FELDENE ® Piroxicam

FELDENE ® is a Piroxicam based drug

THERAPEUTIC GROUP: Non-steroidal anti-inflammatory and antirheumatic drugs

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications FELDENE ® Piroxicam

FELDENE ® is used in the symptomatic therapy of inflammatory states associated with rheumatic diseases such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

In light of the Piroxicam safety profile, FELDENE ® should be used only after a careful evaluation of the cost / benefit ratio.

Mechanism of action FELDENE ® Piroxicam

FELDENE ®, a drug useful in the treatment of inflammatory pain characteristic of rheumatic diseases such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis, presents as an active ingredient Piroxicam, a molecule belonging to the class of benzothiazine heterocyclic carboxyamids and progenitor of the most famous category of oxicams.

Taken orally or rectally, it is absorbed by the intestinal mucosa reaching the maximum plasma peak after about 8 hours, and persisting in circulation for over 24 hours.

Linked to plasma proteins, it is distributed in the circulation, concentrating mainly at the level of synovies and joints, where it massively performs its therapeutic potential.

Especially in these locations, in fact, Piroxicam is able to reversibly bind cyclooxygenases 2, reducing the production of chemical mediators known as prostaglandins, involved in the recruitment of inflammatory cells, in lowering the pain threshold and in the genesis of the pyrogenic stimulus.

Different studies also show how this active ingredient can also perform an antioxidant and histoprotective action, protecting the tissues both from oxidative damage induced by hydrogen peroxide and by inhibiting the activity of different proteases involved in tissue lesions.

After its biological activity, Piroxicam is metabolised in the liver and eliminated in the form of inactive glucoronate catabolites, mainly through the urine.

Studies carried out and clinical efficacy

1. THE PIROXICAM IN DENTISTRY

Angle Orthod. 2011 Nov; 81 (6): 1097-102. Epub 2011 Jun 6.

Piroxicam's preventive administration of 20 mg has been shown to be effective in this study in significantly reducing pain associated with orthodontic therapies. This active ingredient has also proved more effective than ibuprofen.

2. THE PIROXICAM IN THE PROTECTION OF DAMAGE FROM ischemia / REPERFUSION

Transpl Int. 2011 May; 24 (5): 489-500.

Very interesting experimental study that demonstrates how the administration of Piroxicam can protect the endothelial structures from the damage induced by ischemia-reperfusion.

This ability could be traced to the antioxidant role of Piroxicam.

3. THE SIDE EFFECTS OF PIROXICAM

Prescrire Int. 2008 Oct; 17 (97): 193.

Complaint study that draws the attention of international public health agencies to the numerous gastrointestinal and dermatological side effects of Piroxicam, to which at present no type of provision has yet been taken.

Method of use and dosage

FELDENE ®

Piroxicam 20 mg hard capsules;

Soluble 20 mg tablets of Piroxicam;

20 mg suppositories of Piroxicam.

Intramuscular 20 mg of Piroxicam vials per ml of solution.

Piroxicam therapy, in light of its side effects, should be supervised by a doctor experienced in the treatment of rheumatic diseases, who should define the effective dosage based on the physio-pathological characteristics of the patient, the severity of his / her clinical picture and the therapeutic goals to be achieved.

Given the half-life of the active ingredient, the daily mono-administration of this drug should be able to guarantee coverage for all 24 hours.

In order to reduce the incidence of possible side effects, it would be advisable to limit the intake of FELDENE ® for the shortest possible time and to the minimum effective dose.

Warnings FELDENE ® Piroxicam

In order to limit the appearance of side effects and to maintain high therapeutic efficacy, it would be advisable to start therapy with the minimum effective dose, reducing the therapy to the shortest possible period.

The entire therapeutic procedure should be supervised by your doctor so that the latter can assess the safety and efficacy of the therapy in progress.

Particular attention should be paid to patients receiving FELDENE ® and at the same time suffering from liver, kidney, gastrointestinal and cardiovascular diseases, given their greater susceptibility to these side effects.

Given the allergic power of Piroxicam, it would also be advisable to constantly supervise patients suffering from allergic and dermatological diseases, thus avoiding the appearance of serious consequences, even if rare, such as necrotic epidermolysis.

FELDENE ® in tablets contains lactose, therefore it is not recommended to take it in patients with galactose intolerance, lactase enzyme deficiency or glucose-galactose malabsorption syndrome.

PREGNANCY AND BREASTFEEDING

Given the importance of prostaglandins in correctly guiding the differentiation and proliferative process of the embryo first and of the fetus later, and the ability of Piroxicam to inhibit the synthesis of these mediators, it is clear that therapy with FELDENE ® is contraindicated during the period of pregnancy.

The most serious side effects associated with the use of NSAIDs during gestation led to the appearance of birth defects of the cardiovascular, urinary and respiratory system, unwanted abortions and complications in the mother at the time of delivery.

These contraindications have also been extended to the subsequent breastfeeding period, given Piroxicam's tendency to accumulate in breast milk.

Interactions

The patient receiving FELDENE ® should pay particular attention to the simultaneous intake of active ingredients capable of altering the pharmacokinetic and pharmacodynamic characteristics of Piroxicam as well as its therapeutic capacity and its safety profile.

Among the various active ingredients, those to pay more attention to are:

Alcohol, oral anticoagulants and selective serotonin reuptake inhibitors due to increased risk of bleeding;
Diuretics, ACE inhibitors, angiotensin II antagonists, methotrexate and ciclosporin, given the ability to increase the nephrotoxicity of Piroxicam;
Active ingredients capable of altering gastric motility, activated carbon and cimetidine capable of varying the systemic absorption profile of Piroxicam, altering both its therapeutic properties and its safety profile;
Antibiotics and substrates of cytochromial enzymes, capable of altering the pharmacokinetic profile of Piroxicam, enhancing the potential side effects;
NSAIDs, opioids and corticosteroids given the increased analgesic effect of their interaction;
Lithium, due to the increased concentration of this drug with a significant increase in its toxicity.

Contraindications FELDENE ® Piroxicam

The use of FELDENE ® is contraindicated in case of hypersensitivity to the active ingredient or to one of its excipients, hepatic and renal insufficiency, gastric ulcers and gastrointestinal pathologies, severe heart failure and contextual use of anticoagulants or other non-steroidal anti-inflammatory drugs.

Undesirable effects - Side effects

Piroxicam therapy has been the focus of numerous debates among the various international agencies given the high incidence of adverse reactions, especially at the gastrointestinal level, related to the intake of this active ingredient which significantly reduces possible therapeutic applications.

More precisely, the numerous clinical trials present in the literature and an equally detailed post-marketing monitoring have associated the appearance of:

Gastrointestinal reactions such as nausea, vomiting, diarrhea, flatulence, melena, hematemesis, bleeding, enteropathy, gastritis and peptic ulcers;
Fortunately rare metabolic reactions such as hyperkalemia, hypoglycemia and hyperglycemia;
Jaundice, hepatitis and increase in transaminases;
Haematological reactions such as hematocrit reduction, anemia, leukopenia, thrombocytopenia;
Side effects at central level with drowsiness, headache, dizziness, depression, nervousness and insomnia;
Hypertension, angina and associated cardiovascular diseases;
Dermatological hypersensitivity reactions such as eczema, hives, itching, rashes and in the most serious cases but fortunately very rare toxic epidermal necrolysis.