SULIDAMOR ® Nimesulide

SULIDAMOR ® is a drug based on Nimesulide

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

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

Indications SULIDAMOR ® Nimesulide

SULIDAMOR ® is indicated in the treatment of pain symptoms associated with inflammatory or gynecological diseases such as primary dysmenorrhoea.

Mechanism of action SULIDAMOR ® Nimesulide

SULIDAMOR ® is commonly used in the treatment of pain symptoms associated with both articular and gynecological inflammatory states, as a second choice therapy.

The need to resort to nimesulide exclusively following the failure of clinically safer analgesic therapies is due to the numerous studies present in the literature that associate the remarkable therapeutic properties of this drug also with a significant series of side effects among which stand out those at hepatic.

In fact, despite the particular chemical structure of this active ingredient, able to give nimesulide advantageous pharmacokinetic properties and a selective therapeutic activity, the cases of acute hepatitis and gastro-enteric reactions have put into question the advantages deriving from the therapy, even up to withdrawal from trade in Ireland.

From the biological point of view, the therapeutic action of nimesulide is due to the ability to selectively inhibit cyclooxygenases 2, reducing the production of prostaglandins involved in:

Genesis of inflammatory processes, exerting a vasodilatory, vasopermeabilizing and edemigenic as well as chemotactic action;
Genesis of inflammatory pain, lowering the pain threshold to the central level and stimulating the peripheral terminations of nociceptors;
Genesis of fever, acting at the hypothalamic level by raising the thermal set-point.

Studies carried out and clinical efficacy

1. EFFECTIVENESS OF GENERICS BASED ON NIMESULIDE

Rheumatism. 2009 Jan-Mar; 6: e360-1. Epub 2009 May 26.

Case report demonstrating the onset of a typical psoriasiform dermatological reaction caused by the intake of nimesulide. The allergic power of this active ingredient could in fact be potentially dangerous in atopic subjects.

Method of use and dosage

SULIDAMOR ®

Nimesulide 100 mg tablets;

Granules for oral suspension of 100 mg of nimesulide;

In the treatment of the inflammatory pain symptomatology of the adult, it is recommended to take a tablet or a packet of 100 mg of nimesulide, twice a day, preferably after meals.

A further adjustment of the dosages used could be envisaged by the doctor in elderly patients or those suffering from liver and kidney diseases.

Warnings SULIDAMOR ® Nimesulide

Given the potential side effects and the importance of carefully evaluating the cost / benefit ratio that would result from the use of nimesulide, it would be advisable to consult your doctor before starting therapy with SULIDAMOR ®.

The doctor should therefore note the patient's good health and the absence of predisposing conditions, such as liver, kidney, gastro-intestinal and cardiovascular diseases, which can significantly increase the risk of clinically significant side effects.

Furthermore, in order to limit the appearance of clinically relevant side effects it would be advisable to limit the duration of drug therapy as much as possible.

Should any side effects appear, the patient should immediately contact his doctor, taking into consideration the possibility of immediately suspending the therapy in progress.

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

SULIDAMOR ® .granate for oral suspension instead contains sucrose, so it is poorly indicated in patients suffering from hereditary syndromes of fructose intolerance, glucose / galactose malabsorption and sucrose-isomaltase deficiency.

PREGNANCY AND BREASTFEEDING

SULIDAMOR ® is contraindicated during pregnancy, given the ability of non-steroidal anti-inflammatory drugs, therefore also of nimesulide to determine a significant reduction of total prostaglandin concentrations, thus compromising the correct embryonic and fetal development and simultaneously increasing the risk of bleeding and complications to time of birth.

The aforementioned contraindications must necessarily be extended to the subsequent breastfeeding period, given the tendency of nimesulide to concentrate in breast milk.

Interactions

In order to avoid significant changes in the pharmacokinetic and pharmacodynamic properties of nimesulide, particular attention should be paid to the concomitant intake of:

Valproic acid, fenofibrates, salicylates, tolbutamide for the ability to reduce the efficacy of nimesulide, competing with the binding to the active site;
Diuretics, ACE inhibitors, angiotensin II antagonists, methotrexate and ciclosporin, given the ability to increase renal toxicity of nimesulide;
Active ingredients able to alter gastric motility, thus avoiding variations in drug absorption;
Antibiotics and substrates of cytochromial enzymes, capable of altering the pharmacokinetic profile of nimesulide, enhancing the potential side effects.
NSAIDs and opioids, given the increased analgesic effect of their interaction;
Anticoagulants, given the increased risk of bleeding associated with the simultaneous use of NSAIDs.

Contraindications SULIDAMOR ® Nimesulide

The use of SULIDAMOR ® is contraindicated in case of hypersensitivity to the active ingredient or to one of its excipients, hepatic and renal insufficiency, gastric ulcers and gastrointestinal pathologies and severe heart failure.

Undesirable effects - Side effects

For the different side effects, similar to those normally expected for non-steroidal anti-inflammatory drugs, and in particular for hepatotoxicity, nimesulide has for years been in the spotlight of different international agencies for the careful evaluation of the cost-benefit ratio that would derive from the use of this drug.

Among the various adverse reactions induced by the consumption of nimesulide, in addition to hepatotoxicity it has been possible to observe skin rash, pruritus, urticaria and edema, anemia, neutrophilia, thrombocytopenia, granule cytopenia, drowsiness, headache, insomnia and vertigo, tachycardia and hypertension, pain epigastric, nausea, vomiting, diarrhea and gastralgia, hyperkalemia, asthma, dyspnoea and bronchospasm, dysuria, oliguria and isolated hematuria.

However, it is important to reiterate how the incidence and severity of such reactions is proportional to the duration of the therapy and the dosages used.