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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

Millbank House, Arkle Road, Sandyford, Dublin 18, Ireland
Telephone: +353 1 206 3800
Medical Information e-mail: info@mundipharma.ie
Summary of Product Characteristics last updated on medicines.ie: 10/01/2018
SPC OxyContin prolonged release tablets

When a pharmaceutical company changes an SPC or PIL, 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 10/01/2018 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   30-Nov-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

$0Section 4.4$0$0‘benzodiazepines,other CNS depressants (including alcohol) or ‘ has been added.$0$0‘Opioids, such asoxycodone hydrochloride, may influence the hypothalamic-pituitary-adrenal or –gonadalaxes. Some changes that can be seen include an increase in serum prolactin, anddecreases in plasma cortisol and testosterone. Clinical symptoms may manifestfrom these hormonal changes.’ This text regarding opioids was added to the section.$0$0 $0$0Section 4.5$0$0‘There can be anenhanced CNS depressant effect, which canresult in profound sedation, respiratory depression, coma and death, duringconcomitant therapy with benzodiazepinesor other drugs which affect the CNS such as alcohol, phenothiazines, antidepressants, anaesthetics. hypnotics, non-benzodiapine sedatives, musculesrelaxants, other opioids, neuroleptic drugs antihypertensives and SSRIs’The words in bold have been added to this part of section 4.5. $0$0 $0$0Section 5.1$0$0The text below ‘EndocrineSystem’ has been replaced with ‘Seesection 4.4’ $0$0 $0$0Section 10$0$0The date of revision has been updated to read ‘November 2017’$0
Updated on 05/08/2015 and displayed until 10/01/2018
Reasons for adding or 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
Date of revision of text on the SPC:   01-May-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 2 Qualitative and Quantitative Composition (highlighted text has been amended)

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 very rarely occur,  

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, tricyclic antidepressants, anaesthetics, hypnotics,

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 30/07/2014 and displayed until 05/08/2015
Reasons for adding or 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
Date of revision of text on the SPC:   01-Jul-2013
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 crushedThe 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 unknownNot known

Immune system disorders

 

 

hypersensitivity

 

anaphylactic responses

Endocrine disorders

 

 

syndrome of inappropriate antidiuretic hormone secretion (SIADH)

 

 

Metabolism and nutrition disorders

 

decreased appetiteanorexia

dehydration, thirst, weight fluctuation

 

 

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

 

 

abnormal vision, lacrimation disorder, miosis, visual impairment

 

 

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, decreased libido

 

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 overdosageA 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 16/11/2011 and displayed until 30/07/2014
Reasons for adding or 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
Date of revision of text on the SPC:   01-Oct-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 2
"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 08/07/2011 and displayed until 16/11/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 7.  Marketing Authorisation Holder

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 01/06/2011 and displayed until 08/07/2011
Reasons for adding or 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
Date of revision of text on the SPC:   01-May-2011
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
    "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 01/07/2010 and displayed until 01/06/2011
Reasons for adding or 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
Date of revision of text on the SPC:   01-Feb-2010
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
            "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 22/09/2008 and displayed until 01/07/2010
Reasons for adding or 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
Date of revision of text on the SPC:   07/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Sections re-written or modified: 1., 2., 3., 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3, 6.1, 6.5, 10.
Updated on 30/11/2005 and displayed until 22/09/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Updated on 05/08/2005 and displayed until 30/11/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 21/07/2005 and displayed until 05/08/2005
Reasons for adding or 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
Updated on 18/12/2003 and displayed until 21/07/2005
Reasons for adding or 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

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Active Ingredients

 
   Oxycodone Hydrochloride