XENAR ® Naproxen

XENAR ® is a Naproxen 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 XENAR ® Naproxen

XENAR ® is particularly indicated in the treatment of painful states of the musculoskeletal system commonly associated with inflammatory diseases on a rheumatic basis.

XENAR ® Naproxen action mechanism

XENAR ® is a drug based on Naproxen, the active ingredient included among the non-steroidal anti-inflammatory drugs and more specifically belonging to the chemical category of arylproprionic derivatives.

Its therapeutic efficacy, explained above all by its anti-inflammatory and pain-relieving action, can be traced back to Naprossene's ability to reversibly bind a series of enzymes known as cyclooxygenases, and directly involved, during various damaging events, in the conversion of arachidonic acid into chemical mediators with pro-inflammatory activity such as prostaglandins.

These last molecules, particularly expressed during phlogistic processes, are able to support the genesis of the inflammatory process, exerting a vasopermeabilization, vasodilator, platelet and chemotactic anti-aggregation action, also inducing the production of pain mediators, able to activate peripheral terminations nociceptive, responsible for pain transmission.

It is therefore clear that inhibiting the process, which leads to the production of the aforementioned molecules, can preserve the tissue from histological damage and associated pain.

The therapeutic action is also supported by the excellent pharmacokinetic properties, which allow Naproxen to be rapidly absorbed at the intestinal level, and distributed to the various tissues through binding such as plasma proteins.

After a half-life of about 12 hours and a hepatic metabolism, Naproxen, in the form of inactive catabolites, is eliminated mainly through the urine.

Studies carried out and clinical efficacy

1. NAPROSSENE / LANSOPRAZOLE COTHERAPY IN THE PREVENTION OF INDUCED FANS ULCERS

Am J Med. 2005 Nov; 118 (11): 1271-8.

Comparative study that demonstrates how the use of selective cox-2 inhibitors may be as effective as lansoprazole-Naproxen co-therapy in reducing complications affecting the gastro-intestinal tract and in particular ulcers, but causing a greater incidence of dyspepsia .

2 .THE NAPROSSENE IN THE TREATMENT OF MESTRUAL PAINS

Eur J Obstet Gynecol Reprod Biol. 2006 Dec; 129 (2): 162-8. Epub 2006 May 3.

Work demonstrating how the daily intake of 500 mg of Naproxen may be effective in reducing the pain symptomatology associated with primary dysmenorrhea, without clinically relevant side effects

3. THE NAPROSSENE IN GYNECOLOGICAL PRACTICE

Int J Gynaecol Obstet. 2008 Sep; 102 (3): 284-6. Epub 2008 Jul 7.

Study demonstrating that oral Naproxen intake can be as effective as using local painkillers to reduce pain associated with hysterosalpingography.

Method of use and dosage

XENAR ®

Naproxen coated tablets 250 - 50 mg;

Naproxen 750 mg prolonged release tablets;

250-500 mg Naproxen suppositories;

Granules for oral suspension of 375 mg of Naproxen;

Naproxen 375 mg soft capsules.

The dosage of Naproxen to be used should be defined by the doctor based on the patient's health status, the severity of the clinical picture and the therapeutic goals proposed.

Generally the therapeutic range 250 mg - 750 mg of Naproxen per day should be sufficient to guarantee a prompt remission of the symptoms.

In any case, with the exception of prolonged-release tablets, it would be preferable to divide the daily dose into at least 2 intakes, one every 12 hours.

In order to minimize side effects, it would be appropriate to start therapy with the minimum effective dose.

XENAR ® Naproxen warnings

Note the numerous side effects associated with treatment with non-steroidal anti-inflammatory drugs, it would be useful to consult your doctor before taking XENAR ®.

In order to minimize the incidence of these effects the doctor should suggest the minimum effective dose able to guarantee a remission of the symptoms, limiting the therapy to the shortest possible period.

Particular attention should be paid to patients suffering from gastrointestinal, cardiovascular, hepatic and renal diseases, in which the intake of Naproxen could determine the aggravation of the current clinical picture rather than the onset of new side effects.

In this regard, the occurrence of unexpected side effects should therefore alarm the patient, who, after consulting his doctor, should consider the possibility of suspending the treatment.

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

PREGNANCY AND BREASTFEEDING

Numerous studies have long shown the importance of prostaglandins in correctly directing the process of cellular differentiation and proliferation, safeguarding the physiological development of growing tissues.

For this reason it is easy to foresee how the intake of non-steroidal anti-inflammatory drugs during pregnancy, by reducing the production of prostaglandins, can compromise embryonic and fetal growth, facilitating the onset of malformations of the cardiovascular and respiratory system and the incidence of unwanted abortions.

In light of these evidences and also the complications affecting the pregnant woman, linked to NSAID therapy, it is necessary to extend the contraindications to the use of XENAR ® even during pregnancy and breastfeeding.

Interactions

It is known that non-steroidal anti-inflammatory drugs, including Naproxen, can interact with different active ingredients, causing a significant variability in the pharmacological properties and in the safety profile.

In order to minimize the incidence of adverse events, particular attention should be paid to the concomitant administration of Naproxen and:

Oral anticoagulants and inhibitors of serotonin reuptake, responsible for the increased risk of bleeding;
Diuretics, ACE inhibitors, angiotensin II antagonists, methotrexate and cyclosporin, due to the increased hepatotoxic and nephrotoxic effects of Naproxen;
Non-steroidal anti-inflammatory drugs and corticosteroids, given the increased risk of histological damage to the gastro-intestinal mucosa;
Antibiotics, responsible for pharmacokinetic alterations and related therapeutic efficacy;
Sulfonylureas, for disorders affecting glucose metabolism, given the potential hypoglycemic effect induced by NSAIDs.

Contraindications XENAR ® Naproxen

Intake of XENAR ® is contraindicated in case of hypersensitivity to the active ingredient or to one of its excipients, hypersensitivity to acetylsalicylic acid and other analgesics, nasal polyposis, asthma, bronchospasm, angioedema, peptic ulcer, history of intestinal bleeding, colitis ulcer, Crohn's disease or previous history for the same conditions, cerebrovascular bleeding, bleeding diathesis or concomitant anticoagulant therapy, renal failure and liver failure.

Undesirable effects - Side effects

The intake of XENAR ®, as well as those of other medicines based on non-steroidal anti-inflammatory drugs, could be associated with the appearance of various side effects.

The incidence and severity of these adverse reactions is generally dependent on the dose used, the duration of the therapy and the possible presence of predispositions.

More precisely, the use of Naproxen could determine the appearance of: nausea, vomiting, diarrhea, constipation, gastritis, and in more serious cases ulcers with possible erosions and hemorrhages, headache, dizziness and rarely drowsiness, itching, skin rash, eczema, even severe urticaria and bullous reactions, hypotension, hypertension and increase in cardio and cerebrovascular accidents, disturbances of the eyes and of hearing, asthma, dyspnea, pneumonia and alterations of renal and hepatic function.