Instructions for Serrata enteric-coated tablets 10 mg strip No. 150
Composition
active ingredient: serratiopeptidase;
1 tablet contains 10 mg of serratiopeptidase;
excipients: lactose monohydrate, corn starch, light magnesium carbonate, sodium starch glycolate (type A), magnesium stearate, Opadry-YS-1-7027* coating, Opadry-OY-P-7171** coating.
* – Opadry-YS-1-7027 coating: hypromellose, titanium dioxide (E 171), triacetin.
** – Opadry-OY-P-7171 coating: polyvinyl acetate phthalate, titanium dioxide (E 171), diethyl phthalate, stearic acid.
Dosage form
The film-coated tablets are enteric-coated.
Main physicochemical properties: round biconvex tablets, coated with a white enteric-coated film.
Pharmacotherapeutic group
Drugs used in musculoskeletal disorders. Enzymes. ATX code M09A B.
Pharmacological properties
Pharmacodynamics.
Serratiopeptidase is a proteolytic enzyme isolated from the non-pathogenic intestinal bacterium Serratia E15. It has fibrinolytic, anti-inflammatory and anti-edematous activity. In addition to reducing inflammation, serratiopeptidase reduces pain by blocking the release of pain amines from inflamed tissues.
Serratiopeptidase binds in a 1:1 ratio to blood alpha-2-macroglobulin, which masks its antigenicity but retains its enzymatic activity. Then, gradually, at the site of inflammation, it passes into the exudate and, accordingly, its level in the blood decreases.
Serratiopeptidase directly reduces capillary dilation and controls capillary permeability by hydrolyzing bradykinin, histamine, and serotonin. Serratiopeptidase also blocks plasmin inhibitors, thereby enhancing the fibrinolytic activity of plasmin. By proteolysis of sputum structural proteins, it improves the rheological properties of sputum and promotes its clearance.
The enzymatic activity of the drug is 10 times higher than that of α-chymotrypsin. In the focus of chronic inflammation, serratiopeptidase helps reduce the level of inflammatory mediators of polypeptide nature (bradykinin), fibrin, but has no significant effect on proteins of the living organism, such as albumin and α- and γ-globulin.
The drug penetrates well into the areas of inflammation, lyses necrotic tissues and their decomposition products, reduces hyperemia and accelerates the penetration and activity of antibiotics. The drug reduces the viscosity of saliva and nasal secretions, thereby facilitating their removal.
Pharmacokinetics.
The drug passes through the stomach unchanged and is absorbed in the intestine. The drug is not inactivated by gastric juice. The maximum concentration in the blood plasma is reached after 1 hour. Serratiopeptidase reaches the bloodstream in an enzymatically active form, is also excreted in an active form with bile and is detected in small quantities in the urine.
Indication
Surgical diseases: sprains and ligament tears, fractures and dislocations, swelling caused by plastic surgery.
Respiratory diseases: reduces the viscosity of phlegm and facilitates its discharge from the respiratory tract.
ENT diseases: facilitates the drainage of sinus secretions.
Skin diseases: acute inflammatory dermatoses.
Diseases of the female genital organs and mammary glands: hematomas, congestion in the mammary glands.
Contraindication
Hypersensitivity to serratiopeptidase or to any other component of the drug. Blood clotting disorders.
Interaction with other medicinal products and other types of interactions
When used simultaneously, the drug enhances the effect of anticoagulants (such a combination of drugs should be used under close medical supervision), accelerates the penetration of antibiotics and nonsteroidal anti-inflammatory drugs into inflamed tissues.
Application features
Since the drug affects the blood clotting system, it should be used with caution in the following conditions:
- threat of bleeding;
- violation of blood clotting time;
- taking anticoagulants;
- severe liver disease;
- severe kidney disease.
Excipients.
The drug contains lactose, so it should not be used in patients with rare hereditary diseases such as galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Use during pregnancy or breastfeeding
The use of the drug during pregnancy or breastfeeding is not recommended due to the lack of clinical data.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
The drug is prescribed to adults 1 tablet 2-3 times a day after meals.
The tablets should be swallowed without chewing and washed down with 1 glass of water.
The maximum daily dose is 30 mg.
The dose and duration of the treatment course depend on the nature and dynamics of the pathological process and are determined in each case individually by the doctor.
Children.
The drug should not be used in children due to the lack of clinical data.
Overdose
Symptoms: nausea, vomiting, anorexia, epigastric discomfort, in some cases – bleeding and streaks of blood in the sputum.
Treatment: symptomatic therapy.
Adverse reactions
On the part of the digestive system: diarrhea, nausea, vomiting, anorexia, epigastric discomfort, abdominal pain.
Respiratory system: nosebleeds, bloody sputum, acute eosinophilic pneumonia.
On the part of the immune system: hypersensitivity reactions are possible in individuals with individual intolerance to any component of the drug.
Skin: skin rashes, itching, skin hyperemia.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
No. 10: 10 tablets in a strip; 1 strip in a cardboard box;
No. 10´10: 10 tablets in a strip; 1 strip in a cardboard pack, 10 packs in a box;
No. 10´3: 10 tablets in a strip; 3 strips in a cardboard box;
No. 30: 30 tablets in a blister or strip; 1 blister or strip in a cardboard box;
No. 150: 30 tablets in a strip; 5 strips in a cardboard box.
Vacation category
According to the recipe.
Producer
KUSUM HEALTHCARE PVT LTD/
KUSUM HEALTHCARE PVT LTD.
Location of the manufacturer and its business address
SP-289 (A), RIICO Industrial Area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India/
SP-289 (A), RIICO Industrial area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.
