RiteMED Diclofenac

RA, OA, ankylosing spondylitis & other rheumatic disorders; pain & other discomforts associated w/ minor/oral/anorectal surgery, tonsillectomy, childbirth, sports injuries & accidental trauma.

Adult 1 tab every 8-12 hr.

May be taken with or without food.

Hypersensitivity. Complete/partial syndrome of nasal polyps, or in whom asthma, anaphylaxis, urticaria, rhinitis, or other allergic-type reactions are precipitated by aspirin or other NSAIDs. History of GI bleeding or perforation related to previous NSAID therapy; active gastric, duodenal or peptic ulcer, active GI bleeding or perforation, regional ulcer, gastritis or ulcerative colitis. Severe heart, liver or kidney failure. Established CHF NYHA II-IV, ischemic heart disease, or peripheral artery disease. Cerebrovascular bleeding or other bleeding disorders. Inflammatory bowel disease. Known hyperkalemia. Dengue fever. Treatment of perioperative pain in the setting of CABG surgery. Pregnancy (3rd trimester) & lactation. Childn & adolescent <16 yr old.

Anaphylactoid reactions. Increased risk of CV adverse events (eg, MI, stroke or thrombotic events) at higher doses. Patients w/ high risk of developing an adverse CV event, other management strategies that do not include NSAIDs, particularly COX-2 inhibitors & diclofenac. Not recommended in patients w/ pre-existing CV disease (CHF, ischemic heart disease, peripheral arterial disease) cerebrovascular disease, uncontrolled HTN or patients w/ risk factors for CV disease (eg, HTN, hyperlipidemia, DM & smoking). Na-retention in a dose-dependent manner. Increased risk of serious GI adverse events including bleeding, ulceration & perforation of the stomach or intestines. Not recommended for use w/ other NSAIDs, (except low-dose aspirin for CV prophylaxis). Not to be used concomitantly w/ multiple diclofenac-containing prep (including diclofenac K). CV thrombotic events. HTN. Fluid retention & edema. Not a substitute for corticosteroids. Patients w/ ulcerative colitis or Crohn's disease; considerable dehydration. Skin reactions (photosensitivity upon exposure to sunlight or UV light). Anemia. Carefully monitor platelet function. Aseptic meningitis. May affect ability to drive or operate machinery. Advanced renal disease. Patients w/ hepatic porphyria. Pregnancy & lactation. Childn (<16 yr). Frail or debilitated patients. Elderly ≥ 65 yr.

Abdominal pain, abnormal renal function, anemia, constipation, decreased appetite, diarrhea, dizziness, dyspepsia, edema, elevated liver enzymes, flatulence, GI ulcers (gastric/duodenal), gross bleeding/perforation, headache, heartburn, increased bleeding time, nausea, pruritus, rashes, tinnitus, vertigo, vomiting.

Concomitant administration w/ Al & Mg hydroxide antacids may delay absorption. Increased risk of renal impairment & hyperkalemia when given w/ ACE inhibitors (eg, captopril, fosinopril, imidapril, enalapril) & AIIAs (eg, losartan, telmisartan). Increased risk of GI side effects, including ulceration or hemorrhage w/ alcohol. Avoid concomitant use w/ aspirin or other NSAIDs (increased adverse effects). Exacerbate cardiac failure, reduce GFR, increase plasma cardiac glycoside levels w/ digoxin. Increased risk of nephrotoxicity & hyperkalemia w/ ciclosporin & tacrolimus. Colestipol & cholestyramine may induce a delay of decrease in absorption. Increased risk of GI bleeding & ulceration w/ corticosteroids. Co-administration w/ CYP2C9 inhibitors (eg, voriconazole) may enhance exposure & toxicity; CYP2C9 inducers eg, rifampicin (may lead to compromised efficacy of diclofenac). Increased risk of nephrotoxicity & antagonism of diuretic effect w/ thiazides or furosemide. Reduces excretion of lithium & MTX. Increased risk of adverse renal effects w/ paracetamol. Monitor phenytoin plasma conc. Increased risk of hyperkalemia w/ K-sparing diuretics, aldosterone antagonist & trimethoprim. Increased risk of convulsions w/ quinolones. Increased risk of GI bleeding w/ SSRIs. Risk of serious GI bleeding w/ warfarin. Increased risk of hematological toxicity w/ zidovudine.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.

Rx