Side Effects
-Myocardial infarction, New-onset hypertension or exacerbation of hypertension may occur with NSAID, gastrointestinal inflammation, gastrointestinal hemorrhage, gastrointestinal ulcer, and gastrointestinal perforation, an increased risk for hemorrhage, drug-induced hemolytic anemia, agranulocytosis, aplastic anemia, neutropenia, thrombocytopenia, mild transaminase elevations, Hypersensitivity reactions (immediate and delayed) involving the skin (eg, angioedema, urticaria), acute kidney injury, interstitial nephritis.
-Oral formulations: decreased hemoglobin, edema, maculopapular rash, pruritus, skin rash, fluid retention, abdominal cramps, abdominal distress, abdominal pain, bloating, constipation, decreased appetite, diarrhea, dyspepsia, epigastric pain, flatulence, heartburn, nausea, nausea and vomiting, dizziness, headache, nervousness, tinnitus, cardiac arrhythmia, increased blood pressure, palpitations, sinus bradycardia, sinus tachycardia, alopecia, erythema multiforme, skin photosensitivity, urticaria, vesiculobullous dermatitis, acidosis, gynecomastia, heavy menstrual bleeding, hypoglycemia,duodenal ulcer, gastric ulcer, gastritis, gingival ulceration, melena, pancreatitis, xerostomia, azotemia, cystitis, hematuria, abnormal dreams, chills, confusion, depression, drowsiness, emotional lability, hallucination, idiopathic intracranial hypertension, insomnia, paresthesia, amblyopia, cataract, conjunctivitis, diplopia, optic neuritis, xerophthalmia, hearing loss, decreased creatinine clearance, polyuria, renal papillary necrosis, bronchospasm, epistaxis, rhinitis and fever.
-Injections: Hypokalemia, flatulence, vomiting, anemia, eosinophilia, hypoproteinemia, neutropenia, bacteremia, headache, hypertension, hypotension, peripheral edema, hypernatremia, hypoalbuminemia, increased lactate dehydrogenase, urinary retention, hemorrhage, thrombocythemia, wound hemorrhage, infusion-site pain, dizziness, increased blood urea nitrogen, bacterial pneumonia and cough.
Safety Advice
-Should not be given to patients suffering from hypersensitivity to ibuprofen.
-Should not be given to patients suffering from history of asthma, urticaria, or allergic-type reaction to aspirin or other NSAIDs.
-Should not be given to patients suffering from cerebrovascular bleeding or other bleeding disorders.
-Should not be given to patients suffering from active gastric/duodenal/peptic ulcer, active GI bleeding; inflammatory bowel disease.
-Should not be given to patients suffering from heart failure.
-Should not be given to patients suffering from severe renal impairment (creatinine clearance is <30 mL/minute).
-Should not be given to patients suffering from severe hepatic impairment; active hepatic disease.
-Should not be given to patients suffering from hyperkalemia.
-Should not be given to patients suffering from systemic lupus erythematosus.
-Should not be given to children suffering from dehydration as a result of acute diarrhea, vomiting, or lack of fluid intake.
-May cause drowsiness, dizziness, blurred vision, and other neurologic effects which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
-Blurred/diminished vision, scotomata, and changes in color vision.
-May increase the risk of aseptic meningitis, especially in patients with systemic lupus erythematosus.
-Ibuprofen injection: Must be diluted prior to administration; hemolysis can occur if not diluted.
-Elderly patients are at high risk for adverse effects from NSAIDs. Up to 60% of elderly patients can develop an asymptomatic peptic ulcer and/or hemorrhage. So, it is recommended to use the lowest effective dose for shortest period possible.
-In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.
Storage
-Store at room temperature.
-Indications and usage(continue):
2-In case of children ≥12 years and adolescents ≤17 years: IV: 400 mg every 4 to 6 hours as needed; maximum daily dose: 2,400 mg/day.
3-In case of adolescents ≥18 years: IV: 400 to 800 mg every 6 hours as needed; maximum daily dose: 3,200 mg/day.
B-Oral: Weight-directed dosing: Infants, children, and adolescents: Limited data available in infants <6 months: Oral: 4 to 10 mg/kg/dose every 6 to 8 hours; maximum dose: 400 mg/dose; maximum daily dose: 40 mg/kg/day or 3,200 mg/day.
-Antipyretic:
A-Intravenous: Ibuprofen injection:
1-In case of infants ≥6 months and children <12 years: IV: 10 mg/kg/dose (maximum dose: 400 mg/dose) every 4 to 6 hours as needed; maximum daily dose: 40 mg/kg/day or 2,400 mg/day, whichever is less.
2-In case of children ≥12 years and adolescents ≤17 years: IV: 400 mg every 4 to 6 hours as needed; maximum daily dose: 2,400 mg/day.
3-In case of adolescents ≥18 years: IV: Initial dose: 400 mg once, followed by 400 mg every 4 to 6 hours or 100 to 200 mg every 4 hours as needed; maximum daily dose: 3,200 mg/day.
B-Oral: Weight-directed dosing: Infants ≥3 months weighing ≥5 kg, children, and adolescents: Limited data available in infants <6 months: Oral: 5 to 10 mg/kg/dose every 6 to 8 hours; maximum dose: 400 mg/dose; maximum daily dose: 40 mg/kg/day or 2,400 mg/day, whichever is less.
-Juvenile idiopathic arthritis (JIA): Children and adolescents: Oral: Usual range: 30 to 40 mg/kg/day in 3 to 4 divided doses; start at lower end of dosing range and titrate; patients with more severe disease may require up to 50 mg/kg/day; maximum dose: 800 mg/dose; maximum daily dose: 2,400 mg/day.