Dexifen 300 Tablet
Dexibuprofen
300mg
Beximco Pharmaceuticals Ltd.
| Pack size | 100's pack |
|---|---|
| Retail Price | 4.00 |
Indications
Osteoarthritis, Rheumatoid arthritis, Pain and inflammation, Mild to moderate pain, Musculoskeletal pain, Dysmenorrhea, Headache, Toothache
Adult Dose
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 Dose
Renal impairment: Dose reduction is recommended.
Hepatic Dose
Hepatic impairment: Dose reduction is recommended.
Administration
Can be taken with or without a meal
Contra Indications
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).
Precautions
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 medici
Pregnancy-Lactation
Not Classi
Interactions
Avoid concomitant use with anticoagulants, other NSAIDs and salicylates.
Increases risk of methotrexate and lithium toxicity.
Adverse Effects
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 d
Mechanism of Action
Dexibuprofen is a NSAID. It acts by inhibition of cyclo-oxygenase, which is involved in prostaglandin synthesis.
Note
Dexifen 300 300mg Tablet manufactured by Beximco Pharmaceuticals Ltd.. Its generic name is Dexibuprofen.