P - Caution when used during pregnancy
L - Caution when used during lactation
FI - Food *
Ibuprofen from the now outdated nomenclature iso-butyl-propanoic-phenolic acid) is a non-steroidal anti-inflammatory drug (NSAID) originally marketed as Brufen, and since then under various other trademarks (see tradenames section), most notably Nurofen, Advil and Motrin. It is used for relief of symptoms of arthritis, primary dysmenorrhea, fever, and as an analgesic, especially where there is an inflammatory component. Ibuprofen is known to have an antiplatelet effect, though it is relatively mild and short-lived when compared with that of aspirin or other better-known antiplatelet drugs. Ibuprofen is a core medicine in the World Health Organization's "Essential Drugs List", which is a list of minimum medical needs for a basic health care system.
Ibuprofen exhibits anti-inflammatory, analgesic and antipyretic activities. Its analgesic effect is independent of anti-inflammatory activity and has both central and peripheral effects. It potently inhibits the enzyme cyclooxygenase resulting in the blockage of prostaglandin synthesis. It also prevents formation of thromboxane A2 by platelet aggregation. Onset Analgesic: 30-60 min. Anti-inflammatory: ≤7 days. Duration 4-6 hr.
Absorption Oral: Peak plasma concentrations after 1-2 hr. Topical: Minimal.
Distribution Protein-binding: 90-99%.
Metabolism Hepatic via oxidation.
Excretion Via urine (1% as free drug), some feces; 2 hr (plasma half-life).
Information Not Available
Oral: Dyspepsia, vomiting, abdominal pain, heartburn, nausea, diarrhoea, epigastric pain, oedema, fluid retention, dizziness, rash, tinnitus. Parenteral: Intraventricular haemorrhage, skin irritation, hypocalcaemia, hypoglycaemia, GI disorders, anaemia, apnoea, respiratory infection, sepsis. Potentially Fatal: Severe CV thrombotic events. Severe GI bleeding, ulceration and perforation.
Ibuprofen tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. The pharmacological activity of Ibuprofen tablets in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
Asthma; renal or hepatic disorders; bleeding disorders; CV disease. Pregnancy, lactation.
Reduces effects of antihypertensives. Enhanced effect with moclobemide. Increased risk of GI bleeding with warfarin. Potentially Fatal: Reduces antiplatelet effect of aspirin. Increases risk of methotrexate and lithium toxicity.
Food Interactions Decreased peak serum levels if taken with food.
Oral Pain and inflammation Adult: 1.2-1.8 g/day in divided doses. Maintenance: 0.6-1.2 g daily. Max: 2.4 g/day. Oral Juvenile idiopathic arthritis Child: ≥3 mth and weighing >5 kg: 30-40 mg/kg/day in 3-4 divided doses. Max: 2.4 g/day. Oral Fever Adult: 200-400 mg every 4-6 hr. Max: 1.2 g/day. Child: 1-6 mth: 5 mg/kg 3-4 times daily, 6-12 mth: 50 mg tid, 1-2 yr: 50 mg 3-4 times daily, 2-7 yr: 100 mg 3-4 times daily, >7 yr: 200 mg 3-4 times daily. Max: 40 mg/kg/day. Intravenous Closure of patent ductus arteriosus Child: Given as three IV doses infused over 15 min at 24-hr intervals. Initially 10 mg/kg followed by 2 doses of 5 mg/kg. A 2nd course may be given if ductus remains open after 48 hr. Surgery may be required if neonate is unreponsive to two courses of treatment. Dose should be based on birth weight. Topical/Cutaneous Pain and inflammation associated with musculoskeletal and joint disorders Adult: As 5% or 10% gel: Apply onto affected area.
Should be taken with food.
Caution when used during pregnancy Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters). In 3rd trimester or near delivery: Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Caution when used during lactation
Safety and effectiveness of Ibuprofen tablets in pediatric patients have not been established.
As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).
Active peptic ulcer; hypersensitivity. Neonates with congenital heart disease, suspected necrotising enterocolitis and active bleeding (parenteral).
Intravenous Store at room temperature of 20-25 ℃. (68-77 ° F). Oral Cap/Gelcap/Tab: Store at room temperature of 20-25 ℃ (68-77 ° F). Susp/Drops Store at room temperature of 15-30 ℃ (59-86 °F)
Intravenous Store at room temperature of 20-25 ℃. (68-77 ° F). Oral Cap/Gelcap/Tab: Store at room temperature of 20-25 ℃ (68-77 ° F). Susp/Drops Store at room temperature of 15-30 ℃ (59-86 °F)
You will hear from us only if the bid amount matches the minimum threshold and intended usage match our vision. You can resubmit another bid.