Oxycodone and Naloxone interacts in the following cases:
A clinical trial has shown that plasma concentrations of both oxycodone and naloxone are elevated in patients with renal impairment. Naloxone concentrations were affected to a higher degree than oxycodone. The clinical relevance of a relative high naloxone exposure in renal impaired patients is yet not known. Caution should be exercised when administering oxycodone/naloxone to patients with renal impairment.
Concomitant use of alcohol and oxycodone/naloxone may increase the undesirable effects of oxycodone/naloxone; concomitant use should be avoided.
A clinical trial has shown that plasma concentrations of both oxycodone and naloxone are elevated in patients with hepatic impairment. Naloxone concentrations were affected to a higher degree than oxycodone. The clinical relevance of a relative high naloxone exposure in hepatic impaired patients is yet not known. Caution must be exercised when administering these tablets to patients with mild hepatic impairment.
Caution must be exercised when administering oxycodone/naloxone to patients with cholelithiasis.
There is no clinical experience in patients with cancer associated to peritoneal carcinomatosis or with sub-occlusive syndrome in advanced stages of digestive and pelvic cancers. Therefore, the use of these tablets in this population is not recommended.
Oxycodone/naloxone combination is not recommended for pre-operative use or within the first 12-24 hours post-operatively. Depending on the type and extent of surgery, the anaesthetic procedure selected, other co-medication and the individual condition of the patient, the exact timing for initiating post-operative treatment with oxycodone/naloxone depends on a careful risk-benefit assessment for each individual patient.
Caution must be exercised when administering oxycodone/naloxone to patients with myxoedema.
Caution must be exercised when administering oxycodone/naloxone to patients with epileptic disorder or predisposition to convulsions.
There are no data from the use of oxycodone/naloxone in pregnant women and during childbirth. Limited data on the use of oxycodone during pregnancy in humans reveal no evidence of an increased risk of congenital abnormalities. For naloxone, insufficient clinical data on exposed pregnancies are available. However, systemic exposure of the women to naloxone after use of these tablets is relatively low. Both oxycodone and naloxone pass into the placenta. Animal studies have not been performed with oxycodone and naloxone in combination. Animal studies with oxycodone or naloxone administered as single drugs have not revealed any teratogenic or embryotoxic effects.
Long-term administration of oxycodone during pregnancy may lead to withdrawal symptoms in the newborn. If administered during childbirth, oxycodone may evoke respiratory depression in the newborn.
Oxycodone/naloxone should only be used during pregnancy if the benefit outweighs the possible risks to the unborn child or neonate.
Oxycodone passes into the breast milk. A milk-plasma concentration ratio of 3:4:1 was measured and oxycodone effects in the suckling infant are therefore conceivable. It is not known whether naloxone also passes into the breast milk. However, after taking oxycodone/naloxone systemic naloxone levels are very low. A risk to the suckling child cannot be excluded in particular following intake of multiple doses of oxycodone/naloxone by the breastfeeding mother. Breastfeeding should be discontinued during treatment with oxycodone/naloxone.
No data on the effect of oxycodone and naloxone on human fertility are available. In rats, there was no effect on mating or fertility with oxycodone/naloxone treatment.
Oxycodone/naloxone combination has moderate influence on the ability to drive and use machines. This is particularly likely at the beginning of treatment, after dose increase or product rotation and if these tablets are combined with other CNS depressant agents.
Patients stabilised on a specific dosage will not necessarily be restricted. Therefore, patients should consult with their physician as to whether driving or the use of machinery is permitted. Patients being treated with oxycodone/naloxone and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved.
This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:
Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law
The following frequencies are the basis for assessing undesirable effects: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Uncommon: Hypersensitivity
Common: Decreased appetite up to loss of appetite
Common: Insomnia
Uncommon: Abnormal thinking, anxiety, confusional state, depression, libido decreased, nervousness, restlessness
Rare: Drug dependence
Not known: Euphoric mood, hallucination, nightmares, aggression
Common: Dizziness, headache, somnolence
Uncommon: Convulsions (particularly in persons with epileptic disorder or predisposition to convulsions), disturbance in attention, dysgeusia, speech disorder, syncope, tremor, lethargy
Not known: Paraesthesia, sedation
Uncommon: Visual impairment
Common: Vertigo
Uncommon: Angina pectoris (in particular in patients with history of coronary artery disease), palpitations
Rare: Tachycardia
Common: Hot flush
Uncommon: Blood pressure decreased, blood pressure increased
Uncommon: Dyspnoea, rhinorrhoea, cough
Rare: Yawning
Not known: Respiratory depression, Central sleep apnoea syndrome
Common: Abdominal pain, constipation, diarrhoea, dry mouth, dyspepsia, vomiting, nausea, flatulence
Uncommon: Abdominal distension
Rare: Tooth disorder
Not known: Eructation
Uncommon: Hepatic enzymes increased, biliary colic
Common: Pruritus, skin reactions, hyperhidrosis
Uncommon: Muscle spasms, muscle twitching, myalgia
Uncommon: Micturition urgency
Not known: Urinary retention
Not known: Erectile dysfunction
Common: Asthenia, fatigue
Uncommon: Chest pain, chills, drug withdrawal syndrome, malaise, pain, peripheral oedema, thirst
Uncommon: Weight decreased
Rare: Weight increased
Uncommon: Injuries from accidents
For the active substance oxycodone hydrochloride, the following additional undesirable effects are known:
Due to its pharmacological properties, oxycodone hydrochloride may cause respiratory depression, miosis, bronchial spasm and spasms of nonstriated muscles as well as suppress the cough reflex.
Rare: Herpes simplex
Not known: Anaphylactic reaction
Uncommon: Dehydration
Rare: Increased appetite
Common: Altered mood and personality change, decreased activity, psychomotor hyperactivity
Uncommon: Agitation, perception disturbances (e.g. derealisation)
Uncommon: Concentration impaired, migraine, hypertonia, involuntary muscle contractions, hypoaesthesia, abnormal coordination
Not known: Hyperalgesia
Uncommon: Hearing impaired
Uncommon: Vasodilatation
Uncommon: Dysphonia
Common: Hiccups
Uncommon: Dysphagia, ileus, mouth ulceration, stomatitis
Rare: Melaena, gingival bleeding,
Not known: Dental caries
Not known: Cholestasis, Sphincter of Oddi dysfunction
Uncommon: Dry skin
Rare: Urticaria
Common: Dysuria
Uncommon: Hypogonadism
Not known: Amenorrhoea
Uncommon: Oedema, drug tolerance
Not known: Drug withdrawal syndrome neonatal
The list below reflects the adverse drug reactions seen with oxycodone/naloxone in a 12-week, randomised, placebo-controlled clinical trial comprising a total of 150 patients on oxycodone/naloxone and 154 patients on placebo with daily dosages between 10 mg/5 mg and 80 mg/40 mg oxycodone hydrochloride/naloxone hydrochloride. Adverse drug reactions associated with these tablets in pain and not observed in RLS study population were added with the frequency of not known.
Not known: Hypersensitivity
Common: Decreased appetite up to loss of appetite
Common: Insomnia, depression
Uncommon: Libido decreased, sleep attacks
Not known: Abnormal thinking, anxiety, confusional state, nervousness, restlessness, euphoric mood, hallucination, nightmares, drug dependence, aggression
Very common: Headache, somnolence
Common: Dizziness, disturbance in attention, tremor, paraesthesia
Uncommon: Dysgeusia
Not known: Convulsions (particularly in persons with epileptic disorder or predisposition to convulsions), sedation, speech disorder, syncope, lethargy
Common: Visual impairment
Common: Vertigo
Not known: Angina pectoris (in particular in patients with history of coronary artery disease), palpitations, tachycardia
Common: Hot flush, blood pressure decreased, blood pressure increased
Uncommon: Dyspnoea
Not known: Cough, rhinorrhoea, respiratory depression, yawning
Very common: Constipation, nausea
Common: Abdominal pain, dry mouth, vomiting
Uncommon: Flatulence
Not known: Abdominal distension, diarrhoea, dyspepsia, eructation, tooth disorder
Common: Hepatic enzymes increased (alanine aminotransferase increased, gammaglutamyltransferase increased),
Not known: Biliary colic
Very common: Hyperhidrosis
Common: Pruritus, skin reactions
Not known: Muscle spasms, muscle twitching, myalgia
Not known: Micturition urgency, urinary retention
Uncommon: Erectile dysfunction
Very common: Fatigue
Common: Chest pain, chills, thirst, pain
Uncommon: Drug withdrawal syndrome, oedema peripheral,
Not known: Malaise, asthenia
Not known: Weight decreased, weight increased
Uncommon: Injuries from accidents
Repeated use of oxycodone/naloxone can lead to drug dependence, even at therapeutic doses. The risk of drug dependence may vary depending on patient’s individual risk factors, dosage and duration of opioid treatment.
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