OXYMORPHONE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

OXYMORPHONE HYDROCHLORIDE

Composition:

OXYMORPHONE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxymorphone hydrochloride tablets are indicated for the relief of moderate to severe acute pain where the use of an opioid is appropriate. - Oxymorphone hydrochloride tablets are contraindicated in patients with a known hypersensitivity to oxymorphone or to any of the other ingredients in oxymorphone hydrochloride tablets, or with known hypersensitivity to morphine analogs such as codeine. - Oxymorphone hydrochloride tablets are contraindicated in patients with respiratory depression, except in monitored settings and in the presence of resuscitative equipment. - Oxymorphone hydrochloride tablets are contraindicated in patients with acute or severe bronchial asthma or hypercarbia. - Oxymorphone hydrochloride tablets are contraindicated in any patient who has or is suspected of having paralytic ileus [see Warning and Precautions (5.8)] . - Oxymorphone hydrochloride tablets are contraindicated in patients with moderate or severe hepatic impairment [see Warnings and Precautions (5.6)] . The safety of using oxymorphone in pregnancy has not been established with regard to possible adverse effects on fetal development. The use of oxymorphone hydrochloride tablets in pregnancy, in nursing mothers, or in women of child-bearing potential requires that the possible benefits of the drug be weighted against the possible hazards to the mother and the child. Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies of oxymorphone in pregnant women. In animal studies, oxymorphone caused decreased fetal and pup weights, an increase in stillbirth, and a decrease in postnatal pup survival at maternal oxymorphone doses equivalent to 0.4 to 4 times the human daily dose of 120 mg (Based on body surface area). Oxymorphone hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In embryo-fetal developmental toxicity studies, pregnant rats and rabbits received oxymorphone hydrochloride at doses up to about 2 times (rats) and 8 times (rabbits) total human daily dose of 120 mg (based on body surface area). No malformations occurred, but reduced fetal weights occurred at maternal doses of 0.8 (rat) and 4 (rabbit) times the total human daily dose of 120 mg (based on body surface area). There were no adverse developmental effects in rats that received 0.4 times or rabbits that received less than 4 times the total human dose. There were no effects of oxymorphone hydrochloride on intrauterine survival at doses in rats ≤2 times, or in rabbits at ≤8 times the human dose (see Non-teratogenic Effects, below). In a study conducted prior to the establishment of Good Laboratory Practices (GLP) and not according to current recommended methodology, a single subcutaneous injection of oxymorphone hydrochloride on gestation day 8 produced malformations in offspring of hamsters that received a dose equivalent to 10 times the total human daily dose of 120 mg (based on body surface area). This dose also produced 83% maternal lethality. Non-teratogenic Effects Oxymorphone hydrochloride administration to female rats during gestation in a pre- and postnatal developmental toxicity study reduced mean litter size (18%) at a dose of 25 mg/kg/day, attributed to an increase in the incidence of stillborn pups. An increase in neonatal death occurred at doses ≥5 mg/kg/day (0.4 times a total human daily dose of 120 mg, based on body surface area). Low pup birth weight, decreased post-natal weight gain, and reduced post-natal survival of pups occurred following treatment of the dams with 25 mg/kg/day (about 2 times a total human daily dose of 120 mg, based on body surface area). Prolonged use of opioid analgesics during pregnancy may cause fetal-neonatal physical dependence. Neonatal withdrawal may occur. Symptoms usually appear during the first days of life and may include convulsions, irritability, excessive crying, tremors, hyperactive reflexes, fever, vomiting, diarrhea, sneezing, yawning, and increased respiratory rate. Opioids cross the placenta and may produce respiratory depression in neonates. Oxymorphone hydrochloride 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. Occasionally, opioid analgesics may 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. Neonates whose mothers received opioid analgesics during labor should be observed closely for signs of respiratory depression. A specific opioid antagonist, such as naloxone or nalmefene, should be available for reversal of opioid-induced respiratory depression in the neonate. It is not known whether oxymorphone is excreted in human milk. Because many drugs, including some opioids, are excreted in human milk, caution should be exercised when oxymorphone hydrochloride tablets are administered to a nursing woman. Infants exposed to oxymorphone hydrochloride tablets through breast milk should be monitored 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. Safety and effectiveness of oxymorphone hydrochloride tablets in pediatric patients below the age of 18 years have not been established. Oxymorphone hydrochloride tablets should be used with caution in elderly patients [see Clinical Pharmacology ( 12.3 )] . Of the total number of subjects in clinical studies of oxymorphone hydrochloride tablets, 31% were 65 and over, while 7% 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. In general, dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy In a study of extended-release oxymorphone tablets, patients with mild hepatic impairment were shown to have an increase in bioavailability of 1.6 fold. Oxymorphone hydrochloride tablets should be used with caution in patients with mild impairment. These patients should be started with the lowest dose and titrated slowly while carefully monitoring for side effects. Oxymorphone Hydrochloride Tablets are contraindicated for patients with moderate and severe hepatic impairment [see Contraindications ( 4 ), Warnings and Precautions ( 5.6 ), and Dosage and Administration ( 2.5 )] . In a study of extended-release oxymorphone tablets, patients with moderate to severe renal impairment were shown to have an increase in bioavailability ranging from 57-65% [see Clinical Pharmacology ( 12.3 )] . Such patients should be started cautiously with lower doses of oxymorphone hydrochloride tablets and titrated slowly while monitoring for side effects [see Dosage and Administration ( 2.6 )] . Oxymorphone hydrochloride tablets contain oxymorphone, a mu opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine and other opioids. Oxymorphone can be abused and is subject to criminal diversion [see Warnings and Precautions ( 5.2 )]. 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. Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. Addiction is characterized by one or more of the following: impaired control over drug use, compulsive use, use for non-medical purposes, and continued use despite harm. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common. “Drug-seeking” behavior is very common to addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated claims of loss of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating physician(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. Physicians 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 and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Oxymorphone hydrochloride tablets, like other opioids, may be diverted for non-medical use. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised. Oxymorphone hydrochloride tablets are intended for oral use only. Abuse of oxymorphone hydrochloride tablets poses a risk of overdose and death. This risk is increased with concurrent abuse of oxymorphone hydrochloride tablets with alcohol and other substances. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Opioid analgesics may cause physical dependence. Physical dependence results in withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an opioid antagonist or mixed opioid agonist/antagonist agent. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity, e.g., naloxone, nalmefene, or mixed agonist/antagonist analgesics (pentazocine, butorphanol, buprenorphine, nalbuphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. 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). The development of physical dependence and/or tolerance is not unusual during chronic opioid therapy. Oxymorphone hydrochloride tablets should not be abruptly discontinued [see Dosage and Administration ( 2.4 )] . If oxymorphone hydrochloride tablets are abruptly discontinued in a physically-dependent patient, an abstinence syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms [see Use in Specific Populations ( 8.1 , 8.2 )] .

Product summary:

Oxymorphone hydrochloride tablets are supplied as follows: 5 mg Tablet: Blue, round, biconvex tablets debossed with “K” above “70” on one side and plain on the other side. Bottles of 30 tablets with child-resistant closure             NDC  35356-967-30 10 mg Tablet: Red, round, biconvex tablets debossed with “K” above “71” on one side and plain on the other side. Bottles of 30 tablets with child-resistant closure             NDC  35356-968-30                35356-968-60                35356-968-01 Oxymorphone hydrochloride tablets may be targeted for theft and diversion. Healthcare professionals should contact their State Medical Board, State Board of Pharmacy, or State Control Board for information on how to detect or prevent diversion of this product, and security requirements for storing and handling of Oxymorphone hydrochloride tablets. Healthcare professionals should advise patients to store oxymorphone hydrochloride tablets in a secure place, preferably locked and out of the reach of children and other non-caregivers. Store at 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure (as required). Advise patients to dispose of any unused tablets from a prescription by flushing them down the toilet as soon as they are no longer needed [see Patient Counseling Information ( 17 )] .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OXYMORPHONE HYDROCHLORIDE- OXYMORPHONE HYDROCHLORIDE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYMORPHONE
HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR OXYMORPHONE
HYDROCHLORIDE.
OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE) TABLET FOR ORAL
USE.
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
Oxymorphone Hydrochloride Tablets is an opioid agonist indicated for
the relief of moderate to severe
acute pain where the use of an opioid is appropriate. (1).
DOSAGE AND ADMINISTRATION
Titrate the dose based on individual response. (2.1)
Oxymorphone Hydrochloride Tablets should be taken on an empty stomach,
at least one hour prior to
or two hours after eating. (2.2)
Opioid-Naïve Patients: 10 to 20 mg orally every four to six hours.
INITIATION OF THERAPY WITH DOSES
HIGHER THAN 20 MG IS NOT RECOMMENDED. If necessary, may be initiated
with 5 mg (e.g., for renal
or hepatic impairment, geriatric patients). (2)
Conversion to Oxymorphone Hydrochloride Tablets: Follow
recommendations for conversion from other
opioids or parenteral oxymorphone. (2.2)
Cessation of Therapy: Taper gradually. (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg. (3) (3)
CONTRAINDICATIONS
Known hypersensitivity to oxymorphone, any other ingredients in
Oxymorphone Hydrochloride Tablets,
or morphine analogs (4)
Respiratory depression in the absence of resuscitative equipment (4)
Acute or severe bronchial asthma or hypercarbia (4)
Paralytic ileus (4)
Moderate or severe hepatic impairment (4)
WARNINGS AND PRECAUTIONS
Respiratory depression: Increased risk in elderly, debilitated
patients, and those suffering from
conditions accompanied by hypoxia, hypercapnia, or decreased
respiratory reserve. (5.1)
Misuse, abuse, and diversion: Oxymorphone Hydrochloride is an opioid
agonist and a Schedule II
controlled substance with an abuse liability similar to morphine.
(5.2)
CNS effects: Additive CN