PARACETAMOL [ACETAMINOPHEN] AND TRAMADOL Migraine headache: Oral: Acetaminophen 250 mg/ Paracetamol [Acetaminophen] and aspirin 250 mg/caffeine 65 mg: Two tablets once every Tramadol 24 hours (maximum: 2 tablets per 24 hours) Pediatric Minor aches and pain: Children >12 years Brand Names: US Ultracet and Adolescents: Oral: Refer to adult dosing Brand Names: Canada ACT Tramadol/Acet; Apo-Trama- Renal Impairment There are no dosage adjustments dol/Acet; JAMP-ACET-Tramadol; Mar-Tramadol/Acet; provided in the manufacturer’s labeling. Mint-Tramadol/Acet; PMS-Tramadol/Acet; Priva-Trama- Hepatic Impairment There are no dosage adjustments dol/Acet; RAN-Tramadol/Acet; TEVA-Tramadol/Acetami- provided in the manufacturer’s labeling. nophen; Tramacet Additional Information Complete prescribing informa- Index Terms Tramadol Hydrochloride and Acetaminophen tion should be consulted for additional detail. Pharmacologic Category Analgesic Combination Dosage Forms (Opioid); Analgesic, Opioid Caplet, oral: Acetaminophen 250 mg, aspirin 250 mg, Use and caffeine 65 mg; acetaminophen 194 mg, aspirin US labeling: Short-term (≤5 days) management of acute 227 mg, and caffeine 33 mg pain Excedrin Extra Strength [OTC], Excedrin® Migraine Canadian labeling: Management of moderate to moder- [OTC]: Acetaminophen 250 mg, aspirin 250 mg, and ately severe pain caffeine 65 mg Dosing Vanquish Extra Strength Pain Reliever [OTC]: Acetami- Adult Acute pain: Oral: nophen 194 mg, aspirin 227 mg, and caffeine 33 mg US labeling: Two tablets every 4 to 6 hours as needed for Powder, oral: pain relief (maximum: 8 tablets daily); treatment should Goody's Extra Strength Headache Powder [OTC]: Acet- not exceed 5 days aminophen 260 mg, aspirin 520 mg, and caffeine 32.5 mg Canadian labeling: 1 to 2 tablets every 4 to 6 hours as Tablet, oral: needed for pain relief (maximum: 8 tablets daily) Anacin Advanced Headache Formula [OTC], Excedrin® Geriatric Refer to adult dosing. Use with caution due to Extra Strength [OTC], Excedrin® Migraine [OTC], Pain- increased risk of renal or hepatic impairment in elderly Off [OTC]: Acetaminophen 250 mg, aspirin 250 mg, patients. and caffeine 65 mg Renal Impairment Fem-Prin [OTC]: Acetaminophen 194.4 mg, aspirin ≥ CrCl 30 mL/minute: No dosage adjustment necessary. 226.8 mg, and caffeine 32.4 mg US labeling recommends treatment not exceed 5 days. Goody's Extra Strength Pain Relief [OTC]: Acetamino- CrCl <30 mL/minute: Maximum of 2 tablets every 12 phen 130 mg, aspirin 260 mg, and caffeine 16.25 mg hours; US labeling recommends treatment not exceed 5 days. Hepatic Impairment Paracetamol [Acetaminophen], Codeine, US labeling: Mild to severe impairment: There are no and Doxylamine dosage adjustments provided in the manufacturer’s labeling (has not been studied); use is not recom- Brand Names: Canada Mersyndol With Codeine mended. Index Terms Codeine, Doxylamine, and Acetaminophen; Canadian labeling: Doxylamine Succinate, Codeine Phosphate, and Acetami- Mild or moderate impairment: There are no dosage nophen adjustments provided in the manufacturer’s labeling Pharmacologic Category Analgesic, Miscellaneous; (has not been studied); use caution as both acetami- Analgesic, Opioid; Antitussive; Ethanolamine Derivative; nophen and tramadol undergo extensive hepatic Histamine H1 Antagonist; Histamine H1 Antagonist, First metabolism. Generation Severe impairment: Use is not recommended. Additional Appendix Information Additional Information Complete prescribing informa- Beers Criteria − Potentially Inappropriate Medications for tion should be consulted for additional detail. Geriatrics on page 2254 Dosage Forms Use Note: Not approved in the US Tablet, oral: Acetaminophen 325 mg and tramadol Pain/cold symptoms: Relief of headache, cold symp- 37.5 mg toms, and muscular aches/pain Ultracet: Acetaminophen 325 mg and tramadol 37.5 mg Pregnancy Considerations Refer to individual mono- graphs. Breast-Feeding Considerations Refer to individual Paracetamol [Acetaminophen], Aspirin, monographs. and Caffeine Contraindications Hypersensitivity to acetaminophen, codeine, doxylamine, or any component of the formula- Brand Names: US Anacin Advanced Headache Formula tion; preexisting respiratory depression, asthma, or other [OTC]; Excedrin Extra Strength [OTC]; Excedrin Migraine chronic lung disease; last trimester of pregnancy; breast- [OTC]; Fem-Prin [OTC]; Goody's Extra Strength Head- feeding; risk of intestinal obstruction; head injury; seiz- ache Powder [OTC]; Goody's Extra Strength Pain Relief ures; glucose-6-phosphate-dehydrogenase deficiency [OTC]; Pain-Off [OTC]; Vanquish Extra Strength Pain (G6PD) deficiency; CYP2D6 ultrarapid metabolizers; chil- Reliever [OTC] dren and adolescents (<18 years of age) who undergo Index Terms Aspirin, Acetaminophen, and Caffeine; tonsillectomy and/or adenoidectomy to treat obstructive Aspirin, Caffeine and Acetaminophen; Caffeine, Acetami- sleep apnea nophen, and Aspirin; Caffeine, Aspirin, and Acetamino- Warnings/Precautions May cause CNS depression, phen which may impair physical or mental abilities; patients Pharmacologic Category Analgesic, Nonopioid must be cautioned about performing tasks which require Use mental alertness (eg, operating machinery or driving). Use Migraine: Relief of migraine headache may cause or aggravate constipation. Consider preventa- Pain: Relief of minor aches and pain tive measures (eg, stool softener, increased fiber) to Dosing reduce potential for constipation. Acetaminophen may Adult & Geriatric cause severe hepatic toxicity on acute overdose; in addi- Minor aches and pain: Oral: tion, chronic daily dosing in adults has resulted in liver Acetaminophen 194 mg/aspirin 227 mg/caffeine damage in some patients. Hypersensitivity and anaphy- 33 mg: Two tablets every 6 hours as needed (max- lactic reactions to acetaminophen have been reported. imum: 8 tablets per 24 hours) Use with caution in patients with hypersensitivity reactions Acetaminophen 250 mg/aspirin 250 mg/caffeine to other phenanthrene-derivative opioid agonists (hydro- 65 mg: Two tablets every 6 hours as needed (max- codone, hydromorphone, levorphanol, oxycodone, oxy- imum: 8 tablets per 24 hours) morphone). Discontinue immediately if symptoms of Acetaminophen 260 mg/aspirin 520 mg/caffeine allergic or hypersensitivity reactions occur. Rarely, acet- 32.5 mg: Contents of 1 powder packet, placed on aminophen may cause serious and potentially fatal skin tongue or dissolved in water or other liquid, every 6 reactions such as acute generalized exanthematous pus- tulosis, Stevens-Johnson syndrome (SJS), and toxic epi- hours as needed (maximum: 4 powder packets per 24 dermal necrolysis (TEN). Discontinue treatment if severe hours) skin reactions develop. Acetaminophen 325 mg/aspirin 500 mg/caffeine 65 mg: Contents of 1 powder packet, placed on Use with caution in patients with adrenal insufficiency, tongue or dissolved in water or other liquid, every 6 including Addison disease. Long-term opioid use may hours as needed (maximum: 4 powder packets per 24 cause secondary hypogonadism, which may lead to sex- hours) ual dysfunction, infertility, mood disorders, and 1582.