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Neo-Pyrazon

Neo-Pyrazon

diclofenac

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Diclofenac Na
Indications/Uses
RA, OA, ankylosing spondylitis & other rheumatic disorders. Pain & other discomforts associated w/ minor surgery, oral surgery, tonsillectomy, anorectal surgery, childbirth, sports injuries & accidental trauma.
Dosage/Direction for Use
Administration
Should be taken with food: Take immediately after meals.
Contraindications
Hypersensitivity. Complete or 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. Established CHF (NYHA II-IV), ischemic heart disease or peripheral artery disease. Cerebrovascular bleeding or other bleeding disorders. Inflammatory bowel disease. Hypokalemia. Increased risk of bleeding w/ dengue fever. Treatment of perioperative pain in the setting of CABG surgery. Severe heart, liver or kidney failure. Pregnancy (3rd trimester) & lactation. Childn & adolescent <16 yr.
Special Precautions
Increased risk of CV adverse events (eg, MI, stroke or thrombotic events) at higher doses; serious GI adverse events including bleeding, ulceration & perforation of the stomach or intestines. Patients w/ preexisting CV disease (congestive heart failure, ischemic heart disease, peripheral arterial disease), cerebrovascular disease, uncontrolled HTN or w/ risk factors for CV disease (eg, HTN, hyperlipidemia, DM & smoking). Can promote Na retention which can increased BP &/or exacerbation of CHF. Can lead to the new onset of HTN or worsening of preexisting HTN. Patients w/ fluid retention or heart failure. Persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria or cystitis. Impaired response w/ thiazides or loop diuretics. Photosensitivity upon exposure to sunlight or UV light. Hepatic porphyria. Evaluate for evidence of the development of a more severe hepatic reaction. Carefully monitor patients adversely affected by alterations in platelet function eg, coagulation disorders or receiving anticoagulants. Not recommended for use w/ other NSAIDs. Not to be used w/ multiple diclofenac-containing prep (including diclofenac K). Not a substitute for corticosteroids & do not treat corticosteroid insufficiency. May affect ability to drive or operate machinery. Advanced renal disease. Elderly ≥65 yr. Frail or debilitated patients.
Adverse Reactions
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.
Drug Interactions
May delay absorption w/ Al & Mg hydroxide antacids. Increased risk of renal impairment & hyperkalemia w/ ACE inhibitors (eg, captopril, fosinopril, imidapril, enalapril) & AIIA (eg, losartan, telmisartan). Antagonize the effect of ACE inhibitors & AIIA. Increased risk of GI sides effects including ulceration or hemorrhage w/ alcohol. Increased adverse effects w/ aspirin or other NSAIDs. May exacerbate cardiac failure, reduce GFR & increase plasma levels of cardiac glycosides (eg, digoxin). Increased risk of nephrotoxicity & hyperkalemia w/ ciclosporin & tacrolimus. May induce delay of decrease in absorption w/ colestipol & cholestyramine. Increased risk of GI bleeding & ulceration w/ corticosteroids. May enhance exposure & toxicity w/ CYP2C9 inhibitors (eg, voriconazole). May lead to compromised efficacy w/ CYP2C9 inducers (eg, rifampicin). Increased risk of nephrotoxicity & antagonism of effect of diuretics (eg, thiazides, furosemide). Reduced excretion of lithium & methotrexate. Increased risk of adverse renal effects w/ paracetamol. Increased exposure to phenytoin. Increased risk of hyperkalemia w/ K-sparing diuretics & aldosterone antagonist; trimethoprim. Increased risk of convulsions w/ quinolones. Increased risk of GI bleeding w/ SSRIs (eg, fluoxetine, citalopram, sertraline); warfarin. Increased risk of hematological toxicity w/ zidovudine.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Form
Neo-Pyrazon tab 50 mg
Packing/Price
100's
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