PERK

TECHNICAL BULLETIN

 TERRAZEN / TERRAZEN FORTE TABLETS

(SERRATIOPEPTIDASE 5 / 10 MG)

 INTRODUCTION :

The use of digestive enzymes like diastase and pancreatin has been well known since the end of the last century. The observations that Trypsin exerted an anti-inflammatory effect when administered to patients with thrombophlebitis led to the development of anti-inflammatory agents that are proteolytic in nature.

Takeda Chemical Industries in Japan discovered that a new strain E15 of the bacteria belonging to the genus Serratia produces a potent protease and this enzyme was named SERRATIOPEPTIDASE. Takeda, after inventing the methods of purification and procedure of mass production  established the position of the proteolytic enzyme as a medicinal product by conducting studies on pharmacological activities using a new analytical method and elucidating the mechanism of intestinal absorption and biological behaviour, especially anti-inflammatory and sputum liquefying activity of the enzyme. This paved the way for its wide application in medicine worldwide.

Extensive clinical trials have been conducted in India namely by Dr. D.C. Norkotoky, M.B.B.S., F.R.C.P., Professor of Medicine, Gauhati Medical College and Dr. S.K. Chhabra and Prof. M.P.S. Menon, Clinical Research Centre, V.P. Chest Institute, University of Delhi which proved beyond doubt the tremendous efficacy of this enzyme in its sputum liquefying and anti-inflammatory action.

PHARMACOLOGY :

1.         Anti-Inflammatory and Anti-Edema action :

            TERRAZEN/FORTE (Serratiopeptidase) given orally,

(a)  Represses the activation of fibrinolysis and vascular permeability in scalded rats as an inflammation model.

(b)  Inhibits inflammatory edema of the rat skin caused by rat anti-serum. Similiarly the drug inhibits inflammatory edema due to phlogogenic (causing inflammation) substances such as carragenin, dextran, serotonin and bradykinin.

(c)   IN VITRO the drug decomposes bradykinin that are phylogogenic polypeptides.

(d) The drug strongly lyzes fibrin, but does not appreciably affect other proteins in the living body.

2.         The promotion of lysis and discharge of Sputum & Pus : The drug decreases      viscosity of nasal discharge in patients with chronic sinusitis.

3.         Promotion of the Transfer of Antibiotics to the site of Infection :

            The drug accelerates the transfer of ampicillin and sulbenecillin to the maxillary sinus mucosa in patients with chronic sinusitis. The drug also accelerates the transfer of medillinum into the bladder wall in rabbits with experimental cystitis. The drug enhances the penetration of Penicillin-G into the abscess in the back of guinea pigs and the permeability of Gentamycin into the cerebrospinal fluid in rats.

COMPARISON OF CASEINOLYTIC ACTIVITY :

            Enzyme                                              Caseinolytic Activity (units/mg)

                                                                        pH 7.0                                    pH 9.0

            Serratiopeptidase                             1,350                                       2,550

            Chymotrypsin                                        600                                         670

            Trypsin                                                  368                                          531

            Bromeline                                             126                                         105

            Pronase                                                 435                                         740

 COMPARISON OF FIBRINOLYTIC ACTIVITY :

            Enzyme                                     Amount of enzyme required for dissolving

                                                                 fibrin clot within 10 minutes (ug/ml)

             Serratiopeptidase                                                       5

            Chymotrypsin                                                              40

            Trypsin                                                                         25

            Bromeline                                                                 100

            Pronase                                                                       45

This proves beyond doubt that SERRATIOPEPTIDASE is superior in both Fibrinolytic as well as Caseinolytic Activity than Chymotrypsin and Trypsin.

ACTION :

1.     Terrazen/Forte improves circulation in the inflammatory focus by breaking down abnormal exudates and proteins and facilitating the removal of the decomposed product through the blood and lymphatic vessels.

2.     It accelerates the elimination of sputum, pus and haemotoma by breaking down and liquefying mucous secretion and fibrin clot.

3.     The drug increases the concentration of anti-biotics in the focus of infection.

INDICATIONS :

1.     Respiratory Diseases : When Terrazen/Forte was tried in chronic bronchitis, in some cases associated with pulmonary emphysema of varying degree and pulmonary tuberculosis, it was found that there was easier expectoration in 82.6% of the patients, as a main therapeutic effect. There was improvement in various other symptoms like cough (62.5%), sputum (78.2%) and dyspnoea (difficulty in breathing) (66.7%).

2.     Sinusitis : Serratiopeptidase is used for remission of swelling radical operation for chronic sinusitis. It proved significantly superior in improving post-nasal discharge and purulent rhinrrhea.

3.     Surgical Conditions : Terrazen/Forte was assessed to be very effective in cases of swelling, pain, flare and induration. In the fields of orthopaedics, it is administered for suppressing and eliminating post-operative bleeding and resultant formation of haemotoma which are the most serious problems in the field.

      The administration of serratiopeptidase in conjunction with antibiotics, is said to be highly effective for inflammation and it was found that the combined administration was clearly more effective than the administration of antibiotic alone.

      The drug has also been used with success in reducing the swelling which accompany the sprain of the ankle. It also gave excellent results (symptomatically) in haemorrhoidal disturbances.

4.     Inflammatory diseases in Obstetrics and Gynaecology : Terrazen/Forte is found to be quite useful in controlling swelling and pain in perineal laceration and following lateral episiotomy. It is also quite effective in alleviating subjective symptoms of spontaneous pain and tenderness in the breast in puerpereal women suffering from engorgement of the breast.

5.     Optic Haemorrage : The drug has been tried for the treatment of retinal phlebothrombosis and various optic haemorrages. It was particularly effective for subconjunctival bleeding and hyphaema.

6.     Oral Surgery : In the surgical treatment of diseases occurring in the jaw bone and its surrounding tissues, swelling develops around the site of the operation and Terrazen/Forte was found to be very effective in such conditions. It has also been used with great success in conditions like pericoronitis of wisdom tooth, acute alveolar abscess, periodontitis, pain after odontectomy, traumatic alveolar fracture, tooth fracture, etc.

PRECAUTIONS :

In patients with blood coagulation abnormalities, severe hepatic and renal disturbances or under treatment with anti-coagulants, the drug should be given under careful observation. The drug may occasionally cause gastro-intestinal disturbances such as anorexia, gastric discomfort and nausea. Administration should be discontinued when hypersensitive symptoms, such as eruption, appear.

By and large the drug has proven to be absolutely safe with negligible side effects.

DOSAGE :

In Mild to Moderate Cases :                          1 Terrazen Tab. (5mg) TDS after meals.

In Moderate to Severe Cases          :           1 Terrazen Forte (10mg) TDS after meals.

PRESENTATION :

In blisters of 10ís as enteric coated tablets.

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