OXYCODONE HYDROCHLORIDE Oral solution (2022)

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50383-961

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BOXED WARNING SECTION

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

1. Indications and Usage

Oxycodone hydrochloride oral solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations ...

2. Dosage and Administration

2.1 Important Dosage and Administration Instructions Ensure accuracy when prescribing, dispensing, and administering oxycodone hydrochloride oral solution to avoid dosing errors due to confusion between ...

3. Dosage Forms and Strengths

Oxycodone hydrochloride oral solution, USP 5 mg per 5 mL (1 mg /mL).

4. Contraindications

Oxycodone hydrochloride oral solution is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.4)] Acute or severe bronchial asthma in an unmonitored ...

5. Warnings and Precautions

5.1 Risk of Accidental Overdose and Death Due to Medication Errors Dosing errors can result in accidental overdose and death. Avoid dosing errors that may result from confusion between mg and mL and confusion ...

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 (5.2)] Life-Threatening Respiratory ...

7. Drug Interactions

Table 1 includes clinically significant drug interactions with oxycodone hydrochloride oral solution. Table 1: Clinically Significant Drug Interactions with oxycodone hydrochloride oral solution ...

8.1. Pregnancy

Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5)]. Available data with oxycodone hydrochloride ...

8.2. Lactation

Risk Summary 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 ...

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 Adverse Reactions ...

8.4. Pediatric Use

The safety and effectiveness of oxycodone hydrochloride oral solution have not been established in pediatric patients. The safety and pharmacokinetics of a single-dose of oxycodone hydrochloride oral solution ...

8.5. Geriatric Use

Elderly patients (aged 65 years or older) may have increased sensitivity to oxycodone. In general, use caution when selecting a dose for an elderly patient, usually starting at the low end of the dosing ...

8.6. Hepatic Impairment

Since oxycodone is extensively metabolized in the liver, its clearance may decrease in patients with hepatic impairment. Initiate therapy in these patients with a lower than usual dosage of oxycodone hydrochloride ...

8.7. Renal Impairment

Information from oxycodone tablets indicate that patients with renal impairment had higher plasma concentrations of oxycodone than subjects with normal renal function. Initiate therapy with a lower than ...

9.1. Controlled Substance

Oxycodone hydrochloride oral solution contains oxycodone, a Schedule II controlled substance.

9.2. Abuse

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

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 oxycodone hydrochloride oral solution can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and ...

11. Description

Oxycodone hydrochloride oral solution is an opioid agonist, available as solution in 5 mg/5 mL (1 mg/mL) strength for oral administration. Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17- ...

12.1. Mechanism of Action

Oxycodone 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 oxycodone ...

12.2. Pharmacodynamics

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

12.3. Pharmacokinetics

The activity of oxycodone hydrochloride oral solution is primarily due to the parent drug oxycodone. Absorption The oral bioavailability of oxycodone is 60-87%. This high oral bioavailability (compared ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Long-term studies in animals to evaluate the carcinogenic potential of oxycodone have not been conducted. Mutagenesis Oxycodone hydrochloride was genotoxic in an in vitro mouse ...

16.1. How Supplied

Oxycodone Hydrochloride Oral Solution, USP, 5 mg per 5 mL (1 mg/mL) is available as follows: 500 mL bottle packaged with calibrated measuring cup 5 mL unit dose in trays of ten cups, case of 40. Dispense ...

16.2. Storage and Handling

Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions are permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature] Store oxycodone hydrochloride oral solution ...

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 ...