More Information About - Bufen SR 300 mg Cap. - 300mg
Description
Generic Name
Ibuprofen
Precaution
Asthma; renal or hepatic disorders; bleeding disorders; CV disease. Pregnancy, lactation.
Lactation: Drug excreted into breast milk; use not recommended (American Academy of Pediatrics committee states that drug is compatible with nursing)
Active peptic ulcer; hypersensitivity. Neonates with congenital heart disease, suspected necrotising enterocolitis and active bleeding (parenteral).
Dose
N/A
Side Effect
1-10%
Dizziness (3-9%),Epigastric pain (3-9%),Heartburn (3-9%),Constipation (1-3%),Nausea (3-9%),Rash (3-9%),Tinnitus (3-9%),Edema (1-3%),Fluid retention (1-3%),Headache (1-3%),Vomiting (1-3%)
<1%
Acute renal failure (sometimes with acute tubular necrosis or hyperkalemia, polyuria, azotemia, cystitis, hematuria, decreased creatinine clearance, elevations in blood urea nitrogen (BUN) or creatinine without other manifestations of renal failure)
Agranulocytosis,Aplastic anemia,Erythema multiforme,Erythematous macular rashes,Exfoliative dermatitis,Hemolytic anemia (with or without positive direct antiglobulin test results),Neutropenia,Thrombocytopenia (with or without purpura),Toxic epidermal necrolysis (Lyell syndrome) and photosensitivity reactions
Potentially Fatal: Severe CV thrombotic events. Severe GI bleeding, ulceration and perforation.
Pregnancy Category
Name :
Not Classified
Description
FDA has not yet classified the drug into a specified pregnancy category.
Mode of Action
Ibuprofen inhibits synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase-1 and 2. It has anti-inflammatory, analgesic and antipyretic properties.
Interaction
Increased risk of GI bleeding w/ warfarin, corticosteroids, SSRIs and aspirin. May reduce the natriuretic effects of diuretics. Reduced antihypertensive effect of ACE inhibitors and angiotensin II receptor antagonists. May increase toxicity of lithium and methotrexate. Increased nephrotoxicity w/ ciclosporin and tacrolimus.
Pregnancy Category Note
Pregnancy
>30 weeks' gestation: May cause premature closure of ductus arteriosus; avoid during 1st and 3rd trimesters
Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks' gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and in approximately 2.6% of controls
Lactation
Drug excreted into human breast milk in extremely low levels
Ibuprofen has a short half-life and is considered safe in infants in doses much higher than those excreted in breast milk
Considered the preferred choice for analgesia or inflammation in breastfeeding women (LactMed from NIH)
Adult Dose
Pain/Fever/Dysmenorrhea
200-400 mg PO q4-6hr; not to exceed 1.2 g unless directed by physician
Inflammatory Disease
400-800 mg PO q6-8hr; not to exceed 3.2 g/day
Osteoarthritis, Rheumatoid Arthritis
300 mg, 400 mg, 600 mg, or 800 mg PO q6-8hr; not to exceed 3.2 g/day
Severe hepatic impairment: Avoid use
Child Dose
Fever
6 months to 12 years
5-10 mg/kg/dose PO q6-8hr; not to exceed 40 mg/kg/day
Pain
4-10 mg/kg/dose PO q6-8hr; not to exceed 40 mg/kg/day
Juvenile Idiopathic Arthritis
30-50 mg/kg/24hr PO divided q8hr; not to exceed 2.4 g/day
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