Oxycodone Hydrochloride Oral Solution
Generic Name: oxycodone hydrochloride oral solution
Brand Names:
Oxycodone Hydrochloride Oral Solution
11 DESCRIPTION Oxycodone Hydrochloride Oral Solution is an agonist, available as a red solution 5 mg/5 mL (1 mg/mL) and a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R, 9R, 13S, 14S)-4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C18H21NO4.HCl, and it has the following chemical structure.
Overview
11 DESCRIPTION Oxycodone Hydrochloride Oral Solution is an agonist, available as a red solution 5 mg/5 mL (1 mg/mL) and a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R, 9R, 13S, 14S)-4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C18H21NO4.HCl, and it has the following chemical structure.
Uses
1 INDICATIONS AND USAGE Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant patients.
Dosage
2 DOSAGE AND ADMINISTRATION Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is for opioid-tolerant patients only ( 2.1 ) Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. (2.1 ) Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factor for addiction, abuse, and misuse. ( 2.1 ) Initiate dosing with a range of 5 to 15 mg every 4 to 6 hours as needed for pain. ( 2.2 ) For control of chronic pain, administer Oxycodone Hydrochloride Oral Solution on a regularly scheduled basis, at the lowest dosage level to achieve adequate analgesia.
Side Effects
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 Depression [see Warnings and Precautions (5.4)] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5)] • Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.7)] • Adrenal Insufficiency [see Warnings and Precautions (5.9)] • Severe Hypotension [see Warnings and Precautions (5.10)] • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12)] • Seizures [see Warnings and Precautions (5.13)] • Withdrawal [see Warnings and Precautions (5.14)] The following adverse reactions associated with the use of...
Interactions
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 Inhibitors of CYP3A4 and CYP2D6 Clinical Impact: The concomitant use of Oxycodone Hydrochloride Oral Solution and CYP3A4 inhibitors can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Oxycodone Hydrochloride Oral Solution and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of Oxycodone Hydrochloride Oral Solution is achieved [see Warnings and Precautions (5.6) ].
Warnings
WARNING: RISK OF MEDICATION ERRORS; ADDICTION,ABUSE, AND MISUSE;RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME;CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS CNS DEPRESSANTS Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering Oxycodone Hydrochloride Oral Solution. 5 WARNINGS AND PRECAUTIONS • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.( 5.8) • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.9 ) • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Oxycodone Hydrochloride Oral Solution in patients with circulatory shock .(5.10) • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. 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 setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8)] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnin...
Pregnancy
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 Oral Solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses 2.6 and 8.1 times, respectively, the human dose of 60 mg/day did not reveal evidence of teratogenicity or embryo-fetal toxicity.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Oxycodone Hydrochloride Oral Solution 5 mg per 5 mL (1 mg/mL), is a red solution, supplied as: NDC# 13107-261-58: Bottle of 500 mL supplied with a calibrated measuring cup. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg per mL), is a yellow solution, supplied as: NDC# 13107-262-57: Bottle of 30 mL supplied with a calibrated oral syringe.
Frequently Asked Questions
What is Oxycodone Hydrochloride Oral Solution used for?▼
1 INDICATIONS AND USAGE Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant patients.
What are the side effects of Oxycodone Hydrochloride Oral Solution?▼
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 Depression [see Warnings and Precautions (5.4)] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5)] • Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.7)] • Adrenal Insufficiency [see Warnings and Precautions (5.9)] • Severe Hypotension [see Warnings and Precautions (5.10)] • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12)] • Seizures [see Warnings and Precautions (5.13)] • Withdrawal [see Warnings and Precautions (5.14)] The following adverse reactions associated with the use of...
Can I take Oxycodone Hydrochloride Oral Solution during pregnancy?▼
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 Oral Solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses 2.6 and 8.1 times, respectively, the human dose of 60 mg/day did not reveal evidence of teratogenicity or embryo-fetal toxicity.
What are the important warnings for Oxycodone Hydrochloride Oral Solution?▼
WARNING: RISK OF MEDICATION ERRORS; ADDICTION,ABUSE, AND MISUSE;RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME;CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS CNS DEPRESSANTS Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering Oxycodone Hydrochloride Oral Solution. 5 WARNINGS AND PRECAUTIONS • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.( 5.8) • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.9 ) • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Oxycodone Hydrochloride Oral Solution in patients with circulatory shock .(5.10) • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. 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 setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8)] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnin...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.