RU2567725C2 - Method of treating patients suffering winter-type plaque psoriasis of moderate and mild severity - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely dermatology and can be used for treating the patients suffering winter-time plaque psoriasis of moderate and mild severity accompanied by existing gastrointestinal and cardiovascular disorders. The method involves oral administration of medicinal preparations: a second-generation antihistamine and polyunsaturated fatty acids omega-3 and antioxidant vitamin E; the method is characterised by the fact that the above second-generation antihistamine is levocetirizine (Xyzal), whereas polyunsaturated fatty acids omega-3 are represented by Vitrum cardio omega-3; Xyzal is prescribed to administer once a day No. 14-28; for the first 10-20 days, a therapeutic dose of Vitrum cardio omega-3 is prescribed to administer orally, 30 minutes after meals, washed down with water, 1 capsule two times a day; once this period is completed, a preventive dose of the preparation is prescribed that is 1 capsule a day for one to two months.

EFFECT: using the inventions enables prolonging the intercurrent period in the patients by restoring the lipoprotein balance and reducing inflammatory events in derma.

3 cl, 1 tbl, 3 ex

Description

The invention relates to medicine, namely to dermatology, can be used to treat patients with winter type of ordinary psoriasis with moderate and mild course, existing lesions of the gastrointestinal tract (GIT) and cardiovascular system (CVS).

There are various ways to treat common psoriasis. With moderate severity and mild course of ordinary psoriasis, prescribe: vitamins; peripheral circulation enhancers; hepatoprotectors; external therapy - topical steroids, physiotherapy [Methodological materials for the diagnosis and treatment of the most common sexually transmitted infections and skin diseases. Management protocols, drugs / ed. A.A. Kubanova. M .: GEOTAR-MED. - 2003. - S. 94-96].

According to modern concepts, psoriasis is a papulosquamous dermatosis of a multifactorial nature. Of the greatest importance in its development are genetic, lipid and immune-mediated factors. Psoriasis is characterized by hyperproliferation of epidermal cells, impaired keratinization, an inflammatory reaction in the dermis, changes in various organs and systems [“Dermatovenerology”. National Leadership / Ed. Yu.K. Skripkina, Yu.S. Butova, L.L. Ivanova M .: GEOTAR - Media. - 2011. S. 726].

The leading reasons that modern theories of psoriasis are based on are: lipid abnormalities, genetic predisposition, and immunological instability.

Lipid disorders as one of the leading causes in the pathogenesis of psoriasis are being actively studied. The use of one-dimensional chromatography revealed significant structural and functional abnormalities in psoriasis patients in the lipid transport system of high density lipoproteins (HDL). The results of the study showed that in patients with psoriasis there is an imbalance of all lipid components in HDL [G.Yu. Kurnikov “The state of the lipid transport system in patients with psoriasis” / G.Yu. Kournikov, T.V. Kopytova, E.P. Abalikhina. 2002. www.medicum.nnov.ru]; [Klemenova I.A. “Membranopathological changes in psoriasis and correction methods” // Materials of the II All-Russian Congress of Dermatovenerologists, September 25-28, 2007 - St. Petersburg, 2007. - P. 63].

The closest analogue prototype is treatment with a drug containing polyunsaturated fatty acids omega-3-PUFA ω-3 [Nekipelova A.V. "The use is complete in the complex therapy of patients with psoriasis" / Materials Intern. Congr. “Evidence-based medicine is the foundation of modern healthcare,” Sept. 21–25. 2009 - Khabarovsk, 2009. - S. 205-208].

The effectiveness of the use of drugs containing PUFA ω-3 in psoriasis is indicated [Stupin A.V. "Natural factors of the Primorsky Territory in the treatment and rehabilitation of patients with psoriasis" / Stupin A.V., Yutskovsky A.D., Latyshev N.A. // Russian Journal of Skin and Sexually Transmitted Diseases - 2007. - No. 5. - S. 17-19]. Data on the positive effect of PUFA ω-3 in psoriasis were obtained: [Fish oil of dietary in psoriasis - a double - blind randomized placebo - controlled trial / Bittiner S.B., Tucker W.F.Y., Bleehen S.S. // British J. Dermatol. - 1988. - T. 118, No. 1. P. 25-26]; [Effect of diatary supplementation with n-fatty acids jn clinical manifestations of psoriasis / Bjorneboe A., Smith A.K., Bjorneboe G.E. // British J. Dermatol. - 1988 - T. Vol. 118, No. 1. P. 77-83]. In addition, PUFA ω-3 can be prescribed during pregnancy [Gromova O.A. “Micronutrient status in pregnant women and the use of vitamin-mineral complexes to optimize their nutrition” / XIV All-Russian Congress of nutritionists and nutritionists “Nutrition and health” 11/27/2012].

The disadvantages of the prototype method are

The absence of specific dates for prescribing drugs in patients with winter type of ordinary psoriasis with moderate severity and mild course, existing lesions of the gastrointestinal tract and CVS.

The objective of the invention: to propose a method for the treatment of patients with winter type of ordinary psoriasis with moderate severity and mild course, existing lesions of the gastrointestinal tract and CVS, which increases the relapse period.

The technical result is a decrease in manifestations and an increase in the relapse period in patients with winter type of ordinary psoriasis with moderate severity and mild course, existing lesions of the gastrointestinal tract and CVS as a result of the proposed method of treatment.

The technical result is achieved by the fact that along with drug therapy in patients with winter type of ordinary psoriasis with moderate severity and mild course, existing lesions of the gastrointestinal tract and CCC, II generation antihistamines are prescribed, for example Xisal and PUFA ω-3 in combination with an antioxidant - vitamin E - “ Vitrum cardio omega-3 ”, as well as foot baths - if there are contraindications for taking general baths - with a 1-2% solution of sea salt. The use of a low concentration of saline solutions for external use is justified by the fact that they do not irritate the affected skin in patients with psoriasis and do not enhance the proliferation of epidermal cells, which is possible at higher concentrations of saline solutions.

Water procedures carried out at home - shared baths and foot baths, if there are contraindications for taking a common bath, with sea salt help patients increase the body's adaptive capabilities, stimulating biologically active points, get positive emotions, are economically beneficial.

To solve the question of the effect on the inflammatory reaction in the dermis and immunological instability, antihistamines of the second generation, for example, levocetirizine - Xizal, are proposed.

II generation antihistamines, for example Xizal 5 mg (see Appendix 1), are prescribed No. 14-28, prescribed once a day No. 10-20, and ω-3 PUFA with an antioxidant - vitamin E, for example, Vitrum cardio omega- 3 "(see Appendix 2), is prescribed orally, 30 minutes after a meal, washed down with water, moreover, in the first 10-20 days, the therapeutic dose of the drug is taken 1 capsule twice a day, and then the prophylactic dose is taken 1 capsule day for one to two months in the cold season, for example, in late autumn from late November or early spring to March chala. In addition, patients with winter type of ordinary psoriasis with moderate severity and mild course, existing lesions of the gastrointestinal tract and CCC are prescribed common baths or foot baths with sea salt, which is diluted at the rate of 1-2 g per 100 g of water: one or two tablespoons per 2 liters of water every other day at t 37-38 ° C for 20 minutes, on the course No. 10-15.

The appointment of antihistamines of the II generation in patients with winter type of ordinary psoriasis with moderate severity and mild course, existing lesions of the gastrointestinal tract and CCC is justified by the fact that they reduce inflammatory phenomena in the dermis, since ... "The inflammatory reaction in the dermis is caused by the activation of CD4 T lymphocytes with the formation of cell infiltrate in the acute stage of the disease and CD8 T lymphocytes in resolving foci ”[“ Dermatovenerology ”. National Leadership / Ed. Yu.K. Skripkina, Yu.S. Butova, L.L. Ivanova M .: GEOTAR-Media. - 2011. S. 726].

In addition, the composition of Vitrum Cardio Omega-3 includes alpha tocopherol - vitamin E, which is an antioxidant, and among psoriasis patients among the identified concomitant diseases - 35.15% are the most common gastrointestinal lesions - 6.31% and CCC - 5 , 95% [Nekipelova A.V. "A comprehensive method for the treatment of psoriasis patients suffering from lipid metabolism disorders" Diss. ... cand. honey. sciences. - Khabarovsk, 1999. - 90 p.].

The appointment of PUFA ω-3 in patients with winter type of ordinary psoriasis with moderate severity and mild course, existing lesions of the gastrointestinal tract and CCC in the cold period of the year reminds us that it is rational and effective in this period of time, since it is known that exacerbation in patients psoriasis occurs most often in winter. Winter type of psoriasis occurs from 50.4% [Kostyushov V.V. "Improving the treatment of patients with psoriasis with thiol preparations based on the assessment of the state of thioldisulfide and ascorbate systems": Abstract. diss. ... cand. honey. sciences. - M., 1982. - 22 pp.] Up to 80.7% [Yagovdik N.Z. “Complex therapy of psoriasis in the light of new data on the pathogenetic role of metabolic disorders of carbohydrates and the content in the blood, skin and scales of biologically active substances (vitamins, hormones) involved in its regulation: Abstract. diss. ... doctor. honey. sciences. - M., 1984. - 33 p.]. Therefore, drug therapy is required and recommended precisely in this period of time.

The prescription of the drug Vitrum Cardio Omega-3 in late autumn or early spring - from late November to early March - is justified by a change in biorhythms, the laws of adaptation and rehabilitation of desynchronosis. Seasonal prophylaxis of exacerbations of chronic diseases is usually carried out in transitional seasons of the year - in early spring and late autumn - in the cold season, when sharp changes in meteorological parameters are especially sharp. For these periods, it is necessary to coincide with course treatment with pathogenetic agents, in addition, seasonal prevention should include the mandatory use of drugs that increase the nonspecific resistance of the body. These drugs include adaptogens, angioprotectors and vitamin preparations, which are prescribed in medium therapeutic doses [Medical rehabilitology / ed. V.M. Bogolyubov. Book 1. - Ed. 3-3, fix and add. - M.: Publishing house BINOM. - 2010. S. 63].

Patients are assessed using the PASI and DLQI index.

PASI (psoriasis area and severity index) - the area and severity index of psoriatic lesions [Adaskevich V.P. "Diagnostic indices in dermatology." - M .: Medical book. - 2004. - S. 107-108].

The PASI index was used to evaluate the clinical efficacy of treatment. Clinical recovery of psoriasis was recorded in cases where there was a complete regression of rashes, the disappearance of subjective symptoms and a decrease in the PASI index by 96-100%. A significant improvement was the achievement of a regression of clinical symptoms and a decrease in the PASI index by at least 76-95%, as well as the disappearance of subjective symptoms. Improvement was seen as a decrease in the PASI regression of clinical and subjective symptoms by at least 26-75%. The lack of effect from the therapy was evaluated in the case of stability of the skin process and the PASI index by not less than 26%.

DLQI - Dermatology Life Quality Index - a dermatological index of the quality of life is designed for use in adults [Adaskevich V.P. "Diagnostic indices in dermatology." - M .: Medical book. - 2004. - S. 144-146].

Shared baths and foot baths with sea salt stimulate biologically active points in patients with winter type of ordinary psoriasis with moderate severity and mild course, existing lesions of the gastrointestinal tract and CCC, which helps to restore self-regulation processes, improve metabolism, affect the processes of excitation and inhibition in the central nervous system contributing to a sedative effect, they create positive emotions and do not require large economic costs, which are inevitable with a real trip to the sea.

Patients are also prescribed diet food in the form of a salad once a day with the necessary content of PUFA ω-3. The salad consists of the following products: salmon 70 g, walnut-5 g, linseed oil or fish oil - 5 g, carrots 25 g, greens: dill, lettuce - 10 g. Total portion -115 g.

The advantages of the proposed method:

1. The manifest manifestations in patients with the winter type of ordinary psoriasis are reduced with moderate severity and mild course.

2. Itching in patients with winter type of ordinary psoriasis decreases.

3. Reduced inflammation in the dermis in patients with psoriasis.

4. It has a normalizing effect on lipid metabolism, improves lipoprotein metabolism with severe hypertriglyceridemia; contributes to the normalization of LDL and VLDL; restores the imbalance of all lipid components of HDL.

5. It has antioxidant activity, since vitamin E is involved in tissue respiration and other important processes of tissue metabolism; protects tissue cells from the damaging effects of excessive amounts of free radicals and peroxides.

6. Increases the inter-relapse period in patients with winter type of ordinary psoriasis with moderate severity and mild course, existing lesions of the gastrointestinal tract and CVS by 1.5-2 times, since the balance of lipoproteins is restored, and inflammatory phenomena in the dermis are reduced.

Example 1

B-th E., 38 years old. Sick winter type of ordinary psoriasis 5 years. Exacerbations are annual in the winter. A history of hepatitis, gastritis, frequent acute respiratory viral infections. On examination, the patient has lenticular psoriatic papules in the scalp, trunk, limbs, pale pink, covered with silver-white scales. Psoriatic symptoms are positive. Subjectively, itching.

B-mu E., 38 years old, assigned Xizal - 5 mg once a day No. 28; Vitrum Cardio Omega-3, inside, 30 minutes after a meal, washed down with water, and in the first two weeks - 14 days - took a therapeutic dose of the drug: 1 capsule twice a day, and then a preventive dose of the drug: 1 capsule per day for two months in November-December. Along with this, he took a shared bath with sea salt, which he diluted at the rate of 1-2 g per 100 g of water; 100.0 g per bath - 100 l of water at t 37-38 ° C for 20 minutes, every other day, on a course No. 13. The treatment continued at home until the skin process was completely resolved.

The diet is prescribed in the form of a salad containing a daily dose of PUFA-ω-3 found in foods: salmon 70 g, walnut 5 g, linseed oil or fish oil 5 g, carrot 25 g, greens: dill, lettuce 10 Total serving - 115 g.

The PASI index during therapy changed from 18 to 3.6 points, which is 80% - a significant improvement. DLQI during therapy changed from 18 to 8.

After the treatment, there is a decrease in itching, resolution of the skin process, an increase in the relapse period. The remission period was 13 months.

Example 2

B. V., 54 years old. Suffers from the winter type of ordinary psoriasis for 32 years. Exacerbations of the skin process occur in winter and autumn, after hypothermia, stressful situations. A history of gastric ulcer, angina pectoris. On examination, the patient has psoriatic plaques in the trunk, limbs, scalp of bright red color, covered with silver-white scales. The patient received treatment on an outpatient and inpatient basis with a short-term effect. The treatment did not give the desired effect, and therefore turned to a consultative appointment.

B-mu V., 54 years old, assigned Xizal 5 mg once a day No. 28; Vitrum Cardio Omega-3, inside, 30 minutes after a meal, washed down with water, and in the first two weeks - 14 days - took a therapeutic dose of the drug: 1 capsule twice a day, and then a preventive dose of the drug: 1 capsule per day for two months in November - December. Along with this, he took foot baths with sea salt, which he diluted at the rate of 2 g per 100 g of water: one or two tablespoons per 2 liters of water at t 37-38 ° C for 20 minutes, every other day, on course No. 10-15 baths.

The diet is prescribed in the form of a salad containing a daily dose of PUFA-ω-3 found in foods: salmon 70 g, walnut 5 g, linseed oil or fish oil 5 g, carrot 25 g, greens: dill, lettuce 10 Total serving - 115 g.

The PASI index during therapy changed from 14.4 to 3.0 points, which is 79.17% - a significant improvement. DLQI during therapy changed from 17 to 6.

The patient notes a decrease in itching, an improvement in the skin process, an increase in the relapse period. The remission period was 12 months.

Example 3

B.P., 43 years old. Suffers from the winter type of ordinary psoriasis for 10 years. Exacerbations of the disease occur 2 times a year, in winter. The exacerbation of the disease is associated with hypothermia, acute respiratory infections, stress. A history of hepatitis "B", childhood infections. Received treatment on an outpatient basis. The treatment on an outpatient basis according to the prototype did not give the desired effect, in connection with which additional rehabilitation therapy was prescribed. On examination, the patient revealed marked changes in the skin: lenticular and nummular papules in the elbow and knee joints - “plaques on duty”, bright red, covered with silver-white scales, Auspitz symptoms are positive.

B. P., 43 years old. Xizal 5 mg once a day No. 28 is prescribed; Vitrum Cardio Omega-3, by mouth, 30 minutes after a meal, washed down with water, and in the first three weeks - 21 days - took a therapeutic dose of the drug: 1 capsule twice a day, and then a preventive dose of the drug: 1 capsule per day for two months in December-January. In addition, she took baths for feet with sea salt, which she bred at the rate of 2 g per 100 g of water: one or two tablespoons per 2 liters of water at t 37-38 ° C for 20 minutes, every other day, on course No. 10 -15 baths.

The diet is prescribed in the form of a salad containing a daily dose of PUFA-ω-3 found in foods: salmon 70 g, walnut 5 g, linseed oil or fish oil 5 g, carrot 25 g, greens: dill, lettuce 10 Total serving - 115 g.

The PASI index during therapy changed from 13.8 to 2.0 points, which is 85.57% - a significant improvement. DLQI during therapy changed from 17 to 2.

The patient noted an improvement in skin status, a decrease in itching, an increase in the inter-relapse period. The remission period was 12 months.

Annex 1

XYZAL levocetirizine

Registration Certificate Holder: UCB FARCHIM S.A.

ATX Code: R06AE09 (Levocetirizine)

XYZAL: instructions for use

The average price of the drug Ksizal in pharmacies (Moscow)

Xizal TB captive / rev 5 mg bl N7 × 1 USB Farshim ShTsR 283.06 rub Xizal TB captive / rev 5 mg bl N10 × 1 USB Farshim ShTsR 372.50 rub Xizal drops vnutr 5 mg / ml fl drops 10 ml N1 × 1 YUSB Pharma 404.17 rub S.p.A. ITA KSIZAL: all prices in pharmacies

Clinical and pharmacological group

13.001 (Blocker of histamine H1 receptors. Antiallergic drug)

Release form, composition and packaging

Film-coated tablets of white or almost white color, oval; with embossed marking "Y" on one side.

1 tab levocetirizine dihydrochloride 5 mg

Excipients: lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.

Shell composition: opadry Y-1-7000 (hypromellose, titanium dioxide (E171), macrogol 400).

7 pcs - blisters (1) - packs of cardboard.

7 pcs - blisters (2) - packs of cardboard.

10 pieces. - blisters (1) - packs of cardboard.

10 pieces. - blisters (2) - packs of cardboard.

Drops for oral administration in the form of an almost colorless, slightly opalescent solution.

1 ml levocetirizine dihydrochloride 15 mg

Excipients: sodium acetate, acetic acid, propylene glycol, 85% glycerol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium saccharin, purified water.

10 ml - bottles of dark glass with a dropper (1) - packs of cardboard.

20 ml - bottles of dark glass with a dropper (1) - packs of cardboard.

pharmachologic effect

The histamine H1 receptor blocker, the enantiomer of cetirizine, belongs to the group of competitive histamine antagonists. The affinity for histamine H1 receptors in levocetirizine is 2 times higher than in cetirizine.

Levocetirizine affects the histamine-dependent stage of allergic reactions, and also reduces the migration of eosinophils, reduces vascular permeability, and limits the release of inflammatory mediators. It prevents the development and facilitates the course of allergic reactions, has antiexudative, antipruritic effect, practically does not have anticholinergic and antiserotonin effects. In therapeutic doses, it has practically no sedative effect.

Pharmacokinetics

Suction

The pharmacokinetic parameters of levocetirizine vary linearly and practically do not differ from the pharmacokinetics of cetirizine. After oral administration, levocetirizine is rapidly absorbed from the digestive tract. Eating does not affect the degree of absorption, although its speed decreases. After a single oral administration in a therapeutic dose of Cmax in blood plasma in adults, it is achieved after 0.9 hours and amounts to 207 ng / ml, after repeated administration at a dose of 5 mg / day - 308 ng / ml. Bioavailability is 100%.

Distribution

Css is reached after 2 days. The binding of levocetirizine to plasma proteins is 90%. Vd is 0.4 l / kg.

Metabolism

Less than 14% is metabolized in the liver by N- and O-dealkylation (unlike the other 6 locators of histamine H1 receptors, which are metabolized in the liver with the participation of isoenzymes of the P450 cytochrome system) with the formation of a pharmacologically inactive metabolite. Due to the low level of metabolism and the lack of metabolic potential, the interaction of levocetirizine with other drugs seems unlikely.

Breeding

In adults, it is 7.9 ± 1.9 h, the total clearance is 0.63 ml / min / kg. About 85.4% of the dose is excreted by the kidneys unchanged by glomerular filtration and tubular secretion; about 12.9% is excreted through the intestines.

Pharmacokinette in special clinical cases

In patients with renal failure (CC less than 40 ml / min), the clearance of levocetirizine decreases, and T1 / 2 increases (in patients on hemodialysis, the total clearance decreases by 80%), which requires a corresponding change in the dosage regimen. Less than 10% of levocetirizine is removed during the standard 4-hour hemodialysis procedure. In young children, T1 / 2 is shortened.

Dosage

The drug is prescribed orally during meals or on an empty stomach.

Tablets are taken with a small amount of water, without chewing.

Drops for oral administration are taken with a teaspoon. If necessary, the dose can be diluted in a small amount of water immediately before use.

Adults and children over 6 years: daily dose of 5 mg (1 tablet or 20 drops).

Children aged 2 to 6 years: 1.25 mg (5 drops) 2 times / day; the daily dose is 2.5 mg (10 drops).

Since levocetirizine is excreted by the kidneys, when prescribing the drug to elderly patients and patients with renal failure, the dose should be adjusted depending on the size of the CC.

QC can be calculated based on the concentration of serum creatinine, according to the following formula.

For men:

QC (ml / min) = [140-age (years)] × body weight (kg) / 72 × serum creatinine (mg / dl)

For women: obtained value × 0.85

Renal failure QC (ml / min) Dose and frequency of administration Norm > 80 5 mg / day Mild 150-79 5 mg / day Medium grade 30-49 5 mg / day 1 time in 2 days Severe degree <30 5 mg / day 1 time in 3 days Terminal stage (hemodialysis patients) <10 Taking the drug is contraindicated

For patients with renal and hepatic insufficiency, dosing is carried out according to the table above.

Patients with impaired hepatic function only do not need to adjust the dosage regimen.

The duration of use depends on the indications. The course of treatment of hay fever is an average of 1-6 weeks. In chronic diseases (year-round rhinitis, atopic dermatitis), the duration of treatment can increase up to 18 months.

Overdose

Symptoms: drowsiness (in adults), agitation and anxiety, followed by drowsiness (in children).

Treatment: immediately after taking the drug, wash the stomach or induce artificial vomiting. The appointment of activated carbon, symptomatic and supportive therapy is recommended. There is no specific antidote. Hemodialysis is ineffective.

Drug interaction

A study of the interaction of levocetirizine with other drugs has not been conducted.

When studying the drug-drug interaction of cetirizine racemate with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam, no clinically significant adverse interaction was detected.

With simultaneous use with theophylline (400 mg / day), the total clearance of cetirizine is reduced by 16%, the pharmacokinetic parameters of theophylline do not change.

In some cases, with the simultaneous use of levocetirizine with ethanol or drugs that have a depressing effect on the central nervous system, it is possible to increase their effect on the central nervous system, although it has been proven that the cetirizine racemate potentiates the effect of alcohol.

Pregnancy and lactation

Adequate and strictly controlled clinical studies on the safety of the drug in pregnant women have not been carried out, so Xizal should not be prescribed during pregnancy.

Levocetirizine is excreted in breast milk, therefore, if it is necessary to use the drug during lactation, breastfeeding should be discontinued during administration.

In experimental animal studies, no direct or indirect adverse effects of levocetirizine on the developing fetus were revealed (including in the postnatal period), the course of pregnancy and childbirth also did not change.

Side effects

Possible side effects are listed below on the body systems and frequency of occurrence: often (≥1 / 10); infrequently (from ≥1 / 100 to <1/10); rarely (from ≥1 / 1000 to <1/100); very rare (from ≥1 / 10000 to <1/1000).

From the side of the central nervous system: infrequently - headache, fatigue, drowsiness; rarely - asthenia; very rarely - aggression, agitation, convulsions, hallucinations, depression, visual impairment.

From the cardiovascular system: very rarely - tachycardia.

From the respiratory system: very rarely - dyspnea.

From the digestive system: infrequently - dry mouth; rarely - abdominal pain; very rarely - nausea, diarrhea, hepatitis, a change in liver function tests.

From the musculoskeletal system: very rarely - myalgia.

From the side of metabolism: very rarely - an increase in body weight.

Allergic reactions: very rarely - itching, rash, urticaria, angioedema, anaphylaxis.

Terms and conditions of storage

Tablets should be stored out of the reach of children, in a dry place at a temperature not exceeding 25 ° C. Shelf life is 4 years.

Drops for oral administration should be stored out of the reach of children, protected from light at a temperature of no higher than 30 ° C. Shelf life is 3 years. After opening the bottle, the shelf life is 3 months.

Indications

Symptomatic therapy of allergic diseases and conditions:

- year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis (itching, sneezing, rhinorrhea, lacrimation, conjunctival hyperemia, nasal congestion);

- hay fever (hay fever);

- urticaria (including chronic idiopathic urticaria);

- Quincke's edema;

- Other allergic dermatoses, accompanied by itching and rashes.

Contraindications

- terminal stage of renal failure (CC less than 10 ml / min);

- children's age up to 6 years (for tablets);

- children's age up to 2 years (for drops for oral administration);

- pregnancy;

- Hypersensitivity to the components of the drug, especially in patients with galactosemia or severe lactose intolerance (for tablets);

- Hypersensitivity to levocetirizine or piperazine derivatives.

With caution, the drug should be used in chronic renal failure (correction of the dosage regimen is required), in elderly patients (with an age-related decrease in glomerular filtration).

special instructions

The patient should be careful when taking the drug while drinking alcohol.

Influence on the ability to drive vehicles and control mechanisms

An objective assessment of the ability to drive vehicles and work with mechanisms did not reliably reveal any adverse events when prescribing the drug in the recommended dose. Nevertheless, during the treatment period it is advisable to refrain from engaging in potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.

Application for impaired renal function

For patients with chronic renal failure with a QC of 49-30 ml / min, the dose is reduced by 2 times (1 tablet every other day), with a QC of 29-10 ml / min, the dose is reduced by 3 times (1 tab. 1 time in 3 days )

Application for impaired liver function

Dosage adjustment is not required for patients with hepatic insufficiency.

Pharmacy Vacation Terms

The drug is prescription.

Registration numbers

- drops for oral administration 5 mg / 1 ml: fl. 10 ml or 20 ml 1 pc. LSR-001308/08 (2029-02-08-0000-00-00)

- tab. film coating, 5 mg: 7, 10, 14 or 20 pcs. P N016137 / 01 (2019-11-09-0000-00-00)

Appendix 2

VITRUM CARDIO OMEGA-3 (VITRUM CARDIO OMEGA-3)

The owner of the registration certificate:

registered and manufactured by UNIPHARM, Inc. (USA)

ATX code: C10AX06 (Omega-3 triglycerides, including other esters and acids)

VITRUM CARDIO OMEGA-3: instructions for use

The average price of the drug VITRUM CARDIO OMEGA-3 in pharmacies (Moscow)

Vitrum Cardio omega-3 capsules fl p / ethyl N60 × 1 Unipharm Inc. USA 906.83 rub Vitrum Cardio omega-3 capsules fl p / ethyl N30 × 1 Unipharm Inc. USA 1050.00 rub

Clinical and pharmacological group

16.005 (Drug that regulates lipid metabolism)

Release form, composition and packaging

Soft gelatin capsules, transparent, from light yellow to dark yellow, oval; the contents of the capsules are a clear oily liquid from light yellow to dark yellow in color with a specific odor.

1 caps. omega-3 polyunsaturated fatty acids ethyl esters 1000 mg including eicosapentaenoic acid (EPA) 300 mg docosahexaenoic acid (DHA) 200 mg α-tocopherol (Vit.E) 2 mg

Excipients: gelatin - 261.7 mg, glycerol - 117.8 mg, purified water - 235.5 mg.

30 pcs - polyethylene bottles (1) - packs of cardboard.

60 pcs. - polyethylene bottles (1) - packs of cardboard.

pharmachologic effect

A combined preparation containing polyunsaturated fatty acids of the omega-3-eicosapentaenoic acid family, docosahexenoic acid and vitamin E.

It has a therapeutic effect in lipid metabolic disorders caused by severe hypertriglyceridemia, has an anti-inflammatory effect. It contributes to the normalization of LDL and VLDL content, a change in the liquid properties of cell membranes and an increase in the functional activity of membrane receptors, which improves the lipid-cell interaction of lipoproteins with enzymes and lipoprotein metabolism. The antiplatelet effect of the drug is associated with a change in its composition of lipids of cell membranes, including and erythrocyte membranes, characterized by a decrease in their arachidonic acid content and an increase in the level of eicosapentaenoic acid. As a result, there is a decrease in the synthesis of thromboxane A2 and other bi-unsaturated eicosanoids (arachidonic acid derivatives), which enhance platelet aggregation and increase the synthesis of thromboxane A3 and other trisaturated eicosanoids from eicosapentaenoic acid, which do not have a pro-aggregate effect.

This complex of essential polyunsaturated fatty acids is used to normalize lipid metabolism and reduce the risk of developing atherosclerosis.

Vitamin E has antioxidant activity, is involved in tissue respiration and other important processes of tissue metabolism; protects cells and tissues from the damaging effects of excess free radicals and lipid peroxidation products.

Pharmacokinetics

The effect of Vitrum cardio Omega-3 is the combined action of its components, so kinetic observations are not possible; collectively, components cannot be traced using markers or bioassays.

Dosage

The drug is prescribed orally. It is recommended to take with water 30 minutes after eating.

Adults are prescribed 1 caps./day for prophylactic purposes; with therapeutic purpose - 2-3 caps. / day. The course of treatment is at least 3 months. The doctor determines the need for repeated courses individually.

Overdose

Symptoms: manifestations of hypervitaminosis - pain in the epigastric region, dyspeptic symptoms (nausea, vomiting, diarrhea); with prolonged use in high doses, exacerbation of chronic pancreatitis is possible.

Treatment: drug withdrawal, symptomatic therapy.

Drug interaction

No data on drug drug interactions were provided.

Pregnancy and lactation

During pregnancy and lactation, the use of the drug is possible only as directed by a doctor.

Side effects

From the digestive system: there may be a taste of fish, burping with a taste of fish in the first days of admission, a laxative effect.

Other: allergic reactions.

Terms and conditions of storage

The drug should be stored in a dry place inaccessible to children at a temperature of 10 ° to 30 ° C. Shelf life is 3 years.

Indications

- prevention of conditions caused by dyslipidemia (impaired lipid metabolism);

- as part of the complex therapy of lipid metabolism disorders, including diet, statins, antiplatelet agents;

- Vitamin E hypovitaminosis

Contraindications

- exacerbation of chronic cholecystitis;

- exacerbation of chronic pancreatitis;

- exacerbation of diseases of the hepatobiliary system;

- cholelithiasis;

- pathological conditions, including hemorrhagic syndrome;

- Hypersensitivity to the components of the drug.

special instructions

While taking Vitrum Cardio Omega-3, it is not recommended to take other medicines containing vitamin E.

Application for impaired liver function

Contraindicated in exacerbation of chronic cholecystitis; with exacerbation of chronic pancreatitis; with exacerbation of diseases of the hepatobiliary system; with gallstone disease.

Pharmacy Vacation Terms

The drug is approved for use as a means of OTC.

Registration numbers

caps. 1000 mg + 2 mg: 30, 60, 100 or 120 pcs. LS-000548 (2006-05-10-0000-00-00)

The description of the drug is based on officially approved instructions for use and is approved by the manufacturer for 2009 publications.

VITRUM CARDIO OMEGA-3 - description and instructions are provided by the Vidal drug directory.

Claims (3)

1. A method for the treatment of patients with winter type of ordinary psoriasis with moderate severity and mild course, with lesions of the gastrointestinal tract and cardiovascular system, including the use of the following medications: an antihistamine of the second generation and polyunsaturated fatty acids omega-3 with an antioxidant - vitamin " E ”, characterized in that levocetirizine - Xizal is prescribed as an antihistamine of the second generation, and Vitrum cardio omega-3 is used as a polyunsaturated fatty acid omega-3, with Xi Al is prescribed once a day No. 14-28, in the first 10-20 days a therapeutic dose of Vitrum Cardio Omega-3 is prescribed, which is taken orally, 30 minutes after a meal, washed down with water, 1 capsule twice a day, and then after this period a prophylactic dose of the drug is prescribed - 1 capsule per day for one to two months. 2. The method according to claim 1, characterized in that in addition, in the absence of contraindications for taking shared baths, a common bath with sea salt is prescribed, which is diluted at the rate of 100 g of salt per 100 l of water at t 37-38 ° C for 10-20 minutes, every other day, to the course No. 10-15, and if there are contraindications, appoint foot baths with sea salt, which is diluted at the rate of 1-2 g per 100 g of water: one tablespoon per 2 liters of water every other day at t 37- 38 ° C for 20 minutes, on the course No. 10-15. 3. The method according to claim 1, characterized in that in addition, in cold weather, all patients are prescribed a diet in the form of a salad containing a daily norm of omega-3 polyunsaturated fatty acids found in products: salmon - 70 g, walnut - 5 g , linseed oil or fish oil - 5 g, carrots - 25 g, greens: dill, lettuce - 10 g, total portion - 115 g.