Zanac Diclofenac Potassium Tablet

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.

zadip.pharma@gmail.com

 

Exported by

NEST LIFESCIENCE Pvt. Ltd.

nestlifescience@yahoo.in
Manufactured by

Comed Chemicals Limited

359, Rania, Taluka-Sovil, District-Boroda, Gujarat, India.