Analgesic, nonopioid; nonsteroidal anti-inflammatory drug (NSAID), used in the treatment of pain, ankylosing spondylitis, dysmenorrhea, gout, migraine, osteoarthritis and rheumatoid arthritis.

Indication & Usage
-Ankylosing spondylitis Diclofenac potassium or sodium formulations: 100 to 150 mg/day in divided doses. -Dysmenorrhea: Oral: Diclofenac potassium or sodium formulations: 150 mg/day in divided doses -Gout: Diclofenac potassium or sodium formulations: 100 to 150 mg/day in divided doses -Migraine, acute treatment: For use as monotherapy in mild to moderate attacks not associated with vomiting or severe nausea; may be used in combination with triptans for severe migraine, oral: 50 to 100 mg as a single dose -Osteoarthritis: Oral: Diclofenac potassium or sodium formulations: 100 to 150 mg/day in divided doses, Rectal: Insert 50 mg or 100 mg suppository as a single dose. -Pain, acute (monotherapy or as adjunctive agent):Oral: Diclofenac potassium or sodium formulations: 100 to 150 mg/day in divided doses as needed or scheduled. -Rheumatoid arthritis: Oral: Diclofenac potassium or sodium formulations: 100 mg/day in divided doses, rectal: Insert 50 mg or 100 mg suppository as a single dose. -Children dose: Pain, acute (mild to moderate): Children ≥12 years and Adolescents: Oral: 25 mg 4 times daily. Osteoarthritis: Limited data available: Adolescents ≥16 years: Suppository (50 mg or 100 mg).Postoperative pain: Limited data available: Rectal suppository (12.5, 25, or 50 mg): Children and Adolescents: Suppository (12.5 mg, 25 mg, or 50 mg)

Active Ingredients
Diclofenac Sodium

Dosage & Administration
U-Do not crush delayed-release or ER tablets. May administer IR formulations with food or milk to avoid gastric distress. – Suppository : Remove plastic film prior to insertion; insert well into the rectum; for best results, bowels should be empty prior to insertion.

Side Effects
-Common: Edema, nausea , hypertension, diaphoresis , pruritus , skin rash, abdominal pain, constipation , diarrhea , duodenal ulcer, dyspepsia , flatulence , gastric ulcer, gastrointestinal hemorrhage, gastrointestinal perforation, heartburn, upper abdominal pain , vomiting, Increased liver enzymes, increased serum alanine aminotransferase , increased serum aspartate aminotransferase, dizziness , drowsiness , headache, back pain, musculoskeletal pain, tinnitus, increased serum creatinine ,renal function abnormality, sinusitis. -Less common: Acute myocardial infarction, cardiac arrhythmia, cardiac failure, flushing, hypotension, palpitations, syncope, tachycardia, vasculitis, alopecia, ecchymoses, erythema multiforme, exfoliative dermatitis, skin photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, hyperglycemia, weight changes, change in appetite, colitis, eructation, esophagitis, gastritis, glossitis, hematemesis, melena, pancreatitis, peptic ulcer, stomatitis, xerostomia, cystitis, dysuria, hematuria, oliguria, proteinuria, agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia, leukopenia, lymphadenopathy, pancytopenia, purpuric disease, rectal hemorrhage, thrombocytopenia, fulminant hepatitis, hepatic failure.

Safety Advice
-Should not be taken by patients suffering from hypersensitivity to diclofenac (eg, anaphylactoid reactions, serious skin reactions) ; should not be given to patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs. -NSAIDs cause an increased risk of serious gastrointestinal inflammation, ulceration, bleeding, and perforation (may be fatal); elderly patients and patients with history of peptic ulcer disease and/or GI bleeding are at greater risk for serious gastrointestinal events. These events may occur at any time during therapy. – Platelet adhesion and aggregation may be decreased; may prolong bleeding time. -NSAID use may increase the risk of hyperkalemia, particularly in the elderly, diabetics, renal disease, and with concomitant use of other agents capable of inducing hyperkalemia (eg, ACE inhibitors). -Use the lowest effective dose for the shortest duration. Avoid or use with caution in patients at risk for cardiovascular disease, GI disease, kidney impairment, chronic liver disease. -In case of kidney diseases: creatinine clearance ≥60 mL/minute: No dosage adjustment necessary. creatinine clearance >30 to <60 mL/minute: No dosage adjustment necessary, however, use of analgesics other than nonsteroidal anti-inflammatory drugs may be preferred. creatinine clearance ≤30 mL/minute: Avoid use due to increased risk of acute kidney injury. -NSAIDs cause an increased risk of serious (and potentially fatal) adverse cardiovascular thrombotic events, including myocardial infarction and stroke. Risk may occur early during treatment and may increase with duration of use. -Incase of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.

Storage
Store at room temperature.