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Brufen 600 mg 20 Effer. Granules in Sachets

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Medical Description

Nonsteroidal Anti-inflammatory Drug (NSAID) used in the treatment of fever, dysmenorrhea, gout, migraine, pain and inflammation.

Indication & Usage

-Anti-inflammatory (eg, for arthritis associated with rheumatic disease): Oral: 400 to 800 mg every 6 to 8 hours; maximum dose: 3.2 g/day. Some experts generally recommend a maximum dose of 2.4 g/day for chronic use, except during a disease flare when up to 3.2 g/day may be considered for several weeks until flare resolves. -Fever: IV, Oral: 200 to 400 mg every 4 to 6 hours as needed; if fever persists, may titrate up to 600 to 800 mg every 6 hours as needed; maximum dose: 3.2 g/day. -Dysmenorrhea: Oral: Initial: 400 mg every 4 hours as needed or 600 to 800 mg every 6 to 8 hours as needed; maximum dose: 3.2 g/day. Begin at menses onset or 1 to 2 days prior to onset of menses for severe symptoms; usual duration: 1 to 5 days. -Gout: Oral: Initial: 800 mg every 8 hours within 24 to 48 hours of flare onset; reduce dose as symptoms improve; discontinue 2 to 3 days after resolution of clinical signs; usual duration: 5 to 7 days. -Acute migraine: Limit use to ≤14 days per month: Oral: 400 to 600 mg once. -Pain: IV, Oral: 200 to 400 mg every 4 to 6 hours as needed or 600 to 800 mg every 6 to 8 hours as needed; maximum dose: 3.2 g/day. -Pediatric dosing: -Analgesic: 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. -For the rest of indications refer to Storage.

Active Ingredients

Ibuprofen

Recommended Doctors

No Recommended Doctors Found

Dosage & Administration

-Tablet, capsule, suspension, syrup and effervescent granules: Administer with food. -Suspension: Shake well before use, administer with an accurate measuring device (calibrated oral syringe or measuring cup); do not use a household teaspoon or tablespoon to measure dose. -Intravenous: Infuse over at least 30 minutes (adults). -Effervescent granules: Empty the granules from one sachet into a small glass of water (about 125 ml), make sure that you use all of the granules in the sachet, stir the medicine until it stops bubbling and the granules have dissolved.

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.

Drug Interactions

-Acemetacin: May enhance the adverse/toxic effect of NSAIDs. -Agents with antiplatelet properties (e.g., NSAIDs, SSRIs, etc.): May enhance the antiplatelet effect of other agents with antiplatelet properties. -Alcohol (Ethyl): May enhance the adverse/toxic effect of NSAIDs. -Aminoglycosides: NSAIDs may decrease the excretion of Aminoglycosides. -Angiotensin II Receptor Blockers: May enhance the adverse/toxic effect of NSAIDs. Specifically, the combination may result in a significant decrease in renal function. -Angiotensin-Converting Enzyme Inhibitors: May enhance the adverse/toxic effect of NSAIDs. Specifically, the combination may result in a significant decrease in renal function. -Anticoagulants: Agents with antiplatelet properties may enhance the anticoagulant effect of anticoagulants. -Beta-Blockers: NSAIDs may diminish the antihypertensive effect of Beta-Blockers. -Bile Acid Sequestrants: May decrease the absorption of NSAIDs. -Bisphosphonate derivatives: NSAIDs may enhance the adverse/toxic effect of Bisphosphonate derivatives. -Corticosteroids: May enhance the adverse/toxic effect of NSAIDs. -Deferasirox: NSAIDs may enhance the adverse/toxic effect of Deferasirox. -Deoxycholic acid: Agents with antiplatelet properties may enhance the adverse/toxic effect of deoxycholic acid. -Digoxin: NSAIDs may increase the serum concentration of digoxin. -Eplerenone: NSAIDs may diminish the antihypertensive effect of Eplerenone. -Fluconazole: May increase the serum concentration of Ibuprofen. -Ketorolac: NSAIDs may enhance the adverse/toxic effect of Ketorolac. -Lithium: NSAIDs may increase the serum concentration of Lithium. -Loop diuretics: NSAIDs may diminish the diuretic effect of loop diuretics. -For the rest of interactions refer to Pregnancy and Lactation.

Pregnancy & Lactation

-The use of nonsteroidal anti-inflammatory drugs (NSAIDs) close to conception may be associated with an increased risk of miscarriage. Maternal NSAID use may cause fetal renal dysfunction leading to oligohydramnios. Maternal use of NSAIDs should be avoided beginning at 20 weeks' gestation. If NSAID use is necessary between 20 and 30 weeks' gestation, limit use to the lowest effective dose and shortest duration possible. Based on available information, NSAIDs can be continued during the first 2 trimesters of pregnancy in patients with rheumatic and musculoskeletal diseases; use in the third trimester is not recommended. -Ibuprofen is present in breast milk. The relative infant dose (RID) of ibuprofen is 0.6% to 0.9%, breastfeeding is considered acceptable when the RID is <10%. Ibuprofen is considered compatible with breastfeeding when used in usual recommended doses, the decision to breastfeed during therapy consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Maternal use of NSAIDs should be avoided if the breastfeeding infant has platelet dysfunction, thrombocytopenia. -Ask your physician before taking any medication during pregnancy and lactation. -Interactions (continue): -Metformin: NSAIDs may enhance the adverse/toxic effect of Metformin. -Methotrexate: NSAIDs may increase the serum concentration of Methotrexate. -Multivitamins/Minerals (containing vitamins ADEK, Folate, Iron): May enhance the antiplatelet effect of agents with antiplatelet properties. -Omega-3 Fatty Acids: May enhance the antiplatelet effect of agents with antiplatelet properties. -Salicylates: NSAIDs may enhance the adverse/toxic effect of salicylates. -Thiazide diuretics: May enhance the nephrotoxic effect of NSAIDs. -Vitamin E: May enhance the antiplatelet effect of agents with antiplatelet properties. -Vitamin K Antagonists (eg, warfarin): NSAIDs may enhance the anticoagulant effect of vitamin K antagonists.

Manufacture

ABBOTT LABORATORIES

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