Xarelto, 2.5 mg, film-coated tablets, 28 pcs.

Pharmacological properties of the drug Serrata

Pharmacodynamics. Serratiopeptidase is a proteolytic enzyme isolated from the non-pathogenic intestinal bacterium Serratia E15. Clinical studies have shown that serratiopeptidase has fibrinolytic, anti-inflammatory and anti-edematous effects. 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 α2-macroglobulin, which masks its antigenicity but retains enzymatic activity. Serratiopeptidase slowly penetrates into the exudate at the site of inflammation and its level in the blood gradually decreases. By hydrolyzing bradykinin, histamine and serotonin, serratiopeptidase reduces capillary dilatation and controls capillary permeability. Serratiopeptidase blocks plasmin inhibitors, thus promoting the fibrinolytic activity of plasmin. By reducing swelling and improving microcirculation, serratiopeptidase promotes mucus separation. Pharmacokinetics. The drug passes through the stomach unchanged and is absorbed in the intestines. Serratiopeptidase is detected in small amounts in the urine.

Serrata™ 10 mg No. 150 tablet p.o. solution/intestinal

Instructions for medical use of the drug SERRATATM Trade name SERRATATM International nonproprietary name No Dosage form Film-coated tablets, enteric, 10 mg Composition One tablet contains the active substance - serratiopeptidase 10 mg, excipients: lactose monohydrate, corn starch, light magnesium carbonate, sodium starch glycolate, magnesium stearate, shell composition: coating Opadry YS-1-7027 white (titanium dioxide, hypromellose, triacetin), Opadry OY-P-7171 white (diethyl phthalate, titanium dioxide, stearic acid, polyvinyl acetate phthalate), purified water, alcohol isopropyl, methylene chloride. Description Round, biconvex tablet, enteric-coated, white. Pharmacotherapeutic group Other drugs for the treatment of diseases of the musculoskeletal system. Enzyme preparations. ATC code M09 AB Pharmacological properties Pharmacokinetics The drug passes through the stomach unchanged and is absorbed in the intestine. Maximum plasma concentration is achieved after 1 hour. Serratiopeptidase is detected in small amounts in the urine. When prescribing a therapeutic dose of serratiopeptidase, it is not possible to study the pharmacokinetics due to the instability of the enzyme in the blood. Absorption can be studied when high doses are administered to volunteers. Serratiopeptidase in plasma is determined after oral administration at a dosage of 100 mg/kg, its peak concentration is detected after 30 minutes. and within 2 hours after administration, it is absorbed in the small intestine and circulates in the blood in the form of enzyme-like active forms. Pharmacodynamics The active substance of SerrataTM - serratiopeptidase, isolated from the non-pathogenic intestinal bacterium Serratia E15, is a proteolytic enzyme with fibrinolytic, anti-inflammatory and anti-edematous activity. In addition to reducing the inflammatory process, SerrataTM reduces pain by blocking the release of pain mediators from the site of inflammation. SerrataTM binds in a 1:1 ratio to blood alpha-2-macroglobulin, which masks its antigenicity but preserves its enzymatic activity. It slowly turns into exudate at the site of inflammation, and gradually its level in the blood decreases. By hydrolyzing bradykinin, histamine and serotonin, serratiopeptidase directly reduces capillary dilatation and permeability. SerrataTM blocks plasmin inhibitors, thereby increasing fibrinolytic activity. SerrataTM, due to proteolysis of the structural proteins of sputum, improves the rheological properties of sputum and promotes its discharge. Indications for use In complex therapy - sprains and ruptures of ligaments, fractures and dislocations (to reduce swelling and restore microcirculation at the site of injury) - diseases of the upper respiratory tract (to reduce the viscosity of sputum and facilitate its discharge) - diseases of the ENT organs: facilitates the discharge of secretions paranasal sinuses - dermatitis with pain - mastitis (for resorption of hematomas, reducing congestion in the mammary glands) Method of administration and dosage The drug is prescribed as part of complex therapy in a dose of 10 mg (1 tablet) 2-3 times a day after meals. The tablets should be swallowed without chewing with 1 glass of water. The maximum single dose is 10 mg. The maximum daily dose is 30 mg. The duration of treatment depends on the nature and dynamics of the pathological process and is determined individually by the doctor. Side effects Rarely - nausea - vomiting - anorexia - epigastric discomfort - diarrhea Very rarely - nosebleeds - sputum mixed with blood - skin rashes, itching, skin flushing - acute eosinophilic pneumonia - hypersensitivity reactions are possible in persons with individual intolerance to the components of the drug Contraindications - hypersensitivity to the components of the drug - gastric ulcer - pregnancy and lactation - childhood and adolescence up to 18 years For patients with bleeding disorders, impaired liver and kidney function receiving anticoagulant treatment, careful monitoring is necessary when prescribing serratiopeptidase. Drug interactions When used simultaneously, the drug enhances the effect of anticoagulants. Concomitant use of serratiopeptidase and carbamazepine leads to a decrease in serum concentrations, therefore, to a decrease in the effect of carbamazepine. Special instructions Since the drug affects blood clotting, it should be used with caution in patients with a risk of bleeding and impaired clotting time, as well as in patients who are taking anticoagulants. In case of severe liver and kidney diseases, the drug is used with caution. The drug should not be taken by patients with rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Peculiarities of the drug's influence on the ability to drive a vehicle or operate potentially dangerous mechanisms. No effect. Overdose Symptoms: nausea, vomiting, anorexia, epigastric discomfort, blood in the sputum and bleeding. Treatment: symptomatic therapy. Release form and packaging 10 tablets in a contour-free packaging. One contour-free packaging together with instructions for medical use in the state and Russian languages ​​in a cardboard box. 10 cardboard packages are placed in a cardboard box (10x10). 30 tablets in contour-free packaging. 1, 5 and 10 contour cellless packages together with instructions for medical use in the state and Russian languages ​​are placed in a cardboard box. Storage conditions Store in a place protected from light, at a temperature not exceeding 25ºС. Keep out of the reach of children! Shelf life: 3 years Do not use after the expiration date indicated on the package. Conditions for dispensing from pharmacies By prescription Manufacturer Kusum Heltker Pvt. Ltd., SP 289 (A), Riiko Indl. Area, Chopanki, Bhiwadi (Raj), India Registration Certificate Holder Kusum Heltker Pvt. Ltd., India Address of the organization that accepts claims from consumers on the quality of products (products) in the territory of the Republic of Kazakhstan Representative office of the Kusum Care Pvt. Ltd.", India in the Republic of Kazakhstan, Almaty, Dostyk Ave., 117/6, tel/fax: 295-26-50; 295-26-55

Indications for use of the drug Serrata

Surgery : sports injuries, sprains and ruptures of ligaments, fractures and dislocations, postoperative swelling, and is also used if there is a risk of transplant rejection. Plastic surgery : reduces postoperative swelling, restores microcirculation at the site of transplant rejection. Upper respiratory tract diseases : reduces the viscosity of sputum, promotes better penetration of antibiotics. Diseases of the ENT organs : infectious diseases of the ear, sinusitis. Dermatology : acute dermatoses. Obstetrics and gynecology : the anti-inflammatory activity of the drug promotes the resorption of hematomas and reduces swelling of the mammary glands.

Pharmacological profile

Serata is an effective broad-spectrum enzyme agent with many beneficial properties:

• anti-inflammatory;
• painkillers;
• antioxidant;
• decongestants;

• fibrinolytic (thrombolytic).

Thanks to serratiopeptidase, the drug is characterized by proteolysis - the enzyme breaks down bradykinin, fibrin and other mediators of inflammatory pathogenesis. The medicine acts as a diuretic, helps thin the blood, improve blood circulation, including in the kidneys. Moreover, serrapeptase prevents the expansion of capillaries and their permeability, therefore inflammation is prevented and allergic reactions are stopped.

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Since the tablets are enclosed in an enteric capsule, absorption occurs not in the stomach, but in the intestines. The highest content of the main pharmaceutical substance in the blood serum is visualized 60 minutes after administration. Serata is excreted in the urine in small quantities.

Special instructions for the use of Serrata

Since the drug affects blood clotting, it should be used with caution in patients with a risk of bleeding and with impaired clotting time, as well as in patients taking anticoagulants. In case of severe liver and kidney diseases, the drug is used with caution. Children. There is no experience of use in children, so the drug should not be used in this age group. Use during pregnancy or breastfeeding. There is no experience with the use of the drug during pregnancy and lactation, so it should not be used in such patients. The ability to influence reaction speed when driving vehicles or other mechanisms. There is no data regarding the negative effect of serratiopeptidase on reaction speed when driving vehicles or other mechanisms.

Components

Many people mistake Serata for an antibiotic or a hormone, but the drug does not contain a hormonal or antibacterial substance, but an enzyme, serratiopeptidase. Serrapeptase (the second name of the active substance) is capable of breaking down complex protein compounds - two-component proteins that are not observed in a healthy person (blood clots, mucous secretions).

One tablet contains 10 mg of the active ingredient.

Auxiliary components of tablet form:

• sodium salt of carboxymethylated starch;
• anhydrous lactose;
• magnesium carbonate;

• corn starch;
• salt of magnesium and stearic acid.

Serata are enteric-coated, biconvex tablets, sold strictly according to a doctor’s prescription. One pack contains 10, 30, 100 pieces and instructions for use. The medication should be kept away from children at air temperatures no higher than 25 degrees.

Contraindications to the use of the medicine

The medication is contraindicated in case of hypersensitivity to the main active ingredient - serratiopeptidase - and auxiliary components. Serata is prohibited for consumption:

1. patients under 18 years of age;
2. pregnant and lactating women;

3. patients with hemophilia, thrombocytopenia and other disorders of the hematopoietic system;
4. people with kidney and liver failure, metabolic disorders;
5. patients with a history of bleeding and impaired blood clotting.

The medicine is incompatible with the simultaneous use of antithrombotic drugs (anticoagulants).

If the dosage is exceeded, there is a risk of internal bleeding. If the dose is accidentally exceeded, it is recommended to stop using the medication and carry out symptomatic therapy.

Analogs of a universal drug

Serrata is produced by an Indian pharmacological company, does not have Russian registration and is available only in Ukraine. The average cost of tablets No. 30 is 134 rubles.

Generics of the drug are presented in the table:

Due to the lack of proper control over product quality, numerous versions of dietary supplements with serrapeptase are not recommended for use.