Lacidofil-WM capsules in blister pack. in pack №10x2

Pharmacological properties of the drug Lacidofil

Capsules of the drug containing living cells of lactic acid bacteria are used for the treatment and prevention of diarrhea associated with the use of antibiotics, restoration and normalization of intestinal microflora, treatment of gastroenteritis and dyspepsia, improving digestion and increasing tolerance to lactose in milk, for maintenance therapy of atopic dermatitis, as part of a complex therapy of necrotizing enterocolitis in infants. Lactobacilli Lactobacillus rhamnosus R0011 and Lactobacillus acidophilus R0052 are slowly eliminated from the intestines - 7–15 days after the end of the preventive or therapeutic course of Lacidofil. Their presence in the intestinal lumen helps to normalize the intestinal microflora, enhance protection against pathogenic and opportunistic microorganisms by normalizing the intestinal barrier function and increasing local immunity. Lactobacillus rhamnosus R0011 has the ability to reduce allergenicity in the body and increase tolerance to milk.

Liskovich V.V., Naumov I.A., Ganchar E.P., Dembovskaya S.V.

Relevance. Prevention of purulent-septic complications in the postpartum period remains an urgent problem in obstetrics [12]. The occurrence of purulent-septic complications is facilitated by various trophic and hormonal disorders, as well as changes in the quantitative-qualitative relationships between pathogenic and opportunistic resident microflora of the genital tract in postpartum women [8].

As you know, the vagina of a healthy woman is inhabited by a large number of microorganisms, the conditions of existence of which are symbiotic. The vaginal microflora normally contains rod-shaped flora (lactobacillus, corynebacteria and diphtheroids); coccal flora (anaerobic and mostly aerobic cocci, hemolytic and non-hemolytic streptococci, b-hemolytic streptococci, enterococci). Less common are Klebsiella, Enterobacteriaceae, representatives of the Proteus species, Escherichia coli, and fungi of the genus Candida [10]. The most important function of normal microflora is to provide, together with local and general immune factors, colonization resistance, ensuring an optimal ratio of microbial associates that determine the normal microflora of each biotope [3]. The normobiotic existence of endogenous microflora is ensured, in addition to colonization resistance, by hormonal-trophic cyclic changes in the vaginal mucosa, the production of substances with antimicrobial properties (lysozyme, bacteriocins, etc.), local immune defense factors (activators of phagocytic and enzymatic activity) [6]. Normal microflora is involved in various functions of metabolism and vitamin balance, in stimulating immunogenesis, providing resistance, a cellular barrier against the penetration of pathogenic microorganisms, etc. In general, the biocenosis of the female genital organs is a complex component of the microecological system, all participants of which are in strictly balanced equilibrium and symbiosis, provide the so-called state of eubiosis [4]. In connection with pregnancy, a number of changes occur in a woman’s body that contribute to the occurrence of inflammatory diseases of the vagina with the subsequent development of purulent-septic complications. Taking into account the above, it becomes clear that obstetricians and gynecologists pay special attention to drugs used for the prevention of purulent-septic complications in the postpartum period [2]. To prevent purulent-septic complications in the postpartum period, antibiotics are widely used in obstetric practice, despite the well-known significant number of complications and long-term consequences of antibiotic therapy, including antibiotic-associated diarrhea and vaginal dysbiosis [7, 11]. In this regard, it is urgent to search for new means to prevent these complications of antibiotic therapy [13]. Currently, in the prevention of intestinal and vaginal dysbiosis against the background of antibacterial therapy, the effectiveness of prescribing probiotics has been shown as the most physiological in terms of their regulatory effect on the microflora and the mechanism of therapeutic activity and free from the side effects of chemical eubiotics [1]. Probiotic Lactobacillus species are primarily used in dietary supplements, for which very limited clinical data are available. At the same time, clinical studies of drugs made from microorganisms—representatives of the normal human microflora—are currently underway. In recent years, pharmaceutical preparations from probiotic strains of lactobacilli have appeared [15]. Most currently known probiotic strains of microorganisms are part of the normal microflora of the human body or are present in foods consumed by several generations of people around the world. Therefore, WHO, the US Food and Drug Administration (FDA) and the UN Food and Agriculture Organization (FAO) conclude that probiotics are generally considered safe and have GRAS (Generally Regarded As Safe) status. This means that they can be used without restriction in the food and pharmaceutical industries [14]. It was previously shown that local intravaginal use of eubiotics (probiotics) produces a pronounced clinical effect. Abroad, the local use of yoghurts and kefir containing lactic acid bacteria is quite actively used. Research results indicate that correction of vaginal pH and lactobacillary flora, necessary for normal vaginal ecology, provides high clinical effectiveness [1]. At the same time, vaginal colonization is directly related to the woman’s intestinal microflora. Therefore, it is advisable to use not only vaginal, but also oral probiotics. G. Reid et al. reported successful treatment of vaginal dysbiosis in a placebo-controlled study of oral supplementation containing L. rhamnosus and L. fermentum for 60 days [16]. When using vaginal suppositories containing L. acidophilus, beneficial effects were noted in 57% of cases, although only for a limited period. In addition, tampons impregnated with L. fermentum, L. rhamnosus and L. gasseri, used for 5 days after a 3-day course of therapy with suppositories containing clindamycin, have been shown to have a beneficial effect on the vaginal biocenosis. Modern open studies have shown that probiotics from L. rhamnosus and L. acidophilus, reuteri RC-14 strains colonize the vagina after oral administration, which provides a pronounced preventive clinical effect [1, 10]. To confirm or refute this fact, we conducted this study based on the use of the probiotic “Lacidophil-WM”, which is a combination of two strains of live bacteria: Lactobacillus helveticus (acidophilus) Rossel-52 and Lactobacillus rhamnosus Rossel-11. Lacidofil-WM has a high safety profile: it does not contain opportunistic flora, the strains Lactobacillus rhamnosus Rosell-11 and Lactobacillus helveticus (acidophilus) Rosell-52 belong to the usual symbiont of the human intestine, the genomes of the strains are fully identified, have a genetic passport, and do not carry potentially dangerous antibiotic resistance genes and mobile genetic elements. The bacteria that make up Lacidofil-WM have a high degree of resistance to the effects of gastric juice and bile acids, and have a stable probiotic effect due to a high level of adhesion to the epithelium and two-week colonization activity. In addition, Lacidofil-WM has a prebiotic function: due to the synthesis of lactic acid, they create a favorable environment for the development of normal microflora, and have a protective effect on epithelial cells. Lacidofil-WM is recommended to be prescribed from the first day of antibiotic therapy for infectious processes of any localization. Purpose of the study: to study the effectiveness of the probiotic "Lacidophil-WM" in the prevention of vaginal dysbiosis and antibiotic-associated diarrhea when taking antibiotics in the postpartum period in postpartum women after cesarean section. Material and methods. To achieve this goal, 96 postpartum women were examined. The first (main) group consisted of 56 patients receiving antibiotics after cesarean section to prevent purulent-septic complications. The third generation cephalosporin antibiotic cefotaxime was used: 1 g intravenously. every 12 hours for 7 days. Patients in this group were prescribed "Lacidofil-WM" per os, 1 capsule 3 times a day for 7 days. The second (control) group consisted of 40 patients who also received cefotaxime after cesarean section to prevent purulent-septic complications according to a similar regimen. Drugs for the correction of possible disorders of intestinal and vaginal eubiosis were not prescribed to women in this group. Clinical and laboratory data corresponding to the protocols for examining women in the postpartum period were studied, the state of the vaginal biocenosis was studied, and the results of bacteriological and bacterioscopic examination were assessed. Statistical data processing was carried out using computer programs EXCEL, STATISTICA 6.0. Differences were considered statistically significant at p < 0.05. Results and discussion. The compared groups were comparable in age, anthropometric data, and the frequency of occurrence of gynecological and extragenital pathologies. The average age of the examined patients was 27.3±5.6 (23–32) years in the main group, and 26.6±5.4 (22–30) years in the control group. The body weight of postpartum women in the main group was 67.3±3.7 (57-69) kg, in the control group - 68.2±4.7 (58-70) kg. The body length of postpartum women in the main group was 1.64±0.07 m, in the control group - 1.67±0.06 kg. The age at menarche in postpartum women in the main group was 12.59±0.53 years, in the control group - 12.27±0.48 years. The number of births in the anamnesis of postpartum women in the main group was 0.5±0.6, in the control group - 0.6±0.7. The number of abortions in the anamnesis of postpartum women in the main group was 1.4±1.1, in the control group - 1.3±0.9. Gynecological pathology was identified in the anamnesis in 64.3% of postpartum women of the main group: cervical erosion was registered in 50% of those examined, candidiasis - in 26.8%, nonspecific vaginitis - in 17.9%, urea-mycoplasmosis - in 14.3% , trichomonas vaginitis - in 8.9%, chronic salpingoophoritis -7.1%. 62.5% of postpartum women in the control group suffered from a history of gynecological pathology: cervical erosion was registered in 47.5% of those examined, candidiasis - in 25%, nonspecific vaginitis - in 17.5%, urea-mycoplasmosis - in 15%, trichomonas vaginitis - in 7.5%, chronic salpingoophoritis - 7.5%. 25% of women in the main group had a history of diathermocoagulation of the cervix (control – 22.5%); 8.9% - diagnostic intrauterine manipulations and long-term use of antibiotics (control - 10%); 7.1% - cryodestruction (control - 5%), 2 postpartum women from the main group underwent surgery on the pelvic organs (control - 0). There were more than 1.56±0.74 extragenital diseases per postpartum woman in the main group (control - 1.68±0.82). Most often, chronic tonsillitis was recorded in postpartum women of the main group - 25% (control - 20%), euthyroid goiter - 17.5% (control - 20%), anemia - 14.3% (control - 15%), chronic pyelonephritis - 14 .3% (control – 10%), chronic cystitis – in 3.6% (control – 0), 1 postpartum woman from the main group suffered from chronic colitis (control – 0). Thus, postpartum women of both groups had a predisposition to the development of purulent-septic complications after cesarean section. Indications for planned delivery by cesarean section in the main group were: - operated uterus in combination with other obstetric pathology in history - 48.2% of women (control - 47.5%), - diseases of the cardiovascular system - 16.1% of those examined (control - 17.5%), diseases of the visual organs - 8.9% of patients (control - 10%), indications from the fetus - 26.8% (control - 25%). The state of the vaginal biocenosis before antibiotic therapy was prescribed was as follows: - normocenosis: in postpartum women of the main group - 26.8% (control - 25%), - intermediate type: in postpartum women of the main group - 44.6% (control - 45%), - dysbiosis (bacterial vaginosis and vaginal candidiasis): in postpartum women of the main group - 28.6% (control - 30.8%). Purulent-septic complications due to the use of antibiotic therapy were avoided in all examined patients. However, after a course of antibiotic therapy in postpartum women in the control group, pronounced changes in the state of the vaginal biocenosis were registered: in 35% of women, the vaginal biocenosis was characterized by a sharp decrease or absence of microorganisms, in 37.5% of patients - by the presence of single lactobacilli, in 15% - by the presence of aerobic and anaerobic bacteria. flora without lactobacilli, in 12.5% ​​of women - the presence of mycelium. Thus, the state of normocinosis was not detected in any patient. In postpartum women of the main group, while taking the probiotic "Lacidophil-WM", a state of normocenosis was registered in 89.3% of women, an intermediate type of biocenosis was identified in 10.7% of patients. The manifestations of dysbiosis that existed before the start of therapy in women of the main group while taking the probiotic “Lacidophil-WM” were stopped. In the main group, not a single case of antibiotic-associated diarrhea developed during the treatment received; in the control group, this complication was registered in 10% of patients (p <0.05), which required the prescription of additional medications. Conclusion. The probiotic "Lacidophil-WM" is an effective drug in the prevention of complications of antibiotic therapy in the postpartum period in postpartum women after cesarean section. Literature. 1. Berezhnoy, V.V. On the advisability of using opportunistic microorganisms as part of probiotics / V.V. Berezhnoy, D.S. Yankovsky, S.A. Kramarev et al. // Women’s health. – 2004, No. 3(19). – pp. 191–202. 2. Bayramova, G.R. Bacterial vaginosis / G.R. Bayramova // Gynecology/ - 2001, No. 3(2). – P. 52-4. 3. Budanov, P.V. Disturbances of vaginal microcenosis / P.V. Budanov, O.R. Baev, V.M. Pashkov // Issues of gynecology, obstetrics and perinatology. – 2005, No. 4(2). – P. 78-88. 4. Kira, E.F. Terminology and classification of bacterial infectious diseases of the female genital organs / E.F. Kira, Yu.V. Tsvelev // Vestnik Ross. Ass. obstetrics gynek. – 1998, No. 2. – P. 72-77. 6. Mezhevitinova, E.A. Trichomonas vulvovaginitis: ways to increase the effectiveness of treatment / E.A. Mezhevitinova, Z.S. Khodjaeva // Vestnik Ross. Ass. obstetrics gynek. – 2000, No. 3. – P. 124-8. 7. Paliy, G.K. Antiseptics in the prevention and treatment of infections / G.K. Paly. - Kyiv: Health, 1997. - 195 p. 8. Sergeev, A.Yu. Vaginal candidiasis: etiology, epidemiology, pathogenesis / A.Yu. Sergeev, O.L. Ivanov, A.V. Karaulov et al. // Immunopathology, allergology, infectology. - 2000, No. 2. - pp. 99-107. 9. Khodzhaeva, Z.S. Vaginal candidiasis in pregnant women: principles of etiotropic therapy / Z.S. Khodjaeva // Vestn. Ross. Ass. obstetrics gynek. – 2000, No. 2. – pp. 79-82. 10. Yankovsky, D.S. Human microbial ecology. Modern possibilities of its maintenance and restoration // D.S. Yankovsky. - Kyiv: Expert LTD, 2005. - 362 p. 11. Chimura, T. Ecological treatment of bacterial vaginosis and vaginitis with Bio-three / T. Chimura, T. Funayama, K. Murayama, M. Numazaki // Jpn. J. Antibiot. – 1995, No. 48(3). – R.432-436. 12. Crowley, T. Antibiotic prophylaxis to prevent post-abortal upper genital tract infection in women with bacterial vaginosis: randomized controlled trial / T. Crowley, N. Low, A. Turner et al. // BJOG. – 2001, No. 108(4). – R. 396-402. 13. Eriksson, K. A double-blind treatment study of bacterial vaginosis with normal vaginal lactobacilli after an open treatment with vaginal clindamycin ovules / K. Eriksson, B. Carlsson, U. Forsum, PG Larsson // Acta Dermato-Venerol. – 2005, No. 85(1). – R. 42-46. 14. Hughes, G. Characteristics of those who repeatedly acquire sexually transmitted infections: a retro-spective cohort study of attendees at three urban sexually transmitted disease clinics in England / G. Hughes, AR, MA Brady, Catchpole et al. // Sex Transm. Dis. – 2001, No. 28(7). – R. 379-86. 15. L'Souza, A. Probiotics in prevention of antibiotic associated diarrhoea: meta-analysis / A. L'Souza, C. Rajkumar, J. Cooke, Ch. J. Bulpitt // BMJ. – 2002, No. 8. – R. 324. 16. Reid, G. Oral use of Lactobacillus rhamnosus GR-1 and L. fermentum RC-14 significantly alters vaginal flora: Randomized, placebo-controlled trial in 64 healthy women / G. Reid, D. Charbonneau, J. Erb et al. // FEMS. Immunol. Med. Microbiol. – 2003, No. 35(1). – R. 131-134.

Indications for use of the drug Lacidofil

• prevention and treatment of diarrhea caused by taking most antibiotics, especially lincomycin, clindamycin, ampicillin, amoxicillin and cephalosporins;
• as a means of specific prevention of infection caused by Clostridium difficile ;
• in the complex treatment of diseases of the stomach and duodenum associated with Helicobacter pylori (in combination with antibacterial therapy);
• restoration and normalization of intestinal microflora, improvement of digestion;
• treatment of gastroenteritis, dyspepsia;
• as a component of complex therapy for necrotizing enterocolitis in infants;
• treatment of transient intestinal dysfunctions (both diarrhea and constipation) associated with changes in diet, travel and other reasons;
• in the complex treatment of atopic dermatitis;
• prevention of atopy in children (prescribing the drug to a pregnant woman, then to an infant);
• increasing tolerance to milk lactose;
• to improve the condition of chronic fatigue syndrome.

Use of the drug Lacidofil

Capsules are taken with a small amount of cool water during meals. For children under 6 years of age, the capsule can be opened and the contents mixed with cool water or food. For preventive purposes, to maintain normal intestinal microflora, the drug is prescribed in the following doses: infants and children under 3 years of age - 1 capsule every other day; children over 3 years of age - 1 capsule 1 time per day; adults - 1-2 capsules per day. Duration of treatment is 20 days. For the prevention and treatment of diarrhea associated with taking antibiotics (including those caused by the Clostridium difficile bacillus ), Lacidofil is prescribed 2 hours before or after taking antibiotics: for infants and children under 12 months of age - 1 capsule per day; children aged 1 to 3 years - 1 capsule 2 times a day; children aged 3–12 years – 1 capsule 2–3 times a day; children over 12 years of age and adults - 1-2 capsules 3 times a day. The duration of administration is determined by the duration of antibiotic use, or until the symptoms of the disease disappear. In the future, you can switch to prophylactic use of the drug (see above). For transient intestinal dysfunction (both diarrhea and constipation) associated with changes in diet, travel and other reasons, infants and children under 12 months are prescribed 1 capsule 1 time per day, children aged 1 to 3 years years - 1 capsule 2 times a day; children over 3 years of age - 1 capsule 3 times a day until symptoms disappear. If necessary, the dose in children can be increased to 1-2 capsules 3 times a day. Adults are prescribed 1-2 capsules 3 times a day until symptoms disappear. In the future, you can switch to a prophylactic regimen of taking the drug to maintain intestinal microflora (see above). For atopic dermatitis, children under 3 years of age are prescribed 1 capsule once a day, duration of administration is 1–1.5 months.

Analogs

• "Bifidumbacterin";
• "Linex";
• "Yogurt";
• "Lactobacterin - Biopharma";
• "Fermalak";
• "Acipol";
• "Biolact";
• "Bifikol";
• "Mutaflor";
• "Normagut";
• "Probilak";
• "Hilak Forte";
• "Enterol";
• "Extralact";
• "BioGaia".

Summary

• The state of the body and our well-being depend on the composition of the intestinal microflora;
• “Lacidophil” contains probiotics, which, when included in the diet and having a positive effect on the human body, normalize the intestinal microflora;
• The drug is used for disorders of the digestive system, including due to the use of antibiotics, as well as for skin problems, and as a prevention of allergies;
• "Lacidophil" can be taken by pregnant women and infants;
• There are cheaper analogues of the drug.

Video on the topic: Healthy intestines and strong immunity

Special instructions for the use of the drug Lacidofil

There have not been any cases of negative effects of Lacidophil. There are certain groups of patients in whom the use of any probiotic preparations, including those containing lactobacilli, is recommended under medical supervision: patients with immunodeficiency conditions, especially patients with late stages of AIDS or patients with allografts, as well as those receiving chemotherapy; patients with endocarditis who have undergone surgery on the large intestine, oral cavity or teeth; children with short bowel syndrome; patients who have bloody diarrhea. In all of these cases, the beneficial effects of probiotics outweigh the possible risks.

Side effects

Not observed.

Contraindications

There are no strict contraindications. With caution (under medical supervision):

• AIDS;

• during treatment with chemotherapy;
• allotransplantation;
• bloody diarrhea;
• endocarditis;
• after dental surgery;
• after intestinal surgery;
• short bowel syndrome (children).

During pregnancy

Pregnancy is not a contraindication for taking lactic acid bacteria.