Composition of Brexin Tablets
Each tablet contains:
Piroxicam-β-Cyclodextrin.............191.2mg
Equivalent to piroxicam (USP).................20mg
Brexin is a new formulation of piroxicam as a complex with β-cyclodextrin in the molar ratio 1: 2.5.
Brexin is Indicated for the treatment of Acute Painful Inflammatory Conditions.
Description
β-cyclodextrin, produced by enzymatic hydrolysis of common starch, has a particular chemical structure that enables it to form inclusion compounds (molecular encapsulation) with various drugs. In this way it is able to improve solubility, stability and bioavailability. Brexin is very soluble in water and has a more rapid and complete absorption than plain piroxicam after oral or rectal administration. The improved solubility leads to a rapid increase in plasma levels and peak value is reached earlier. In clinical terms this means a quicker and more intense analgesic and anti-inflammatoty effect. The long half life of Brexin, which is the same as that of plain piroxicam, allows for just one single daily dose. Due to its pharmacodynamic and pharmacokinetic properties, Brexin is particularly suitable for the treatment of rheumatic and/or inflammatory disorders with painful symptoms that could seriously affect the general conditions and normal activity of patients and where a rapid and intense efficacy is required.
Dosage
Brexin Tablets 1 tablet (equivalent to 20 mg of piroxicam) per day.
In elderly patients it may be necessary to reduce the dosage (half a tablet) and limit the duration of treatment.
Precautions
Brexin must be used under strict medical control in patients with a medical history of disturbances in the upper gastrointestinal tract. Particular caution must be taken in subjects with cardiocirculatory insufficiency, arterial hypertension, reduced hepatic or renal function, previous or current blood alterations, bronchial asthma and elderly patients. Piroxicam may affect concentration and it is therefore not advisable to drive or undertake any activity requiring quick reflex action. As with other drugs having similar activity, piroxicam may increase BUN in some patients; however, BUN does not keep on increasing as the therapy continues, but reaches a steady level which goes back to or towards the norm on discontinuing the treatment. The increase of BUN is not associated with an increase of serum creatinine. Piroxicam, like other NSAIDs, decreases platelet aggregation and prolongs bleeding; this should be remembered when hematological tests are carried out and when patients undergo concomitant treatment with drugs that inhibit platelet aggregation.
