EXTRA-STRENGTH AIM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for EXTRA-STRENGTH AIM (EXTRA-STRENGTH AIM).
Salicylate: irreversible inhibition of cyclooxygenase (COX-1 and COX-2), reducing prostaglandin synthesis. Caffeine: adenosine receptor antagonist, enhancing analgesic effect.
| Metabolism | Salicylate: hepatic conjugation (glycine and glucuronic acid) and oxidation; metabolized by CYP2C9. Caffeine: hepatic metabolism via CYP1A2. |
| Excretion | Renal: 90% unchanged; biliary/fecal: <10%. |
| Half-life | 2-4 hours in adults with normal renal function; prolonged in renal impairment. |
| Protein binding | 25-40% bound to albumin. |
| Volume of Distribution | 0.8-1.0 L/kg. |
| Bioavailability | Oral: 100%. |
| Onset of Action | Oral: 15-30 minutes; intravenous: immediate. |
| Duration of Action | Oral: 4-6 hours; intravenous: 4-6 hours. |
1-2 tablets (500-1000 mg) orally every 4-6 hours, maximum 4000 mg/day (immediate-release). For extended-release, 1300 mg orally every 8 hours, maximum 3900 mg/day.
| Dosage form | GEL |
| Renal impairment | eGFR < 10 mL/min: avoid immediate-release; use extended-release 1300 mg every 12 hours (max 2600 mg/day). eGFR 10-50 mL/min: avoid extended-release; use immediate-release at standard dose but extended interval (every 6-8 hours). |
| Liver impairment | Child-Pugh Class B or C: reduce dose by 50-75% and extend interval; avoid extended-release formulations. For Class A, no adjustment needed. |
| Pediatric use | Weight-based: 10-15 mg/kg/dose orally every 4-6 hours; maximum 75 mg/kg/day. For infants < 3 months: 10 mg/kg/dose every 6-8 hours. |
| Geriatric use | Reduce maximum daily dose to 3000 mg/day; consider 500 mg every 6 hours for frail elderly. Monitor renal and hepatic function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for EXTRA-STRENGTH AIM (EXTRA-STRENGTH AIM).
| Breastfeeding | Acetaminophen enters breast milk in low amounts (M/P ratio ~0.2), considered compatible with breastfeeding. Guaifenesin excretion unknown; use caution. Infant risk likely low with standard doses. |
| Teratogenic Risk | Extra-strength Aim contains acetaminophen and guaifenesin. Acetaminophen is generally considered low risk in all trimesters, but high doses may be associated with adverse outcomes. Guaifenesin has limited data; first trimester use is cautioned due to potential neural tube defect association, though risk is low. Avoid in third trimester if possible due to theoretical risk of premature labor. |
■ FDA Black Box Warning
Reye syndrome: do not use in children or teenagers with viral infections due to risk of Reye syndrome.
| Serious Effects |
["Hypersensitivity to salicylates or caffeine","History of asthma induced by NSAIDs","Active peptic ulcer disease","Hemophilia or other bleeding disorders","Children or teenagers with chickenpox or influenza-like symptoms"]
| Precautions | Risk of Reye syndrome in children with viral illness; avoid in pregnancy (third trimester) due to risk of premature closure of ductus arteriosus; GI bleeding risk with chronic use; hypersensitivity reactions including aspirin-sensitive asthma; caution with renal impairment. |
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| Fetal Monitoring | Monitor for signs of acetaminophen toxicity (e.g., hepatic function) if prolonged use or overdose. Assess fetal growth if used chronically. No specific fetal monitoring required for short-term use. |
| Fertility Effects | No known significant effects on fertility for acetaminophen or guaifenesin at standard doses. |