Trade Name: DEXIBU TABLET 200 MG
Generic Name: Dexibuprofen

Presentation

Dexibu-200 : Each film coated tablet contains Dexibuprofen INN 200 mg.
Dexibu-300 : Each film coated tablet contains Dexibuprofen INN 300 mg.
Dexibu-400 : Each film coated tablet contains Dexibuprofen INN 400 mg.

Indications

Dexibu is indicated in the treatment of mild to moderate pain and inflammation in conditions such as dysmenorrhoea, headache, postoperative pain, dental pain, sprains and soft-tissue rheumatism. Dexibu is used in musculoskeletal and joint disorders such as ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis. It may be used as an antipyretic to reduce fever.

Dosage and administration

The dosage should be adjusted to the severity of the disorder and the complaints of the patient. During chronic administration, the dosage should be adjusted to the lowest maintenance dose that provides adequate control of symptoms.

The recommended dosage is 600 to 900 mg Dexibuprofen daily, divided in up to three single doses. For the treatment of mild to moderate pain, initially single doses of 200 mg Dexibuprofen and daily doses of 600 mg Dexibuprofen are recommended. The maximum single dose is 400 mg Dexibuprofen. The maximum daily dose is 1200 mg. For dysmenorrhoea a daily dose of 600 to 900 mg Dexibuprofen, divided in up to three single doses, is recommended. The maximum single dose is 300 mg; the maximum daily dose is 900 mg.

Dexibuprofen has not been studied in children and adolescents (< 18 years), safety and efficacy have not been established and therefore it is not recommended in these age groups. In elderly patients the lowest effective dose is recommended. The dosage may be increased to that recommended for general population only after good general tolerance has been ascertained.

Hepatic dysfunction: Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses and be closely monitored. Dexibuprofen should not be used in patients with severe hepatic dysfunction.

Renal dysfunction: The initial dosage should be reduced in patients with mild to moderate impaired renal function. Dexibuprofen should not be used in patients with severe renal dysfunction.

Contraindications

Dexibuprofen is contraindicated in patients previously sensitive to Dexibuprofen, to any other NSAID or to any of the excipients of the product or in patients in whom substances with a similar action (e.g. aspirin or other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema. It is also contraindicated in patients wilh active or suspected gastrointestinal ulcer or history of recurrent gastrointestinal ulcer, active Crohn's disease or active ulcerative colitis, patients with severe heart failure or severe renal dysfunction (GFR < 30 mVmin) and severely impaired hepatic function.

Precautions

Care is recommended in conditions that predispose patients to the gastrointestinal adverse effects of NSAIDs, including existing gastrointestinal disorders, previous gastric or duodenal ulcer, ulcerative cofitis, Crohn's disease. In the rare instances where gastrointestinal bleeding or ulceration occurs In patients receiving Dexibuprofen, treatment should be' immediately discontinued. As with other NSAtOs, allergic reactions, including anaphylactic/anaphyfactoid reactions can also occur without earlier exposure to the drug. In the treatment 01 patients with heart failure, hypertension, renal or hepatic disease, especially during concomitant diuretic treatment, the risk of fluid retention and deterioration in renal function must be taken into account. If used in these patients, the dose of Dexibuprofen should bi! kept as low as possible and renal function should be regularly monitored. Dexibuprofen should only be given wilh care to 'patients with systemic ltipus erythematosus and mixed connective tissue disease, because such patients may be predisposed to NSAID-induced CNS and renal side effects. Caution is required in patients suffering from or with a previous history of bronchial asthma since NSAIDs can cause bronchospasm in such patients.

Side effects

Clinical experience has shown that the risk of undesirable effects induced by Dexibuprofen is comparable to that of racemic ibuprofen. The most common adverse events are gastrointestinal in nature. Common side effects I9ported are dyspepsia, diarrhoea, nausea, vomiting, abdominal pain, rash, fatigue or drowsiness, headache, dizziness, vertigo. It should be noted that the adverse events those reported predominantly for racemic ibuprofen, even though in some cases the adverse event has either not yet been observed with Dexibuprofen or has not yet been reported in the frequency mentioned.

Drug Interactions

Drug interactions of Dexibuprofen are similar to that of racemic Ibuprofen. In general, NSAIDs should be used with caution with other drugs that can increase the risk of gastrointestinal ulceration or gastrointestinal bleeding or renal impairment. Concomitant use with anticoagulants, Methotrexate used at doses of 15 mgiweek or more, Lithium, other NSAIDs and salicylates are not recommended. Caution should be taken in to account while using with acetylsalicylic acid, antihypertensives (Beta-blockers, ACE inhibitors or Angiotensin-II receptor antagonists), Ciclosporin, Tacrolimus, Corticosteroids, Digoxin, Methotrexate used at doses lower than 15 mgiweek, thiazides, thiazide-related substances, loop diuretics and potassium-sparing diuretics. Caution is required when Dexibuprofen is combined with thrombolytics, Ticlopidine and other anti platelet agents, because of the risk of increased antiplatelet effect.

Use In pregnancy and lactation

For Dexibuprofen, no clinical data on exposed pregnancies are available. Dexibuprofen, like other drugs of this class, should only be administered in the first 5 months of pregnancy if clearly needed, in the lowest effective dose and as short as possible. From the beginning of the 6th month of pregnancy onward Dexibuprofen is contraindicated. Ibuprofen is slightly excreted in human milk. Breast-feeding is possible with Dexibuprofen if dosage is low and the treatment period is short.

Commercial pack

Dexibu - 200 : Each box contains 6 alu-alu strips of 7 film coated tablets.
Dexibu - 300 : Each box contains 5 alu-alu strips of 7 film coated tablets.
Dexibu - 400 : Each box contains 4 alu-alu strips of 7 film coated tablets.