MOMENDOL ® Naproxen

MOMENDOL ® is a Naproxen-based drug

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

Indications MOMENDOL ® Naproxen

MOMENDOL ® is indicated in the short-term symptomatic treatment of painful conditions on a modest inflammatory basis of various organs and systems
MOMENDOL ® could be used as adjuvant therapy in febrile states.

Mechanism of action MOMENDOL ® Naproxen

Naproxen, active ingredient of MOMENDOL ®, is a non-steroidal anti-inflammatory drug derived from arylproprionic acid, characterized by a strong anti-inflammatory and analgesic activity.
Like other NSAIDs, Naproxen is also able to reversibly bind cyclooxygenase enzymes on an arginine residue, exerting a reversible competitive inhibition action which results in a transient reduction in prostaglandin production.
This biological mechanism takes the form of:

• Antipyretic action which, albeit modest, is present and guaranteed by the inhibition of the release of PGE2 (prostanoid with pyrogenic activity) at the hypothalamic level;
• Anti-inflammatory action, determined by the inhibition of molecular mechanisms, such as the increase in vascular permeability and the chemotactic action in primis, exerted by prostaglandins;
• Analgesic action, carried out by the inhibition of the production of inflammatory mediators such as bradykinin, capable of activating peripheral nociceptors.

Following oral intake, Naproxen reaches its maximum plasma concentration in just 60 minutes, while maintaining its therapeutic action for several hours, until complete elimination, which occurs mainly via the kidney.

Studies carried out and clinical efficacy

1.NAPROXENE / EXOMPRAZOLE IN "OSTEOARTHRITIS
s Aging. 2011 Mar 1; 28: 237-48.

Naproxen / esomeprazole fixed-dose combination: for the treatment of arthritic symptoms and to reduce the risk of gastric ulcers.

Dhillon S.

Work that demonstrates how the concomitant administration at fixed doses of Naproxen and Esomperazole can be effective in the treatment of pain associated with diseases such as osteoarthritis, and at the same time safe, given the contextual presence of a pump inhibitor capable of potentially reducing the effects harmful effects of the treatment, on the gastric mucosa.

2. NAPROXENE IN THE TREATMENT OF MIGRAINE
Headache. 2010 May; 50: 808-18. Epub 2010 Mar 5.

Meta-analysis of the efficacy and safety of naproxen sodium in the acute treatment of migraine.

Suthisisang CC, Poolsup N, Suksomboon N, Lertpipopmetha V, Tepwitukgid B.

Study that demonstrates how Naproxen can be effective in the treatment of migraine, reducing the intensity of pain and lengthening the time free from pain. Unfortunately, in addition to efficacy, there was also a significant increase in the side effects associated with NSAID therapy.

3. NAPROXENE AS AN ANTICANCER AGENT
Cancer Prev Res (Phila). 2009 Nov; 2: 951-6.

Chemopreventive efficacy of naproxen and nitric oxide-naproxen in rodent models of colon, urinary bladder, and mammary cancers.

Steele VE, Rao CV, Zhang Y, Patlolla J, Boring D, Kopelovich L, Juliana MM, Grubbs CJ, Lubet RA.

Completely experimental study, conducted on animal models, which demonstrates the efficacy of Naproxen in interfering with the processes of urinary and colon carcinogenesis, significantly reducing the size of the neoplastic masses.

Method of use and dosage

MOMENDOL ®
200 mg Naproxen granules for oral solution;
Naproxen 220 mg coated tablets;
5-10% Naproxen gel for skin use.

The treatment of pain on an inflammatory basis should include a dosage schedule based on the assumption of one tablet or sachet every 8 - 12 hours, for a maximum of 3 tablets / sachets per day.
The entire treatment period should not exceed 7 days for painful states and 3 days for febrile states.
If the symptoms do not regress following the intake of MOMENDOL ®, it would be useful to consult your doctor.

Warnings MOMENDOL ® Naproxen

Although MOMENDOL ® is a drug that can be sold without a prescription, in light of the numerous side effects associated with systemic therapy with NSAIDs, it would be advisable to consult your doctor before starting therapy with Naproxen.
The simultaneous presence of gastrointestinal, cardiovascular, hepatic and renal pathologies could in fact make the intake of this medicine particularly dangerous, increasing the risk of incidence of new side effects rather than exacerbating any symptoms already present.
The onset of unexpected side effects should therefore alarm the patient, who, after consulting his doctor, should consider stopping the treatment.
MOMENDOL ® contains:

• Sucrose, therefore it is not recommended to take it in patients suffering from glucose-galactose malabsorption syndrome, sucrase-isomaltase enzymatic deficiency or fructose intolerance;
• Aspartame, a source of phenylalanine, and therefore potentially dangerous for patients with phenylketonuria;

PREGNANCY AND BREASTFEEDING

It is known that prostaglandins are essential in directing the correct process of cell proliferation and differentiation during the normal phases of embryonic and fetal growth.
For this reason, the use of non-steroidal anti-inflammatory drugs, altering the normal pattern of expression of these molecules, could compromise the normal growth profile of the fetus, facilitating the appearance of malformations in the cardiovascular and respiratory systems by increasing hence the number of unwanted abortions.
In light of these clinical and experimental evidences, the use of MOMENDOL ® is contraindicated during pregnancy and in the subsequent period of breastfeeding.

Interactions

As with other non-steroidal anti-inflammatory drugs, the therapeutic efficacy and safety profile of Naproxen could also be compromised by the simultaneous intake of other active ingredients.
More precisely, the concomitant administration of:

• Oral anticoagulants and serotonin reuptake inhibitors, could lead to an increased risk of bleeding;
• Diuretics, ACE inhibitors, angiotensin II antagonists, methotrexate and cyclosporine, could be associated with an increase in the toxic effects of Naproxen, mainly concentrated in the kidney and liver;
• Non-steroidal anti-inflammatory and cortisone drugs, it could increase the risk of damage to the gastro-enteric mucosa;
• Antibiotics, on the other hand, could alter the pharmacokinetic characteristics of both active ingredients.
• Sulfonylureas could alter normal glucose homeostasis leading to unpredictable consequences.

Contraindications MOMENDOL ® Naproxen

The intake of MOMENDOL ® is contraindicated in case of hypersensitivity to the active substance 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 disease, Crohn's disease or previous history of the same conditions, cerebrovascular bleeding, haemorrhagic diathesis or concomitant anticoagulant therapy, renal insufficiency and hepatic insufficiency.

Undesirable Effects - Side Effects

Although the intake of MOMENDOL ®, if carried out according to the prescribed dosage schedules, is free of clinically significant side effects, the prolonged use of non-steroidal anti-inflammatory drugs over time could lead to the onset of adverse reactions to the:

• The gastrointestinal tract exposed to nausea, vomiting, diarrhea, constipation, gastritis, and in the most serious cases ulcers with possible erosions and bleeding;
• The nervous system with the appearance of headache, dizziness and rarely drowsiness;
• The integumentary system with the appearance of dermatological reactions such as itching, skin rash, eczema, urticaria and even severe bullous reactions;
• The kidney and liver, subjected to the increased risk of cytotoxicity and functional deterioration;
• The cardiovascular system with hypotension, hypertension and an increase in cardio and cerebrovascular accidents.

Note

MOMENDOL ® can be sold without a prescription.

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