PHLOGENZYME film-coated tablets No. 40


Nosological classification (ICD-10)

  • B19 Viral hepatitis, unspecified
  • G35 Multiple sclerosis
  • I20 Angina [angina pectoris]
  • I22 Recurrent myocardial infarction
  • I25.9 Chronic ischemic heart disease, unspecified
  • I63 Cerebral infarction
  • I70.2 Atherosclerosis of the arteries of the extremities
  • I74 Embolism and thrombosis of arteries
  • I79.8 Other lesions of arteries, arterioles and capillaries in diseases classified elsewhere
  • I80.0 Phlebitis and thrombophlebitis of superficial vessels of the lower extremities
  • I87.0 Postphlebitic syndrome
  • I89.0 Lymphoedema, not elsewhere classified
  • J18 Pneumonia without specifying the pathogen
  • J44 Other chronic obstructive pulmonary disease
  • K10.2 Inflammatory diseases of the jaws
  • K76.9 Liver disease, unspecified
  • L91.0 Keloid scar
  • M02 Reactive arthropathy
  • M35.3 Polymyalgia rheumatica
  • M45 Ankylosing spondylitis
  • N30.9 Cystitis, unspecified
  • N34 Urethritis and urethral syndrome
  • N39.0 Urinary tract infection without established location
  • N41.9 Inflammatory disease of the prostate, unspecified
  • N70 Salpingitis and oophoritis
  • N95.1 Menopausal and menopausal conditions in women
  • N99.4 Postoperative adhesions in the pelvis
  • T02.9 Multiple fractures, unspecified
  • T14.9 Injury, unspecified
  • T30 Thermal and chemical burns of unspecified location
  • T79.3 Post-traumatic wound infection, not elsewhere classified
  • T84.5 Infection and inflammatory reaction due to arthroplasty
  • Z100* CLASS XXII Surgical practice
  • Z54.0 Convalescent period after surgery
  • Z96.5 Presence of dental and jaw root implants
  • Z96.7 Presence of other bone and tendon implants

Compound

Enteric-coated tablets1 table
active substances:
bromelain450 units (FIP)
trypsin1440 units (FIP) (24 μkat)
rutin (rutoside)100 mg
excipients: lactose monohydrate - 148.58 mg; corn starch - 24 mg; magnesium stearate - 12.72 mg; stearic acid - 11.28 mg; purified water - 6.6 mg; colloidal silicon dioxide - 6.36 mg; talc - 2.46 mg
shell: methacrylic acid and methyl methacrylate copolymer (1:1) - 11.89 mg; macrogol 6000 - 0.67 mg; talc - 4.08 mg; triethyl citrate - 1.2 mg; vanillin - 0.15 mg

Pharmacodynamics

PHLOGENZYME is a new generation drug consisting of a combination of highly active proteolytic enzymes (enzymes) of plant and animal origin - bromelain and trypsin in combination with rutin. In combination, enzymes have a pleiotropic (multiple) effect, having a variety of pharmacological effects on pathophysiological and biochemical processes. The enzymes of the drug realize their therapeutic effects through anti-inflammatory, immunomodulatory, antiplatelet, fibrinolytic, thrombolytic, decongestant and secondary analgesic effects. Enteric-coated tablets of the drug pass transiently through the upper gastrointestinal tract without injuring the stomach and are absorbed in the small intestine by resorption of intact molecules (endocytosis, pinocytosis). The proteases of the drug, binding to the transport proteins of the blood (α-2-macroglobulin and α-1-antitrypsin), form a reversible protease-antiprotease complex, in which the antigenic determinants of the exogenous proteases of the drug are masked, which prevents allergic reactions. As a result of the formation of a complex with enzymes, antiprotease (α-2-macroglobulin) transforms into an active form, which functions as an extracellular regulator of proinflammatory cytokines and growth factors, carrying out their transport, clearance and elimination.

The formation of an active protease-antiprotease complex allows the safe movement of proteolytic enzymes along the vascular bed to the site of inflammation and to the site of injury, regardless of the location in the body. The complex retains and slows down the excretion of proteolytic enzymes of the drug from the body, increases their circulation time in the vascular bed and, accordingly, the therapeutic effect. Once at the site of inflammation and wounds, proteolytic enzymes break down (hydrolyze) damaged proteins and tissues and eliminate (remove) cellular debris (detritus), helping to accelerate the cleansing and healing of the wound.

The drug has a positive effect on the course of the inflammatory process, modulates the body's defense reactions, which contributes to the physiological course of inflammation at different stages. The proteolytic enzymes of the drug accelerate the breakdown of inflammatory mediators, break down immune complexes and membrane deposits, increase the activity of phagocytes and natural killer cells, and stimulate interferonogenesis. Proteases of the drug reduce the level of pro-inflammatory cytokines (IL-1β, IL-6, IL-8, IFN-γ, TNF-α) and promote increased production of anti-inflammatory cytokines (including IL-4, IL-10), regulate the level Ig and blood antibodies. The drug's enzymes limit the pathological manifestations of autoimmune and immune complex processes and restore the body's immunological reactivity.

The drug's proteases reduce the level of transforming growth factor β, an increase in which leads to excessive scarring. Proteolytic enzymes have a regulatory effect on the synchronization of the formation of the basement membrane (laminin), modulation of the wound process and the expression of angiogenesis factors (vasculoendothelial growth factor, fibroblast growth factor and a number of other factors). Thus, the enzymes of the drug help improve reparative processes, prevent the formation of hypertrophic and keloid scars, and the development of adhesive disease after surgical interventions in the abdominal cavity.

The enzymes of the drug break down and remove damaged tissue, accelerate the resorption of hematomas and edema by normalizing the permeability of vascular walls, reducing the infiltration of the interstitium with plasma proteins, increasing the elimination of protein detritus and fibrin deposits, improving microcirculation and trophic processes in the damaged area. Optimization of the inflammatory process by proteolytic enzymes by reducing oncotic pressure and tissue edema, reducing pressure on nerve endings, eliminating ischemia and normalizing microcirculation, direct proteolysis of inflammatory mediators allows proteases to have a secondary analgesic effect. At the same time, proteolytic enzymes stimulate the healing and repair processes, reduce the risk of thromboembolic complications during prolonged immobilization, and prevent the development of trophic disorders and purulent complications.

The enzymes of the drug have a positive effect on improving microcirculation, increasing the delivery of oxygen and nutrients to the wound, reducing inflammation at the site of damage, maintaining the physiological process of regeneration and accelerating the restoration of the function of organs and tissues.

The drug improves the rheological properties of blood (viscosity and fluidity) due to a positive effect on the functional state of blood cells and the vascular wall, plasticity (deformability) of red blood cells, stabilization of endothelial permeability, increasing fibrinolytic activity of blood serum, reducing the density of adhesive molecules, reducing platelet aggregation (sticking together) .

Proteolytic enzymes reduce the number of activated forms of platelets (spheroechinocytes) and micro- and macroaggregates, i.e. reducing the risk of thrombus formation in blood vessels, and at the same time participate in the lysis of formed blood clots. Proteolytic enzymes reduce the level of atherogenic lipids, helping to increase HDL, reducing the risk of atherosclerosis and vascular disorders.

The drug improves blood supply to the bronchi and lung tissue in chronic respiratory diseases, incl. caused by smoking, improves the viscosity properties of bronchial secretions, the function of the ciliated epithelium, restores the drainage function of the bronchi, thins sputum, which makes breathing easier and reduces cough.

The proteolytic enzymes of the drug increase the effectiveness of antibiotics, while simultaneously reducing the undesirable effects of antibiotic therapy (dysbiosis, irritable bowel syndrome). Proteases improve the breakdown of substrates, optimize the balance of microbiota, and contribute to the restoration of intestinal endoecology.

Pharmacological properties of the drug Phlogenzyme

Phlogenzyme is a combination drug containing enzymes and rutoside (rutin). Bromelain and trypsin help accelerate the breakdown of metabolic products formed during the inflammatory process, and rutoside normalizes the permeability of the vascular wall, reducing swelling and accelerating the resorption of hematomas. Phlogenzyme reduces blood viscosity, preventing thrombus formation and improving microcirculation. Helps reduce pain. After oral administration, from 4 to 20% of the active components of the drug are absorbed in the small intestine, the rest takes part in the digestion process and is excreted in feces. Enzymes entering the systemic circulation bind to antiproteases - α2-macroglobulin, forming a complex of the active form of enzyme-α2-macroglobulin. The maximum concentration in the blood is reached 2 hours after oral administration and persists for 4 hours. The half-life is about 8 hours.

Indications for the drug Phlogenzyme

In complex therapy and prevention of the following diseases and conditions:

surgery - postoperative recovery and rehabilitation of patients (improving reparative processes and regeneration), postoperative purulent-inflammatory complications, preventing the development of adhesions and the formation of a keloid scar, reducing the risk of thromboembolic complications during prolonged immobilization;

traumatology - bone fractures, tendon and ligament injuries, soft tissue bruises and hematomas, sports injuries, burns, improving the integration of endoprostheses, osteosynthesis;

angiology - acute deep vein thrombosis, superficial vein thrombophlebitis, post-thrombotic disease, obliterating atherosclerosis of the arteries of the lower extremities and other chronic angiopathy, microcirculation disorders, lymphatic edema (lymphedema);

urology - acute and chronic inflammation of the genitourinary tract (cystitis, urethritis, cystopyelitis, prostatitis);

gynecology - acute and chronic inflammatory diseases of the pelvic organs (adnexitis, salpingoophoritis), vascular complications of the menopause, reducing the frequency and severity of complications of hormone replacement therapy;

cardiology - coronary artery disease, prevention of angina attacks, reducing the risk of vascular accidents and recurrent heart attacks;

gastroenterology - hepatitis;

rheumatology - rheumatoid arthritis, ankylosing spondylitis, reactive arthritis, rheumatic soft tissue lesions;

neurology - ischemic stroke, multiple sclerosis;

pulmonology - pneumonia, chronic obstructive pulmonary disease;

dentistry - prevention of complications in the postoperative period during tooth extraction, purulent-inflammatory diseases of the maxillofacial area, rehabilitation and recovery after surgical interventions in the maxillofacial area, improvement of implant integration, osteosynthesis.

Indications for use of the drug Phlogenzyme

Acute inflammatory processes, exacerbations of chronic inflammatory diseases; wounds, burns, injuries, including sports, post-traumatic and postoperative inflammation and swelling, lymphedema, lymphangitis, phlebitis, arteritis; rheumatic myositis, tennis elbow, tendinitis, inflammatory-dystrophic diseases of the joints in the acute phase, osteoarthritis; in combination with antibiotics and other drugs, the drug is used to treat infectious and inflammatory diseases of the oral cavity, paranasal sinuses, respiratory tract, genitourinary system, and digestive organs.

Side effects

The drug is well tolerated by patients. In some cases, there may be an increase in stool frequency, a change in the consistency and odor of the stool, which quickly resolves with a temporary reduction in the dosage of the drug. Occasionally, an allergic reaction (skin rash, itching) may occur, which disappears after reducing the dose or discontinuing the drug. If the conditions for using the drug are violated, nausea, bloating and abdominal pain, headache, dizziness, exanthema, general weakness, and a feeling of intestinal fullness may occur. These conditions disappear after reducing the dosage or temporarily discontinuing the drug.

Side effects of the drug Phlogenzyme

Phlogenzyme is usually well tolerated, no significant side effects are observed even with long-term treatment with high doses. In rare cases, allergic reactions (skin rash that disappears after discontinuation of the drug) may occur. Taking high doses of the drug may cause a feeling of fullness in the stomach, flatulence and general malaise (rarely). These phenomena can be prevented by dividing the daily dose into several fractional doses. In some cases, slight changes in the color and smell of stool may be observed.

Directions for use and doses

Inside.

Take at least 30 minutes before meals, without biting, with water (200 ml). After surgery, it is recommended to take the drug from the 2nd–3rd day.

Treatment. The drug is taken after injuries and operations or acute inflammation to split and remove damaged tissue, resolve hematomas, improve tissue trophism and reparative processes, reduce inflammation and swelling, reduce the risk of complications - thrombosis, the development of adhesions, the formation of a keloid scar and wound suppuration: 3 each table 3 times a day for 2 weeks. If necessary, to improve recovery and healing, the course of taking the drug can be extended to 4 weeks or more, 2 tablets. 3 times a day.

Prevention of complications. To prevent long-term consequences after surgery - thromboembolic complications, the development of adhesive disease of the abdominal cavity, trophic disorders during prolonged bed rest and immobilization of the patient: the drug is recommended to be taken over a long course in a dosage of 2 tablets. 3 times a day for 4 weeks or more or for the entire period of immobilization.

Use with antibiotics. When prescribing antibiotics, the drug is used to increase the effectiveness of antibiotic therapy and reduce the undesirable effects of antibiotics. It is recommended to take the drug during the entire course of antibiotic therapy, 2 tablets. 3 times a day.

Use with hormones. When prescribing long-term courses of hormones, it is recommended to take the drug to reduce the risk of complications (thrombosis) according to 2 tables. 3 times a day during the entire course of taking hormonal medications. When prescribing hormone replacement therapy to reduce the risk of thrombosis of the veins of the lower extremities, it is recommended to take 2 tablets. 3 times a day in repeated courses for 2 weeks with breaks of 3 weeks 3-4 times a year.

Prevention. To prevent thrombosis of the veins of the lower extremities and reduce the risk of vascular accidents (heart attack), it is recommended to take the drug in 2 tablets. 3 times a day for a course of at least 3-4 weeks, repeating courses of taking the drug 3-4 times a year.

Changing the course and dosage of the drug is recommended after consultation with a doctor.

PHLOGENZYME film-coated tablets No. 40

PHLOGENZYME is a new generation drug consisting of a combination of highly active proteolytic enzymes (enzymes) of plant and animal origin - bromelain and trypsin in combination with rutin. In combination, enzymes have a pleiotropic (multiple) effect, having a variety of pharmacological effects on pathophysiological and biochemical processes. The enzymes of the drug realize their therapeutic effects through anti-inflammatory, immunomodulatory, antiplatelet, fibrinolytic, thrombolytic, decongestant and secondary analgesic effects. Enteric-coated tablets of the drug pass transiently through the upper gastrointestinal tract without injuring the stomach and are absorbed in the small intestine by resorption of intact molecules (endocytosis, pinocytosis). The proteases of the drug, binding to the transport proteins of the blood (α-2-macroglobulin and α-1-antitrypsin), form a reversible protease-antiprotease complex, in which the antigenic determinants of the exogenous proteases of the drug are masked, which prevents allergic reactions. As a result of the formation of a complex with enzymes, antiprotease (α-2-macroglobulin) transforms into an active form, which functions as an extracellular regulator of proinflammatory cytokines and growth factors, carrying out their transport, clearance and elimination. The formation of an active protease-antiprotease complex allows the safe movement of proteolytic enzymes along the vascular bed to the site of inflammation and to the site of injury, regardless of the location in the body. The complex retains and slows down the excretion of proteolytic enzymes of the drug from the body, increases their circulation time in the vascular bed and, accordingly, the therapeutic effect. Once at the site of inflammation and wounds, proteolytic enzymes break down (hydrolyze) damaged proteins and tissues and eliminate (remove) cellular debris (detritus), helping to accelerate the cleansing and healing of the wound. The drug has a positive effect on the course of the inflammatory process, modulates the body's defense reactions, which contributes to the physiological course of inflammation at different stages. The proteolytic enzymes of the drug accelerate the breakdown of inflammatory mediators, break down immune complexes and membrane deposits, increase the activity of phagocytes and natural killer cells, and stimulate interferonogenesis. Proteases of the drug reduce the level of pro-inflammatory cytokines (IL-1β, IL-6, IL-8, IFN-γ, TNF-α) and promote increased production of anti-inflammatory cytokines (including IL-4, IL-10), regulate the level Ig and blood antibodies. The drug's enzymes limit the pathological manifestations of autoimmune and immune complex processes and restore the body's immunological reactivity. The drug's proteases reduce the level of transforming growth factor β, an increase in which leads to excessive scarring. Proteolytic enzymes have a regulatory effect on the synchronization of the formation of the basement membrane (laminin), modulation of the wound process and the expression of angiogenesis factors (vasculoendothelial growth factor, fibroblast growth factor and a number of other factors). Thus, the enzymes of the drug help improve reparative processes, prevent the formation of hypertrophic and keloid scars, and the development of adhesive disease after surgical interventions in the abdominal cavity. The enzymes of the drug break down and remove damaged tissue, accelerate the resorption of hematomas and edema by normalizing the permeability of vascular walls, reducing the infiltration of the interstitium with plasma proteins, increasing the elimination of protein detritus and fibrin deposits, improving microcirculation and trophic processes in the damaged area. Optimization of the inflammatory process by proteolytic enzymes by reducing oncotic pressure and tissue edema, reducing pressure on nerve endings, eliminating ischemia and normalizing microcirculation, direct proteolysis of inflammatory mediators allows proteases to have a secondary analgesic effect. At the same time, proteolytic enzymes stimulate the healing and repair processes, reduce the risk of thromboembolic complications during prolonged immobilization, and prevent the development of trophic disorders and purulent complications. The enzymes of the drug have a positive effect on improving microcirculation, increasing the delivery of oxygen and nutrients to the wound, reducing inflammation at the site of damage, maintaining the physiological process of regeneration and accelerating the restoration of the function of organs and tissues. The drug improves the rheological properties of blood (viscosity and fluidity) due to a positive effect on the functional state of blood cells and the vascular wall, plasticity (deformability) of red blood cells, stabilization of endothelial permeability, increasing fibrinolytic activity of blood serum, reducing the density of adhesive molecules, reducing platelet aggregation (sticking together) . Proteolytic enzymes reduce the number of activated forms of platelets (spheroechinocytes) and micro- and macroaggregates, i.e. reducing the risk of thrombus formation in blood vessels, and at the same time participate in the lysis of formed blood clots. Proteolytic enzymes reduce the level of atherogenic lipids, helping to increase HDL, reducing the risk of atherosclerosis and vascular disorders. The drug improves blood supply to the bronchi and lung tissue in chronic respiratory diseases, incl. caused by smoking, improves the viscosity properties of bronchial secretions, the function of the ciliated epithelium, restores the drainage function of the bronchi, thins sputum, which makes breathing easier and reduces cough. The proteolytic enzymes of the drug increase the effectiveness of antibiotics, while simultaneously reducing the undesirable effects of antibiotic therapy (dysbiosis, irritable bowel syndrome). Proteases improve the breakdown of substrates, optimize the balance of microbiota, and contribute to the restoration of intestinal endoecology.

special instructions

In case of infectious processes, PHLOGENZYME does not replace antibiotics.

In case of exacerbation of the underlying disease while taking the drug, it is recommended to temporarily reduce the dose of the drug or temporarily discontinue the drug after consultation with a doctor.

Patients suffering from diabetes should take into account that each tablet of the drug contains 0.015 XE.

Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. The drug is not a dope and does not have a negative effect on driving a car or performing work that requires a high speed of mental and physical reactions.

Special instructions for the use of the drug Phlogenzyme

Caution must be exercised when prescribing the drug to patients on hemodialysis, as well as before surgery. For infectious and inflammatory diseases, the use of Phlogenzyme does not replace etiotropic therapy, but increases the effectiveness of antibacterial agents. In some chronic diseases, at the beginning of treatment with the drug, the severity of the symptoms of the disease may increase, which should be regarded as a manifestation of the body’s positive reaction to the therapy. Taking Flogenzyme should not be interrupted; a temporary dose reduction is recommended. During pregnancy, indications for the use of Phlogenzyme, like other drugs, must be carefully substantiated.

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