● Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements reinforcing patient-prescriber responsibilities. Give special safety instructions to patients with young children, especially toddlers, and those who live with a child or adult who is cognitively impaired. For example, prescribing a controlled substance to a patient with Alzheimer’s disease or other cognitive impairments must involve instructions to a responsible adult in the home. Family members should also have a plan for accidental overdoses, including poison control (1-800-222-1222) for unintentional ingestion of a known or unknown substance. Family members should call 911 and initiate emergency services if the individual is in respiratory distress.
(FDA, 2021). Prescribers are strongly encouraged to do all of the following. ● Complete a REMS-compliant education program offered by an accredited continuing education (CE) provider or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain. ● Use the Patient Counseling Guide (PCG) to discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and their caregivers. ● Emphasize to patients and their caregivers the importance of reading the medication guide provided by their pharmacist every time an opioid analgesic is dispensed to them.
Table 7. Oral Opioids for Acute Pain in Opioid-Naïve Adults Medication
Available Oral Strengths Moderate Pain
Severe Pain
Clinical Considerations Incremental efficacy decreases and increases in adverse reactions with increasing doses. Limit codeine to no more than 60 mg/dose. Do not exceed codeine 360 mg/24 hours. The maximum dose of acetaminophen is 4,000 mg/day (from all sources). Metabolism of codeine to morphine (its active form) varies between patients; drug interactions may affect response. Dosage limited by acetaminophen maximum dose (4,000 mg/day [from all sources]).
Codeine-acetaminophen • Tylenol with Codeine
Tablets : 15 mg/300 mg 30 mg/300 mg 60 mg/300
1 to 2 tablets every four hours as needed for pain
Hydrocodone- acetaminophen
Tablets: 2.5 mg/325 mg 5 mg/300 mg 5 mg/325 mg 7.5 mg/300 mg 7.5 mg/325 mg 10 mg/300 mg 10 mg/325 mg Oral solution:
1 to 2 tablets PO every 6 hours as needed
1 to 2 tablets PO every 4 to 6 hours as needed
• Lorcet • Lortab • Norco • Vicodin
7.5 mg/325 mg per 15 mL 10 mg/300 mg per 15 mL 10 mg/325 mg per 15 mL
Oxycodone- acetaminophen*
Tablets: 2.5 mg/325 mg 5 mg/325 mg 7.5 mg/325 mg 10 mg/325 mg
1 to 2 tablets PO every 6 hours as needed
1 to 2 tablets PO every 4 to 6 hours as needed
Dosage limited by acetaminophen maximum dose (4,000 mg/day [from all sources]).
• Endocet • Percocet • Primlev • Roxicet • Xolox
Oral solution: 5 mg/325 mg per 5 mL
Medication
Available Oral Strengths Moderate Pain
Severe Pain
Clinical Considerations Only FDA-approved for 5 days or less of treatment of acute pain. Maximum dose: Eight tablets/24 hours. FDA-approved for short- term, acute, severe pain (<10 days). Do not exceed 5 tablets/day.
Tramadol-acetaminophen • Ultracet
Tablets: 37.5 mg/325 mg
1 to 2 tablets PO every six hours needed
1 to 2 tablets PO every 4r hours as needed
Ibuprofen- hydrocodone • lbudone
Tablets: 5 mg/200 mg 7.5 mg/200 mg 10 mg/ 200 mg
1 tablet PO every 4to 6hours as needed
• Reprexain • Vicoprofen • Xylon
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