( piroxicam – ß– cyclodextrin 191.2 mg.)
- Each tablet contains:-
• Active ingredients: Piroxicam – ß – cyclodextrin 191.2 mg ( equivalent to 20 mg Piroxicam ).
• Inactive ingredients: Cross povidone , Sod.starch glycolate , Pregelatinized starch , Colloidal silicon dioxide , Mg stearate ,
Lactose spray dried.
- Piroxicam – ß – cyclodextrin is a NSAID's which act through mechanism of prostaglandin's synthetase inhibition.
- Brexin is a new formulation of piroxicam as a complex with ß – cyclodextrin in the molar ratio 1 : 2.5 , produced by enzymatic hydrolysis of common strach, 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 administration as rapid dissociation of complex and liberation of piroxicam from the complex and reach peak plasma level within 3-5 hours.
- Found that 99% of plasma piroxicam is bound to plasma protiens , and so the long half life of Brexin which reach about 50 hours, that 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.
Treatment of painful conditions and inflammation in rheumatic diseases ( rheumatic arthritis, osteoarthritis , ) and musculoskeletal affections ( tendinitis, brusitis, post traumatic pain ) post operative pain , primary dysmenorrhea .
Dosage and Administration:-
- One 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.
- Hypersensitivity to the component of the product or to chemically strictly related substances.
- The product must not be used in the presence of gastrointestinal ulcer, gastritis, dyspepsia, serious hepatic or renal disease, serious heart failure, severe hypertension, serious hematic impairment or hemorrhgic diathesis.
- Cross sensitivity is possible with acetylasalicylic acid or other NSAIDs. Therefore, the product must not be administered to patients in whom acetylsalicylic acid or other NSAID's cause asthmatic symptoms, rhinitis, nasal polyposis, angioedema or urticaria.
- The product is contraindicated for use in children.
- The most commonly found side effects are gastrointestinal disturbances which includes: nausea, constipation, diarrhea, flatulence, epigastric pain, anorexia. Rare cases of gastric ulcer with or without bleeding or perforation.
- Other reported side effects: signs of hypersensitivity (skin rash), headache, dizziness,somnolence, discomfort , tinnitus, changes in blood parameters,decrease of haemoglobin and haematocrit , increase of BUN.
- Seldom vomiting, allergic oedema of the face and hands, increase of skin photosensitivity, sight disturbances, aplastic and haemolytic anemia, pancytopenia, decrease platelets, Schoenlein-Henoch's purpura, eosinophilia.
- increase of liver function parameters, jaundice with rare cases of fatal hepatitis have been reported, Piroxicam therapy should be discontinoued when clinical signs and symptoms of hepatic disturbances occur.