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Cataflam (diclofenac potassium)

BOXED WARNING

NSAIDs may cause an increased risk of serious cardiovascular (CV) thrombotic events, MI, stroke, and serious GI adverse events, including bleeding, ulceration, and perforation of the stomach or intestines. Contraindicated for the treatment of perioperative pain in the setting of CABG surgery.

THERAPEUTIC CLASS

NSAID

DEA CLASS

RX

INDICATIONS

Relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. Treatment of primary dysmenorrhea and relief of mild to moderate pain.

ADULT DOSAGE

Osteoarthritis

100-150mg/day in divided doses, 50mg bid or tid

Rheumatoid Arthritis

150-200mg/day in divided doses, 50mg tid or qid

Mild to Moderate Pain

50mg tid; may give initial dose of 100mg followed by 50mg doses in some

Primary Dysmenorrhea

50mg tid; may give initial dose of 100mg followed by 50-mg doses in some

ADMINISTRATION

Oral route

HOW SUPPLIED

Tab: 50mg

CONTRAINDICATIONS

Aspirin (ASA) or other NSAID allergy that precipitates asthma, urticaria, or allergic reactions. Treatment of perioperative pain in the setting of CABG surgery.

WARNINGS/PRECAUTIONS

May lead to onset of new HTN or worsening of preexisting HTN; monitor BP closely. Fluid retention and edema reported; caution in patients with fluid retention or heart failure (HF). Caution with history of ulcer disease or GI bleeding. Caution in patients with considerable dehydration. Renal papillary necrosis and other renal injury reported after long-term use. Caution with impaired renal function, HF, liver dysfunction, and the elderly. Not recommended for use with advanced renal disease; if therapy must be initiated, monitor renal function. May cause elevations of LFTs; d/c if liver disease develops or systemic manifestations occur. Anaphylactoid reactions may occur. May cause serious skin adverse events (eg, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis). Avoid in late pregnancy; may cause premature closure of ductus arteriosus. Not a substitute for corticosteroids or for the treatment of corticosteroid insufficiency. Anemia may occur; with long-term use, monitor Hgb/Hct if signs or symptoms of anemia develop. May inhibit platelet aggregation and prolong bleeding time; monitor with coagulation disorders. Caution with asthma and avoid with ASA-sensitive asthma.

ADVERSE REACTIONS

Dyspepsia, constipation, diarrhea, GI ulceration/perforation, N/V, flatulence, abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headache, increased bleeding time, rash, tinnitus.

DRUG INTERACTIONS

Avoid use with ASA. May enhance methotrexate toxicity; caution when coadministering. May increase nephrotoxicity of cyclosporine; caution when coadministering. May diminish antihypertensive effect of ACE inhibitors. May reduce natriuretic effect of furosemide and thiazides; monitor for renal failure. May increase lithium levels; monitor for toxicity. Synergistic effects on GI bleeding with warfarin. Caution with hepatotoxic drugs (eg, antibiotics, antiepileptics). Increased risk of GI bleeding with concomitant oral corticosteroids, anticoagulants, or alcohol. ACE inhibitors and diuretics may increase the risk of overt renal decompensation.

PREGNANCY AND LACTATION

Category C, not for use in nursing.

MECHANISM OF ACTION

NSAID (benzeneacetic acid derivative); suspected to inhibit prostaglandin synthetase.

PHARMACOKINETICS

Absorption: Absolute bioavailability (55%), Tmax=1 hr. Distribution: Vd=1.3L/kg; serum protein binding (>99%). Metabolism: Metabolites: 4'-hydroxy-, 5-hydroxy-, 3'-hydroxy-, 4',5-dihydroxy-, and 3'-hydroxy-4'-methoxy diclofenac. Elimination: Urine (65%), bile (35%); T1/2=2 hrs.

ASSESSMENT

Assess for history of a hypersensitivity reaction to ASA or other NSAIDs, asthma, cardiovascular disease (CVD) (eg, preexisting HTN, congestive heart failure) or risk factors for CVD, risk factors for a GI event (eg, prior history of ulcer disease or GI disease, smoking), fluid retention, renal/hepatic dysfunction, coagulation disorders, pregnancy/nursing status, and for possible drug interactions. Assess baseline LFTs, renal function, and CBC.

MONITORING

Monitor for signs/symptoms of CV thrombotic events, new onset or worsening of preexisting HTN, GI events (eg, inflammation, bleeding, ulceration, perforation), fluid retention and edema, renal effects (eg, renal papillary necrosis), hepatic effects (eg, jaundice, liver necrosis, liver failure), anaphylactoid reactions, skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis), hematological effects (eg, anemia, prolongation of bleeding time), and for bronchospasm. Monitor BP. Perform periodic monitoring of CBC, renal function, and LFTs.

PATIENT COUNSELING

Instruct to seek medical attention for symptoms of hepatotoxicity (eg, nausea, fatigue, jaundice), anaphylactic reactions (eg, difficulty breathing, swelling of the face/throat), rash, CV events (eg, chest pain, SOB, weakness, slurring of speech), or if unexplained weight gain or edema occurs. Inform of risks if used during pregnancy.

STORAGE

Do not store at >30°C (86°F). Dispense in tight container.

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