Buy Ansaid Online

Flurbiprofen (flurbiprofen)

BOXED WARNING

NSAIDs may increase risk of serious cardiovascular (CV) thrombotic events, myocardial infarction (MI), stroke; may increase risk w/ duration of use and w/ cardiovascular disease (CVD) or risk factors for CVD. Increased risk of serious GI adverse events (eg, bleeding, ulceration, stomach/intestine perforation) that can be fatal and occur anytime during use w/o warning symptoms; elderly patients are at a greater risk. Contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

OTHER BRAND NAMES

Ansaid (Discontinued)

THERAPEUTIC CLASS

NSAID

DEA CLASS

RX

INDICATIONS

Relief of the signs and symptoms of rheumatoid arthritis (RA) or osteoarthritis (OA).

ADULT DOSAGE

Rheumatoid Arthritis

Initial: 200-300mg/day, given as bid, tid, or qid
Titrate: Adjust dose/frequency based on response to initial therapy
Largest recommended single dose in a multiple-dose regimen is 100mg/day

Osteoarthritis

Initial: 200-300mg/day, given as bid, tid, or qid
Titrate: Adjust dose/frequency based on response to initial therapy
Largest recommended single dose in a multiple-dose regimen is 100mg/day

ADMINISTRATION

Oral route

HOW SUPPLIED

Tab: 50mg, 100mg

CONTRAINDICATIONS

Treatment of perioperative pain in the setting of CABG surgery. History of asthma, urticaria, or allergic-type reactions w/ aspirin (ASA) or other NSAIDs.

WARNINGS/PRECAUTIONS

Use lowest effective dose for the shortest duration possible. May lead to onset of new HTN or worsen preexisting HTN; use w/ caution and monitor BP closely during the initiation of treatment and throughout the course of therapy. Fluid retention and edema reported; caution w/ fluid retention or heart failure (HF). Caution w/ prior history of ulcer disease, GI bleeding, or risk factors for GI bleeding (eg, smoking, prolonged NSAID therapy, old age, poor general health status); monitor for GI ulceration/bleeding and d/c if serious GI events occur. Renal injury reported w/ long-term use; increased risk w/ renal/hepatic impairment, HF, and in the elderly. Not recommended w/ advanced renal disease; if therapy must be initiated, closely monitor renal function. Anaphylactoid reactions may occur; caution w/ asthma and avoid w/ ASA-sensitive asthma and the ASA-triad. Avoid in late pregnancy; may cause premature closure of the ductus arteriosus. Not a substitute for corticosteroids nor treatment for corticosteroid insufficiency; may mask signs of inflammation. May cause elevated LFTs or severe hepatic reactions (eg, jaundice, fulminant hepatitis, liver necrosis, hepatic failure); d/c if liver disease or systemic manifestations occur. Anemia reported; monitor Hgb/Hct if anemia develops. May prolong bleeding time; monitor patients w/ coagulation disorders. Blurred and/or diminished vision reported. Caution in elderly. Caution in patients who are known or suspected to be poor CYP2C9 metabolizers based on previous history/experience w/ other CYP2C9 substrates (eg, warfarin, phenytoin); may have abnormally high plasma levels due to reduced metabolic clearance.

ADVERSE REACTIONS

CV thrombotic events, GI adverse events, MI, stroke, edema, abdominal pain, constipation, dyspepsia, N/V, headache, nervousness, asthenia, somnolence, dizziness, tinnitus.

DRUG INTERACTIONS

Increased risk of GI bleeding w/ oral corticosteroids, anticoagulants (eg, warfarin), and alcohol use. May diminish antihypertensive effect of ACE inhibitors. Not recommended w/ ASA. May attenuate hypotensive effects of β-blockers (eg, propranolol) but not atenolol; monitor to ensure that a satisfactory hypotensive effect is achieved. May reduce natriuretic effect of loop (eg, furosemide) or thiazide diuretics; monitor for signs of renal failure and diuretic efficacy. May increase lithium levels; monitor for lithium toxicity. May enhance methotrexate toxicity; caution w/ concomitant use. ACE inhibitors and diuretics may increase risk of overt renal decompensation. Reduced rate of absorption w/ antacids in elderly patients. Cimetidine may increase flurbiprofen exposure. Slight reduction in blood sugar concentrations reported during concomitant administration w/ oral hypoglycemic agents.

PREGNANCY AND LACTATION

Category C, not for use in nursing.

MECHANISM OF ACTION

NSAID; has not been established, exhibits anti-inflammatory, analgesic, and antipyretic activities; may be related to prostaglandin synthetase inhibition.

PHARMACOKINETICS

Absorption: Rapid; bioavailability (96%); Tmax=2 hrs, (Healthy) Cmax=14Tg/mL, AUC=83Tg•h/mL. Distribution: Vd=0.12L/kg; plasma protein binding (>99%); found in breast milk. Metabolism: CYP2C9. 4'-hydroxy-flurbiprofen (major metabolite). Elimination: Urine (<3% unchanged) (70% parent drug and metabolites); T1/2=4.7 hrs (R-flurbiprofen), 5.7 hrs (S-flurbiprofen).

ASSESSMENT

Assess for history of asthma, urticaria, or allergic-type reactions w/ ASA or other NSAIDs, renal impairment, CVD, risk factors for CVD, HTN, CHF, fluid retention, history of ulcer disease, history of/risk factors for GI bleeding, hepatic impairment, coagulation disorder, pregnancy/nursing status, or any other conditions where treatment is contraindicated or cautioned. Assess for possible drug interactions. Obtain baseline CBC and BP.

MONITORING

Monitor for GI bleeding/ulceration/perforation, CV thrombotic events, MI, stroke, HTN, fluid retention, renal injury, skin/allergic reactions, and for other adverse reactions. Perform ophthalmologic exam if patient has eye complaints. Monitor BP, CBC, bleeding time, LFTs, renal function, and chemistry profile periodically.

PATIENT COUNSELING

Inform to seek medical advice if symptoms of CV events (eg, chest pain, SOB, weakness, slurred speech), GI ulceration/bleeding (eg, epigastric pain, dyspepsia, melena, hematemesis), skin/hypersensitivity reactions (eg, rash, blisters, fever, itching), unexplained weight gain or edema, hepatotoxicity (eg, nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, flu-like symptoms), or anaphylactoid reactions (eg, face/throat swelling, difficulty breathing) occur. Instruct to avoid in late pregnancy.

STORAGE

20-25°C (68-77°F).

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