KANA-SULIDE
Tablets

Analgesics - Non-steroidal anti-inflammatory drugs

  • Chemical Composition

    Nimesulide 100 mg

  • Packing

    20Tablets

  • Medical Id

    T107

  • License Number

    151/2015

  • License date

    9/6/2015

Excipients Maize starch ‚ Lactose monohydrate ‚ Croscarmelose sodium ‚ Magnesium stearate ‚ Polysorbate ‚ Colloidal Silicon dioxide ‚ Povidone
Mechanism Of Action Nimesulide is well absorbed when given by mouth,peak plasma levels reached after 2-3 hr,it is extensively metabolized by the liver and excreted mainly in the urine
INDICATIONS It is used as second line treatment for • Treatment of acute pain • Primary dysmenorrhea
CONTRAINDICATIONS • For painful osteoarthritisConditions • Known hypersensitivity to nimesulide or to any of the excipients of the products. • History of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. • History of hepatotoxic reactions to nimesulide • Concomitant exposure to other potentially hepatotoxic substances. • Alcoholism, drug addiction. • Active gastric or duodenal ulcer, a history of recurrent ulceration or gastrointestinal bleeding. • Cerebrovascular bleeding or other active bleeding or bleeding disorders. • Severe coagulation disorders. • Severe heart failure • Severe renal impairment. • Hepatic impairment. • Patients with fever and/or flu-like symptoms. • Children under 12 years. • The third trimester of pregnancy and breastfeeding • The maximum duration of use is 15 days because of hepatitis and jaundice conditions occurring.
Side EFFECTS • Common: diarrhea, nausea, vomiting, hepatic enzymes increased. • Uncommon :Dizziness, hypertension ,dyspnea , ,constipation , flatulence , gastritis ,pruritus , rash , sweating increased , edema.
WARNINGS • The risk of undesirable effects may be reduced by using Nimesulide for the shortest possible duration. • Treatment should be discontinued if no benefit is seen. • Patients receiving nimesulide who develop fever and/or flu-like symptoms should discontinue treatment. • Simultaneous use of different NSAIDs is not recommended • If gastrointestinal bleeding or ulceration occurs, nimesulide should be discontinued. Nimesulide should be used with caution in patients with gastrointestinal disorders, including history of peptic ulceration, history of gastrointestinal haemorrhage, ulcerative colitis or Crohn’s disease • In patients with renal or cardiac impairment, caution is required since the use of Nimesulide may result in deterioration of renal function. In the event of deterioration, the treatment should be discontinued • Elderly patients are particularly susceptible to the adverse effects of NSAIDs; therefore, appropriate clinical monitoring is advisable. • Nimesulide can interfere with platelet function; it should be used with caution in patients with bleeding diathesis. • The use of Nimesulide may impair female fertility and its use is not recommended in women attempting to conceive.
DRUG INTERACTIONS • Patients receiving warfarin or similar anticoagulants agent or aspirin have an increased risk of bleeding complications , when treated with nimesulide , therefor this combinations is not recommended and it is contraindicated in patients with severe coagulation disorders. • Co-administrations of furosemide and nimesulide results in a decrease of the AUC and cumulative excretion of furosemide without affecting its renal clearance , the concomitant use requires caution in susceptible renal or cardiac patients. • NSAID have been reported to reduce the clearance of lithium resulting in elevate plasma levels and lithium toxicity, if the combination is required together the lithium levels should be monitored closely. • Nimesulide inhibits CYP2C9,therefore, the plasma concentrations of drugs that are substrate of this enzyme may be increased when nimesulide are used concomitantly. • Caution is required if nimesulide is used less that 24 hrs before or after treatment with methotrexate because the serum levels of methotrexate might increase and therefor the toxicityof this drug might increase. • prostaglandins synthetase inhibitors like nimesulide may increase the nephrotoxicity of cyclosporine.
Pregnancy And lactations • The use is contraindicated in the third trimester of pregnancy, like other NSAID nimesulide is not recommended in women attempting to conceive. The potential risk is unknown for prescribing the drug during the first two trimesters of pregnancy and it is not recommended. • It is not known if nimesulide is excreted in breast milk, and it is use during lactation is contraindicated
Dosage And Administration Tablets: 100 mg bid after meal .
OVERDOSE Symptoms following overdose are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain which are generally reversible with supportive care. Patients should be managed by symptomatic and supportive care following an NSAID overdose, there are no specific antidote ,emesis or activated charcoal are indicated in patients seen within 4 hr of ingestion with symptoms or following a large overdose .
Storage Conditions Keep below 25º C Keep out of reach of children