Composition:
Each enteric coated tablet contains:
Serratiopeptidase ………… 10 mg
Description:
White colored, circular, biconvex, enteric coated tablets having plain surface on both sides.

Indications:
Surgery:
Sport injuries, sprain and rupture of ligaments, fractures and dislocations, edemas caused by operation; the medicine is also used in risk of graft rejection.
Plastic surgery:
The medicine reduces postoperative edemas and renews the microcirculation in place of graft rejection.
Upper airways diseases:
The medicine reduces the sputum viscosity and promotes for better antibiotics penetration.
ENT organs diseases:
Medicine confers mucolytic activity in infection of ear cavity and sinus.
Dermatology:
The medicine is used in acute painful inflammatory dermatosis.
Obstetrics and gynecology:
Medicine has anti-inflammatory activity and promotes resorption of haematomas and reduces the edema of mammary glands.

Dosage:
Adults:
Depending on the severity of the disease 3 times daily.
Children ≥ 6 years:
Depending on the severity of the disease 2 to 3 times daily.
The treatment is usually carried out until the symptoms resolve. In general, a treatment period of 1 – 2 weeks is sufficient.
Mode of administration:
The tablet should be swallowed whole with water after meals.

Undesirable effects:
Rarely the stomach and intestinal discomfort, nausea, vomiting and diarrhea can occur. The allergic reactions such as rash, erythema, urticaria, pruritus and respiratory problems and edema are observed in few patients.
Very rarely sputum streaked with blood or nasal bleeding.
In individual cases, elevations of liver enzyme values (SGOT, SGPT, ALP, GGT) as well as jaundice and hepatitis, severe skin (Stevens-Johnson syndrome, Lyell’s syndrome) and pulmonary responses (Loeffler’s syndrome, pneumonitis) and shock have been observed.

Interactions with other medicaments:
In one case, concomitant administration of Serratiopeptidase and carbamazepine resulted in decrease in blood serum concentration and decreased effect of carbamazepine.

Warnings and precautions:
Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take Kuserta.

Pregnancy and lactation:
Use in pregnancy:
There are no adequate data on humans to prove the safety of Serratiopeptidase during pregnancy. Similarly, no adequate experimental animal studies are available regarding the effects of Serratiopeptidase on pregnancy, embryonic/fetal development, birth and postnatal development. Serratiopeptidase may be prescribed only after strict evaluation in pregnancy.
Use during lactation:
It is not known whether Serratiopeptidase is transferred in breast milk. In children of mothers treated with Serratiopeptidase no adverse effects were observed during lactation.

Overdose and treatment:
Symptoms:
Nausea and vomiting, epigastric discomfort. In rare cases there may be blood in sputum or bleeding.
Treatment:
Symptomatic therapy

Contraindications:
Kuserta is contraindicated for patients with a history of hypersensitivity to the ingredients of this drug product.
In patients having ulcers in the upper digestive tract i.e. stomach. Kuserta is not suitable for infants and toddlers.
Note: In patients with coagulation disorders, liver and kidney damage as well those who are under anticoagulant therapy, treatment with Kuserta must be carefully monitored.

Pharmacodynamic properties:
Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system, Enzymes.
ATC code: M09 AB
Serratiopeptidase that is known also as Serrapeptase is a proteolytic enzyme, which is extracted from nonpathogenic intestinal bacteria. Clinical trials shown serratiopeptidase has fibrinolytic, anti-inflammatory and antioedemic activity. Other than reducing inflammatory process, serratiopeptidase reduces pain via blocking release of painful amines from inflamed tissues. Serratiopeptidase combines with alfa-2- macroglobulin of blood in ratio 1:1, which masks its antigenicity, but it retains its enzyme activity. Serratiopeptidase is released in exudates at the focus of inflammation and its level in blood decreases gradually.
Serratiopeptidase directly reduces the capillary dilatation and controls theirs permeability via hydrolysis of bradykinin, histamine and serotonin. Serratiopeptidase blocks plasmin inhibitors and in that way promotes plasmin fibrinolytic activity. By reducing edema and improving microcirculation, Serratiopeptidase makes sputum expectoration easier.
Mechanism of action:
It binds to alpha-2-macroglobulin in the blood in the ratio of 1:1 which helps to mask its antigenicity but retains its enzymatic activity and is slowly, transferred to site of inflammation. Serratiopeptidase hydrolyses bradykinin, histamine and serotonin responsible for oedematic status. It reduces swelling, improves microcirculation & expectoration of sputum etc. Thus serratiopeptidase has anti-inflammatory, antioedemic and fibrinolytic activity and acts rapidly on localized inflammation.
Serratiopeptidase exhibits following activities:
1. Anti-inflammatory and anti-swelling:
a. Inhibition of vascular permeability due to scald or injury.
b. Inhibition of inflammatory edema due to histamin, serotonin, bradykinin.
c. Excellent decomposability of bradykinin.
d. Strong decomposability of fibrin.
e. No effects on alpha-, beta-globulin and albumin.
2. Action to promote the lysis and discharge of sputum and pus:
a. Decreased pus viscosity in patients with chronic sinusitis.
b. Decreased sputum viscosity in patients with sub-acute bronchitis.
3. Action to promote transfer of antibiotics to the focal site.
It can promote the transfer of ampicillin and sulbenicillin to the palate of patients with chronic sinusitis.
Pharmacokinetic properties:
The medicine passes through stomach in unchanged form and is absorbed in the intestines. Serratiopeptidase is detected in urine in insignificant quantity.

Storage conditions:
Store below 30°C in dry place. Protect from direct sunlight.
Keep all medicines out of reach of children.
Dosage forms and packaging available:
Alu-Alu strip of 10 tablets. 3 or 10 strips in a carton.
Name and address of manufacturer:
Kusum Healthcare Pvt. Ltd.
SP 289(A), RIICO Indl. Area,
Chopanki, Bhiwadi (Rajasthan), India
MM Reg. No.: 1812AA 7074 14066001461705
Date of revision of package Insert:
Not Applicable