naloxone hydrochloride dihydrate + oxycodone hydrochloride at a glance
Medicine class
Prolonged-release opioid analgesic combined with a locally acting opioid antagonist.
Licensed uses
Severe opioid-responsive pain and second-line treatment of severe to very severe idiopathic restless legs syndrome in adults.
Administration
Swallow the prolonged-release tablet whole with liquid; it may be taken with or without food.
Important safety point
Oxycodone can cause sedation, respiratory depression, tolerance, dependence and opioid use disorder.
What is naloxone hydrochloride dihydrate + oxycodone hydrochloride used for?
The selected prolonged-release product is licensed for adults in the following circumstances:
Severe pain that can be adequately managed only with opioid analgesics.
Second-line symptomatic treatment of severe to very severe idiopathic restless legs syndrome after dopaminergic treatment has failed; treatment should be supervised by a clinician experienced in the condition.
How does naloxone hydrochloride dihydrate + oxycodone hydrochloride work?
Oxycodone activates opioid receptors in the brain and spinal cord, reducing the perception of pain. Naloxone blocks opioid receptors mainly within the gut because very little reaches the systemic circulation after oral administration; this helps counter oxycodone-related bowel dysfunction without usually reversing its central analgesic effect.
naloxone hydrochloride dihydrate + oxycodone hydrochloride preparations and strengths
Modified-release tablet
Route: Oral
Strengths: 5 mg + 2.5 mg, 10 mg + 5 mg, 20 mg + 10 mg, 40 mg + 20 mg
How to take naloxone hydrochloride dihydrate + oxycodone hydrochloride
Swallow each prolonged-release tablet whole with sufficient liquid, with or without food.
Do not break, chew or crush the tablet; doing so can release oxycodone rapidly and may cause a fatal overdose.
This formulation is not intended for breakthrough or rapidly developing pain.
The empty tablet matrix may sometimes be visible in the stool.
Do not stop suddenly unless urgently directed by a clinician; planned withdrawal is normally gradual.
naloxone hydrochloride dihydrate + oxycodone hydrochloride side effects
Common or expected effects
- Constipation, diarrhoea, nausea, vomiting or abdominal discomfort
- Dizziness, headache or sleepiness
- Dry mouth, indigestion or wind
- Itching, skin reactions or increased sweating
- Weakness or fatigue
- Reduced appetite or difficulty sleeping
Get urgent medical advice
- Slow, weak or shallow breathing, profound sedation or inability to wake
- A severe allergic reaction, including throat or tongue swelling and difficulty breathing
- Severe confusion, fainting, seizures or symptoms suggesting serotonin toxicity
- Dependence, loss of control over use or significant withdrawal symptoms
naloxone hydrochloride dihydrate + oxycodone hydrochloride in pregnancy
Evidence for the combination in pregnancy is limited. Oxycodone and naloxone cross the placenta; prolonged opioid exposure may cause neonatal withdrawal, while use near delivery may suppress the newborn's breathing. It should be considered only after a prescriber has weighed maternal benefit against fetal and neonatal risks.
naloxone hydrochloride dihydrate + oxycodone hydrochloride while breastfeeding
The selected product's SmPC states that breastfeeding should be discontinued during treatment because oxycodone enters breast milk and effects in the infant cannot be excluded. Specialist UK advice notes that oxycodone–naloxone may sometimes be used cautiously for pain with close infant monitoring, although another opioid is preferred. Product-specific prescriber or specialist advice is essential.
naloxone hydrochloride dihydrate + oxycodone hydrochloride interactions
Tell the prescriber or pharmacist about all medicines, supplements and recreational substances. Important interactions include:
Benzodiazepines, sleeping tablets and other sedatives
Additive sedation can cause respiratory depression, coma or death; combined use requires careful justification and monitoring.
Other opioids, gabapentin or pregabalin
These can increase drowsiness and respiratory depression.
Alcohol
Alcohol increases sedation and other serious opioid effects and should be avoided.
Common questions about naloxone hydrochloride dihydrate + oxycodone hydrochloride
Answers are fully visible for fast scanning and source review.
Is naloxone hydrochloride dihydrate + oxycodone hydrochloride an opioid?
It contains oxycodone, a strong opioid agonist. Naloxone is an opioid antagonist added mainly to act within the bowel.
Why is naloxone combined with oxycodone in naloxone hydrochloride dihydrate + oxycodone hydrochloride?
Oral naloxone mainly blocks opioid receptors in the gut, helping reduce opioid-related bowel dysfunction while oxycodone acts centrally.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.