TAUXIB ® Etoricoxib

TAUXIB ® is a drug based on Etoricoxib

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

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

Indications TAUXIB ® Etoricoxib

TAUXIB ® is a drug useful for the symptomatic treatment of painful states on an inflammatory basis present at the joint level in rheumatic diseases such as rheumatoid arthritis, ankylosing spondyloarthritis, osteoarthritis and acute gouty attack.

Numerous studies are also evaluating the pain-relieving efficacy of etoricoxib in post-operative pain.

Mechanism of action TAUXIB ® Etoricoxib

TAUXIB ®, a drug with a strong anti-inflammatory activity, presents as an active ingredient etoricoxib, a molecule synthetically obtained from pyrazoles and included among the selective non-steroidal anti-inflammatory drugs COX2.

Taken orally, in fact, it is absorbed at the gastro-intestinal level reaching the maximum plasma concentration in about 1 hour, and distributed bound to the plasma proteins between the various tissues.

Here it is able to selectively inhibit cyclooxygenases 2, enzymes induced by inflammatory stimuli, involved in the conversion of membrane phospholipids such as arachidonic acid into prostaglandins with pro-inflammatory, edemiginena and algic activity.

Compared to other NSAIDs, etoricoxib instead leaves unchanged the activity of COX1, constitutively expressed in the various tissues, and in particular at the level of the gastro-enteric mucosa, where they intervene in the regulation of gastric acidity, in the production of mucus, in the regulation of renal function and in the control of platelet aggregation and vasoconstriction.

The selective activity of the etoricoxib therefore, allows to modulate the inflammatory process, at the same time safeguard the gastro-enteric mucosa from the damage induced by the non-specific inhibition of prostaglandin synthesis, increasing however the risk of cardiovascular events in predisposed patients.

After its activity, after a half-life of about 22 hours, it is metabolized to the hepatic level and subsequently excreted in the form of catabolites inactive via the kidney.

Studies carried out and clinical efficacy

1. THE EFFECTIVENESS OF ETHORICOXIB IN THE CONTROL OF POST-OPERATIVE PAIN

Cochrane Database Syst Rev. 2012 Apr 18; 4: CD004309.

Single dose oral etoricoxib for acute postoperative pain in adults.

Double-blind clinical trial that reveals how the administration of a single 120 mg dose of etoricoxib can be particularly effective as an analgesic, significantly reducing post-operative pain, even after major surgery.

2. ETHORICOXIB IN RHEUMATIC DISEASES: COST / BENEFIT REPORT

Int J Rheumatol. 2011; 2011: 160326. Epub 2011 Jun 24.

Cost-Effectiveness Evaluation of Etoricoxib versus Celecoxib and Nonselective NSAIDs in the Treatment of Ankylosing Spondylitis in Norway.

Interesting study conducted on the Norwegian population suffering from ankylosing spondylitis which shows that treatment with etoricoxib is more effective and more convenient in terms of costs / benefits than that with celecoxib.

3. ETORICOXIB AND CARDIOVASCULAR RISK

Rheumatology (Oxford). 2009 Apr; 48 (4): 425-32. Epub 2009 Feb 17.

Cardiovascular safety and gastrointestinal tolerability of etoricoxibvs diclofenac in a randomized controlled clinical trial (The MEDAL study).

Long-term study demonstrating that prolonged use of etoricoxib may be associated with a significantly higher cardiovascular risk than that induced by diclofenac, but is more tolerated by the gastro-enteric apparatus.

Method of use and dosage

TAUXIB ®

Coated tablets of 30, 60, 90 and 120 mg of etoricoxib.

The dosing schedule, useful for overcoming the painful inflammatory articular states present during rheumatic diseases, makes use of a very wide therapeutic range of 30 to 120 mg daily of etoricoxib.

The dose to be used should be defined by your doctor based on the patient's overall health, the severity of the clinical picture and the therapeutic goals.

Variations in standard dosages should be considered by the doctor in the case of elderly patients or those with kidney and liver disease.

TAUXIB ® Etoricoxib warnings

The use of TAUXIB ® should be under strict medical supervision, given the nature of the drug and the potential side effects associated with taking etoricoxib.

In order to minimize the incidence and severity of potential side effects it would be advisable to take TAUXIB ® for the shortest possible time and at the minimum effective dose, meaning this treatment as a short-term therapy useful for overcoming acute painful episodes.

Patients suffering from gastro-intestinal, cardiovascular, hepatic and renal diseases should pay particular attention, given the greater susceptibility to develop adverse reactions, to etoricoxib, requiring continuous medical supervision.

The possible appearance of side effects should alarm the patient, who after consulting his doctor could consider suspending the therapy in progress.

TAUXIB ® contains lactose, therefore its use is not recommended in patients with lactose intolerance, lactase enzyme deficiency or glucose-galactose malabsorption syndrome.

Given the ability of etoricoxib to temporarily compromise the patient's alertness and concentration, it would be advisable to avoid driving cars or using machines after taking TAUXIB ®.

PREGNANCY AND BREASTFEEDING

Given the absence of clinical trials able to characterize the safety profile of etoricoxib on fetal health and given the presence in the literature of numerous experimental studies attesting to the potential fetal toxicity of this active ingredient, the intake of TAUXIB ® is contraindicated during pregnancy.

The contraindication also extends to the subsequent period of breastfeeding, given the tendency of etoricoxib to concentrate in breast milk.

Interactions

Also the etoricoxib, active ingredient of TAUXIB ®, is subject to different pharmacological interactions able to modify the pharmacokinetic, pharmacodynamic characteristics and the related safety profile.

For this reason the patient should pay particular attention to the simultaneous assumption of:

Oral anticoagulants, due to possible variations due to normal coagulation processes;
ACE inhibitors, angiotensin II antagonists, cyclosporin and tacrolimus for their ability to enhance the nephrous and hepatotoxic properties of etoricoxib;
Fluconazole and other active ingredients inducers or inhibitors of CYP2C9, given the ability to vary the pharmacokinetic characteristics of etoricoxib.

However, etoricoxib, being a CYP2C9 inhibitor, may vary the pharmacokinetic characteristics of numerous drugs including antidepressants, anticonvulsants and antiepileptics.

Contraindications TAUXIB ® Etoricoxib

The use of TAUXIB ® is contraindicated in case of hypersensitivity to the active ingredient or to one of its excipients, hepatic and renal insufficiency, chronic inflammatory diseases of the intestine, peptic ulcer, congestive heart failure, ischemic heart disease and arteriopathies and vasculopathies both central and peripherals.

Undesirable effects - Side effects

Different clinical trials and careful post-marketing monitoring show that selective COX 2 non-steroidal anti-inflammatory drugs can also be associated with the appearance of numerous side effects.

Dizziness, headache, palpitations, gastrointestinal disorders such as nausea, flatulence and abdominal pain, hepatotoxicity, nephrotoxicity, asthenia and flu-like symptoms, hypertension, visual and hearing disorders, cardiac and vascular pathologies and hypersensitivity reactions, both cutaneous and vascular, represent the main adverse reactions described following the intake of etoricoxib.

However, the incidence and severity of the above reactions is related to the duration of therapy and to the doses of drug used.