drugs

CLAVERSAL ® Mesalazine

CLAVERSAL ® is a drug based on mesalazine

THERAPEUTIC GROUP: Non-steroidal intestinal anti-inflammatory - Aminosalicylic acid and analogues

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

Indications CLAVERSAL ® Mesalazina

CLAVERSAL ® is a drug based on mesalazine, useful in the treatment and prevention of recurrences during chronic inflammatory bowel disorders such as ulcerative colitis and Crohn's disease.

Mechanism of action CLAVERSAL ® Mesalazine

CLAVERSAL ® is a drug with anti-inflammatory activity, with particular selectivity towards the intestinal mucosa.

This therapeutic action, particularly important in protecting the intestinal mucosa from the inflammatory insult present in particular pathologies, is guaranteed by the active principle mesalazine, belonging to the category of salicylates.

Taken orally, the aforementioned active ingredient, reaches intact the intestinal environment where it is able to modulate the production of chemical inflammation mediators, with particular specificity towards the metabolites of arachidonic acid, reducing the recall in the seat of inflammatory cells, the production of cytokines, the formation of edema, the production of free oxygen radicals, thus safeguarding the structural and functional integrity of the intestinal mucosa.

Although from the pharmacodynamic point of view the activity of mesalazine is not yet fully characterized, the well-defined pharmacokinetic properties characterized by poor systemic absorption, allow this active principle to reach concentrations at the intestinal level, able to sustain an important activity therapeutic.

After its action, the mesalazine present in the lumen is eliminated through the faeces, while the absorbed one, following a hepatic and intestinal metabolism is excreted mainly through the urine.

Studies carried out and clinical efficacy

1. THE MESALAZINE AND ENDOSCOPIC EXAMINATION

This study conducted on patients suffering from ulcerative colitis, shows how the intake of 4.6 grams of mesalazine per day, in just 6 weeks of treatment, can improve intestinal mucosa health, observed through endoscopy, in 80% of treated patients. This characteristic is important in the resolution of complex pathologies such as inflammatory diseases of the gastro-intestinal tract.

2. MESALAZINA AND CELIAC DISEASE

The administration of mesalazine to intestinal release has proved particularly useful in improving the histological features of the intestinal mucosa in patients suffering from refractory celiac disease. This new therapeutic approach could associate a dated drug like mesalazine with the therapy of emerging pathologies such as celiac disease.

3. MESALAZINE INTOSICATION

First case report, which reports mesalazine intoxication in a 20-year-old boy with ulcerative colitis. The massive ingested dose resulted in hyperemia and widespread edema throughout the gastro-intestinal tract, with ulcers expanded even at the rectal level. Fortunately, in about 15 days a significant improvement in symptoms was observed.

Method of use and dosage

CLAVERSAL ® coated with 500 mg mesalazine: we recommend taking 1 tablet 3 times a day, preferably on an empty stomach.

CLAVERSAL ® mesalazine suppositories of 500 mg : it is recommended to take 1 suppository 3 times a day, for diseases affecting the rectum.

In any case, in order for the drug to perform its maximum therapeutic action, it is necessary for the suppository to be retained for long periods, such as at night.

CLAVERSAL ® rectal solution of 2 - 4 gr of mesalazine: it is recommended to take a dose of 4 grams once a day, or two doses of 2 grams twice a day

The intake should preferably take place in the morning and at bedtime.

All the aforesaid dosages, are purely indicative, as the doctor could vary the dosage and the timing of intake based on the patient's clinical conditions.

Warnings CLAVERSAL ® Mesalazine

Close medical supervision and periodic monitoring of hepatic, renal and hematological features is necessary in patients undergoing CLAVERSAL ® therapy and characterized by reduced liver and kidney function.

The presence of salicylates and compounds such as potassium metabisulfite is responsible, in predisposed patients, for serious clinical pictures due to hypersensitivity to the aforementioned molecules for which it is necessary to immediately suspend therapy.

Furthermore, in patients with particularly slow gastric digestion, the oral intake of mesalazine could be associated with even severe irritation of the gastric mucosa.

The presence of headache, among the side effects associated with CLAVERSAL ® therapy, could make driving cars and the use of machinery dangerous.

PREGNANCY AND BREASTFEEDING

Given the absence of clinical trials and significant studies relating to the effects of mesalazine on fetal and infant health when taken during pregnancy and lactation, it would be good to avoid taking CLAVERSAL ® during these periods, or to resort exclusively to real needs and after contacting your doctor.

Interactions

Several pharmacokinetic studies have demonstrated the low risk of interaction between various active ingredients and CLAVERSAL ® emphasizing the safety deriving from the reduced systemic absorption of its active principle.

Nevertheless, given that mesalazine belongs to the category of salicylates, it is not possible to exclude possible interactions with coumarin derivatives, methotrexate, probenecid, sulfinpyrazone, spironolactone, furosemide, rifampicin and sulfonylureas.

Furthermore, the concomitant administration of agents capable of lowering intestinal pH could reduce the therapeutic efficacy of the drug, when taken orally.

The intake of corticosteroids, useful in the acute phases of the disease, could enhance the anti-inflammatory effects of mesalazine, while the simultaneous intake of drugs metabolized at the kidney level, could increase the workload of these organs, exposing the patient to the risk of nephrotoxicity.

Contraindications CLAVERSAL ® Mesalazine

CLAVERSAL ® is contraindicated in patients suffering from intestinal haemorrhagic diseases, gastric and duodenal ulcers and hemorrhagic diathesis.

Furthermore, CLAVERSAL ® should not be used in patients who are hypersensitive to mesalazine or other salicylates.

Undesirable effects - Side effects

Several clinical trials and a careful post-marketing assessment support the reduced toxicity and good tolerability of mesalazine.

In fact the main side effects described, were all of modest entity and concentrated at the gastro-intestinal level with nausea, diarrhea and abdominal pain, and nervous with headache.

However, in spite of the good tolerability profile, especially in predisposed patients, it was possible to observe the presence of alterations of the hematological picture, of liver and renal function, and the development of allergic reactions with a serious course.

In all the aforementioned cases, discontinuation of therapy guaranteed a rapid regression of symptoms.

Note

CLAVERSAL ® is a medicine that can be sold under prescription.