OXYMORPHONE HYDROCHLORIDE Tablet (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

KVK-Tech, Inc.

Λέξεις κλειδιά

10702-070 10702-071

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BOXED WARNING SECTION

WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION ...

1. Indications and Usage

Oxymorphone hydrochloride tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because ...

2. Dosage and Administration

2.1 Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)] ...

3. Dosage Forms and Strengths

Tablets 5 mg: blue, round, biconvex tablet debossed with K above 70 on one side and plain on the other. Tablets 10 mg: red, round, biconvex tablet debossed with K above 71 on one side and ...

4. Contraindications

Oxymorphone hydrochloride tablets are contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.3)]. Acute or severe bronchial asthma in an unmonitored ...

5. Warnings and Precautions

5.1 Addiction, Abuse, and Misuse Oxymorphone hydrochloride tablets contains oxymorphone, a Schedule II controlled substance. As an opioid, oxymorphone hydrochloride tablets exposes users to the risks of ...

6. Adverse Reactions

The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)]. Life-Threatening Respiratory ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of opioids. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

Table 2 includes clinically significant drug interactions with oxymorphone hydrochloride tablets. Table 2. Clinically Significant Drug Interactions withOxymorphone Hydrochloride Tablets: ...

8.1. Pregnancy

Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4) and Clinical Considerations]. Data from randomized ...

8.2. Lactation

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. The developmental and health benefits of ...

8.3. Females and Males of Reproductive Potential

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 [see Clinical Pharmacology ...

8.4. Pediatric Use

Safety and effectiveness for pediatric patients, 0 to 17 years, have not been established. An open-label study was conducted in 58 pediatric patients 12 years of age and older with postoperative pain using ...

8.5. Geriatric Use

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 ...

8.6. Hepatic Impairment

In a study of extended-release oxymorphone tablets, patients with mild hepatic impairment were shown to have an increase in bioavailability compared to the subjects with normal hepatic function. Oxymorphone ...

8.7. Renal Impairment

In a study of extended-release oxymorphone tablets, patients with moderate to severe renal impairment were shown to have an increase in bioavailability compared to the subjects with normal renal function ...

9.1. Controlled Substance

Oxymorphone hydrochloride tablets contains oxymorphone, a Schedule II controlled substance.

9.2. Abuse

Oxymorphone hydrochloride tablets contains oxymorphone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone ...

9.3. Dependence

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 ...

10. Overdosage

Clinical Presentation Acute overdose with oxymorphone hydrochloride tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy ...

11. Description

Oxymorphone hydrochloride tablets are an opioid agonist available in 5 mg and 10 mg tablet strengths for oral administration. The chemical name for oxymorphone hydrochloride is 4, 5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one ...

12.1. Mechanism of Action

Oxymorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxymorphone ...

12.2. Pharmacodynamics

Effects on the Central Nervous System Oxymorphone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness ...

12.3. Pharmacokinetics

Absorption The absolute oral bioavailability of oxymorphone is approximately 10%. Studies in healthy volunteers reveal predictable relationships between oxymorphone hydrochloride tablets dosage and plasma ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis No evidence of carcinogenic potential was observed in long-term animal studies in mice and rats. Oxymorphone hydrochloride was administered to Sprague Dawley rats (2.5, 5, and 10 mg/kg/day ...

14. Clinical Studies

The analgesic efficacy of oxymorphone hydrochloride tablets has been evaluated in acute pain following orthopedic and abdominal surgeries. 14.1 Orthopedic Surgery Two double-blind, placebo-controlled, ...

16.1. How Supplied

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. Bottles of 60 tablets with child-resistant ...

16.2. Storage and Handling

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 ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store ...