Non-steroidal anti-inflammatory drugs

  • Chemical Composition

    Ibuprofen 400 mg /1C.T.D

  • Packing

    20Coated Tablets

  • Medical Id


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  • License date


Mechanism Of Action : Ibuprofen possesses analgesic and antipyretic activities. Its mode of action, like that of other nonsteroidal anti- inflammatory agents, may be related to prostaglandin synthetase inhibition
INDICATIONS :KANAPROFEN is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis, back pain, sciatica, and toothaches. KANAPROFEN is indicated for relief of mild to moderate pain. KANAPROFEN is also indicated for the treatment of primary dysmenorrhea.KANAPROFEN Oral Suspension is indicated for the relief of fever and minor pains due to the common cold, flu, sore throat, headaches and toothaches
CONTRAINDICATIONS KANAPROFEN tablets are contraindicated in patients with known hypersensitivity to Ibuprofen. KANAPROFEN tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe anaphylactic-like reactions to NSAIDs have been reported in such patients. KANAPROFEN tablets are contraindicated for the treatment of peri-operative pain in the setting of coronaryarterybypassgraft (CABG) surgery, because of increasing incidence of myocardialinfarction and stroke.
Side EFFECTS The most common side effects from ibuprofen are rash, ringing in the ears, headaches, dizziness, drowsiness, abdominal pain, nausea, diarrhea, constipation and heartburn. Ibuprofen may cause ulceration of the stomach or intestine, and the ulcers may bleed. Sometimes, ulceration and bleeding can occur without abdominal pain, and black tarry stools, weakness, and dizziness upon standing (orthostatic hypotension) may be the only signs of a problem. Elderly patients are at greater risk for serious gastrointestinal events. NSAIDs reduce the flow of blood to the kidneys and impair function of the kidneys. The impairment is most likely to occur in patients with preexisting impairment of kidney function or congestive heart failure, and use of NSAIDs in these patients should be done cautiously.
WARNINGS : Clinical trials of several COX-2 selective and nonselective NSAIDs have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke. NSAIDs, including ibuprofen, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Fluid retention and edema have been observed in some patients taking NSAIDs. KANAPROFEN should be used with caution in patients with fluid retention or heart failure. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcerdisease or gastrointestinal bleeding. Other factors that increase the risk of GIbleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Therefore, special care should be taken in treating this population with ibuprofen or the other NSAIDs. To minimize the potentialrisk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Treatment with KANAPROFEN is not recommended in patients with advanced renal disease. If KANAPROFEN therapy must be initiated, close monitoring of the patients renalfunction is advisable. NSAIDs, including ibuprofen, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning.
DRUG INTERACTIONS Aspirin&Other NSAIDS including cyclooxygenase-2 selective inhibitors:Aspirin may increase the risk of adverse reactions. Avoid concomitant use of two or more NSAIDS as this may increase the risk of adverse effects. Ibuprofen should be used with caution in combination with: • Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding. •Antihypertensives and diuretics: since NSAIDs may diminish the effects of these drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter. Diuretics can increase the risk of nephrotoxicity of NSAIDs. • Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin. • Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. • Cardiac glycosides: NSAIDs may exacerbate cardiac failure, and increased plasma glycoside levels. • Lithium. There is evidence for potential increases in plasma levels of lithium. •Methotrexate: There is evidence for the potential increase in plasma levels of methotrexate. •Ciclosporin: Increased risk of nephrotoxicity •Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone. •Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus. •Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. • Quinolone antibiotics: NSAIDs can increase the risk of convulsions associated with quinolone antibiotics.
Pregnancy And lactations : Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. During the first and second trimester of pregnancy, Ibuprofen should not be given unless clearly necessary. If Ibuprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: - cardiopulmonary toxicity (with premature closure of the ductusarteriosus and pulmonary hypertension); - renal dysfunction, which may progress to renal failure with oligohydroamniosis; the mother and the neonate, at the end of the pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, Ibuprofen is contraindicated during the third trimester of pregnancy. Lactation: Ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely.
Dosage And Administration KANAPROFEN film-coated tablets: Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease: Suggested Dosage: 1200 mg-1800 mg daily (400 mg, 600 mg three times daily), this can be increased to 2400 mg (800 mg three times daily), in acute conditions. The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at time of initiating drugtherapy or as the patient responds or fails to respond. Mild to moderate pain: 200-400 mg every 4 to 6 hours as necessary for relief of pain. Dysmenorrhea: For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, KANAPROFEN tablets should be given in a dose of 200- 400 mg every 4 hours as necessary for the relief of pain.
OVERDOSE In cases of acuteoverdosage, the stomach should be emptied by vomiting or lavage. Because the drug is acidic and is excreted in the urine, it is theoretically beneficial to administer alkali and induce diuresis. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption and reabsorption of Ibuprofen.
Storage Conditions “Keep out of reach of children” “Store below 30° C”