Anti-inflammatory for chronic diseases (Proteolytic enzymes) THERAPEUTIC INDICATIONS: WOBENZYM ® is useful in chronic inflammatory processes such as rheumatoid arthritis, osteoarthritis, chronic inflammatory joint and soft tissue, especially in those patients in whom the use of other anti-inflammatory drugs (NSAIDs) is not possible. Pharmacokinetics and pharmacodynamics: The absorption of macromolecular substances in intact seemed impossible until recently. However, with the progress of highly specific methods of analysis has been possible to verify the absorption enzymes and other substances of macromolecular gastrointestinal tract to the bloodstream or lymphatic vessels in a qualitative way and scientifically verifiable. In fact, a way of demonstrating that it is absorbed by the therapeutic effect is achieved by his administration. We need to recognize that the methodology for the analysis of the absorption of these compounds is difficult because we must take into account the role they can play endogenous factors, exogenous and pharmacology in the determination of these values. That is why tests marked with radioisotopes with enzymes (Seifert, 1979; Steffen, 1979) demonstrate the absorption of macromolecular complexes that may correspond to the hydrolases contained in the formulation of WOBENZYM ®. Another way to demonstrate the absorption of enzymes is to determine the hydrolytic activity of the plasma before and after oral administration of an enzyme preparation as WOBENZYM ®, a situation demonstrated by Kleine, 1993. With the above can demonstrate the following range of absorption: amylase, 44%; Bromelin, 39%; chymotrypsin, 16%; pancreatin, 19%; papain, 7%; trypsin, 28%; routine, 10%. Though it seems little, the pharmacological activity gained justifies its administration. Once absorbed, enzymes were join the antiproteasas a-1-antitrypsin and a-2-macroglobulin, which prevents the patient's immune system to recognize antigens such as enzymes, without this meaning that inhibits the activity enzyme. In fact, these complex enzyme-antiproteasa have demonstrated pharmacological activity. The enzymes are absorbed by the liver or eliminated by the system mononuclear fagocítico. Some studies assumed that the enzymes could be eliminated absorbed by the pancreatic juice. The mechanism of action of enzymes in its process to inhibit the inflammatory reaction seems to be over-contributing to the degradation of plasma proteins that invade the interstitial space during the process of acute inflammation, facilitating their elimination by the blood or lymphatic system. It also seems to participate in the removal of inflammatory mediators, such as bradiquinina, which despolimeriza and removed. Finally, it appears that the enzymes also help to degrade and remove the "cloak" fibrin formed on the site of inflammation. With this, which is accomplished by the inflammatory edema is absorbed more quickly and the swelling is reduced and disappear. This will achieve a return of the microcirculation, thus removing the product is faster and more efficient, resulting in a significant decrease in pain and discomfort of the patient. CONTRAINDICATIONS: Hypersensitivity to the components of the formula. PRECAUTIONS GENERAL: Because we can expect a fibrinolytic activity of the enzyme preparation, it is advisable to exercise caution in patients with anticoagulant therapy. RESTRICTIONS ON USE DURING PREGNANCY AND BREAST: To date have not shown teratogenic or embryotoxic with WOBENZYM ®. Like any drug, its use during pregnancy and lactation is under strict responsibility of the physician. Not established their safety in children. If it is considered necessary to use in this type of patient, it should assess the benefits. REACTIONS AND SIDE EFFECTS: Seldom have allergic-type reactions, which disappear upon discontinuation of treatment. In some patients have reported an increase in symptoms at the start of treatment, a situation that must be interpreted as positive and should not be suspending the administration of WOBENZYM ®. In isolated cases it has been reported that WOBENZYM ® may cause a change in the odor, color and / or consistency of stool. The repeated use of WOBENZYM ® at high doses has, in very few patients, mild sedation, hyporexia and light weight loss. INTERACTION OF DRUGS AND OTHER GENDER: There have been clinical observations of interaction WOBENZYM ® with other medicines to justify the experimental exploration level. However, in patients under treatment with anticoagulants should be justified on security WOBENZYM ®. ALTERATIONS IN LABORATORY TESTS RESULTS: We do not recommend the use of evidence pre-WOBENZYM ® operating pancreatic or intestinal absorption. The absorption of WOBENZYM ® can reduce the time and recalcificación lysis of euglobina. The use of WOBENZYM ® may increase the thromboplastin time and partial thromboplastin time in patients with post-thrombotic syndrome. Some studies have shown that the use of WOBENZYM ® can reduce blood viscosity and aggregation of red blood cells in some patients. PRECAUTIONS ON EFFECTS OF Carcinogenesis, Mutagenesis, teratogenesis AND ON FERTILITY: In studies have found no effects carcinogenic, mutagenic, teratogenic or on fertility attributable to the use of WOBENZYM ®. DOSAGE AND ROUTE OF ADMINISTRATION: Oral. Suggests 6 to 9 pills a day spread over 3 shots (2 to 3 pills every 8 hours), preferably one hour before the meal. The dose can be increased without the risk of toxicity. The management time will depend on the patient's clinical condition, and is known to the attending physician. In cases of very severe processes, a higher dose can be used without requiring additional diagnostic studies or have the possibility of severe side effects. EVENTS AND HANDLING OF THE ACCIDENTAL OVERDOSES O INTAKE: WOBENZYM ® has been the subject of many studies on its toxicity and the results are as follows: Failed to determine the median lethal dose (LD50) ® WOBENZYM administered orally, including the dose of 15 g / kg (representing the administration of 3750 pills in a single socket). The administration of WOBENZYM ® long-term doses suggested there has been no signs or symptoms of toxicity. AVISO: Este producto puede tardar en servirse de 7 a 12 días.
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