
Euphoria
Exfoliative dermatitis
Facial flushing
Flatulence
Gastritis
Gastrointestinal disorder
Hallucinations
Headache
Herpes simplex
Hiccups
Hyperacusis
Hyperhidrosis
Hypersensitivity reactions
Hypertonia
Hypoaesthesia
Hypotension
Hypotonia
Ileus
Increases in hepatic enzymes
Insomnia
Lability of affect
Lacrimation disorder
Lymphadenopathy
Malaise
Miosis
Mood changes
Muscle contraction
Muscle rigidity
Nausea
Nervousness
Oedema
Orthostatic hypotension
Palpitations
Paraesthesia
Peripheral oedema
Pharyngitis
Pruritus
Pyrexia
Rash
Reduced libido
Respiratory depression
Restlessness
Sedation
Somnolence
Speech disturbances
Supraventricular tachycardia
Syncope
Taste disturbances
Thirst
Tolerance
Tremor
Ureteric spasm
Urinary retention
Urticaria
Vasodilatation
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: November 2020
Reference Sources
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.
Summary of Product Characteristics: Lynlor 5mg Capsules, hard. Actavis UK Ltd. Revised September 2020.
Summary of Product Characteristics: Lynlor 10mg Capsules, hard. Actavis UK Ltd. Revised September 2020.
Summary of Product Characteristics: Lynlor 20mg Capsules, hard. Actavis UK Ltd. Revised September 2020..
Summary of Product Characteristics: Oxyact 5mg film coated tablets. G. L Pharma. Revised June 2019.
Summary of Product Characteristics: Oxyact 10mg film coated tablets. G. L Pharma. Revised June 2019.
Summary of Product Characteristics: Oxyact 20mg film coated tablets. G. L Pharma. Revised June 2019.
Summary of Product Characteristics: OxyNorm Capsules. Napp Pharmaceuticals Ltd. Revised November 2020.
Summary of Product Characteristics: OxyNorm liquid and OxyNorm concentrate. Napp Pharmaceuticals Ltd. Revised July 2020.
Summary of Product Characteristics: Shortec 5mg capsules. Qdem Pharmaceuticals Ltd. Revised November 2020.
Summary of Product Characteristics: Shortec 10mg capsules. Qdem Pharmaceuticals Ltd. Revised November 2020.
Summary of Product Characteristics: Shortec 20mg capsules. Qdem Pharmaceuticals Ltd. Revised November 2020.
Summary of Product Characteristics: Shortec Liquid 5 mg/5 ml Oral Solution. Qdem Pharmaceuticals Ltd. Revised November 2020.
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: 12 November 2020
New drug driving offence: implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: https://www.mhra.gov.uk Last accessed: 12 November 2020
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 24 June 2021.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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