OXYMORPHONE HYDROCHLORIDE tablet, film coated, extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

OXYMORPHONE HYDROCHLORIDE (UNII: 5Y2EI94NBC) (OXYMORPHONE - UNII:9VXA968E0C)

Prieinama:

Amneal Pharmaceuticals LLC

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage - Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)] , reserve oxymorphone hydrochloride extended-release tablets 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. - Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. Oxymorphone hydrochloride extended-release tablets are contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.3)] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.6)] - Hypersensitivity (e.g., anaphylaxis) to oxymorphone, any other ingredients in oxymorphone hydrochloride extended-release tablets [see Warnings and Precautions (5.7) and Adverse Reactions (6)]. - Moderate and severe hepatic impairment [see Warnings and Precautions (5.9) and Clinical Pharmacology (12.3)] - Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12)] Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)] . Available data with oxymorphone hydrochloride extended-release tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, reduced postnatal survival of pups and an increased incidence of stillborn pups were observed following oral treatment of pregnant rats with oxymorphone during gestation and through lactation at doses 2.4 and 12 times the human daily dose of 20 mg/day (HDD), respectively. Reduced fetal weights were observed with oral administration of oxymorphone to pregnant rats and rabbits during organogenesis at exposures up to 4.9 and 48.8 times the HDD, respectively [see Data] . Based on animal data, advise pregnant women of the potential risk to a fetus. The estimated 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 clinical recognized pregnancies is 2% to 4% and 14% to 20%, respectively. Clinical Considerations Fetal/Neonatal adverse reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes may cause fetal-neonatal physical dependence and neonatal 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 pyscho-physiologic effects in neonates. An opioid antagonist, such as naloxone must be available for reversal of opioid-induced respiratory depression in the neonate. Oxymorphone hydrochloride extended-release tablets are not recommended for use in women during and immediately prior to labor, when use of shorter acting analgesics or other analgesic techniques are more appropriate. Opioid analgesics, including oxymorphone hydrochloride extended-release tablets, 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 oxymorphone hydrochloride from Gestation Day 6 to 17 via oral gavage doses of 5, 10, or 25 mg/kg/day (2.4, 4.9, or 12.2 times the HDD based on body surface area, respectively). Reduced mean fetal weights were observed at 4.9 times the HDD. Maternal toxicity was noted in all treatment groups (reduced food consumption and body weights in all groups and mortality in the high dose group). Pregnant rabbits were treated with oxymorphone hydrochloride from Gestation Day 7 to 20 via oral gavage doses of 10, 25, or 50 mg/kg/day (9.8, 24.4, or 48.8 times the HDD based on body surface area, respectively). Decreased mean fetal weights were noted at 48.8 times the HDD. Maternal toxicity was noted in all treatment groups (reduced food consumption and body weights). Pregnant rats were treated with oxymorphone hydrochloride from Gestation Day 6 to Lactation Day 20 via oral gavage doses of 1, 5, 10, or 25 mg/kg/day (0.5, 2.4, 4.9, or 12.2 times the HDD based on body surface area, respectively). Increased neonatal death (postnatal day 0 to 1) was noted at 2.4 times the HDD. Decreased pup survival over the first week of life, reduced pup birth weight, and reduced postnatal weight gain were noted at 4.9 times the HDD. Maternal toxicity was noted in all treatment groups (reduced food consumption and body weights in all groups and mortality in the 10 and 25 mg/kg/day groups). In a published study, neural tube defects (exencephaly and cranioschisis) were noted following subcutaneous administration of 153 mg/kg oxymorphone hydrochloride (62.2 times the HDD) on Gestation Day 8 to pregnant hamsters. This dose also produced significant maternal toxicity (20% maternal deaths). Risk Summary There is no information regarding the presence of oxymorphone in human milk, the effects on the breastfed infant, or the effects 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 oxymorphone hydrochloride extended-release tablets. Clinical Considerations Monitor infants exposed to oxymorphone through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [Clinical Pharmacology (12.2) and Nonclinical Toxicology (13.1)] . The safety and effectiveness of oxymorphone hydrochloride extended-release tablets in patients below the age of 18 years have not been established. Two open-label studies were conducted in a total of 42 pediatric patients between the ages of 7 to 17 years requiring continuous, around the clock opioid treatment. The available safety and efficacy data were inconclusive for chronic use of oxymorphone hydrochloride extended-release tablets. Limited data from one of the studies suggested that oxymorphone hydrochloride extended-release tablets is not recommended for post-surgical pain. Of the total number of subjects in clinical studies of oxymorphone hydrochloride extended-release tablets, 27% were 65 and over, while 9% were 75 and over. No overall differences in effectiveness were observed between these subjects and younger subjects. There were several adverse events that were more frequently observed in subjects 65 and over compared to younger subjects. These adverse events included dizziness, somnolence, confusion, and nausea. On average, age greater than 65 years was associated with an increase in oxymorphone AUC and Cmax . Initiate dosing with oxymorphone hydrochloride extended-release tablets in patients 65 years of age and over using the 5 mg dose and monitor closely for signs of respiratory and central nervous system depression when initiating and titrating oxymorphone hydrochloride extended-release tablets. For patients on prior opioid therapy, start at 50% of the starting dose for a younger patient on prior opioids and titrate slowly. Oxymorphone 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 the elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Patients with mild hepatic impairment have an increase in oxymorphone bioavailability compared to the subjects with normal hepatic function. In opioid-naïve patients with mild hepatic impairment, initiate oxymorphone hydrochloride extended-release tablets using the 5 mg dose and monitor closely for respiratory and central nervous system depression. Oxymorphone hydrochloride extended-release tablets are contraindicated for patients with moderate and severe hepatic impairment [see Dosage and Administration (2.6), Contraindications (4) , Warnings and Precautions (5.9), and Clinical Pharmacology (12.3)] . For patients on prior opioid therapy, start at the 50% of the dose for that a patient with normal hepatic function on prior opioids and titrate slowly. Patients with moderate to severe renal impairment were shown to have an increase in oxymorphone bioavailability compared to the subjects with normal renal function [see Clinical Pharmacology (12.3)] . Start opioid-naïve patients with the 5 mg dose of oxymorphone hydrochloride extended-release tablets and titrate slowly while closely monitoring for respiratory and central nervous system depression [see Dosage and Administration (2.6)] . For patients on prior opioid therapy, start at 50% of the dose for a patient with normal renal function on prior opioids and titrate slowly. Oxymorphone hydrochloride extended-release tablets contain oxymorphone, a Schedule II controlled substance. Oxymorphone hydrochloride extended-release tablets contains oxymorphone a substance with a high potential for abuse similar to other opioids fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, and tapentadol. Oxymorphone hydrochloride extended-release tablets can be abused and is subject to misuse, addiction, and criminal diversion [see Warnings and Precautions (5.1)] . The high drug content in extended-release formulations adds to the risk of adverse outcomes from abuse and misuse. All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “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 drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction. Oxymorphone hydrochloride extended-release tablets, like other opioids, can be diverted for non-medical 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 re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to reduce abuse of opioid drugs. Risks Specific to Abuse of Oxymorphone Hydrochloride Extended-Release Tablets Oxymorphone hydrochloride extended-release tablets are for oral use only. Abuse of oxymorphone hydrochloride extended-release tablets poses a risk of overdose and death. This risk is increased with concurrent abuse of oxymorphone hydrochloride extended-release tablets with alcohol and other substances. Taking cut, broken, chewed, crushed, or dissolved oxymorphone hydrochloride extended-release tablets enhances drug release and increases the risk of over dose and death. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. Physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity, (e.g., naloxone, nalmefene), 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 opioid usage. Do not abruptly discontinue oxymorphone hydrochloride extended-release tablets in a patient physically dependent on opioids. Rapid tapering of oxymorphone hydrochloride extended-release tablets 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 oxymorphone hydrochloride extended-release tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of oxymorphone hydrochloride extended-release tablets 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 a long duration 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 (2.5) and Warnings and Precautions (5.14)] . 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 (8.2)].

Produkto santrauka:

Oxymorphone hydrochloride extended-release tablets, USP are supplied as the following strengths: Oxymorphone Hydrochloride Extended-Release Tablets USP, 5 mg are purple, round, film-coated extended-release tablets debossed with “G71” on one side and blank on the other side. They are available as follows: Bottles of 30:                                                   NDC 64896-695-08 Bottles of 60:                                                   NDC 64896-695-13 Bottles of 100:                                                 NDC 64896-695-01 Bottles of 1000:                                               NDC 64896-695-03 Oxymorphone Hydrochloride Extended-Release Tablets USP, 7.5 mg are gray, round, film-coated extended-release tablets debossed with “G75” on one side and blank on the other side. They are available as follows: Bottles of 30:                                                   NDC 64896-696-08 Bottles of 60:                                                   NDC 64896-696-13 Bottles of 100:                                                 NDC 64896-696-01 Bottles of 1000:                                               NDC 64896-696-03 Oxymorphone Hydrochloride Extended-Release Tablets USP, 10 mg are orange, round, film-coated extended-release tablets debossed with “G72” on one side and blank on the other side. They are available as follows: Bottles of 30:                                                   NDC 64896-697-08 Bottles of 60:                                                   NDC 64896-697-13 Bottles of 100:                                                 NDC 64896-697-01 Bottles of 1000:                                               NDC 64896-697-03 Oxymorphone Hydrochloride Extended-Release Tablets USP, 15 mg are white, round, film-coated extended-release tablets debossed with “G76” on one side and blank on the other side. They are available as follows: Bottles of 30:                                                   NDC 64896-698-08 Bottles of 60:                                                   NDC 64896-698-13 Bottles of 100:                                                 NDC 64896-698-01 Bottles of 1000:                                               NDC 64896-698-03 Oxymorphone Hydrochloride Extended-Release Tablets USP, 20 mg are green, round, film-coated extended-release tablets debossed with “G73” on one side and blank on the other side. They are available as follows: Bottles of 30:                                                   NDC 64896-699-08 Bottles of 60:                                                   NDC 64896-699-13 Bottles of 100:                                                 NDC 64896-699-01 Bottles of 1000:                                               NDC 64896-699-03 Oxymorphone Hydrochloride Extended-Release Tablets USP, 30 mg are brown, round, film-coated extended-release tablets debossed with “G77” on one side and blank on the other side. They are available as follows: Bottles of 30:                                                  NDC 64896-700-08 Bottles of 60:                                                  NDC 64896-700-13 Bottles of 100:                                                NDC 64896-700-01 Bottles of 1000:                                              NDC 64896-700-03 Oxymorphone Hydrochloride Extended-Release Tablets USP, 40 mg are orange, round, film-coated extended-release tablets debossed with “G74” on one side and blank on the other side. They are available as follows: Bottles of 30:                                                  NDC 64896-701-08 Bottles of 60:                                                  NDC 64896-701-13 Bottles of 100:                                                NDC 64896-701-01 Bottles of 1000:                                              NDC 64896-701-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure (as required). Store oxymorphone hydrochloride extended-release tablets securely and dispose of properly [see Patient Counseling Information (17)] .

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

Amneal Pharmaceuticals LLC
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MEDICATION GUIDE
Oxymorphone Hydrochloride (ox” i mor’ fone hye” droe klor’
ide) Extended-Release Tablets, USP for
oral use, CII
Oxymorphone hydrochloride extended-release tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain
severe enough to require daily around-the-clock, long-term treatment
with an opioid, when other
pain treatments such as non-opioid pain medicines or immediate-release
opioid 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 for use to treat pain that is not around-the-clock.
Important information about oxymorphone hydrochloride extended-release
tablets:
•
Get emergency help or call 911 right away if you take too much
oxymorphone hydrochloride
extended-release tablets (overdose). When you first start taking
oxymorphone hydrochloride
extended-release tablets, 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 oxymorphone hydrochloride extended-release tablets 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 oxymorphone hydrochloride extended-release
tablets. They could
die from taking it. Selling or giving away oxymorphone hydrochloride
extended-release tablets is
against the law.
•
Store oxymorphone hydrochloride extended-release tablets securely, out
of sight and reach of
children, and in a location not accessible b

Prekės savybės

OXYMORPHONE HYDROCHLORIDE- OXYMORPHONE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED RELEASE
AMNEAL PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYMORPHONE
HYDROCHLORIDE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS.
OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 1959
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION
STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL
INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND INTERACTION WITH
ALCOHOL; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER
CNS DEPRESSANTS.
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS EXPOSES USERS TO
RISKS OF
ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH.
ASSESS
PATIENT'S RISK BEFORE PRESCRIBING, AND MONITOR REGULARLY THESE
BEHAVIORS AND
CONDITIONS. (5.1)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION,
ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED
A RISK
EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. (5.2)
SERIOUS LIFE-THREATENING OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY,
ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. INSTRUCT
PATIENTS TO SWALLOW
OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS WHOLE TO AVOID
EXPOSURE TO A
POTENTIALLY FATAL DOSE OF OXYMORPHONE. (5.3)
ACCIDENTAL INGESTION OF OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE
TABLETS,
ESPECIALLY BY CHILDREN, CAN RESULT IN FATAL OVERDOSE OF OXYMORPHONE.
(5.3)
PROLONGED USE OF OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS
DURING
PREGNANCY CAN RESULT IN NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY
BE LIFE-
THREATENING IF NOT RECOGNIZED AND TREATED. IF OPIOID USE IS REQUIRED
FOR A PROLONGED
PERIOD IN A PREGNANT WOMAN, ADVI