OXYMORPHONE HYDROCHLORIDE tablet, film coated, extended release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Amneal Pharmaceuticals of New York LLC

INN (Mezinárodní Name):

OXYMORPHONE HYDROCHLORIDE

Složení:

OXYMORPHONE HYDROCHLORIDE 5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Oxymorphone Hydrochloride Extended-Release Tablets are 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. Limitations of Usage: - 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 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), Adverse Reactions (6)]. - Moderate and severe hepatic impairment [see Warnings and Precautions (5.9),  Clinical Pharmacology (12.3)] - Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12)] 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)] . 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 Use of opioid analgesics for an extended period of time 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 psycho-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 mg/kg/day, 10 mg/kg/day 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 mg/kg/day, 25 mg/kg/day 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 mg/kg/day, 5 mg/kg/day, 10 mg/kg/day 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 mg/kg/day 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 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 [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 frequently reevaluate the patient for signs of respiratory and central nervous system depression when initiating and titrating Oxymorphone Hydrochloride Extended-Release Tablets [see Warnings and Precautions (5.2)] . 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 regularly evaluate 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 regularly evaluate 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 regularly evaluate 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 contain oxymorphone, a substance with a 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 intentinal use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare 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 to other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of Oxymorphone Hydrochloride Extended-Release Tablets 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 Oxymorphone Hydrochloride Extended-Release Tablets with alcohol and 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 Oxymorphone Hydrochloride Extended-Release Tablets abuse include those with a history of prolonged use of any opioid, including products containing oxymorphone, those with a history of drug or alcohol abuse, or those who use Oxymorphone Hydrochloride Extended-Release Tablets 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. Pre-occupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. Oxymorphone Hydrochloride Extended-Release Tablets, 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 Oxymorphone Hydrochloride Extended-Release Tablets Abuse of Oxymorphone Hydrochloride Extended-Release Tablets poses a risk of overdose and death. This risk is increased with concurrent use of Oxymorphone Hydrochloride Extended-Release Tablets with alcohol and/or other CNS depressants. Taking cut, broken, chewed, crushed or dissolved Oxymorphone Hydrochloride Extended-Release Tablets enhance drug release and increases the risk of overdose and death. Oxymorphone Hydrochloride Extended-Release Tablets is approved for oral use only. Inappropriate intravenous, intramuscular, or subcutaneous use of Oxymorphone Hydrochloride Extended-Release Tablets can result in death, local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis, and valvular heart injury, and embolism. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. 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 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 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 (2.5)  and 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)].

Přehled produktů:

Oxymorphone Hydrochloride Extended-Release Tablets, USP are supplied as follows: 5 mg Purple, round, film-coated extended-release tablets debossed with "G71" on one side and blank on the other side. Bottles of 30                                                  NDC 0115-1231-08 Bottles of 60                                                  NDC 0115-1231-13 Bottles of 100                                                NDC 0115-1231-01 Bottles of 1,000                                             NDC 0115-1231-03 7.5 mg Gray, round, film-coated extended-release tablets debossed with "G75" on one side and blank on the other side. Bottles of 30                                                  NDC 0115-1315-08 Bottles of 60                                                  NDC 0115-1315-13 Bottles of 100                                                NDC 0115-1315-01 Bottles of 1,000                                             NDC 0115-1315-03 10 mg Orange, round, film-coated extended-release tablets debossed with "G72" on one side and blank on the other side. Bottles of 30                                                  NDC 0115-1232-08 Bottles of 60                                                  NDC 0115-1232-13 Bottles of 100                                                NDC 0115-1232-01 Bottles of 1,000                                             NDC 0115-1232-03 15 mg White, round, film-coated extended-release tablets debossed with "G76" on one side and blank on the other side. Bottles of 30                                                  NDC 0115-1316-08 Bottles of 60                                                  NDC 0115-1316-13 Bottles of 100                                                NDC 0115-1316-01 Bottles of 1,000                                             NDC 0115-1316-03 20 mg Green, round, film-coated extended-release tablets debossed with "G73" on one side and blank on the other side. Bottles of 30                                                  NDC 0115-1233-08 Bottles of 60                                                  NDC 0115-1233-13 Bottles of 100                                                NDC 0115-1233-01 Bottles of 1,000                                             NDC 0115-1233-03 30 mg Brown, round, film-coated extended-release tablets debossed with "G77" on one side and blank on the other side. Bottles of 30                                                  NDC 0115-1317-08 Bottles of 60                                                  NDC 0115-1317-13 Bottles of 100                                                NDC 0115-1317-01 Bottles of 1,000                                             NDC 0115-1317-03 40 mg Orange, round, film-coated extended-release tablets debossed with "G74" on one side and blank on the other side. Bottles of 30                                                  NDC 0115-1234-08 Bottles of 60                                                  NDC 0115-1234-13 Bottles of 100                                                NDC 0115-1234-01 Bottles of 1,000                                             NDC 0115-1234-03 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)] .

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

Amneal Pharmaceuticals of New York LLC
----------
MEDICATION GUIDE
Oxymorphone Hydrochloride
(ox” i mor’ fone hy” droe klor’ ide)
Extended-Release Tablets, USP for oral use, CII
Oxymorphone Hydrochloride Extended-Release Tablets are:
•
A strong prescription pain medicine that contains and 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.
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 by others, including
visitors to the home.
Do not take Oxy

Charakteristika produktu

OXYMORPHONE HYDROCHLORIDE- OXYMORPHONE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED RELEASE
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
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: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYMORPHONE
HYDROCHLORIDE EXTENDED-RELEASE TABLETS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS EXPOSE 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)
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. (5.2)
ACCIDENTAL INGESTION OF OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE
TABLETS,
ESPECIALLY BY CHILDREN, CAN RESULT IN FATAL OVERDOSE OF OXYMORPHONE.
(5.2)
INSTRUCT PATIENTS NOT TO CONSUME ALCOHOL OR ANY PRODUCT CONTAINING
ALCOHOL WHILE
TAKING OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS BECAUSE
CO-INGESTION
CAN RESULT IN FATAL PLASMA OXYMORPHONE LEVELS. (5.3)
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; LIMIT DOSAGES
AND DURATIONS
TO THE MINIMUM REQUIRED; AND FOLLOW PATIENTS FOR SIGNS AND SYMPTOMS OF
RESPIRATORY
DEPRESSION AND SEDATION. (5.3, 7)
PROLONGED USE OF OXYM