SYNFLEX ® Naproxen

SYNFLEX ® is a drug based on Naproxen sodium

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

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

Indications SYNFLEX ® Naproxen

SYNFELX ® is used in the treatment of painful diseases on an inflammatory basis for various organs and systems.

Mechanism of action SYNFLEX ® Naproxen

SYNFELX ® is commonly used successfully in clinical practice, for the treatment of pain states on an inflammatory basis, given the particular pharmacokinetic properties of sodium Naproxen, which allow the aforementioned active ingredient, following oral intake, to be rapidly absorbed by the mucosa intestinal, reaching maximum plasma concentrations in approximately 90 minutes.

In the circulatory stream, Naproxen, bound to plasma proteins, is effectively distributed among the various organs and systems, where, reversibly binding some enzymes known as cyclooxygenases, it inhibits the production of prostaglandins.

Prostaglandins, whose concentrations tend to increase significantly during phlogistic processes of various kinds, thanks to the vasopermeabilization action, chemotactic against inflammatory cells and antiplatelet agents, support the inflammatory process active in the area of damage.

Consequently the intake of active ingredients such as Naproxen, or non-steroidal anti-inflammatory drugs, stopping the production of prostaglandins guarantees:

A sensitive anti-inflammatory action, reducing the damaging events affecting the fabric;
An analgesic action, inhibiting the production of pain mediators, active on peripheral nociceptive endings;
A modest antipyretic action, reducing the production of cytokines such as IL1 and prostaglandins such as PGE2 capable of acting at the hypothalamic level triggering the febrile mechanisms.

After its action the Naproxen, following a hepatic metabolism, is excreted in the form of inactive catabolites mainly through the urine.

Studies carried out and clinical efficacy

1.THE NAPROSSENE IN THE TREATMENT OF NEURODEGENERATIVE PATHOLOGIES

Arch Pharm Res. 2012 Mar; 35 (3): 523-30. Epub 2012 Apr 5.

Very interesting study that tries to best characterize the possible delivery systems able to guarantee an effective release of Naproxen at the level of the liquor, therefore of the central nervous system. This need arises from recent evidence that has shown that this active ingredient can be used as a neuroprotector in the course of severe neurodegenerative diseases.

2. THE NAPROSSENE IN POST-OPERATIVE PHASES

Eur J Cardiothorac Surg. 2004 Oct; 26 (4): 694-700.

Clinical trial that demonstrates how the administration of Naproxen in the post-operative phases of coronary artery bypass surgery can be effective in ensuring pain control, without clinically relevant complications.

3.NAPROSSENE AND OSTEOARTRITE

Ann Rheum Dis. 2006 Jun; 65 (6): 781-4. Epub 2005 Nov 3.

Work that demonstrates how Naproxen-based treatment can be effective in improving the painful symptoms of the hip and knee in patients suffering from osteoarthritis.

Method of use and dosage

SYNFELX ®

275 mg hard capsules of Naproxen sodium;

Tablets coated with 550 mg of Naproxen sodium;

Suppositories of 275-550 mg of Naproxen sodium;

Granules for oral suspension of 550 mg of Naproxen sodium.

The intake of SYNFELX ® should be supervised by your doctor, who should establish the correct dosing schedule according to the patient's physiopathological characteristics, taking care to further adapt it in elderly patients or those suffering from kidney and liver disease.

Generally, we recommend taking 550 mg of Naproxen sodium every 12 hours, rather than 275 mg of Naproxen sodium every 6-8 hours.

In any case it would be advisable to start therapy with the minimum effective dose, in order to reduce as much as possible the incidence of unwanted side effects.

Warnings SYNFLEX ® Naproxen

Therapy with SYNFELX ® should be supervised by your doctor, in order to avoid the occurrence of serious side effects while maintaining maximum therapeutic efficacy.

Treatment should be understood as short-term symptomatic therapy, necessary to guarantee a remission of the painful symptoms in progress.

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.

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

PREGNANCY AND BREASTFEEDING

The use of SYNFELX ® is contraindicated during pregnancy, given the numerous studies that demonstrate the important toxic effects of non-steroidal anti-inflammatory drugs on fetal health.

More precisely, the scientific literature reports several cases of cardiorespiratory malformations and unwanted abortions, following the intake of NSAIDs at high doses during gestation, and in particular in the last trimester of pregnancy.

This contraindication is also supported by the effects on the pregnant woman, subjected to an increased risk of bleeding as well as complications during childbirth.

Interactions

Despite the pharmacological studies show numerous possible interactions between non-steroidal anti-inflammatory drugs such as Naproxen and other active ingredients, from the clinical point of view, those that are of most concern are:

Oral anticoagulants and serotonin reuptake inhibitors, responsible for the increased risk of bleeding;
Diuretics, ACE inhibitors, angiotensin II antagonists, methotrexate and cyclosporine, due to the increased hepatotoxic and nephrotoxic effects of Naproxen;
Non-steroidal anti-inflammatory and corticosteroids, given the increased risk of irritant and 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 SYNFLEX ® Naproxen

Intake of SYNFELX ® 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

Naproxen therapy, as well as that with other non-steroidal anti-inflammatory drugs, is often related to the onset of side effects, the incidence and severity of which tend to increase with increasing doses and duration of therapy.

Despite the intake of SYNFELX ®, according to the planned dosage schedules, it tends to minimize the occurrence of adverse reactions, it is necessary to remember how the Naproxen-based therapy can determine the appearance of symptoms:

Gastroenteritis such as nausea, vomiting, diarrhea, constipation, gastritis, and in severe cases ulcers with possible erosions and bleeding;
Nervous symptoms such as headache, dizziness and rarely drowsiness;
Dermatological such as itching, skin rash, eczema, urticaria and even severe bullous reactions;
Cardiovascular with hypotension, hypertension and increased cardio and cerebrovascular accidents;
Sensory with vision and hearing disorders;
Respirators such as asthma, dyspnoea, pneumonia and edema;
Renal and hepatic, with impaired functionality of both organs and related systems.