The relevance of the use of povidone-iodine in the practice of obstetrician-gynecologist

Instructions for use BETADINE

Long-term use of povidone-iodine preparations may result in the absorption of significant amounts of iodine. In some cases, mainly in persons with pre-existing thyroid pathology, iodine-induced hyperthyroidism was observed. Therefore, if it is necessary to use Betadine suppositories in such patients, the course of treatment should be as short as possible.

Particular caution is required when using the drug regularly in patients with renal failure.

Long-term use of Betadine vaginal suppositories should be avoided in patients receiving lithium preparations.

With the use of povidone-iodine, there may be a decrease in iodine uptake by the thyroid gland, which may affect the results of diagnostic studies (thyroid scintigraphy, determination of protein-bound iodine, measurements using radioactive iodine) or may interfere with iodine therapy of the thyroid gland. After prolonged use of povidone-iodine, an interval of 1 to 4 weeks should be observed before performing the above procedures.

The oxidative effects of povidone-iodine may cause false-positive results in some diagnostic tests, such as occult blood in stool and urine, or glucose in urine.

The use of Betadine suppositories in childhood before reaching puberty is contraindicated.

The doctor must decide on the possibility of using the drug in virgins and administer the suppository for the first time.

Do not allow children to accidentally ingest the suppository.

Impact on the ability to drive vehicles and operate machinery

Betadine does not affect the ability to drive vehicles and other activities that require high concentration and speed of psychomotor reactions.

Experimental results

Preclinical safety studies have shown that symptoms of acute toxicity in animals were observed only when administered systemically at doses significantly higher than those administered topically in humans. When studying chronic toxicity, also with systemic administration in high doses, a completely reversible dose-dependent increase in protein-bound serum iodine and nonspecific histopathological changes in the thyroid glands were detected.

Povidone-iodine does not have a mutagenic effect.

Given the long clinical experience with iodine, long-term studies of carcinogenic properties in animals have not been conducted.

Betadine 200 mg 14 pcs. vaginal suppositories

pharmachologic effect

Antiseptic.

Composition and release form Betadine 200 mg 14 pcs. vaginal suppositories

Suppositories - 1 sup.:

• Active substance: povidone-iodine - 200 mg, which corresponds to the content of active iodine - 18-24 mg;
• Excipients: macrogol 1000 - 2800 mg.

7 vaginal suppositories per blister made of PVC/PE film.

1 or 2 blisters per cardboard box along with instructions for use.

Description of the dosage form

Vaginal suppositories are torpedo-shaped, homogeneous, dark brown in color.

Directions for use and doses

It is recommended to moisten the suppository with water and insert it deep into the vagina in the evening before bed.

For acute vaginitis, 1 suppository is prescribed 1-2 times a day for 7 days.

For chronic and subacute vaginitis - 1 suppository 1 time per day before bedtime for 14 days, if necessary - for a longer period.

It is also recommended to use sanitary pads during the course of treatment. You should not stop using suppositories during menstruation.

Pharmacodynamics

It has an antiseptic, disinfectant, antifungal and antiprotozoal effect. Blocks amino groups of cellular proteins. Has a wide spectrum of antimicrobial action. Active against bacteria (including Escherichia coli, Staphylococcus aureus), fungi, viruses, protozoa. Released from the complex with polyvinylpyrrolidone upon contact with the skin and mucous membranes, iodine forms iodamines with bacterial cell proteins, coagulates them and causes the death of microorganisms. It has a rapid bactericidal effect on gram-positive and gram-negative bacteria (with the exception of M. tuberculosis).

Pharmacokinetics

When applied topically, there is almost no reabsorption of iodine from the mucous membrane.

Indications for use Betadine 200 mg 14 pcs. vaginal suppositories

Acute or chronic vaginitis (mixed, nonspecific infection), bacterial vaginosis (caused by Gardnerella vaginalis), candidiasis, Trichomonas vaginalis infection.

Vaginal infections following antibiotic or steroid therapy.

Prevention before surgical or diagnostic interventions in the vagina.

Contraindications

Hypersensitivity to iodine and other components of the drug; dysfunction of the thyroid gland (nodular colloid goiter, endemic goiter and Hashimoto's thyroiditis, hyperthyroidism); thyroid adenoma; Dühring's dermatitis herpetiformis; simultaneous use of radioactive iodine; children up to 8 years old.

With caution: pregnancy and breastfeeding.

Application Betadine 200 mg 14 pcs. vaginal suppositories during pregnancy and breastfeeding

The use of Betadine® is not recommended from the 3rd month of pregnancy and during lactation (breastfeeding). If necessary, in these cases, treatment is possible under individual medical supervision. Contraindicated in premature and newborn babies.

special instructions

Due to the oxidizing properties of povidone-iodine, trace amounts may cause false-positive results in some types of tests to detect occult blood in the stool and blood or glucose in the urine.

During use of povidone-iodine, iodine uptake by the thyroid gland may be decreased, which may affect the results of some diagnostic tests (eg, thyroid scintigraphy, protein-bound iodine, radioiodine measurements), and may also interact with iodine supplements used. for the treatment of thyroid diseases. To obtain undistorted results of thyroid scintigraphy after long-term therapy with povidone-iodine, it is recommended to maintain a sufficiently long period of time without this drug.

If the function of the thyroid gland is impaired, the drug can be used only as directed by a doctor. If symptoms of hyperthyroidism occur during treatment, thyroid function should be checked. It is necessary to monitor thyroid function in newborns and breastfed infants whose mothers used Betadine®.

Caution should be exercised when using the drug regularly in patients with previously diagnosed renal failure. Regular use of Betadine® vaginal suppositories should be avoided in patients receiving lithium preparations.

The use of povidone-iodine is permitted from the neonatal period, but taking into account the form of release - vaginal suppositories, the drug is not recommended for use before 8 years of age and caution is used when administering to virgins.

Coloring on leather and fabrics is easily washed off with water. After contact with the drug, avoid contact with the eyes.

Suppositories have a spermicidal effect, and therefore their use is not recommended for people planning pregnancy.

During the use of suppositories, the use of sanitary pads can be recommended.

Impact on the ability to drive vehicles and operate machinery

Correct use of the drug does not affect the ability to drive vehicles or operate machinery.

Overdose

Acute iodine intoxication is characterized by the following symptoms: metallic taste in the mouth, increased salivation, burning sensation or pain in the mouth or throat; irritation and swelling of the eyes; skin reactions; gastrointestinal disorders and diarrhea; renal dysfunction and anuria; circulatory failure; laryngeal edema with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.

Treatment: Symptomatic and supportive therapy should be carried out with special attention to electrolyte balance, renal and thyroid function.

Side effects Betadine 200 mg 14 pcs. vaginal suppositories

Hypersensitivity reactions to the drug, hyperemia, itching.

In rare cases, it can cause hypersensitivity reactions, such as contact dermatitis with the formation of psoriasis-like red small bullous lesions. If such phenomena occur, use of the drug should be discontinued.

Long-term use of povidone iodine may result in the absorption of significant amounts of iodine. The development of iodine-induced hyperthyroidism has been described in some cases, mainly in patients with pre-existing thyroid disease.

Drug interactions

Incompatible with other disinfectants and antiseptics, especially those containing alkalis, enzymes and mercury.

The combined use of povidone iodine and hydrogen peroxide, as well as enzyme preparations containing silver and tauloridine, for the treatment of wounds, as well as antiseptic drugs, leads to a mutual decrease in effectiveness.

In the presence of blood, the bactericidal effect may decrease, but by increasing the concentration of the solution, the bactericidal activity may be increased.

The relevance of the use of povidone-iodine in the practice of obstetrician-gynecologist

Currently, the frequency of relapses of viral diseases, specific and nonspecific vulvovaginitis, and bacterial vaginosis (BV) attracts attention. It is noted that vaginitis refers to diseases that in themselves do not pose a direct threat to a woman’s health, however, in these conditions, opportunistic microorganisms accumulate and are constantly preserved in high concentrations in the lower parts of the genital tract, which are the main causative agents of purulent-inflammatory diseases of the small organs. pelvis [16]. The role of BV as a trigger of inflammatory diseases of the pelvic organs has been proven. The issues of early and adequate diagnosis and prevention of the spread of infectious and inflammatory diseases remain relevant.

The problem of resistance and antibiotic resistance makes it necessary to optimize treatment regimens. It should be recognized that currently there is information about strains of microorganisms resistant to antiseptics, but these reports appear much less frequently than reports about microorganisms resistant to antibiotics. Some researchers demonstrate results in which certain strains of microorganisms, especially hospital ones, become resistant to antiseptics such as an aqueous solution of chlorhexidine, potassium permanganate solution, furatsilin, etc. In this regard, the search for new drugs that reliably prevent the spread of hospital infections is being actively pursued.

Thus, well-known iodine preparations, especially its various complex compounds, are increasingly used.

Iodine as a local antiseptic was first described in 1839. In the process of searching for ways to reduce iodine deficiencies, the ideal solution was found in the development of a polyvinylpyrrolidone complex. Polyvinylpyrrolidone (PVP) is a high molecular weight polymer that was used as a plasma expander during World War II. PVP forms a water-soluble complex with iodine. The first reports of topical use of this complex came from Shelanski and Bogash in 1956.

The biologically active substance povidone-iodine is a free complex of elemental iodine with a neutral, amphipathic organic compound, polyvinylpyrrolidone, which serves as a slow-release iodine reservoir. Povidone-iodine is a broad-spectrum antiseptic with bactericidal, sporicidal and antiviral properties (that is, the spectrum of action extends to gram-positive and gram-negative bacteria, fungi, viruses, protozoa and even prions). Prions are a special class of infectious agents represented by proteins with an abnormal tertiary structure and not containing nucleic acids. Prions are not living organisms, but they can reproduce using the functions of living cells (in this respect, prions are similar to viruses). A prion is a protein with an abnormal three-dimensional (tertiary) structure that can catalyze the conformational transformation of a normal cellular protein homologous to it into a similar one (prion).

Povidone-iodine (Betadine) is an antiseptic and disinfectant whose antimicrobial effect is due to its bactericidal properties. The bactericidal effect of iodine is explained by its strong oxidizing properties. Iodine damages the cell walls of pathogenic microorganisms due to the oxidation of amino acids of bacterial proteins containing SH and OH groups. These are mainly bacterial enzymes and transmembrane proteins that do not have membrane protection. When oxidized, their quaternary structure changes and they lose their catalytic and enzymatic activity. Intracellular iodine blocks the electron transport system in the cytoplasmic membrane of bacteria. The effect develops quickly, usually within 15–60 s. The spectrum of action of Betadine is presented in Table 1.

Average time of antimicrobial effect on microorganisms:

• Gram+/gram- – 15–30 s;
• viruses – 15 s;
• mushrooms – 15–30 s;
• trichomonas – 30–60 s.

Betadine is a complex compound of iodine and polyvinylpyrrolidone (PVP), which is an inert synthetic polymer and acts as a carrier that does not have toxic and antigenic properties and is capable of reversibly attaching other substances, such as medicinal toxins, drugs, hormones. All pharmacological properties of the drug are related directly to iodine, while the ability to cause burning of tissues when applied is lost, but high bactericidal activity remains, which has made it possible to expand the scope of its use as an antiseptic. During contact with the skin and mucous membranes, iodine, which is in complex with PVP, is released gradually and evenly, which is manifested by a thin colored layer, which remains until the entire amount of iodine is released, acts more slowly and for a long time [Nikulin V.N., Gerasimenko V.V., Svirskaya E., 2008]. Thanks to the polymer molecule, iodine penetrates deep into the wound, into inflamed tissue and under the scab. Penetration into tissue to a depth of about 1 mm does not interfere with normal regeneration processes.

Compared to other antiseptics, povidone-iodine has a number of significant advantages:

• more effective than other antiseptics in suppressing the proliferation of microorganisms even in large dilutions (up to 1/256);
• physicochemical conditions at the site of inflammation, determined by pH, protein, blood, enzymes, have little effect on the effect of povidone-iodine;
• has the highest specific activity against most infections and a wider antiviral spectrum of action (enteroviruses, polio viruses, herpes, adenoviruses, influenza viruses, and HPV).

Povidone-iodine has been proven to be highly effective in the local treatment of herpetic lesions of the mucous membranes [15] and is highly active in the prevention of transmission of human papillomavirus infection to a sexual partner [14]. It was noted that papillomavirus is not sensitive to other antiseptics. In some studies, povidone-iodine has been shown to be more effective in the treatment and prevention of viral infections compared to specific antiviral agents.

According to S. Tsutomu, S. Junko (1996–1998), R. Kawana et al. (1998), E. Shanbrom (1996):

• anti-infectives containing povidone-iodine can be used to combat diseases caused by HIV, chlamydia, gonococci, treponema and herpes simplex virus (Table 2);
• not a single fact of the development of resistance of microorganisms to povidone-iodine has been described, despite a long period of use in surgical practice;
• lack of systemic effect due to the large size of the povidone-iodine complex (400–4000 kDa);
• povidone-iodine, unlike other antiseptics, normalizes the acidity of the vaginal environment, which creates conditions for the rapid restoration of normal vaginal microflora, which is an important factor in the absence of relapses of vaginal infection after treatment.

For 10 years, we have used Betadine suppositories:

• for the treatment of common vaginitis;
• for prevention in everyday life (unprotected sexual intercourse during a casual relationship, visiting a dubious pool in a sauna, rape, etc.);
• before inserting an intrauterine device (IUD);
• before planned gynecological surgical interventions and then together with taking antibiotics throughout the entire course of antibiotic therapy;
• before treatment of uterine fibroids using uterine artery embolization;
• before transvaginal microcatheter balloon radiopaque recanalization of the fallopian tubes in the treatment of infertility;
• in the complex treatment of cervical lesions.

One of our studies is indicative of the prevention of postoperative complications. Before an abortion or diagnostic curettage, 80 women were prescribed Betadine for 7 days, 1 suppository at night, and immediately before the procedure, ultrasound resonance instillation of the cervical canal was performed with a 10% Betadine solution for 2 minutes. As a result, we did not record a single case of inflammatory changes either on the day of discharge or 10 days later. Of the 80 women who did not receive preventive therapy with Betadine, 45% had to be prescribed modern antibiotics in the postoperative period. Our study indicates that about 45% of patients in surgical gynecology have disorders of the vaginal microcenosis, which can cause the development of infectious complications after surgical interventions on the pelvic organs. In this case, the administration of antibiotics long before surgery is not justified (they do not provide preoperative decontamination of the patient, and the risk of the emergence of antibiotic-resistant microorganisms significantly increases).

A large number of studies have been devoted to the effectiveness of Betadine, however, they do not pay due attention to the individual tolerability of this drug in women. For this purpose, we conducted another study. 60 women took part in the study. In 20 of them, Betadine suppositories were prescribed before invasive procedures (abortion, separate diagnostic curettage, installation of an IUD), in 20 - in parallel with antibiotics, 10 women used Betadine for prophylactic purposes, and 10 patients were treated with Betadine for vaginitis.

The regimens for using Betadine, depending on the reason for which it was prescribed, were as follows: before planned invasive interventions - 7 days before the procedure, 1 suppository at night; parallel to taking antibiotics - 1 suppository at night during the entire course of antibiotic therapy; for preventive purposes - 1 suppository at once, then 1 suppository at night for 6 days; for the treatment of colpitis - 1 suppository at night for 14 days. All women who used Betadine were asked to complete a questionnaire that included questions regarding its tolerability. In addition, the study assessed the effectiveness of Betadine in the situations in which it was prescribed. As a result of the study, it was found that the main inconvenience when using Betadine, which was noted by 52 (86.6%) women, is staining of linen, while 50 women rated the severity of this discomfort as insignificant. Vaginal burning and itching were noted by 8 (13.3%) women. To the question “how do you assess the effectiveness of Betadine,” 98% of women answered “effective,” and only 2% of patients did not find any particular effect from the use of Betadine. All women who took part in the study found it acceptable to use Betadine for preventive purposes in everyday life; 98%, after talking with a doctor, expressed a desire to always have Betadine with them. At the same time, the results of microbiological studies showed that in all observations, when the patient was prescribed Betadine before invasive interventions, inflammatory complications did not develop. In women who used Betadine in parallel with taking antibacterial drugs, the development of vulvovaginal candidiasis was not observed (in this case, the action of Betadine is aimed not only at sanitizing the lesion, but also at preventing the development of candidal infection). In the group of women who were prescribed Betadine for the treatment of colpitis, at the end of the course of therapy, all noted normalization of the flora in the vagina and the disappearance of signs of inflammation. Local use of antiseptic drugs that effectively decontaminate mucous membranes is also necessary if it is impossible to quickly verify the causative agent of the inflammatory process.

The wide spectrum of action of Betadine provides great opportunities for its use in diseases such as:

• vaginitis of any etiology (bacterial, fungal, viral, trichomoniasis);
• bacterial vaginosis;
• chlamydial, ureaplasma and mycoplasma infection (in combination with etiotropic therapy);
• genital herpes and genital warts (as a local etiotropic drug and for the prevention of superinfection);
• vaginitis of mixed etiology (up to 30% of all vaginitis is mixed!) is the drug of choice.

When using Betadine, it is important to remember that you can start treatment with it immediately after taking a smear. The earlier the drug is used, the less often the need for antibiotics arises. Long-term antibacterial treatment of chronic nonspecific vulvovaginitis changes the endogenous microflora, causing an increase in the number of strains resistant to antibacterial drugs. That is why most researchers assign the main role to local treatment of vulvovaginitis. The advantages of local treatment are the minimal risk of adverse reactions, simplicity and ease of use, the absence of contraindications (except for individual intolerance to the drug) and the possibility of use for extragenital pathology [2].

Considering the certain sensitivity of human papillomavirus infection and the ability of povidone-iodine to penetrate under the scab, we used Betadine in surgical treatment of cervical pathology in the amount of excision/conization. In the first group (20 people) after surgical treatment of the cervix, Betadine was prescribed 1 suppository at night for 10 days, in the second (20 people) - before destructive treatment for 3 days and after treatment of the cervix for 7 days Betadine 1 suppository at night, in the third (20 people) - after surgical treatment of the cervix, suppositories containing dexpanthenol + chlorhexidine bigluconate were prescribed. In the first and second groups, faster epidermization of the cervix by 5±3 days was noted, and no significant difference in the epidermization of the cervix in the 1st and 2nd groups (using Betadine) was noted.

Betadine is of great importance in preconception decontamination of women; it can be used for the treatment of BV and mixed vaginitis in the first trimester of pregnancy, when it is undesirable to use antibacterial drugs. Betadine is used for disinfection in the stages of preparation for childbirth or cesarean section, during childbirth, for treating the skin, umbilical cord and palpebral fissure in newborns. Clinical experience has shown that treating the skin of newborns with a 0.1% Betadine solution completely eliminates the possibility of developing a nosocomial infection. It is also important to note that Betadine solution is more effective and less toxic than traditional means for the prevention of conjunctivitis in newborns. Belarusian researchers [Safina M.R., Soloshkina D.A., 2006] report convincing results of using Betadine for the treatment of mixed vaginal infections in pregnant women in the first trimester. The effectiveness of therapy was assessed after 7–8 days. The criteria for cure were a subjective assessment of the patient, a decrease in vaginal discharge and normalization of the bacterioscopic picture during a control smear examination. In the group of pregnant women treated with Betadine, the clinical cure rate for mixed infections reached 91%, which coincides with literature data. Use this drug for 7 days at 37–40 weeks. pregnancy is an effective way to prevent septic complications after vaginal delivery, as well as after surgical delivery. Prenatal prevention reduces the incidence of traumatic damage to the tissues of the birth canal during childbirth and improves the results of healing of postpartum injuries [12].

In addition to the prevention of inflammatory diseases during invasive procedures, Betadine is indispensable in situations of unprotected sexual intercourse, rape or condom rupture, when there is a possibility of infection from a sexual partner. In these cases, the prompt administration of Betadine followed by its use of 1 suppository at night for 7 days helps to avoid the development of the inflammatory process.

Betadine can replace frequent vaginal douches and douching in women prone to mysophobia (fear of infection). In addition, for prophylactic purposes, Betadine can be used in the premenstrual period in women with frequent relapses of BV, since it is in this phase that the vaginal pH increases, which can help activate the growth of anaerobes.

Thus, it is necessary to clearly identify the main areas of application of the drug Betadine. Firstly, Betadine is an antiseptic, its task is not treatment, but prevention, although in relation to BV, Betadine can be considered from a therapeutic point of view. Betadine is used for the prevention of inflammatory diseases of the pelvic organs during invasive interventions and infectious complications in obstetrics. The use of Betadine in combination with antibiotics can reduce the incidence of vulvovaginal candidiasis. In a woman’s daily life, Betadine is a means of preventing BV and sexually transmitted infections.

Literature

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