Apo-Diclo

Apo-Diclo

diclofenac

Manufacturer:

Apotex

Distributor:

Pharmaforte
Concise Prescribing Info
Contents
Diclofenac Na
Indications/Uses
Symptomatic treatment of RA & OA including degenerative joint disease of the hip.
Dosage/Direction for Use
RA Initially 75-150 mg/day in 3 or 4 doses. Maintenance: 75-100 mg/day in 3 divided doses. OA 75 mg/day in 3 divided doses. Max daily dose: 150 mg.
Contraindications
Hypersensitivity to diclofenac Na, aspirin or other NSAIDs. Active or recent history of GI inflammation (eg, peptic ulcer, gastritis, regional enteritis or ulcerative colitis). High doses for >4 wk in patients w/ established CV disease (CHF, established ischemic heart disease, peripheral arterial disease) or uncontrolled HTN.
Special Precautions
Peptic ulceration, perforation & GI bleeding. Patients prone to GI irritation. Small increased risk of serious CV thrombotic events (including MI & stroke) particularly at high dose & long-term treatment. Patients w/ impaired renal function, heart failure, liver dysfunction, those taking diuretics. Periodical monitoring of kidney function during long-term therapy. Avoid use during late pregnancy. Not recommended for use during lactation. Elderly, frail & debilitated patients.
Adverse Reactions
Epigastric or abdominal discomfort, pressure, heaviness, or distention, nausea, anorexia, diarrhea, vomiting, flatulence, constipation or eructation, gastric & duodenal ulcerations & bleeding, hyperacidity, stomatitis, coated tongue, peptic ulcer w/ perforation, lower gut disorders (eg, nonspecific hemorrhagic colitis & exacerbation of ulcerative colitis); dizziness, headache, malaise, insomnia, drowsiness, impaired concentration & vision, tiredness, irritability, sweating, vertigo, disturbances of sensation, tinnitus, convulsions; rash, pruritus, skin eruption, eczema, urticaria, erythema. In isolated cases: Photosensitivity reactions [loss of hair, erythema multiforme & variants (Stevens-Johnson syndrome, Lyell syndrome).
Drug Interactions
Reduced bioavailability of acetylsalicylic acid. Elevated serum levels of digoxin, methotrexate, K-sparing diuretics & lithium. Caution w/ concurrent use w/ anticoagulants. May inhibit the activity of diuretics. May aggravate GI side effects w/ glucocorticoids.
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
Apo-Diclo tab 25 mg
Packing/Price
100's
Form
Apo-Diclo tab 50 mg
Packing/Price
500's
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