IBU-TAB 200
Clinical safety rating: caution
Comprehensive clinical and safety monograph for IBU-TAB 200 (IBU-TAB 200).
Cyclooxygenase (COX-1 and COX-2) inhibitor, reducing prostaglandin synthesis.
| Metabolism | Hepatic metabolism primarily via CYP2C9. |
| Excretion | Renal: 90% as metabolites (glucuronides, hydroxylated derivatives), <10% unchanged. Fecal: <5%. |
| Half-life | 2-4 hours (terminal half-life). Short half-life requires frequent dosing for sustained analgesic/antipyretic effect. |
| Protein binding | 99% bound to albumin. |
| Volume of Distribution | 0.1-0.2 L/kg (low Vd, confined to plasma and interstitial fluid). |
| Bioavailability | Oral: 80-100% (with food may reduce rate). |
| Onset of Action | Oral: 30-60 minutes (analgesic); rectal: 60-90 minutes. |
| Duration of Action | Oral: 4-6 hours (analgesic), 6-8 hours (antipyretic). Rectal: similar but variable. |
| Molecular Weight | 206.28 |
200-400 mg orally every 4-6 hours as needed; maximum 1200 mg/day for nonprescription use.
| Dosage form | TABLET |
| Renal impairment | eGFR 30-59 mL/min: reduce dose by 50% or increase interval to every 8-12 hours; eGFR <30 mL/min: avoid use or maximum 400 mg/day. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: avoid use. |
| Pediatric use | 6 months to 12 years: 5-10 mg/kg/dose orally every 6-8 hours; maximum 40 mg/kg/day. For fever or pain: 5 mg/kg per dose for temperatures <102.5°F, 10 mg/kg per dose for higher fever. |
| Geriatric use | Start at lowest effective dose (200 mg every 6-8 hours); maximum 400 mg/day due to increased risk of renal and GI adverse effects. |
| 1st trimester | Avoid use; associated with increased risk of miscarriage and congenital malformations (cardiac defects, gastroschisis). |
| 2nd trimester | Use only if clearly needed; may cause oligohydramnios and premature ductus arteriosus constriction with prolonged use. |
| 3rd trimester | Avoid after 30 weeks; third trimester use associated with premature ductus arteriosus closure, oligohydramnios, and neonatal renal impairment. |
Clinical note
Comprehensive clinical and safety monograph for IBU-TAB 200 (IBU-TAB 200).
| Placental transfer | Ibuprofen crosses the placenta; peak cord blood concentrations approximately 30-70% of maternal plasma levels. Transfer is limited early in pregnancy but increases with gestational age. |
| Breastfeeding | Ibuprofen is excreted into breast milk in very low concentrations (less than 1% of maternal dose). It is considered compatible with breastfeeding due to minimal infant exposure. However, monitor infant for potential adverse effects such as gastrointestinal upset or bleeding if maternal doses are high or prolonged. |
■ FDA Black Box Warning
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors may be at greater risk.
| Serious Effects |
Hypersensitivity to ibuprofen or any component of the formulationHistory of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDsActive peptic ulcer disease or gastrointestinal bleedingSevere renal impairment (CrCl <30 mL/min)Severe hepatic impairment (Child-Pugh class C)Third trimester of pregnancy (after 30 weeks gestation)History of serious NSAID-related adverse events (e.g., Stevens-Johnson syndrome)
| Precautions | Cardiovascular risk, gastrointestinal bleeding, renal toxicity, hypertension, anaphylactoid reactions, hepatic effects, asthma exacerbation, pregnancy avoidance (third trimester). |
| Food/Dietary | Avoid alcohol. Take with food or milk to minimize gastric irritation. Grapefruit juice may modestly increase ibuprofen absorption but clinical significance is low; no strict restriction. Administer with a full glass of water. |
Loading safety data…
| Lactation Rating | L1 (Safe in lactation) |
| Teratogenic Risk | First trimester: Avoid due to potential increased risk of miscarriage and congenital malformations (cardiac defects, gastroschisis). Second trimester: Use only if clearly needed; no clear teratogenic risk but may cause premature closure of ductus arteriosus. Third trimester: Contraindicated due to risk of premature ductus arteriosus closure, oligohydramnios, and neonatal renal impairment. |
| Fetal Monitoring | Monitor maternal renal function, blood pressure, and signs of gastrointestinal bleeding. Fetal monitoring includes ultrasound for amniotic fluid index and ductus arteriosus patency if used in third trimester. |
| Fertility Effects | Reversible impairment of female fertility via inhibition of prostaglandin synthesis affecting ovulation. May also affect male fertility through a negative impact on semen quality; effects are reversible upon discontinuation. |
| Clinical Pearls | Ibuprofen (IBU-TAB 200) is an NSAID; avoid in patients with CrCl <30 mL/min. Dose adjustment not needed for mild hepatic impairment but contraindicated in severe hepatic disease. Use lowest effective dose for shortest duration to minimize renal and GI risk. Can mask signs of infection; monitor for fever in at-risk patients. Not recommended in late pregnancy (after 30 weeks) due to risk of premature ductus arteriosus closure. |
| Patient Advice | Take with food or milk to reduce gastrointestinal upset. · Do not exceed 1200 mg per day without consulting your doctor. · Avoid drinking alcohol while taking this medication as it increases the risk of stomach bleeding. · If you have high blood pressure, heart disease, or kidney disease, use only under medical supervision. · Stop use and seek medical help if you experience chest pain, weakness, slurred speech, or signs of allergic reaction (rash, swelling, difficulty breathing). · Do not take with other NSAIDs (e.g., aspirin, naproxen) unless directed by your doctor. |