Dexifen 400 Tablet

Dexifen 400 Tablet is used for: Osteoarthritis, Rheumatoid arthritis, Pain and inflammation, Mild to moderate pain, Musculoskeletal pain, Dysmenorrhea, Headache, Toothache

Oral Pain and inflammation associated with musculoskeletal and joint disorders; Dysmenorrhoea Adult: 600-900 mg daily in 2-3 divided doses. May increase to 1200 mg daily for patients with acute conditions or exacerbations. Max Dosage: 400 mg/dose and 1200 mg/day.

Renal impairment: Dose reduction is recommended.

Can be taken with or without a meal

Hypersensitivity to aspirin or NSAIDs; active or suspected GI ulcer or history of recurrent GI ulcer; GI bleeding or other active bleedings or bleeding disorders; active Crohn's disease or ulcerative colitis; haemorrhagic diasthesis and other coagulation disorders, or patients receiving anticoagulant therapy; severe heart failure, renal or hepatic impairment; child <18 yrs; pregnancy (third trimester).

Gastrointestinal bleeding, ulceration and perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID dose, in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation, alcoholism and in the elderly. Caution is advised in patients with bronchial asthma (acute or in the past), seasonal allergic rhinitis, nasal congestion (e.g. nasal polyps), chronic obstructive pulmonary disease or chronic respiratory infections, since NSAIDs may induce bronchospasm in these patients. Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed very rarely. Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with dexibuprofen after careful consideration and high doses (1200 mg/day) should be avoided. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking particularly when high doses of dexibuprofen (1200 mg/day) are required. Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose. Caution is required in patients suffering hepatic and renal disease; in hypertensive patients, in the elderly or in patients taking concomitant diuretics or other medicinal products affecting renal function; the risk of fluid retention, oedema and a deterioration in renal function must be taken into account. If used in these patients, the dose of dexibuprofen should be kept as low as possible and renal function should be regularly monitored. In patients with dehydration in the extracellular space from any cause, e.g. during the peri- or post-operative phases of major surgical interventions, appropriate caution is required when using NSAIDs because of possible bleeding, electrolyte and volume complications. Monitoring of renal function is recommended as a precautionary measure in these cases. As with all NSAIDs, dexibuprofen can increase plasma levels of urea and creatinine. As with other NSAIDs, dexibuprofen can be associated with adverse effects on the renal system, which can lead to glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure. As with other NSAIDs, dexibuprofen can cause transient small increases in some liver parameters, and also significant increases in SGOT and SGPT. In case of a relevant increase in such parameters, therapy must be discontinued. In common with other NSAIDs dexibuprofen may reversibly inhibit platelet aggregation and function and prolong bleeding time. Caution should be exercised in patients with haemorrhagic diathesis and other coagulation disorders and when dexibuprofen is given concurrently with oral anticoagulants. Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Steven-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in association with the use of dexibuprofen.

Avoid concomitant use with anticoagulants, other NSAIDs and salicylates. Increases risk of methotrexate and lithium toxicity.

Side effects of Dexibuprofen : Infections and infestation Very rare: Infection related inflammation may be aggravated (necrotising fasciitis). Blood and lymphatic system disorders Bleeding time could be prolonged. Rare: Cases of blood disorders including thrombocytopenia, leukopenia, granulocytopenia, pancytopenia, agranulocytosis, aplastic anaemia or haemolytic anaemia. Immune system disorders Uncommon: Purpura (including allergic purpura), angioedema. Rare: Anaphylactic reaction. Very rare: Generalized hypersensitivity reactions, including symptoms like fever with rash, abdominal pain, headache, nausea and vomiting, signs of liver injury, even aseptic meningitis. In the majority of cases in which aseptic meningitis has been reported with ibuprofen, some form of underlying auto-immune disease (such as systemic lupus erythematosus or other collagen diseases) was present as a risk factor. In the case of a severe generalized hypersensitivity reaction swelling of face, tongue and larynx, bronchospasm, asthma, tachycardia, hypotension and shock can occur. Psychiatric disorders Uncommon: Anxiety. Rare: Psychotic reaction, depression, irritability. Nervous system disorders Common: Drowsiness, headache, dizziness, vertigo. Uncommon: Insomnia, restlessness. Rare: Disorientation, confusion, agitation. Very rare: Aseptic meningitis (see immune system disorders). Eye disorders Uncommon: Visual disturbances. Rare: Reversible toxic amblyopia. Ear and labyrinth disorders Uncommon: Tinnitus. Rare: Impaired hearing. Cardiac Disorders Not known: Kounis syndrome Heart and vascular diseases Oedema, hypertension, and cardiac failure have been reported in association with NSAID treatment. Gastrointestinal disorders Very common: Dyspepsia, abdominal pain. Common: Diarrhoea, nausea, vomiting. Uncommon: Gastrointestinal ulcers and bleeding, gastritis, ulcerative stomatitis, melaena. Rare: Gastrointestinal perforation, flatulence, constipation, esophagitis, oesophageal strictures, exacerbation of diverticular disease, unspecific haemorrhagic colitis, ulcerative colitis or Crohn's disease. If gastrointestinal blood loss occurs, this may cause anaemia and haematemesis. Skin and subcutaneous tissue disorders Common: Rash. Uncommon: Urticaria, pruritus. Very rare: Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, bullous reactions including Stevens-Johnson-Syndrome, and toxic epidermal necrolysis (Lyell-Syndrome)), systemic lupus erythematosus, alopecia, photosensitivity reactions and allergic vasculitis. Not known: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Acute generalized exanthematous pustulosis (AGEP) Respiratory, thoracic and mediastinal disorders Uncommon: Rhinitis, bronchospasm. Metabolism and Nutrition Disorders Not known: Decreased Appetite, Hypokalaemia* Renal and urinary disorder Very rare: Interstitial nephritis, nephrotic syndrome or Acute renal failure, papillary necrosis Not known: Ureteric colic, dysuria, Renal tubular acidosis* *Renal tubular acidosis and hypokalaemia have been reported in the post-marketing setting typically following prolonged use of the ibuprofen component at higher than recommended doses. Hepatobiliary disorders Rare: Abnormal liver function, hepatitis and jaundice. General disorders Common: Fatigue. Fluid retention: patients with hypertension or renal impairment seem to be predisposed.

Dexibuprofen is a NSAID. It acts by inhibition of cyclo-oxygenase, which is involved in prostaglandin synthesis.

Dexifen 400 400mg Tablet manufactured by Beximco Pharmaceuticals Ltd.. Its generic name is Dexibuprofen. Dexifen 400 is availble in Bangladesh. Farmaco BD drug index information on Dexifen 400 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.