Each soft gelatin capsule contains lbuprofen 400 mg.
Pharmacology: Pharmacodynamics/Pharmacokinetics: Onset of action: Analgesic: 30-60 minutes; Anti-inflammatory: ≤ 7 days.
Duration: Oral: 4-6 hours.
Absorption: Oral: Rapid (85%).
Distribution: Vd: 6.35 L; Premature infants (highly variable between studies): Day 3: 160-328 mL/kg; Subset with ductal closure: 145-349 mL/kg.
Day 5: 94-248 mL/kg; Subset with ductal closure: 72-222 mL/kg.
Protein binding: 90% to 99%; Premature infants: ~95%.
Metabolism: Hepatic via oxidation.
Half-life elimination: Premature infants (highly variable between studies): 23-75 hours.
Children 3 months to 10 years: 1.6 ± 0.7 hours; Adults: 2-4 hours; End-stage renal disease: Unchanged.
Time to peak: Oral: ~1-2 hours.
Excretion: Urine (primarily as metabolites; 1% as unchanged drug); some feces.
Oral: Inflammatory diseases and rheumatoid disorders including juvenile idiopathic arthritis (JIA), mild-to-moderate pain, fever (not caused by Dengue virus), dysmenorrhea, osteoarthritis.
Adults: Inflammatory disease: 400-800 mg/dose 3-4 times/day (maximum dose: 3.2 g/day).
Analgesia/pain/fever/dysmenorrhea: Oral: 200-400 mg/dose every 4-6 hours (maximum daily dose: 1.2 g, unless directed by physician; under physician supervision daily doses ≤ 2.4 g may be used).
Migraine: 400 mg at onset of symptoms (maximum: 400 mg/24 hours unless directed by healthcare provider).
Mode of Administration: Oral: Administer with food.
Symptoms: There was a substantial increase in the number of cases of ibuprofen overdose reported to the National Poisons Information Service of the UK in the 2 years after its introduction as an 'over-the-counter' medication. However, no concurrent increase in severity of poisoning was found and in only 1 of 203 cases was ibuprofen thought to have caused serious problems. It was concluded that ibuprofen appeared to be much less toxic in acute overdose than either aspirin or paracetamol. Current advice is that doses below 100 mg/kg are unlikely to cause toxicity in children, whereas clinical features will occur in children who have ingested more than 400 mg/kg. In adults the dose-response effect is less clear cut, but those who have ingested less than 100 mg/kg are unlikely to require treatment.
Nonetheless, reports illustrate the complexity of major overdosage with ibuprofen.
1. A syndrome of coma, hyperkalaemia with cardiac arrhythmias, metabolic acidosis, pyrexia, and respiratory and renal failure.
2. In a 17-year-old man after major overdosage with ibuprofen and minor overdosage with doxepin. Hyperkalaemia was not evident until 14 hours after hospital admission and was thought to be due to a combination of potassium replacement for initial hypokalaemia, acidosis, muscle damage, and ibuprofen-induced renal failure.
3. A 6-year-old child developed shock, coma, and metabolic acidosis after ingestion of a dose of ibuprofen equivalent to 300 mg/kg.
4. In another report 21-month-old child had ingested the equivalent of 500 mg/kg of ibuprofen, the presenting symptoms were acute renal failure with severe metabolic acidosis. The child developed tonic-clonic seizures 46 hours after ingestion, with significant hypocalcaemia and hypomagnesaemia.
5. The seizures, which could not be controlled with diazepam, phenytoin, and phenobarbital, ceased on correction of electrolyte balance.
Treatment: Treatment consisting of intubation, mechanical ventilation, fluid resuscitation, gastric lavage, and activated charcoal proved successful.
Which may have been exacerbated by use of sodium polystyrene sulfonate and furosemide.
Hypersensitivity to ibuprofen, history of asthma, urticaria, or allergic-type reaction to aspirin or other NSAIDs; aspirin triad (eg, bronchial asthma, aspirin intolerance, rhinitis); perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
It is contraindicated in patients who have previously exhibited hypersensitivity to the drug or in individuals with the syndrome of asthma, rhinitis, angioedema or urticaria in response to aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
It is especially important not to use the drug during third trimester of pregnancy unless specifically directed to do so by a physician.
It is contraindicated in patients with active or history of recurrent gastrointestinal bleeding or peptic ulceration.
It is contraindicated in patients with severe hepatic failure and renal failure.
It is contraindicated in patients with dengue hemorrhagic fever.
If the drug with a rash or symptoms similar to flu, stop the medicine and consult a doctor immediately.
NSAIDs may cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines.
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke. This risk may increase with high dosage and duration of use.
Fluid retention and peripheral edema have been observed in some patients receiving the drug; therefore, the drug should be used with caution in patients with a history of cardiac decompensation or renal function impairment.
Caution is advised when the drug is required in hypertension and elderly.
The drug may decrease platelet aggregation and prolong bleeding time. Because this prolonged bleeding effect may be exaggerated in patients with underlying hemostatic defects, it should not be used in suspected patient with dengue hemorrhagic fever or persons with intrinsic coagulation disorders and those on anticoagulant therapy.
When using this medication, if the symptoms are as follows such as fever, rash, Epidermolysis bullosa, the stripping of the skin and the mucous membrane, such as in the oral cavity, throat, nose, sexual organs and Conjunctivitis, stop and consult a physician because it may be Stevens-Johnson syndrome.
NSAIDs may increase risk of gastrointestinal irritation, inflammation, ulceration, bleeding, and perforation. These events can be fatal and may occur at any time during therapy and without warning. Use caution with a history of GI disease (bleeding or ulcers), concurrent therapy with aspirin, anticoagulants and/or corticosteroids, smoking, use of ethanol, the elderly or debilitated patients. When used concomitantly with aspirin, a substantial increase in the risk of gastrointestinal complications (eg, ulcer) occurs; concomitant gastroprotective therapy (eg, proton pump inhibitors) is recommended.
Use the lowest effective dose for the shortest duration of time, consistent with individual patient goals, to reduce risk of cardiovascular or GI adverse events. Alternate therapies should be considered for patients at high risk.
Pregnancy: Pregnancy Considerations: Adverse event were not observed in the initial animal reproduction studied; therefore, the manufacturer classifies ibuprofen as pregnancy category C (category D: ≥30 weeks gestation).
Lactation: Breast-Feeding Consideration: Based on limited data, only very small amounts of ibuprofen are excreted into breast milk. Adverse event have not been reported in nursing infants. Because there is a potential for adverse event to occur in nursing infants, the manufacturer does not recommend the use of ibuprofen while breast-feeding. Use with caution in nursing woman with hypertensive disorders of pregnancy or pre-existing renal disease.
Cardiovascular: Edema.
Central nervous system: Dizziness, headache, nervousness.
Dermatologic: Itching, rash.
Endocrine & metabolic: Fluid retention.
Gastrointestinal: Abdominal pain/cramps/distress, appetite decreased, constipation, diarrhea, dyspepsia, epigastric pain, heartburn, nausea, vomiting.
Otic: Tinnitus.
Metabolism/Transport Effects Substrate of CYP2C19 (minor), CYP2C9 (minor); Note: Assignment of major/Minor substrate status based on clinically relevant drug interaction potential; Inhibit CYP2C9 (weak).
Avoid Concomitant Use: Avoid concomitant use of Ibuprofen with any of the following: Floctafenine; Ketorolac (Nasal); Ketorolac (Systemic); NSAIDs (COX-2 Inhibitor); Omacetaxine.
Store below 30°C. Protect from light and moisture.
M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Brusoft soft gelatin cap 400 mg
6 × 10's
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