OxyContin prolonged release tablets
- Name:
OxyContin prolonged release tablets
- Company:
Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/02/21
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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 17 February 2021 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
Section 2 - Warnings and precautions - Addition of section regarding use in non-cancer pain
Section 2 - Interactions - Addition of gabapentin and pregabalin
Section 3 - How to take - Addition of recommendation that the tablets be taken in a consistent manner in relation to timing of meals
Updated on 17 February 2021 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 - Addition of statement that the lowest effective dose should be used. Addition of section on transfer of patients between oral and parenteral oxycodone. Addition of recommendation that tablets are taken consistently in relation to timing of meals. Administrative changes.
Section 4.4 - Addition of section regarding chronic non-malignant pain.
Section 4.5 - Addition of gabapentinoids to the list of drugs which depress the CNS.
Section 5.2 - Reorganisation of section into ADME format and addition of absorption, distribution and biotransformation data. Addition of sections on hepatic and renal dysfunction.
Section 5.3 - Addition of detailed reproductive and developmental toxicity data, genoxicity data, and carcinogenicity data.
Updated on 3 April 2019 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 3 April 2019 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to section 4.5 of the SPC to include concomitant administration of oxycodone with serotonin agents.
Updated on 21 November 2018 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 21 November 2018 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of text to sections 4.4. and 4.5 of the SmPC in relation to concomitant use of benzodiazepines :
Section 4.4:
Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs:
Concomitant use of opioids, including oxycodone and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma, and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe oxycodone concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).
Section 4.5:
The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4). Drugs which affect the CNS include, but are not limited to: alcohol, phenothiazines, antidepressants, anaesthetics, hypnotics, non-benzodiazepine sedatives, muscle relaxants, other opioids, neuroleptic drugs, antihypertensives and SSRIs. Oxycodone should be used with caution and the dosage may need to be reduced in patients using these medications.
Updated on 10 January 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 10 January 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 10 January 2018 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 January 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 5 August 2015 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
For the full list of excipients
4.2 Posology and method of administration
Headings - Route of administration and Oral Use have been deleted.
4.4 Special warnings and precautions for use
Highlighted text has been removed
Hyperalgesia that will not respond to a further dose increase of oxycodone may
4.5 Interaction with other medicinal products and other forms of interaction
Highlighted text has been removed.
There can be an enhanced CNS depressant effect during concomitant therapy with drugs which affect the CNS such as phenothiazines,
The following text has been added
Concomitant administration of oxycodone with anticholinergics or medicines with anticholinergic activity (e.g. tricyclic anti-depressants, antihistamines, antipsychotics, muscle relaxants, anti-Parkinson drugs) may result in increased anticholinergic adverse effects. Oxycodone should be used with caution and the dosage may need to be reduced in patients using these medications.
4.8 Undesirable effects
Frequency category Unknown has been changed to Not known.
Nervous system disorders - lethargy has been added to common.
Reproductive system and breast disorders - uncommon - hypogonadism has been added
General disorders - fatigue has been added to common, drug withdrawal syndrome neonatal has been added to Not known.
The following has been added:
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie
4.9 Overdose: highlighted text has been added
Acute overdose with oxycodone can be manifested by respiratory depression, somnolence, progressing to stupor or coma, hypotonia, miosis, bradycardia, hypotension, pulmonary oedema and death.
5.1 Pharmacodynamic properties: highlighted text has been added
Gastrointestinal System
Opioids may induce spasm of the sphincter of Oddi.
Updated on 8 June 2015 PIL
Reasons for updating
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Addition of information on reporting a side effect.
Updated on 30 July 2014 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.2 Posology and method of administration
Route of administration
Oral use
Posology
Prescribers should consider concomitant treatment with antiemetics and laxatives for the prevention of nausea, vomiting and constipation.
Missed dose:
If a patient forgets to take a dose but remembers within 4 hours of the time the dose was due to be taken, the tablets can be taken straight away. The next dose should be taken at the normal time. Beyond 4 hours the prescriber may need to consider alternative rescue medicine until the next dose is due.
Discontinuation of treatment:
When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
Adults and the elderly:
OxyContin tablets should be taken at 12-hourly intervals. The dosage is dependent on the severity of the pain, the patient’s previous history of analgesic requirements, the patient’s body weight, and sex (higher plasma concentrations are produced in females).
The usual starting dose for debilitated elderly patients, opioid naïve patients or patients presenting with severe pain uncontrolled with weaker opioids is 10 mg 12-hourly. Some patients may benefit from a starting dose of 5 mg to minimise the incidence of side effects. The dose should then be carefully titrated, every day if necessary, to achieve pain relief. Given the time to reach steady state, patients’ doses should only be titrated up after 24 hours and increases should be made, where possible, in 25% - 50% increments. The correct dosage for any individual patient is that which controls the pain and is well tolerated, for a full 12 hours. The need for escape medication more than twice a day indicates that the dosage of OxyContin tablets should be increased.
Conversion from oral morphine:
Patients receiving oral morphine before oxycodone therapy should have their daily dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It must be emphasised that this is a guide to the dose of OxyContin tablets required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.
Elderly patients:
A dose adjustment is not usually necessary in elderly patients.
Controlled pharmacokinetic studies in elderly patients (aged over 65 years) have shown that compared with younger adults the clearance of oxycodone is only slightly reduced. No untoward adverse drug reactions were seen based on age, therefore adult doses and dosage intervals are appropriate.
Non-malignant pain:
Treatment with oxycodone should be short and intermittent to minimise the risk of dependence. The need for continued treatment should be assessed at regular intervals. Patients should not usually require more than 160 mg per day.
Cancer-related pain:
Patients should be titrated up to a dose which achieves pain relief unless unmanageable adverse drug reactions prevent this.
Patients with renal or hepatic impairment:
Unlike morphine preparations, the administration of oxycodone does not result in significant levels of active metabolites. However, the plasma concentration of oxycodone in this patient population may be increased compared with patients having normal renal or hepatic function. Therefore dose initiation should follow a conservative approach in these patients. The recommended adult starting dose should be reduced by 50% (for example a total daily dose of 10 mg orally in opioid naïve patients), and, i.e. one-third to one half the usual dose with careful dose titration. There are no data in patients with severe renal and/or hepatic impairment. A reduced dosage may be appropriate in these patients but each patient should be titrated to adequate pain control according to their clinical responsesituation.
Paediatric population and adults under 20 years of age:
Not recommended. Experience in children is limited. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on posology can be made.
Method of administration
OxyContin tablets are for oral use.
OxyContin tablets must be swallowed whole and are not to be broken, chewed or crushed. Taking broken, chewed or crushed OxyContin tablets may lead to a rapid release and absorption of a potentially fatal dose of oxycodone.
Missed dose:
If a patient forgets to take a dose but remembers within 4 hours of the time the dose was due to be taken, the tablets can be taken straight away. The next dose should be taken at the normal time. Beyond 4 hours the prescriber may need to consider alternative rescue medicine until the next dose is due.
Duration of treatment:
Oxycodone should not be used longer than necessary.
Discontinuation of treatment:
When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4.3 Contraindications
Hypersensitivity to oxycodone or to any of the excipients listed in section 6.1.
Oxycodone must not be used in Aany situation where opioids are contra-indicated: severe respiratory depression with hypoxia, elevated carbon dioxide levels in the blood (hypercarbia), head injury, paralytic ileus, acute abdomen, delayed gastric emptying, severe chronic obstructive airways lung disease, severe bronchial asthma, cor pulmonale, hypercarbia, known sensitivity to oxycodone, morphine or other opioids, hypersensitivity to any of the excipients, acute hepatic disease, concurrent administration of monoamine oxidase inhibitors (see section 4.5) or within 2 weeks of discontinuation of their use. The safety of OxyContin used pre-operatively and for up to 24 hours post-operatively has not been established and cannot be recommended.
4.4 Special warnings and precautions for use
The major risk of opioid excess is respiratory depression.
Caution must be exercised when administering oxycodone to the debilitated elderly; patients with severely impaired pulmonary function, impaired hepatic or renal function; patients with myxoedema, hypothyroidism, Addison’s disease, Use with caution in opioid dependent patients, patients with toxic psychosis, adrenocortical insufficiency, prostate hypertrophy, head injury (due to the risk of raised intracranial pressure), convulsive disorders, delirium tremens, disorders of consciousness, hypotension, hypovolaemia., Use with caution in opioid dependent patients, diseases of the biliary tract, biliary or ureteric colic, pancreatitis, obstructive and inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, hypothyroidism, chronic obstructive airways disease, severely impaired pulmonary function, reduced respiratory reserve, alcoholism, or patients taking MAO inhibitors.chronic renal and hepatic disease (see section 4.2), debilitated, elderly or infirm patients. In patients in whom caution is required, a reduction in dosage may be advisable.
Doses of OxyContin tablets in excess of 60 mg may cause fatal respiratory depression when administered to patients not previously exposed to opioids and should only be used in opioid-tolerant patients. Care should be taken in the prescription of daily oxycodone dosages of 120 mg or more.
OxyContin tablets should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, OxyContin tablets should be discontinued immediately (see section 4.3). As with all opioid preparations, patients about to undergo additional pain relieving procedures (e.g. surgery, plexus blockade) should not receive oxycodone for 12 hours prior to the intervention. If further treatment with OxyContin tablets is indicated then the dosage should be adjusted to the new post-operative requirement.
As with all opioid preparations, oxycodone products OxyContin tablets should be used with caution following abdominal surgery as opioids are known to impair intestinal motility and should not be used until the physician is assured of normal bowel function.
OxyContin is not recommended for pre-operative use or within the first 12-24 hours post-operatively.
The patient Patients may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. There may also be cross-tolerance with other opioids. Prolonged use of this product may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. Withdrawal symptoms may include yawning, mydriasis, lacrimation, rhinorrhoea, tremor, hyperhidrosis, anxiety, agitation, convulsions and insomnia.
Hyperalgesia that will not respond to a further dose increase of oxycodone may very rarely occur, particularly in high doses. An oxycodone dose reduction or change to an alternative opioid may be required.
Oxycodone has an abuse profile similar to that of other strong agonist opioids. Oxycodone may be sought and abused by people with latent or manifest addiction disorders. There is potential for development of psychological dependence (addiction)to opioid analgesics, including oxycodone. OxyContin tablets should be avoided used with particular care in patients with a history of or present alcohol or and drug abuse.
The prolonged release tablets must be swallowed whole, and not be broken, chewed or crushed. The administration of broken, chewed or crushed controlled release oxycodone tablets leads to a rapid release and absorption of a potentially fatal dose of oxycodone (see section 4.9)., as this may lead to an overdose (see section 4.2 and 4.9).
Concomitant use of alcohol and OxyContin may increase the undesirable effects of OxyContin; concomitant use should be avoided.
Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, such as local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis and valvular heart injury, which may be fatal.
It should be emphasised that patients, once titrated to an effective dose of a certain opioid, should not be changed to other analgesic preparations without clinical assessment and careful retitration as necessary. Otherwise, a continuous analgesic action is not ensured.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Empty matrix (tablets) may be seen in the stool.
4.5 Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults.
There can be an enhanced CNS depressant effect during concomitant therapy with drugs which affect the CNS such as phenothiazines, tricyclic antidepressants, anaesthetics, hypnotics, sedatives, muscle relaxants, other opioids, neuroleptic drugs, antihypertensives and SSRIs. Oxycodone should be used with caution and the dosage may need to be reduced in patients using these medications. Monoamine oxidase inhibitors are known to interact with narcotic analgesics, producing CNS excitation or depression associated with hypertensive- or hypotensive crisis (see section 4.4). Oxycodone should be used with caution in patients administered MAO-inhibitors or who have received MAO-inhibitors during the last two weeks (see section 4.43).
Alcohol may enhance the pharmacodynamic effects of OxyContin; concomitant use should be avoided.
Oxycodone is metabolised mainly by CYP3A4, with a contribution from CYP2D6. The activities of these metabolic pathways may be inhibited or induced by various co-administered drugs or dietary elements.
CYP3A4 inhibitors, such as macrolide antibiotics (e.g. clarithromycin, erythromycin and telithromycin), azol-antifungals (e.g. ketoconazole, voriconazole, itraconazole, and posaconazole), protease inhibitors (e.g. boceprevir, ritonavir, indinavir, nelfinavir and saquinavir), cimetidine and grapefruit juice may cause a reduced clearance of oxycodone that could cause an increase of the plasma concentrations of oxycodone. Therefore the oxycodone dose may need to be adjusted accordingly.
Some specific examples are provided below:
· Itraconazole, a potent CYP3A4 inhibitor, administered 200 mg orally for five days, increased the AUC of oral oxycodone. On average, the AUC was approximately 2.4 times higher (range 1.5 - 3.4).
· Voriconazole, a CYP3A4 inhibitor, administered 200 mg twice-daily for four days (400 mg given as first two doses), increased the AUC of oral oxycodone. On average, the AUC was approximately 3.6 times higher (range 2.7 - 5.6).
· Telithromycin, a CYP3A4 inhibitor, administered 800 mg orally for four days, increased the AUC of oral oxycodone. On average, the AUC was approximately 1.8 times higher (range 1.3 – 2.3).
· Grapefruit Juice, a CYP3A4 inhibitor, administered as 200 ml three times a day for five days, increased the AUC of oral oxycodone. On average, the AUC was approximately 1.7 times higher (range 1.1 – 2.1).
CYP3A4 inducers, such as rifampicin, carbamazepin, phenytoin and St John´s Wort may induce the metabolism of oxycodone and cause an increased clearance of oxycodone that could cause a reduction of the plasma concentrations of oxycodone. The oxycodone dose may need to be adjusted accordingly.
Some specific examples are provided below:
· St Johns Wort, a CYP3A4 inducer, administered as 300 mg three times a day for fifteen days, reduced the AUC of oral oxycodone. On average, the AUC was approximately 50% lower (range 37-57%).
· Rifampicin, a CYP3A4 inducer, administered as 600 mg once-daily for seven days, reduced the AUC of oral oxycodone. On average, the AUC was approximately 86% lower
Drugs that inhibit CYP2D6 activity, such as paroxetine and quinidine, may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations.
Oxycodone is metabolised by the cytochrome P450 enzyme system (CYP2D6 and CYP3A4) but a full evaluation of interactions with other drugs metabolised by this route has not been undertaken. Concurrent administration of quinidine, an inhibitor of cytochrome P450-2D6, resulted in an increase in oxycodone Cmax by 11%, AUC by 13% and t½ elim by 14%; also an increase in the metabolite noroxycodone level was observed. The pharmacodynamic effects of oxycodone were not altered. This interaction may be observed for other potent inhibitors of the cytochrome P450-2D6 enzyme such as paroxetine and fluoxetine. Cimetidine and inhibitors or substrates of cytochrome P450-3A4 such as ketoconazole, voriconazole and erythromycin may inhibit the metabolism of oxycodone.
4.6 Fertility, pregnancy and lactation
Use of this medicinal product should be avoided to the extent possible in patients who are pregnant or lactating.
Pregnancy
There are no or limited amount of data from the use of oxycodone in pregnant women. Infants born to mothers who have received opioids during the last 3 to 4 weeks before giving birth should be monitored for respiratory depression. Withdrawal symptoms may be observed in the newborn of mothers undergoing treatment with oxycodone.
For animal studies see section 5.3.
Oxycodone penetrates the placenta. Oxycodone should not be used during pregnancy and labour due to impaired uterine contractility and the risk of neonatal respiratory depression.
For animal studies see section 5.3.Infants born to mothers who have received opioids during pregnancy should be monitored for respiratory depression. Withdrawal symptoms may be observed in the newborn of mothers undergoing treatment with oxycodone.
OxyContin should not be used during pregnancy.
Breastfeeding
Oxycodone is may be secreted in breast milk and may cause respiratory depression in the newborn.
Oxycodone should, therefore, not be used in breast-feeding mothers.
Breastfeeding should be discontinued during treatment with OxyContin.
Fertility
Non-clinical toxicology studies in rats have not shown any effects upon fertility (see section 5.3).
4.7 Effects on ability to drive and use machines
Oxycodone may impair the ability to drive and use machines. Oxycodone may modify patients’ reactions to a varying extent depending on the dosage and individual susceptibility. If affected, patients should not drive or operate machinery.
4.8 Undesirable effects
The most commonly reported adverse reactions are nausea and constipation, both occurring in approximately 25 to 30 % of patients. If nausea or vomiting are troublesome, oxycodone may be combined with an antiemetic. Constipation should be anticipated as with any strong opioid, and treated appropriately with laxatives. Should opioid related adverse events persist, they should be investigated for an alternative cause.
Adverse drug reactions are typical of full opioid agonists, and tend to reduce with time, with the exception of constipation. Anticipation of adverse drug reactions and appropriate patient management can improve acceptability.
The most serious adverse reaction, as with other opioids, is respiratory depression (see section 4.9). This is most likely to occur in elderly, debilitated or opioid-intolerant patients.
The following frequency categories form the basis for classification of the undesirable effects:
|
Term |
Frequency |
|
Very common |
≥ 1/10 |
|
Common |
≥ 1/100 to <1/10 |
|
Uncommon |
≥ 1/1,000 to <1/100 |
|
Rare Very rare |
≥1/10,000 to <1/1,000 <1/10,000 |
|
Frequency unknown |
Cannot be estimated from the available data |
The adverse drug reactions seen during clinical trials and from spontaneous reports are listed below with the following frequencies:
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).
|
|
Very Common |
Common |
Uncommon |
Rare |
Frequency unknown |
|
Immune system disorders |
|
|
hypersensitivity |
|
anaphylactic responses |
|
Endocrine disorders |
|
|
syndrome of inappropriate antidiuretic hormone secretion (SIADH) |
|
|
|
Metabolism and nutrition disorders |
|
decreased appetite |
dehydration, |
|
|
|
Psychiatric disorders |
|
abnormal dreams, abnormal thinking, anxiety, confusional state, depression, insomnia, nervousness |
agitation, abnormal thinking, depersonalisation, affect lability, euphoric mood, hallucinations, decreased libido, drug dependence (see section 4.4) |
|
aggression |
|
Nervous system disorders |
somnolence, dizziness, headache |
tremor |
amnesia, convulsion, hyperkinesia, hypertonia, hypoaesthesia, hypotonia, involuntary muscle contractions, speech disorder, stupor, paraesthesia, dysgeusia, syncope |
|
hyperalgesia |
|
Eye disorders |
|
|
|
|
|
|
Ear and labyrinth disorders |
|
|
tinnitus, vertigo |
|
|
|
Cardiac disorders |
|
|
palpitations (in the context of withdrawal syndrome) |
|
|
|
Vascular disorders |
|
|
vasodilatation |
hypotension, orthostatic hypotension |
|
|
Respiratory, thoracic and mediastinal disorders |
|
dyspnoea, bronchospasm |
rhinitis, epistaxis, hiccup, voice alteration, respiratory depression |
|
|
|
Gastrointestinal disorders |
constipation, nausea, vomiting |
abdominal pain, diarrhoea, dry mouth, dyspepsia |
dysphagia, flatulence, gastritis, mouth ulceration, eructation, gastrointestinal disorders, ileus, stomatitis |
|
dental caries |
|
Hepatobiliary disorders |
|
|
hepatic enzyme increased |
|
biliary colic, cholestasis |
|
Skin and subcutaneous tissue disorders |
pruritus |
rash, hyperhidrosis |
dry skin |
urticaria |
|
|
Renal and urinary disorders |
|
urinary disorders |
urinary retention |
|
|
|
Reproductive system and breast disorders |
|
|
erectile dysfunction |
|
amenorrhoea |
|
General disorders and administration site conditions |
|
asthenic conditions, fever |
chills, chest pain, drug withdrawal syndrome, gait disturbance, malaise, oedema, peripheral oedema, drug tolerance, thirst |
|
|
Tolerance may occur in patients treated with oxycodone, although this has not been a significant problem in the clinical trial programme. Patients requiring marked dose escalation should have their pain control regimen carefully reviewed.
Abrupt withdrawal of OxyContin tablets or administration of an opioid antagonist may result in a withdrawal syndrome characterised by anxiety, irritability, chills, hot flushes, piloerection, joint pain, rhinorrhoea, diaphoresis, abdominal cramps and diarrhoea. If the dose reduction regimen recommended in Section 4.2 results in a withdrawal syndrome, the dose should be slightly increased until the signs and symptoms disappear. Dose reduction should then begin again with longer periods of time between each reduction.
Paediatric population and adults under 20 years of age:
The frequency, type and severity of adverse reactions in children and adults under 20 years of age are expected not to be different from adults 20 years and over.
For infants born to mothers receiving oxycodone see section 4.6.
4.9 Overdose
Acute overdosage with oxycodone can be manifested by respiratory depression, somnolence, progressing to stupor or, coma, hypotonia, miosisskeletal muscle flaccidity, miotic pupils, bradycardia, hypotension, and death.
Treatment of oxycodone overdosage: A patent airway must be maintained. The pure opioid antagonists such as naloxone are specific antidotes against symptoms from opioid overdose. Other supportive measures should be employed as needed.
Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.
In the case of massive overdosage, administer naloxone 0.8 mg intravenously. Repeat at 2-3 minute intervals as necessary, or by an infusion of 2 mg in 500 ml of normal saline or 5% dextrose (0.004 mg/ml).
The infusion should be run at a rate related to the previous bolus doses administered and should be in accordance with the patient’s response. However, because the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. OxyContin tablets will continue to release and add to the oxycodone load for up to 12 hours after administration and the management of oxycodone overdosage should be modified accordingly.
For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.
Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdosage. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on oxycodone. In such cases, an abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.
Gastric contents may need to be emptied as this can be useful in removing unabsorbed drug, particularly when a prolonged release formulation has been taken.
Updated on 28 May 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
Updated on 16 November 2011 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4 - Clinical particulars
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
"Each" has been added before the strength of the tablet
The following has been added:
Excipient:
Each 5 mg tablet contains 77.30 mg of lactose monohydrate
Each 10 mg tablet contains 69.25 mg of lactose monohydrate
Each 20 mg tablet contains 59.25 mg of lactose monohydrate
Each 40 mg tablet contains 35.25 mg of lactose monohydrate
Each 80 mg tablet contains 78.50 mg of lactose monohydrate
Section 3
Diameter of each strength of tablet has been added.
Section 4.1
"OxyContin is indicated in adults 20 years of age and over" has been added
Section 4.2
Has been re-written
Sectoin 4.3
(see section 4.5) has been added.
Section 4.4
The following has been added:
Doses of OxyContin tablets in excess of 60 mg may cause fatal respiratory depression when administered to patients not previously exposed to opioids and should only be used in opioid-tolerant patients. Care should be taken in the prescription of daily oxycodone dosages of 120 mg or more.
Empty matrix (tablets) may be seen in the stool.
The following has been deleted
"OxyContin 80 mg tablet strength may cause fatal respiratory depression when administered to patients not previously exposed to opioids."
"OxyContin tablets 80 mg are for use only in opioid-tolerant patients requiring daily oxycodone dosages of 160 mg or more. Care should be taken in the prescription of this tablet strength."
"The tablets contain 77.30 mg (5 mg strength), 69.25 mg (10 mg strength), 59.25 mg (20 mg strength) 35.25 mg (40 mg strength) and 78.50 mg (80 mg strength) of lactose per tablet"
Section 4.5
The following has been added:
"Interaction studies have only been performed in adults"
OxyContin has been replaced with oxycodone.
Concurrent administration of quinidine, an inhibitor of cytochrome P450-2D6, resulted in an increase in oxycodone Cmax by 11%, AUC by 13% and t½ elim by 14%; also an increase in the metabolite noroxycodone level was observed. "metabolite" has been added to this sentence.
Section 4.6
Has been re-written
Section 4.8
Has been re-written
Section 5.1
"Opioids, analgesics" has been added.
The therapeutic effect is mainly analgesic, anxioltic, antitussive and sedative. (antitussive has been added).
The following has been added:
Paediatric population
Overall the safety data obtained with oral oxycodone in 9 clinical, pharmacodynamic and pharmacokinetic studies including a total of 629 infants and children (aged 2 months to 17 years) demonstrate that oral oxycodone is tolerated well in paediatric patients with only minor adverse events affecting mainly the gastrointestinal and nervous system. The positive safety data obtained with oral oxycodone are confirmed by 9 studies performed with bucally, intramuscularly and intravenously administered oxycodone in a total of 1860 infants and children who also experienced only mild adverse events comparable to those observed with the use of oral oxycodone.
The dose of oxycodone administered parenterally to infants and children in clinical trials was in the range of 0.025 mg/kg to 0.1 mg/kg, with 0.1 mg/kg being the most frequently used dosage followed by 0.05 mg/kg. The dose of i.v. oxycodone was in the range of 0.025 mg/kg to 0.1 mg/kg, with 0.1 mg/kg being the most frequently used dosage followed by 0.05 mg/kg. The dose of i.m. oxycodone was in the range of 0.02 mg/kg to 0.1 mg/kg. The dose of orally administered oxycodone was in the range of 0.1 mg/kg (starting dose) to 1.24 mg/kg/day. Buccally administered dose of oxycodone was 0.1 mg/kg.
Overall, the adverse events in these studies of oxycodone in infants and children appear consistent with the known safety profile of oxycodone elaborated in the numerous clinical trials performed in adults and described in the SmPC. No new or unexpected safety signals were identified in these studies. All of the adverse events reported were consistent with the known safety profile of oxycodone as well as of other comparable strong opioids. However OxyContin is not recommended in children and adults below 20 years of age due to insufficient data on safety and efficacy.
Section 5.2
It has an elimination half-life of approximately 3 hours and is metabolised principally to noroxycodone via CYP 3A4 and and oxymorphone via CYP 2D6. "CYP 3A4 and CYP 2D6" has been added.
"All strengths of" has replaced "tablets 5 mg, 10mg, 20 mg, 40 mg and 80 mg.
The following has been added:
Paediatric population
The pharmacokinetic properties of oral oxycodone in infants and children were examined in 3 studies including a total of 63 infants and children aged 0.5 to 7.6 years. In addition pharmacokinetics of buccal and sublingual oxycodone was studied in 30 children aged 0.5-7.5 years. These studies did not reveal significant different results in comparison to adults. Oral oxycodone was tolerated well in these pharmacokinetic studies with only minor adverse events.
Section 5.3
Has been re-written.
Section 6.1
Lactose monohydrate "monohydrate" has been added.
Updated on 9 November 2011 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about drinking alcohol
- Change to further information section
- Change to dosage and administration
Updated on 8 July 2011 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Changed from Napp Pharmaceuticals Ltd
Cambridge Science Park
Milton Road
Cambridge
CB4 0GW
U.K.
to Mundipharma Pharmaceuticals Ltd
Millbank House
Arkle Road
Sandyford
Dublin 18
Section 8. Marketing authorisation numbers
Changed to PA 1688/1-5
Updated on 6 July 2011 PIL
Reasons for updating
- Change of licence holder
- Change to date of revision
Updated on 1 June 2011 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
"OxyContin tablets should not be taken with alcoholic drinks." has been removed.
Section 4.4
"Intake of OxyContin tablets with alcoholic drinks should be avoided because this may lead to more frequent undesirable effects such as somnolence and respiratory depression (See Section
4.5) has been removed.
"Concomitant use of alcohol and OxyContin may increase the undesirable effects of OxyContin; concomitant use should be avoided." has been added.
Section 4.5
"alcohol" has been removed from the first sentence.
"Alcohol may enhance the pharmacodynamic effects of OxyContin; concomitant use should be avoided." has been added.
Updated on 1 June 2011 PIL
Reasons for updating
- Change to information about drinking alcohol
Updated on 1 July 2010 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
"OxyContin should not be taken with alcoholic drinks" has been added.
Section 4.4
"Intake of OxyContin tablets with alcoholic drinks should be avoided because this may lead to more frequent undesirable effects such as somnolence and respiratory depression (see section 4.5)." has been added.
"OxyContin tablets should be avoided in patients with a history of or present alcohol or drug abuse" has been added.
Updated on 28 June 2010 PIL
Reasons for updating
- Change to information about drinking alcohol
Updated on 22 September 2008 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 22 September 2008 PIL
Reasons for updating
- Change to improve clarity and readability
Updated on 30 November 2005 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 9 August 2005 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 5 August 2005 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 21 July 2005 SPC
Reasons for updating
- Change to section 4 - Clinical particulars
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 14 July 2005 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 26 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 18 December 2003 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Addition of joint SPC covering all presentations
Legal category: Product subject to medical prescription which may not be renewed (A)