Pain, Dysmenorrhea, Rheumatic disorders
Should be taken on an empty stomach. Take 30 min before meals, esp for quick relief of acute pain.
Adult: PO Rheumatic disorders 100-200 mg/day in 2-4 divided doses. Max: 300 mg/day in divided doses. Pain and inflammation 25-50 mg 6-8 hrly. Max: 300 mg/day. Elderly: Initial total daily dose should not exceed 50 mg/day. May increase to the doses recommended for general population only if well tolerated. Hepatic Impairment: Mild to moderate impairment: Reduce initial dose to 50 mg/day. Not to be used in severe hepatic impairment.
Mild renal impairment: Reduce initial dose to 50 mg/day. Not to be used in moderate to severe renal impairment.
Dexketoprofen tablets are not recommended to use in patients who are: - Allergic to this product or any of its components, aspirin or other non-steroidal anti-inflammatory medicines. - Have suffered attacks of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria, angioedema (swollen face, eyes, lips, or tongue, or difficulty in breathing), after taking aspirin or other non-steroidal anti-inflammatory medicines. - Have or have previously suffered from a peptic ulcer or chronic gastro-intestinal disorders. - Have had previously gastro-intestinal haemorrhage (bleeding). - Have suffered from bronchial asthma. - Have severe heart failure, moderate to severe renal dysfunction or severely impaired hepatic function. - Have a bleeding disorder, a blood clotting disorder or taking an anticoagulant. - Pregnant or breast-feeding.
Dexketoprofen exhibits anti-inflammatory, analgesic and antipyretic properties. It potently inhibits the enzyme cyclooxygenase resulting in prostaglandin synthesis inhibition.
The medicine should be used with caution in conditions mentioned below: - Allergic to any other medicines. - Kidney disease, liver disease, heart disease or fluid retention conditions. - Blood disorder, systemic lupus erythematosus or mixed connective tissue disease.
As with all medicines, Dexketoprofen may cause some unwanted effects in some patients. These are described below and are characteristic of non steroidal anti-inflammatory drugs: - Common (1 - 10%): nausea, vomiting, diarrhoea, stomach pain or heartburn. - Uncommon (0.1 - 1%): sleep disorders, nervousness, headache, dizziness,vertigo, palpitations, constipation, dry mouth, flatulence, skin rash, fatigue, hot flushes, shivering, general malaise. - Rare (0.01-0.1%): stomach ulceration, gastric haemorrhage or perforation, pins and needles, high blood pressure, water retention, slowed breathing rate, increased hepatic enzymes, increased sweating. - Very rare / isolated cases (<0.01%): blurred vision, ringing in the ear, low blood pressure, haematological reactions, hepatic or renal damage, dermatological and photosensitivity reactions, bronchospasm or anaphylaxis. - In patients with systemic lupus erythematosus or mixed connective tissue disease, anti-inflammatory medicines may rarely cause isolated cases of fever, headache and rigidity of the nape (back of the neck).
Increased risk of GI ulcers & bleeding (synergistic effect) w/ other NSAIDs. Increased risk of haemorrhagic effect of oral anticoagulants. Increased risk of haemorrhage w/ heparin. Increased blood lithium levels, which may reach toxic values, w/ lithium. Increased haematological toxicity of methotrexate at high dose of ?15 mg/wk. Increased toxic effects of hydantoins & sulphonamides. Increase risk of bleeding & damage of GI mucosal w/ anticoagulant. Increase hypoglycemic effect of sulfonylurea agents.