IBU-TAB
Clinical safety rating: caution
Comprehensive clinical and safety monograph for IBU-TAB (IBU-TAB).
Non-selective inhibition of cyclooxygenase (COX-1 and COX-2), reducing prostaglandin synthesis, thereby decreasing pain, inflammation, and fever.
| Metabolism | Primarily hepatic via CYP2C9; also undergoes glucuronidation. Metabolites include hydroxy- and carboxy-ibuprofen, which are inactive. |
| Excretion | Renal excretion of conjugated metabolites (approximately 90% of an administered dose) with less than 1% excreted unchanged. Biliary/fecal elimination accounts for less than 5%. |
| Half-life | 2-4 hours (terminal elimination half-life); in overdose or hepatic impairment, may be prolonged to >4 hours. Clinically, the short half-life supports dosing every 6-8 hours for acute pain. |
| Protein binding | Approximately 99% bound to albumin. |
| Volume of Distribution | 0.1-0.3 L/kg. The low Vd indicates limited tissue distribution, primarily confined to plasma and extracellular fluid. |
| Bioavailability | Oral: 80-100% (well absorbed). Topical: approximately 5-10% systemically absorbed (varies with formulation and application site). |
| Onset of Action | Oral: 30-60 minutes for analgesic effect; peak effect at 1-2 hours. Topical: onset within 1-2 hours for local analgesia. |
| Duration of Action | Analgesic: 4-6 hours. Antipyretic: 6-8 hours. Note: Duration may be shorter with immediate-release formulations; sustained-release forms may extend to 12 hours. |
200-400 mg orally every 4-6 hours as needed; maximum 1200 mg/day without prescription.
| Dosage form | TABLET |
| Renal impairment | CrCl 30-60 mL/min: reduce dose by 50% and avoid in CrCl <30 mL/min. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated. |
| Pediatric use | 5-10 mg/kg/dose orally every 6-8 hours; maximum 40 mg/kg/day. |
| Geriatric use | Initiate at lowest effective dose (e.g., 200 mg every 8-12 hours); monitor renal function and avoid long-term use. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for IBU-TAB (IBU-TAB).
| Breastfeeding | Excreted in breast milk in low concentrations (M/P ratio <0.02). American Academy of Pediatrics considers compatible with breastfeeding. Monitor infant for gastrointestinal distress or rash. Use lowest effective dose for shortest duration. |
| Teratogenic Risk | First trimester: Association with increased risk of miscarriage and congenital cardiac defects (odds ratio 1.86). Second/third trimester: Premature closure of ductus arteriosus, oligohydramnios, fetal renal impairment; avoid after 30 weeks gestation. Use not recommended during pregnancy. |
■ FDA Black Box Warning
NSAIDs increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk increases with duration of use. Patients with cardiovascular disease or risk factors may be at greater risk. NSAIDs are contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
| Serious Effects |
History of hypersensitivity to ibuprofen or any other NSAID; active peptic ulcer disease or GI bleeding; severe renal impairment; history of serious cardiovascular event; perioperative pain in CABG surgery; third trimester of pregnancy.
| Precautions | Risk of serious GI adverse events including bleeding, ulceration, and perforation; NSAIDs should be used with caution in patients with history of peptic ulcer disease or GI bleeding. May cause renal toxicity, especially in patients with pre-existing renal impairment. Use with caution in patients with asthma, congestive heart failure, or hypertension. |
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| Fetal Monitoring |
| Monitor maternal renal function, blood pressure, and signs of bleeding (platelet function). Fetal ultrasound for ductus arteriosus patency and amniotic fluid volume if used late pregnancy. Assess for fetal growth restriction if chronic use. |
| Fertility Effects | Reversible impairment of female fertility via inhibition of prostaglandin synthesis, affecting ovulation and implantation. No known effect on male fertility. |