Ibuprofen Tablets USP 800mg

inhibition of prostaglandin synthesis at the peripheral level.

– Oral route: rheumatoid arthritis (including juvenile rheumatoid arthritis), ankylopoietic spondylitis, osteoarthritis and other acute or chronic rheumatic processes. Musculoskeletal and traumatic disorders with pain and inflammation. Treatment symptomatic of mild or moderate pain (dental pain, post-surgical pain, headache, migraine). Primary dysmenorrhea. feverish pictures.
– Via IV: tto. short-term symptom of moderate pain and fever, when IV administration is clinically justified and other routes of administration are not possible.

oral.
Ads:
– Painful processes of mild-moderate intensity and febrile episodes: 200-400 mg/4-6 h or 400 mg/6-8 h; max. 1200 mg/day or 600 mg/6-8 h; max. 2400mg/day.
– Rheumatoid arthritis: 1200-1800 mg/day; maintenance: 800-1200 mg/day; max. 2400mg/day.
– Dysmenorrhea 1 ^ary : 400 mg until pain relief; max. 1200mg/day.
Comp. Retard “600”: 600mg/12h; ads. max. 2400mg/day. Adolescents 12-18 years old: 1600 mg/day.
Comp. Prolonged release “800”: ads. and children from 12 years: 1600 mg/day (single dose). In severe or acute situations: 2400 mg/day (800 mg/morning and 1600 mg/afternoon).
Kids:
– Symptomatic relief of occasional mild or moderate pain and fever: 3 months-12 years: 20-30 mg/kg/day in 3-4 doses, the interval between doses will depend on the evolution of symptoms, but it will never be less to 4 hours
– Juvenile rheumatoid arthritis: max. 40mg/kg/day.
Mild-moderate IR and/or mild-moderate HI, reduce dose.
IV.
Ads.:
– Tto. of moderate pain and fever: recommended daily dose: 1200-1600 mg in multiple doses. 400-600 mg/6-8 hours as needed, not to exceed the maximum daily dose of 2400 mg in multiple doses. Use the lowest effective dose and for the shortest time possible according to the needs of each patient.

N/A

hypersensitivity to ibuprofen or other NSAIDs; history of bronchospasm, asthma, rhinitis, angioedema, or urticaria associated with the use of ASA or other NSAIDs; history of treatment-related gastrointestinal bleeding or perforation. previous NSAIDs, active or recurrent peptic ulcer/gastrointestinal bleeding (2 or more distinct episodes of proven ulceration or bleeding), or history of recurrent peptic ulcer/bleeding; sick active inflammatory bowel disease; severe RI; severe HI; insuf. severe cardiac; bleeding diathesis or other coagulation disorders; third trimester of pregnancy; cerebrovascular or other active bleeding, coronary disorders; severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake). Also IV:

Mild-moderate HI (reduce initial dose), mild-moderate IR (reduce initial dose), elderly, children with severe dehydration. History of: ulcerative colitis, enf. Crohn’s, HTA and/or insuf. heart disease, bronchial asthma, allergic reactions, hematopoietic disorders, systemic lupus erythematosus or enf. mixed connective tissue. Risk of gastrointestinal bleeding, ulcer, or perforation is greater when increasing doses of NSAIDs are used, with a history of ulcer, and the elderly. Concomitant with oral anticoagulants of the dicoumarinic type, antiplatelet agents of the ASA type, oral corticosteroids and SSRIs since they could increase the risk of ulcer or gastrointestinal bleeding. Assess risk/benefit in: AHT, CHF, sick. established coronary artery disease, peripheral artery disease and/or disease. cerebrovascular, acute intermittent porphyria. in treatment of long duration (mainly if high doses are required) with known cardiovascular risk factors (HTN, hyperlipidemia, diabetes mellitus, smokers), with serious heart disease such as heart failure. heart disease (New York Heart Association-NYHA classification II-IV), established ischemic heart disease, enf. peripheral arterial disease or cerebrovascular, avoid doses of 2400 mg/day or higher; as they are associated with an increased risk of arterial thrombosis. It can mask symptoms of infections (avoid in case of chicken pox). Control in undergoing major surgery. Renal, hepatic and hematological control. Risk of severe skin reactions at the start of treatment. Cases of acute generalized exanthematous pustulosis (AGEP) have been reported. Ibuprofen treatment should be discontinued immediately after the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Use dose min. effective for the shortest possible time to minimize adverse reactions. May alter female fertility by affecting ovulation. Via IV also: control at the beginning of the infusion, for possible anaphylactic/hypersensitivity reactions. Children, security not established.

Contraindicated in severe IH. Caution in mild-moderate HI, reduce initial dose.

Contraindicated in severe IR. Caution in mild-moderate IR, reduce initial dose.

Increased risk of gastrointestinal ulceration and bleeding with: NSAIDs, dicoumarinic-type oral anticoagulants, ASA-type antiplatelet agents, oral corticosteroids and SSRIs.
Reduces efficacy of: furosemide, thiazide diuretics.
Reduces hypotensive effect of: ß-blockers, ACE inhibitors, angiotensin II antagonists.
Risk of hyperkalaemia with: potassium-sparing diuretics.
Reduces effect of: mifepristone.
Increases plasma levels of: digoxin, phenytoin and lithium.
Increases toxicity of: methotrexate, hydantoins, sulfonamides, baclofen.
Potentiates gastrointestinal lesions with: salicylates, phenylbutazone, indomethacin and other NSAIDs.
Increases effect of: oral hypoglycemic agents and insulin.
Additive effect on platelet inhibition with: ticlopidine.
Increased risk of hematotoxicity from: zidovudine.
Bleeding time potency of: anticoagulants.
Increased risk of nephrotoxicity with: tacrolimus, cyclosporine.
Increased risk of gastrointestinal bleeding and ulceration with: corticosteroids, bisphosphonates or oxypentifylline, selective cyclooxygenase-2 inhibitors.
Risk of bleeding with: ginkgo biloba, thrombolytics.
Plasma concentrations increased by: probenecid and sulfinpyrazone.
Decreased effect by: ion exchange resins (cholestyramine).
Potency toxicity of: tacrine.
Potentiates the nephrotoxic effect of: aminoglycosides

First and second trimester of pregnancy: the inhibition of prostaglandin synthesis can negatively affect pregnancy and/or the development of the embryo/fetus. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformations and gastroschisis following the use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. It appears that the risk increases with the dose and duration of treatment. During the first and second trimesters of pregnancy, it should not be administered unless it is considered strictly necessary.
Third trimester of pregnancy: During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to:
– Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension).
– Renal dysfunction, which may progress to renal failure with oligohydroamniosis.
– Possible prolongation of bleeding time, due to an antiaggregant-type effect that can occur even at very low doses.
– Inhibition of uterine contractions, which can cause delay or prolongation of labor.
Consequently it’s contraindicated during the third trimester of pregnancy.

Ibuprofen and its metabolites pass in low concentrations into breast milk. To date, there are no known harmful effects in children, so it is generally not necessary to stop breast-feeding during a short course of treatment at the recommended dose for pain and fever.

peptic ulcer, gastrointestinal perforation and bleeding, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of ulcerative colitis, and colitis. Crohn’s; fatigue or drowsiness, headache, dizziness; Vertigo; acne; pain and burning sensation at injection site