ZANAC
Diclofenac Potassium Tablets 50mg
COMPOSITION
Each uncoated tablet contains:
Diclofenac Potassium BP 50mg
Excipients Q.S.
Colour: Brilliant Blue FCF, Erythrosine, Sunset yellow FCF
NOT FOR VETERINARY USE
INDICATION
For treatment of primary dysmenorrhoeal, for relief of mild to moderate pain, for relief of the signs and symptoms of osteoarthritis, & for relief of the signs and symptoms of rheumatoid arthritis.
DOSAGE AND ADMINISTRATION
For treatment of pain or primary dysmenorrhoea the recommended dosage is 50 mg t.i.d. with experience, physicians may find that in some patients an initial dose of 100 mg of Diclofenac Potassium Tablets, followed by 50 mg doses, will provide better relief for the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses, 50 mg b.i.d. or t.i.d.
For the relief of rheumatoid arthritis the recommended dosage is 150-200 mg/day in divided doses, 50mg t.i.d. or q.i.d.
CONTRAINDICATION
ZANAC tablets are contraindicated in patients with known hypersensitivity to Diclofenac Potassium. ZANAC tablets should not be given to patients who have experienced asthma, urticaria, or allergic type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal anaphylactic-Iike reactions to NSAIDs have been reported in such patients. ZANAC tablets are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
DRUG INTERACTIONS
Aspirin: When ZANAC tablets are administered with aspirin, its protein binding is reduced.
Methotrexate: Caution should be used when NSAIDs are administered concomitantly with methotrexate.
Cyclosporine: Caution should be used when ZANAC tablets are administered concomitantly with cyclosporine.
ACE-Inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors.
Diuretics: During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy.
Lithium: When NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.
WARNING & PRECAUTION
Cardiovascular Risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. ZANAC tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse effects including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal effects.
PREGNANCY
Teratogenic effects: ZANAC tablets should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Nonteratogenic Effects: Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided.
NURSING MOTHERS
The potential for serious adverse reactions in nursing infants from ZANAC tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
PEDIATRIC USE
Safety and effectiveness in pediatric patients have not been established.
GERIATRIC USE
As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).
ADVERSE REACTIONS
Body as a Whole: fever, infection, sepsis
Cardiovascular System: congestive heart failure, hypertension, tachycardia, syncope.
Digestive System: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice.
Hemic and Lymphatic System: ecchymosis, eosinophilia, Ieukopenia, meIena, purpura, rectal bleeding, stomatitis, thrombocytopenia.
Metabolic and Nutritional: weight changes
Nervous System: anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo
Respiratory System: asthma, dyspnea
Skin and Appendages: alopecia, photosensitivity, sweating increased
Special Senses: blurred vision
Urogenital System: cystitis, dysuria, hematuria, Interstitial nephritis, oliguria/polyuria, proteinuria, renal failure
Other adverse reactions, which occur rarely are:
Body as a Whole: anaphylactic reactions, appetite changes, death
Cardiovascular System: arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis
Digestive System: colitis, eructation, liver failure, pancreatitis
Hemic and Lymphatic System: agranulocytosis, hemolytic anaemia, oplastic anaemia, lymphadenopathy, pancytopenia
Metabolic and Nutritional: hyperglycemia
Nervous System: convulsions, coma, hallucinations, meningitis
Respiratory System: respiratory depression, pneumonia
Skin and Appendages: angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria
Special Senses: conjunctivitis, hearing impairment.
OVERDOSAGE
Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
Patients should be managed by symptomatic and supportive core following on NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
STORAGE
Store in a cool & dry place. Protect from light.
KEEP MEDICINE OUT OF REACH OF CHILDREN
PRESENTATION
Available in a 1 x 10 & 1 x 12 Tablets in a blister pack.
NAFDAC Reg. No.: A4-9736
Imported by
ZADIP PHARMA NIG. LTD.
48B, Town Planning Way, llupeju, Lagos.
Exported by
NEST LIFESCIENCE Pvt. Ltd.
nestlifescience@yahoo.in
Manufactured by
Comed Chemicals Limited
359, Rania, Taluka-Sovil, District-Boroda, Gujarat, India.
