OXYCONTIN- oxycodone hydrochloride tablet, film coated, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)

Tilgjengelig fra:

Purdue Pharma LP

INN (International Name):

OXYCODONE HYDROCHLORIDE

Sammensetning:

OXYCODONE HYDROCHLORIDE 80 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

OXYCONTIN is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate in: - Adults; and - Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent. Limitations of Use - Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions (5.1)] , reserve OXYCONTIN for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - OXYCONTIN is not indicated as an as-needed (prn) analgesic. OXYCONTIN is contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.2)] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8)] - Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.13)] - Hypersensitivity (e.g., anaphylaxis) to oxycodone [see Adverse Reactions (6.2)] Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)] . There are no available data with OXYCONTIN in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, there was no embryo-fetal toxicity when oxycodone hydrochloride was orally administered to rats and rabbits, during the period of organogenesis, at doses 1.3 to 40 times the adult human dose of 60 mg/day, respectively. In a pre- and postnatal toxicity study, when oxycodone was orally administered to rats, there was transiently decreased pup body weight during lactation and the early post-weaning period at the dose equivalent to an adult dose of 60 mg/day. In several published studies, treatment of pregnant rats with oxycodone hydrochloride at clinically relevant doses and below resulted in neurobehavioral effects in offspring [see Data] . Based on animal data, advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.4)] . Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. OXYCONTIN is not recommended for use in women immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate. Opioid analgesics, including OXYCONTIN, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Animal Data Pregnant rats were treated with 0.5, 2, 4, and 8 mg/kg oxycodone hydrochloride (0.08, 0.3, 0.7, and 1.3 times the human daily dose of 60 mg/day, respectively based on a mg/m2 basis) during the period of organogenesis. Oxycodone did not cause adverse effects to the fetus at exposures up to 1.3 times the human dose of 60 mg/day. The high dose produced maternal toxicity characterized by excessive gnawing on forelimbs and decreased body weight gain. Pregnant rabbits were treated with 1, 5, 25, and 125 mg/kg oxycodone hydrochloride (0.3, 2, 8, and 40 times the human daily dose of 60 mg/day, respectively, based on a mg/m2 basis) during the period of organogenesis. Oxycodone did not cause adverse effects to the fetus at exposures up to 40 times the human dose of 60 mg/day. The 25 mg/kg and 125 mg/kg doses high doses produced maternal toxicity characterized by decreased food consumption and body weight gain. Pregnant rats were treated with 0.5, 2, and 6 mg/kg oxycodone hydrochloride (0.08, 0.32, and 1 times the human daily dose of 60 mg/kg, respective, based on a mg/m2 basis, during the period of organogenesis through lactation. Decreased body weight was found during lactation and the early post-weaning phase in pups nursed by mothers given the highest dose used (6 mg/kg/day, equivalent to an adult human dose of 60 mg/day, on a mg/m2 basis). However, body weight of these pups recovered. In published studies, offspring of pregnant rats administered oxycodone hydrochloride during gestation have been reported to exhibit neurobehavioral effects including altered stress responses and increased anxiety-like behavior (2 mg/kg/day IV from Gestation Day 8 to 21 and Postnatal Day 1, 3, and 5; 0.3 times an adult human oral dose of 60 mg/day on a mg/m2 basis), and altered learning and memory (15 mg/kg/day orally from breeding through parturition; 2.4 times an adult human oral dose of 60 mg/day on a mg/m2 basis). Oxycodone is present in breast milk. Published lactation studies report variable concentrations of oxycodone in breast milk with administration of immediate-release oxycodone to nursing mothers in the early postpartum period. The lactation studies did not assess breastfed infants for potential adverse reactions. Lactation studies have not been conducted with extended–release oxycodone, including OXYCONTIN, and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with OXYCONTIN. Clinical Considerations Monitor infants exposed to OXYCONTIN through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breast-fed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. Infertility Use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [see Adverse Reactions (6.2), Clinical Pharmacology (12.2), Nonclinical Toxicology (13.1)] . The safety and efficacy of OXYCONTIN have been established in pediatric patients ages 11 to 16 years. Use of OXYCONTIN is supported by evidence from adequate and well-controlled trials with OXYCONTIN in adults as well as an open-label study in pediatric patients ages 6 to 16 years. However, there were insufficient numbers of patients less than 11 years of age enrolled in this study to establish the safety of the product in this age group. The safety of OXYCONTIN in pediatric patients was evaluated in 155 patients previously receiving and tolerating opioids for at least 5 consecutive days with a minimum of 20 mg per day of oxycodone or its equivalent on the two days immediately preceding dosing with OXYCONTIN. Patients were started on a total daily dose ranging between 20 mg and 100 mg depending on prior opioid dose. The most frequent adverse events observed in pediatric patients were vomiting, nausea, headache, pyrexia, and constipation [see Dosage and Administration (2.5), Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14)] . In controlled pharmacokinetic studies in elderly subjects (greater than 65 years) the clearance of oxycodone was slightly reduced. Compared to young adults, the plasma concentrations of oxycodone were increased approximately 15% [see Clinical Pharmacology (12.3)] . Of the total number of subjects (445) in clinical studies of oxycodone hydrochloride controlled-release tablets, 148 (33.3%) were age 65 and older (including those age 75 and older) while 40 (9.0%) were age 75 and older. In clinical trials with appropriate initiation of therapy and dose titration, no untoward or unexpected adverse reactions were seen in the elderly patients who received oxycodone hydrochloride controlled-release tablets. Thus, the usual doses and dosing intervals may be appropriate for elderly patients. However, a dosage reduction in debilitated, non-opioid-tolerant patients is recommended [see Dosage and Administration (2.8)] . Respiratory depression is the chief risk for elderly patients treated with opioids and has occurred after large initial doses were administered to patients who are not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of OXYCONTIN slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression. [see Warnings and Precautions (5.8)] . Oxycodone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function. A study of OXYCONTIN in patients with hepatic impairment demonstrated greater plasma concentrations than those seen at equivalent doses in persons with normal hepatic function [see Clinical Pharmacology (12.3)] . Therefore, a dosage reduction is recommended for these patients [see Dosage and Administration (2.9)]. Regularly evaluate closely for signs of respiratory depression, sedation, and hypotension. In patients with renal impairment, as evidenced by decreased creatinine clearance (<60 mL/min), the concentrations of oxycodone in the plasma are approximately 50% higher than in subjects with normal renal function [see Clinical Pharmacology (12.3)] . Follow a conservative approach to dose initiation and adjust according to the clinical situation. In pharmacokinetic studies with OXYCONTIN, opioid-naïve females demonstrate up to 25% higher average plasma concentrations and greater frequency of typical opioid adverse events than males, even after adjustment for body weight. The clinical relevance of a difference of this magnitude is low for a drug intended for chronic usage at individualized dosages, and there was no male/female difference detected for efficacy or adverse events in clinical trials. OXYCONTIN contains oxycodone, a Schedule II controlled substance. OXYCONTIN contains oxycodone, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see Warnings and Precautions (5.1)]. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of OXYCONTIN increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. The risk is increased with concurrent abuse of OXYCONTIN with alcohol and/or other CNS depressants. Abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of addiction. All patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Patients at high risk of OXYCONTIN abuse include those with a history of prolonged use of any opioid, including products containing oxycodone, those with a history of drug or alcohol abuse, or those who use OXYCONTIN in combination with other abused drugs. “Drug-seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. OXYCONTIN, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Risks Specific to Abuse of OXYCONTIN Abuse of OXYCONTIN poses a risk of overdose and death. This risk is increased with concurrent abuse of OXYCONTIN with alcohol and/or other CNS depressants [see Warnings and Precautions (5.1, 5.3), Drug Interactions (7)] . Taking cut, broken, chewed, crushed, or dissolved OXYCONTIN enhances drug release and increases the risk of overdose and death. OXYCONTIN is approved for oral use only. With parenteral abuse, the inactive ingredients in OXYCONTIN can be expected to result in local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis, valvular heart injury, embolism, and death. Cases of thrombotic microangiopathy (a condition characterized clinically by thrombocytopenia, microangiopathic hemolytic anemia) associated with parenteral abuse have been reported. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Abuse Deterrence Studies OXYCONTIN is formulated with inactive ingredients intended to make the tablet more difficult to manipulate for misuse and abuse. For the purposes of describing the results of studies of the abuse-deterrent characteristics of OXYCONTIN resulting from a change in formulation, in this section, the original formulation of OXYCONTIN, which is no longer marketed, will be referred to as “original OxyContin” and the reformulated, currently marketed product will be referred to as “OXYCONTIN". In Vitro Testing In vitro physical and chemical tablet manipulation studies were performed to evaluate the success of different extraction methods in defeating the extended-release formulation. Results support that, relative to original OxyContin, there is an increase in the ability of OXYCONTIN to resist crushing, breaking, and dissolution using a variety of tools and solvents. The results of these studies also support this finding for OXYCONTIN relative to an immediate-release oxycodone. When subjected to an aqueous environment, OXYCONTIN gradually forms a viscous hydrogel (i.e., a gelatinous mass) that resists passage through a needle. Clinical Studies In a randomized, double-blind, placebo-controlled 5-period crossover pharmacodynamic study, 30 recreational opioid users with a history of intranasal drug abuse received intranasally administered active and placebo drug treatments. The five treatment arms were finely crushed OXYCONTIN 30 mg tablets, coarsely crushed OXYCONTIN 30 mg tablets, finely crushed original OxyContin 30 mg tablets, powdered oxycodone HCl 30 mg, and placebo. Data for finely crushed OXYCONTIN, finely crushed original OxyContin, and powdered oxycodone HCl are described below. Drug liking was measured on a bipolar drug liking scale of 0 to 100 where 50 represents a neutral response of neither liking nor disliking, 0 represents maximum disliking and 100 represents maximum liking. Response to whether the subject would take the study drug again was also measured on a bipolar scale of 0 to 100 where 50 represents a neutral response, 0 represents the strongest negative response (“definitely would not take drug again”) and 100 represents the strongest positive response (“definitely would take drug again”). Twenty-seven of the subjects completed the study. Incomplete dosing due to granules falling from the subjects’ nostrils occurred in 34% (n = 10) of subjects with finely crushed OXYCONTIN, compared with 7% (n = 2) of subjects with finely crushed original OxyContin and no subjects with powdered oxycodone HCl. The intranasal administration of finely crushed OXYCONTIN was associated with a numerically lower mean and median drug liking score and a lower mean and median score for take drug again, compared to finely crushed original OxyContin or powdered oxycodone HCl as summarized in Table 5. Figure 1 demonstrates a comparison of drug liking for finely crushed OXYCONTIN compared to powdered oxycodone HCl in subjects who received both treatments.  The Y-axis represents the percent of subjects attaining a percent reduction in drug liking for OXYCONTIN vs. oxycodone HCl powder greater than or equal to the value on the X-axis. Approximately 44% (n = 12) had no reduction in liking with OXYCONTIN relative to oxycodone HCl. Approximately 56% (n = 15) of subjects had some reduction in drug liking with OXYCONTIN relative to oxycodone HCl. Thirty-three percent (n = 9) of subjects had a reduction of at least 30% in drug liking with OXYCONTIN compared to oxycodone HCl, and approximately 22% (n = 6) of subjects had a reduction of at least 50% in drug liking with OXYCONTIN compared to oxycodone HCl. Figure 1: Percent Reduction Profiles for Emax of Drug Liking VAS for OXYCONTIN vs. oxycodone HCl, N=27 Following Intranasal Administration The results of a similar analysis of drug liking for finely crushed OXYCONTIN relative to finely crushed original OxyContin were comparable to the results of finely crushed OXYCONTIN relative to powdered oxycodone HCl. Approximately 43% (n = 12) of subjects had no reduction in liking with OXYCONTIN relative to original OxyContin. Approximately 57% (n = 16) of subjects had some reduction in drug liking, 36% (n = 10) of subjects had a reduction of at least 30% in drug liking, and approximately 29% (n = 8) of subjects had a reduction of at least 50% in drug liking with OXYCONTIN compared to original OxyContin. Summary The in vitro data demonstrate that OXYCONTIN has physicochemical properties expected to make abuse via injection difficult. The data from the clinical study, along with support from the in vitro data, also indicate that OXYCONTIN has physicochemical properties that are expected to reduce abuse via the intranasal route. However, abuse of OXYCONTIN by these routes, as well as by the oral route, is still possible. Additional data, including epidemiological data, when available, may provide further information on the impact of the current formulation of OXYCONTIN on the abuse liability of the drug. Accordingly, this section may be updated in the future as appropriate. OXYCONTIN contains oxycodone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit, including fentanyl, hydromorphone, methadone, morphine, and oxymorphone. OXYCONTIN can be abused and is subject to misuse, addiction, and criminal diversion [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.1)]. Both tolerance and physical dependence can develop during use of opioid therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. Do not abruptly discontinue OXYCONTIN in a patient physically dependent on opioids. Rapid tapering of OXYCONTIN in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. When discontinuing OXYCONTIN, gradually taper the dosage using a patient-specific plan that considers the following: the dose of OXYCONTIN the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. In patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see Dosage and Administration (2.10), Warnings and Precautions (5.15)] . Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Use in Specific Populations (8.1)].

Produkt oppsummering:

OXYCONTIN (oxycodone hydrochloride) extended-release tablets 10 mg are film-coated, round, white-colored, bi-convex tablets debossed with OP on one side and 10 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-410-10 ) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-410-20 ). OXYCONTIN (oxycodone hydrochloride) extended-release tablets 15 mg are film-coated, round, gray-colored, bi-convex tablets debossed with OP on one side and 15 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-415-10 ) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-415-20 ). OXYCONTIN (oxycodone hydrochloride) extended-release tablets 20 mg are film-coated, round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-420-10 ) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-420-20 ). OXYCONTIN (oxycodone hydrochloride) extended-release tablets 30 mg are film-coated, round, brown-colored, bi-convex tablets debossed with OP on one side and 30 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-430-10 ) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-430-20 ). OXYCONTIN (oxycodone hydrochloride) extended-release tablets 40 mg are film-coated, round, yellow-colored, bi-convex tablets debossed with OP on one side and 40 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-440-10 ) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-440-20 ). OXYCONTIN (oxycodone hydrochloride) extended-release tablets 60 mg are film-coated, round, red-colored, bi-convex tablets debossed with OP on one side and 60 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-460-10 ) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-460-20 ). OXYCONTIN (oxycodone hydrochloride) extended-release tablets 80 mg are film-coated, round, green-colored, bi-convex tablets debossed with OP on one side and 80 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 59011-480-10 ) and unit dose packaging with 10 individually numbered tablets per card; two cards per glue end carton (NDC 59011-480-20 ). Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Store OXYCONTIN securely and dispose of properly [see Patient Counseling Information (17)] . Dispense in tight, light-resistant container.

Autorisasjon status:

New Drug Application

Informasjon til brukeren

Purdue Pharma LP
----------
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Issued: 12/2023
Medication Guide
OXYCONTIN® (ox-e-KON-tin) (oxycodone hydrochloride) extended-release
tablets, CII
OXYCONTIN is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage
severe and persistent pain, that requires an extended treatment period
with a daily opioid pain
medicine when other pain medicines do not treat your pain well enough
or you cannot tolerate
them.
•
A long-acting (extended-release) opioid pain medicine that can put you
at risk for overdose and
death. Even if you take your dose correctly as prescribed you are at
risk for opioid addiction,
abuse, and misuse that can lead to death.
•
Not to be taken on an “as-needed” basis.
•
Not for use in children less than 11 years of age and who are not
already using opioid pain
medicines regularly to manage pain severe enough to require daily
around-the-clock long-term
treatment of pain with an opioid.
Important information about OXYCONTIN:
•
Get emergency help or call 911 right away if you take too much
OXYCONTIN (overdose). When
you first start taking OXYCONTIN, when your dose is changed, or if you
take too much
(overdose), serious or life-threatening breathing problems that can
lead to death may occur. Talk
to your healthcare provider about naloxone, a medicine for the
emergency treatment of an opioid
overdose.
•
Taking OXYCONTIN with other opioid medicines, benzodiazepines,
alcohol, or other central
nervous system depressants (including street drugs) can cause severe
drowsiness, decreased
awareness, breathing problems, coma, and death.
•
Never give anyone else your OXYCONTIN. They could die from taking it.
Selling or giving
away OXYCONTIN is against the law.
•
Store OXYCONTIN securely, out of sight and reach of children, and in a
location not accessible
by others, including visitors to the home.
Do not take OXYCONTIN if you have:
•
severe asthma, trouble breathing, or other

Preparatomtale

OXYCONTIN- OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
PURDUE PHARMA LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYCONTIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXYCONTIN.
OXYCONTIN (OXYCODONE HYDROCHLORIDE) EXTENDED-RELEASE TABLETS, FOR ORAL
USE, CII
INITIAL U.S. APPROVAL: 1950
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCONTIN
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
OXYCONTIN EXPOSES USERS TO RISKS OF ADDICTION, ABUSE AND MISUSE, WHICH
CAN LEAD
TO OVERDOSE AND DEATH. ASSESS PATIENT’S RISK BEFORE PRESCRIBING AND
REASSESS
REGULARLY FOR THESE BEHAVIORS AND CONDITIONS. (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY,
ESPECIALLY UPON INITIATION OR FOLLOWING A DOSAGE INCREASE. TO REDUCE
THE RISK OF
RESPIRATORY DEPRESSION, PROPER DOSING AND TITRATION OF OXYCONTIN ARE
ESSENTIAL.
INSTRUCT PATIENTS TO SWALLOW OXYCONTIN TABLETS WHOLE TO AVOID EXPOSURE
TO A
POTENTIALLY FATAL DOSE OF OXYCODONE. (5.2)
ACCIDENTAL INGESTION OF OXYCONTIN, ESPECIALLY BY CHILDREN, CAN RESULT
IN A FATAL
OVERDOSE OF OXYCODONE. (5.2)
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM
(CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION,
RESPIRATORY
DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT PRESCRIBING FOR USE
IN PATIENTS
FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE. (5.3, 7)
IF OPIOID USE IS REQUIRED FOR AN EXTENDED PERIOD OF TIME IN A PREGNANT
WOMAN,
ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME,
WHICH MAY
BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED. ENSURE THAT
APPROPRIATE
MANAGEMENT BY NEONATOLOGY EXPERTS WILL BE AVAILABLE AT DELIVERY. (5.4)
HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO COMPLETE A
REMS-COMPLIANT
EDUCATION PROGRAM AND TO COUNSEL PATIENTS AND CAREGIVERS ON SERIOUS
RISKS, SAFE
USE, AND THE IMPORTANCE OF READING THE MEDICATION GUIDE WITH EACH
PRE