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.
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.
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.
"Concomitant use of alcohol and OxyContin may increase the undesirable effects of OxyContin; concomitant use should be avoided." has been added.
"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.