LEUTROL ® Meloxicam

LEUTROL ® is a Meloxicam 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 LEUTROL ® Meloxicam

LEUTROL ® is used in the short-term symptomatological treatment of inflammatory pain present during rheumatic diseases such as osteoarthritis, rheumatoid arthritis and spondyloarthritis.

Mechanism of action LEUTROL ® Meloxicam

LEUTROL ® is a medicine belonging to the category of non-steroidal anti-inflammatory drugs commonly used in the symptomatic therapy of joint pain present during rheumatic diseases.

Its active ingredient meloxicam, belonging to the class of oxicam, taken orally and absorbed at the intestinal level, is able to concentrate at the level of the synovies, exercising its anti-inflammatory action mainly at the joint level.

This action, determined by the inhibition of inducible cyclooxygenases (COX2) and the consequent reduction of prostaglandin synthesis, is flanked by the analgesic and antioxidant one.

Recent studies have shown that meloxicam can contribute to the proper functioning of the body's detoxification systems, reducing the amount of hydrogen peroxide and thus counteracting the tissue damage induced by reactive oxygen species.

The analgesic role of meloxicam is also clear, guaranteed by the reduction of the local production of bradykinin, responsible for activating the peripheral endings of nociceptors, and probably also from an effect at the central level capable of counteracting the lowering of the pain threshold.

Studies carried out and clinical efficacy

1. THE INFFICACY OF MELOXICAM IN THE CONTROL OF ACUTE POST-OPERATIVE PAIN

Cochrane Database Syst Rev. 2009 Oct 7; (4): CD007552.

A countercurrent study that, after carefully evaluating the literature currently present, denies the efficacy of meloxicam in single dose, in the control of acute post-operative pain.

2 . THE MELOXICAM IN THE ONCOLOGICAL CLINIC

Jpn J Clin Oncol. 2009 Nov; 39 (11): 720-6. Epub 2009 Aug 14.

Very interesting phase II clinical trial that demonstrates how meloxicam / interferon alfa combined therapy can be effective in the first-line treatment of metastatic renal carcinoma.

3. THE EXCELLENT TOLERABILITY TO MELOXICAM

J Investig Allergol Clin Immunol. 2006; 16 (6): 364-6.

Work demonstrating that meloxicam can be better tolerated than other non-steroidal anti-inflammatory drugs in patients normally intolerant to NSAIDs. Despite these results, it would still be advisable to subject the patient to all relevant tests before administering meloxicam.

Method of use and dosage

LEUTROL ®

Meloxicam coated tablets 15 mg;

15 mg solution for injection of meloxicam per 1.5 ml of solution;

Meloxicam therapy should be supervised by a doctor who specializes in treating rheumatic pain.

The dosages used should be formulated based on the patient's physiopathological characteristics, the severity of his clinical picture and tolerability to the drug.

The standard dosage of a daily tablet could therefore be re-evaluated in elderly patients or those suffering from liver and kidney diseases.

Warnings LEUTROL ® Meloxicam

Given the numerous side effects associated with meloxicam therapy, it would be advisable to consult your doctor both before taking LEUTROL ® and throughout the treatment.

The doctor, in order to reduce the incidence and severity of the side effects, while preserving the therapeutic efficacy, should identify the minimum effective dosage and prolong the therapy for the shortest possible time useful to guarantee an improvement or remission of the symptomatology in place.

Patients suffering from liver, kidney, gastro-intestinal and cardiovascular diseases should take LEUTROL ® only under strict medical supervision, taking care to periodically monitor the status of liver, renal, cardiac and coagulative function, remembering that meloxicam may vary some blood chemistry parameters.

If undesired effects appear, the patient, after contacting his doctor, should seriously consider suspending therapy.

LEUTROL ® contains lactose so its intake is contraindicated in patients with lactase enzyme deficiency, glucose-galactose malabsorption syndrome and galactose intolerance.

PREGNANCY AND BREASTFEEDING

Given the numerous studies in the literature that show how the use of non-steroidal anti-inflammatory drugs during pregnancy can be associated with a greater risk of fetal malformations as well as serious complications in the pregnant woman during childbirth, it is necessary to extend the contraindications to the use of LEUTROL ® also during pregnancy and subsequent breastfeeding period.

Interactions

The systemic absorption of meloxicam taken orally or parenterally injected, exposes the patient subjected to therapy with LEUTROL ® to possible drug interactions capable of altering both the safety profile and the therapeutic profile of the medicine.

Among the active ingredients able to interact with meloxicam, those to which more attention should be paid are:

Oral anticoagulants and inhibitors of serotonin reuptake, due to the increased risk of bleeding;
Diuretics, ACE inhibitors, angiotensin II antagonists, methotrexate and cyclosporin, due to their ability to enhance the hepatotoxic and nephrotoxic effects of meloxicam;
Non-steroidal anti-inflammatory and corticosteroids, for damage to the gastro-intesintal mucosa
Lithium, given the increased toxic effects of the same;
Cholestyramine, given the ability to alter the half-life and clearance of meloxicam.

Contraindications LEUTROL ® Meloxicam

The use of LEUTROL ® is contraindicated in case of hypersensitivity to the active ingredient or to one of its excipients or to chemically and functionally related active ingredients, angioedema, peptic ulcer, history of intestinal bleeding, ulcerative colitis, Crohn's disease or previous history for the same pathologies, cerebrovascular bleeding, hemorrhagic diathesis or concomitant anticoagulant therapy, renal and hepatic failure.

Undesirable effects - Side effects

Meloxicam intake, as well as that of other non-coxib non-steroidal anti-inflammatory drugs, is often followed by sometimes clinically relevant side effects.

Among the apparatuses concerned the gastro-intestinal and integumentary apparatuses seem to report the most critical side effects.

These include gastric pyrosis, gastralgia, nausea and vomiting, constipation and in severe cases ulcers and hemorrhages, increased bleeding time, anemia, thrombocytopenia and leukopenia, hearing and sight disorders, headache, insomnia, drowsiness, confusion and tremors, erythema, rash, urticaria and in severe cases bullous reactions, edema, anaphylactic and anaphylactoid reactions, increased transaminases, hyperbilirubinemia and hepatitis, palpitations, sloping edema and myocardial infarction are the most frequent and clinically worrying ones.