NIMESULIDE DOC ® Nimesulide

NIMESULIDE DOC ® 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 NIMESULIDE DOC ® Nimesulide

NIMESULIDE DOC ® should be used, only after having evaluated the cost / benefit ratio, for the symptomatic treatment of acute pain on an inflammatory basis.

NIMESULIDE DOC ® is also indicated in the treatment of pain symptoms associated with gynecological diseases such as primary dysmenorrhoea.

Mechanism of action NIMESULIDE DOC ® Nimesulide

NIMESULIDE DOC ® is one of several generic drugs based on nimesulide, released on the market following the expiry of the patent, and commonly used for the treatment of pain symptoms associated with inflammatory stimuli or painful conditions such as primary dysmenorrhea.

Nimesulide has been particularly successful in the last 20 years as a non-steroidal anti-inflammatory, given its ability to selectively inhibit cyclooxygenases 2 by reducing the production of prostaglandins involved in pain transmission and the genesis of the inflammatory process, while preserving the activity of constitutively expressed enzymes, important in preserving kidney function and the health of the gastro-enteric mucosa.

However, this active ingredient is today the subject of numerous discussions concerning some important side effects, the first of which is hepatotoxicity, documented by numerous studies in the literature and which represent a serious limitation to the use of nimesulide as an analgesic and anti-inflammatory.

For this reason therapy with NIMESULIDE DOC ® should be evaluated as a second therapeutic option and as a short-term treatment, necessarily less than 15 days.

Studies carried out and clinical efficacy

1. THE NIMESULIDE IN THE KNEE OSTEOARTRITIS

J Clin Rheumatol. 2007 Oct; 13 (5): 251-5.

Interesting study that demonstrates how the topical application of nimesulide can reduce the inflammatory pain present in patients suffering from knee osteoarthritis, improving their quality of life.

2. THE NIMESULIDE IN THE PROTECTION OF NEURONAL DAMAGE FROM ischemia

Pharmacol Res. 2008 Apr; 57 (4): 266-73. Epub 2008 Mar 22.

Recent study that supports the neuroprotective role of nimesulide, demonstrating how in experimental models this active principle can protect the nervous system from the damage induced by the ischemic condition.

Yet another case report that reports a case of acute liver failure following the intake of nimesulide, thus reaffirming the important hepatotoxic effects of the drug, especially when taken for periods longer than 15 days.

Method of use and dosage

NIMESULIDE DOC ®

Nimesulide 100 mg tablets;

Granules for oral suspension of 100 mg of nimesulide;

we recommend taking a tablet or a 100 mg sachet of nimesulide, twice a day after the main meals.

Therapy should not extend beyond 15 days and in the absence of improvement it would be advisable to contact your doctor.

A dosage adjustment should be expected in elderly patients or those with liver and kidney disease.

Warnings NIMESULIDE DOC ® Nimesulide

In light of the numerous side effects described for nimesulide therapy, it would be advisable to consult your doctor before taking NIMESULIDE DOC ®.

Furthermore, in order to reduce the incidence of liver disease and gastralgia it is recommended not to prolong the therapy beyond 15 days and to take the active ingredient preferably after the two main meals.

Patients with hepatic, renal, gastrointestinal and cardiovascular diseases should pay particular attention given the increased susceptibility to the side effects of nimesulide.

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

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

NIMESULIDE DOC ® granulate for oral suspension instead contains sucrose, thus being little indicated in patients suffering from hereditary syndromes of fructose intolerance, glucose / galactose malabsorption and sucrose-isomaltase deficiency.

PREGNANCY AND BREASTFEEDING

In light of the different studies present in the literature that have shown the increased incidence of serious fetal malformations both cardiovascular and respiratory and of undesired abortions following the intake of nimesulide in pregnancy, it is contraindicated to take NIMESULIDE DOC ® during the entire gestational period.

This contraindication also extends to the subsequent breastfeeding period, given the tendency of nimesulide to concentrate in breast milk.

Interactions

The patient receiving NIMESULIDE DOC ® should pay particular attention to the simultaneous intake of active ingredients capable of varying the therapeutic profile and tolerability of nimesulide.

More precisely it would be advisable to avoid the concomitant administration 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 NIMESULIDE DOC ® Nimesulide

The use of NIMESULIDE DOC ® 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

Despite the selective action of nimesulide, theoretically useful for reducing the side effects on the gastro-enteric mucosa and urinary tract, the administration of NIMESULIDE DOC ® could be associated with the appearance of:

Gastrointestinal reactions such as epigastric pain, nausea, vomiting, diarrhea and gastralgia;
Central side effects such as drowsiness, headache, insomnia and dizziness;
Cardiovascular side effects such as tachycardia and hypertension;
Hypersensitivity reactions such as skin rash, pruritus, urticaria and edema, asthma, dyspnoea and bronchospasm;
Reactions against the urinary tract such as dysuria, oliguria and isolated hematuria;
Haematological reactions such as anemia, neutrophilia, thrombocytopenia, granulocytopenia.

However, it is useful to remember that the incidence and severity of these side effects is proportional to the duration of the therapy and to the doses of the drug used.