Mayanmar Product

Kuserta Tablets

Kuserta Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:

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.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

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.

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

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.

What to do if you accidentally take too much (overdose) of the medicine?

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

Is it safe in pregnancy and breast-feeding?

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.

Storage Conditions:

Store below 30°C in dry place. Protect from direct sunlight. Keep all medicines out of reach of children.

Drug Description

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

Indications and dosage.

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:
Route of administration: Oral
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.

Side effects and drug interactions.

Side effect
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.

Drug interactions
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.

Overdosage and Contraindications

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


Clinical pharmacology.

Pharmacotherapeutic group:
Other drugs for disorders of the musculo-skeletal system, Enzymes.
ATC Code: M09 AB

Pharmacological properties.
Pharmacodynamics:
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 activity. antioedemic 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. 

Pharmacokinetics:
The medicine passes through stomach in unchanged form and is absorbed in the intestines. Serratiopeptidase is detected in urine in insignificant quantity. 

Shelf life 3 years.
Storage condition
Store below 30°C in dry place. Protect from direct sunlight. Keep all medicines out of reach of children..

Package
Alu-Alu strip of 10 tablets. 3 or 10 strips in a carton.

Conditions of supply
On prescription.

Manufacturer
KUSUM HEALTHCARE PVT LTD.

Address
SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.


CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
D-158A, OKHLA,INDUSTRIAL AREA,
PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575