SINARTROL CREMA ® Cinnoxicam

ZELIS ® is a Cinnoxicam based drug

THERAPEUTIC GROUP: Non-steroidal anti-inflammatory drugs for topical use

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

Indications ZELIS ® Cinnoxicam

ZELIS ® is used in the symptomatic treatment of pain associated with rheumatic and degenerative diseases on an inflammatory basis.

Mechanism of action ZELIS ® Cinnoxicam

Cinnoxicam, the active ingredient of ZELIS ®, is an innovative drug derived from the more well-known Piroxicam, belonging to the category of non-steroidal anti-inflammatory drugs and more specifically to the class of oxycam-benzothiazine derivatives.

Despite the therapeutic activity, similar to other non-steroidal anti-inflammatory drugs on the market, which can be compared to the other non-steroidal anti-inflammatory drugs, with the only difference concerning the selectivity of action, cinnoxicam and its predecessors have assumed an important clinical relevance, however still discussed, due to the particular pharmacokinetic properties that allow these drugs to carry out their biological activity for over 24 hours, thus allowing their intake in a single dose.

Taken orally or rectally Cinnoxicam is absorbed by the intestinal mucosa, reaching the plasma peak about 6 hours after intake, and distributed to the various peripheral districts through binding to plasma proteins.

Here it is able to mediate its own anti-inflammatory and analgesic action by inhibiting the activity of cyclooxygenases, with greater selectivity for COX2, and guaranteeing:

A reduction in prostaglandin concentrations with chemotactic, vasopermeabilizing and edemigenic activity;
An increase in the pain threshold at the central nervous level, imposing at the same time the activation of the bradykinin-mediated peripheral nociceptive endings;
A reduction in tissue damage induced by reactive oxygen species and proteolytic enzymes.

After its activity, Cinnoxicam is metabolised to the liver and excreted, in the form of inactive catabolites, mainly via the kidney.

Studies carried out and clinical efficacy

1. CINNOXICAM IN THE TREATMENT OF MALE INFERTILITY

J Androl. 2004 Sep-Oct; 25 (5): 761-70; discussion 771-2.

Interesting Italian study on male fertility that demonstrates the efficacy of combined therapy between Cinnoxicam and L-Acetyl Carnitine in the treatment of low-grade varicocele and idiopathic oligoastenospermia.

2 . THE CHEMICAL-PHYSICAL STABILITY OF CINNOXICAM

J Pharm Biomed Anal. 1999 Jun; 20 (1-2): 283-8.

Pharmaceutical chemistry study that seeks to assess the chemical and physical stability of Cinnoxicam in different pharmaceutical preparations. These properties are fundamental in the characterization of the real therapeutic efficacy and in the understanding of some often unexplained side effects.

3. THE EFFECTIVENESS OF CINNOXICAM IN THE TREATMENT OF OSTEOARTROSI

Minerva Med. 1996 Apr; 87 (4): 155-60.

Clinical trial demonstrating the efficacy of treatment with Cinnoxicam at 30 mg / day for 13 consecutive days, in guaranteeing a regression of pain symptomatology presents in the course of osteoarthritis.

Method of use and dosage

ZELIS ®

Cinnoxicam 30 mg coated tablets;

Cinnoxicam 30 mg suppositories.

The administration of a daily tablet / suppository is generally effective in controlling the symptoms associated with rheumatic and degenerative inflammatory diseases.

The doctor may vary the standard dosage based on the severity of the clinical picture, the physiopathological condition and the individual tolerability to the therapy.

Warnings ZELIS ® Cinnoxicam

Therapy with ZELIS ® should be supervised by a doctor specialized in the treatment of rheumatic diseases, who should ascertain the patient's state of health, the real need for NSAID therapy and the possible presence of conditions that can increase the risk of side effects.

For this reason particular attention should be paid to all patients contextually affected by cardiovascular, coagulative, renal, hepatic, allergic and gastrointestinal pathologies due to the high susceptibility of these towards the toxicity of NSAID therapy.

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

It is useful to remember how ZELIS ® therapy could interfere with some blood tests related above all to liver and kidney function, concealing at the same time any complementary inflammatory states as well as the related symptoms.

PREGNANCY AND BREASTFEEDING

In light of the different studies that have shown the remarkable importance of prostaglandins in correctly guiding fetal development and the known serious malformations of the cardiovascular and respiratory system of the unborn child as well as of spontaneous abortions associated with the administration of NSAIDs during pregnancy, it is evident the importance of avoiding taking ZELIS ® during pregnancy and also during the subsequent breastfeeding period.

Interactions

In order to avoid variations in the therapeutic efficacy and safety profile of ZELIS ®, particular attention should be paid to the simultaneous assumption of:

Oral anticoagulants and inhibitors of serotonin reuptake, due to the increased risk of bleeding;
Diuretics, ACE inhibitors, angiotensin II antagonists, methotrexate and ciclosporin, due to their ability to enhance the hepatotoxic and nephrotoxic effects of Cilloxicam;
Non-steroidal anti-inflammatory drugs and corticosteroids due to damage to the gastro-intesintale mucosa;
Lithium, given the increased toxic effects of the same;

Contraindications ZELIS ® Cinnoxicam

The use of ZELIS ® 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

Different clinical trials and careful post-marketing monitoring demonstrate the excellent tolerability of ZELIS ®, which is rarely associated with the appearance of clinically relevant side effects.

Nevertheless, it should be remembered that Cilloxicam, belonging to the category of non-steroidal anti-inflammatory drugs, could determine, especially in predisposed patients, the appearance of:

gastric pyrosis, gastralgia, nausea and vomiting, constipation and in severe cases ulcers and hemorrhages;
hearing and sight disorders, headache, insomnia, drowsiness, confusion and tremors;
erythema, rash, urticaria and in severe cases bullous reactions;
hypertension, sloping edema and heart failure.