piroxicam beta-cyclodextrin


Platinum Pharma


Full Prescribing Info
Each tablet contains Piroxicam-β-cyclodextrin 20 mg.
Pharmacology: Cyclodex is a new formulation of piroxicam as a complex with β-cyclodextrin in the molar ratio 1: 2.5.
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. Cyclodex 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-inflammatory effect. The long half-life of Cyclodex, which is the same as that of plain piroxicam, allows for just one single daily dose. Due to its pharmacodynamic and pharmacokinetic properties, Cyclodex 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.
Acute painful conditions.
Dosage/Direction for Use
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.
In the event of an overdosage with Cyclodex a supportive and symptomatic therapy should be given.
Piroxicam must not be used in subjects known to be hypersensitive to the drug, nor in subjects with gastroduodenal ulcer, gastritis, dyspepsia, severe hepatic or renal disturbances, severe heart failure, severe hypertension, severe blood alterations or hemorrhagic diathesis. It is possible that cross sensitivity with acetylsalicylic acid or other NSAIDs exist. Therefore, piroxicam must not be administered to patients in whom acetylsalicylic acid or other NSAIDs induce the symptoms of asthma, rhinitis or urticaria. The product is contraindicated in ascertained or suspected pregnancy, during lactation and in children.
Special Precautions
The product 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.
Use In Pregnancy & Lactation
Cyclodex is contraindicated in ascertained or suspected pregnancy and during lactation.
Side Effects
The most commonly found side effects are gastrointestinal disturbances which are not represented by nausea, epigastric distress, constipation and diarrhoea. Other noted side effects: signs of hypersensitivity (skin, rash), headache, vertigo, asthenia, changes in blood chemistry, increase in BUN.
Rare side effects: gastric ulcers with or without hemorrhages, vomiting, allergic oedema of the face and hands, increase of cutaneous photosensitivity, ocular disturbances, aplastic anemia, pancytopenia, thrombocytopenia, increase of liver function parameters, jaundice, acute renal insufficiency, water retention that may occur in the form of oedema (mainly ankle oedema) or cardiocirculatory disturbances (hypertension, congestive heart failure). Sporadic cases of gastric ulcer with perforation, Stevens-Johnson syndrome, Lyell's disease, agranulocytosis, bladder disorders, shock and warning symptoms, acute heart failure, stomatitis, alopecia and nail growth disorders have been associated with the use of piroxicam.
Cyclodex tablet should be store below 25°C in a dry place protect from light.
ATC Classification
M01AC01 - piroxicam ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, oxicams.
Tab 20 mg x 2 x 10's.
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