Source: Health Products and Food Branch (CA) Revision Year: 2020
MOTRIN (ibuprofen) is indicated for fast and effective relief of:
Geriatrics (>65 years of age): Evidence from clinical studies and experience suggest that use in the geriatric population is associated with differences in safety or effectiveness and a brief discussion can be found in the appropriate sections (e.g., Warnings and Precautions).
Pediatrics (<12 years of age): Children’s MOTRIN formulations are available to treat children under 12 years of age (see Children’s MOTRIN Product Monograph).
Do not take for pain for more than 5 consecutive days or fever for more than 3 days unless directed by a physician.
If your condition deteriorates or new symptoms occur (such as the painful area becomes unusually red, swollen or tender), consult a physician.
Individuals older than 65 years who are frail or debilitated should be given a starting dose lower than the one usually recommended, with individual adjustments when necessary.
Use the lowest effective dose for the shortest duration.
If you miss a dose, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take your medicine and skip the missed dose. Do not take two doses at the same time.
Mild to moderate pain or fever.
Single oral dose may be taken every 4–6 hours, as required, not to exceed the maximum daily dose (1200 mg) in 24 hours unless directed by a physician.
| Product | Strength (Ibuprofen mg/tablet) | Single oral dose | Maximum daily dose (1200 mg) |
|---|---|---|---|
| (Regular Strength) MOTRIN 200 mg | 200 mg | 1 or 2 tablets | 6 tablets |
| (Extra Strength) MOTRIN 300 mg | 300 mg | 1 tablet | 4 tablets |
| (Super Strength) MOTRIN 400 mg | 400 mg | 1 tablet | 3 tablets |
Children’s MOTRIN formulations are available to treat children under 12 years of age. Children’s MOTRIN may be also used for adults requiring liquid dosage forms (see Children’s MOTRIN Product Monograph).
For management of a suspected drug overdose, contact your regional Poison Control Centre.
A clear pattern of clinical features associated with accidental or intentional overdose of ibuprofen has not been established. Reported cases of overdose have often been complicated by co-ingestions or additional suicidal gestures. The range of symptoms observed has included nausea, vomiting, abdominal pain, drowsiness, nystagmus, diplopia, headache, tinnitus, impaired renal function, coma and hypotension lethargy, central nervous system depression, seizures, metabolic acidosis, coma, rhabdomyolysis, hypothermia, fulminant hepatic failure, apnea (primarily in very young children), cardiovascular toxicity including bradycardia, tachycardia and atrial fibrillation. A review of four fatalities associated with ibuprofen overdose indicates other contributing factors co-existed so it would be difficult to identify the toxicity of ibuprofen as a specific cause of death (0, 11).
Post-ingestion blood levels may be useful to confirm a diagnosis and to quantify the degree of exposure but otherwise have not been helpful in predicting clinical outcome. Generally, full recovery can be expected with appropriate symptomatic management.
The following cases of overdose have been reported. A 19-month-old child, 1-1/2 hours after the ingestion of seven to ten 400 mg tablets of ibuprofen presented apnea, cyanosis and responded only to painful stimuli. After treatment with O2, NaHCO3, infusion of dextrose and normal saline, the child was responsive and 12 hours after ingestion appeared completely recovered. Blood levels of ibuprofen reached 102.9 μg/mL, 8-1/2 hours after the accident. Two other children weighing approximately 10 kg had taken an estimated 120 mg/kg. There were no signs of acute intoxication or late sequelae. In one child the ibuprofen blood level at 90 minutes after ingestion was approximately 700 μg/mL. A nineteen-year-old male who ingested 8000 mg of ibuprofen reported dizziness and nystagmus was noted. He recovered with no reported sequelae after parenteral hydration and 3 days of bed rest.
For perspective, a single 200 mg oral dose study in 6 fasting healthy men produced a peak plasma concentration of 15.0 μg/mL at 0.75 hr (12). Another study using a single oral 400 mg dose in humans produced a peak serum level of 31.9 + 8.8 μg/mL 0.5 hour after ingestion, and at 16 hours serum concentrations had dropped to 1 μg/mL (13). (See Detailed Pharmacology – Human Studies – Pharmacokinetics – Absorption).
Appropriate interventions to decontaminate the gastrointestinal tract may be beneficial within the first four hours after ingestion. Routine symptomatic and supportive treatment is then recommended (11). Physicians should contact the Regional Poison Control Centre for additional guidance about ibuprofen overdose management.
Tablets: Store at 15 to 30°C (59 to 86°F).
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