Full Prescribing Info
Each enteric coated tablet contains: Serratiopeptidase 10 mg (equivalent to 20,000 units of Serratiopeptidase).
Excipients/Inactive Ingredients: Lactose monohydrate, maize starch, light magnesium carbonate, sodium starch glycolate, magnesium stearate, opadry white (YS-1-7027), opadry enteric white (OY-P-7171), isopropyl alcohol, dichloromethane and purified water.
Pharmacotherapeutic group: Drugs for disorders of the musculo-skeletal system, Enzymes. ATC code: M09 AB.
Pharmacology: Pharmacodynamics: Serratiopeptidase acts as a fibrinolytic, anti-inflammatory, anti-oedematous and inactivates bradykinin. It is able to increase the diffusion of antibiotics and cytostatic agents in tissue.
Pharmacokinetics: There is still no data on the bioavailability in humans. Animal experimental findings shows that Serratiopeptidase is absorbed from the duodenum. After 10 mg/kg Serratiopeptidase administered intraduodenally to dogs, radioimmunoassay identified peak concentrations in the lymph (26 ng/ml), in the portal vein blood (16 ng/ml) and in arterial blood (about 11 ng/ml), by binding to alpha 2-macroglobulin Serratiopeptidase loses its antigenicity; while maintaining a sufficient proteolytic activity.
As an anti-inflammatory therapy in inflammatory swelling and suppuration, in addition to causal - eg antibiotic or surgical - therapy, or when a causal therapy is missing or when it is not applied in individual cases.
Inflammation after surgery or injury; Inflammation of the following diseases: In otorhinolaryngology: Sinusitis.
In dentistry: Pericoronitis of wisdom teeth or alveolar abscess of other teeth, when a surgical therapy is not possible or advisable.
In gynecology: Breast swelling and discomfort in the early postpartum lactation due to hormone caused galactostasis.
In Urology: In case of cystitis in addition to antibiotic therapy.
Dosage/Direction for Use
Depending on the severity of the disease, swallow 1-2 tablets, 3 times a day without chewing 2 hours after meals.
Intoxications have not occurred even after high doses (till 15 tablets daily for 60 days). If necessary, gastric lavage should be considered.
Hypersensitivity to Serratiopeptidase or any of the excipients.
Ulcers in upper GI tract caused by gastric acid.
This product is not suitable for infants and young children.
Special Precautions
If symptoms persist or worsen, discontinue use and consult a health care practitioner.
If the patient is pregnant or breastfeeding, a health care practitioner should be consulted prior to use.
If the patient has a gastrointestinal lesion/ulcer, is taking anticoagulant/blood thinner or anti-inflammatory medication, has coagulation disorders, liver and kidney damage, or is having surgery, a healthcare practitioner should be consulted prior to use.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Kuserta.
Effects on ability to drive and use machines: There have been no studies on the effects on the ability to drive and the ability to drive or operate machinery.
Use In Pregnancy & Lactation
Use in pregnancy: There is no sufficient data to determine the safety of Serratiopeptidase for humans during pregnancy. There are insufficient animal studies regarding the effects of Serratiopeptidase on pregnancy, embryonal/fetal development, birth and postnatal development. Serratiopeptidase may be prescribed during pregnancy only if clearly indicated.
Use in lactation: It is not known that Serratiopeptidase, the active ingredient of Kuserta is excreted in human milk. No adverse effects were observed during lactation in children of mothers undergoing treatment with serratiopeptidase.
Adverse Reactions
In rare cases: Stomach and intestinal discomfort, nausea, vomiting and diarrhea.
In isolated cases: Hypersensitivity reaction, e.g. skin rash, erythema, urticaria, itching, also dyspnoea and edema.
In individual cases: Elevated liver enzymes (SGOT, SGPT, AP, γ-GT), jaundice and hepatitis, severe skin (Stevens-Johnson-Syndrome, Lyell-syndrome) and respiratory disorders (Löffler-Syndrome, Pneumonitis) and shock.
Drug Interactions
Since the concomitant use of Serratiopeptidase with an anticoagulant may intensify the anticoagulant effect, Serratiopeptidase should be administered with care under close observation.
In a single case, the co-administration of carbamazepine and Serratiopeptidase led to a decrease in blood serum concentration and thus a decreased effect of carbamazepine.
Store below 30°C in dry place. Protect from direct sunlight.
ATC Classification
M09AB - Enzymes ; Used in the treatment of musculo-skeletal disorders.
EC tab 10 mg (white colored, circular, biconvex, plain on both sides) x 5 x 30's.
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