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.
Betadine in the practice of a gynecologist
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After the introduction of PCR methods for identifying microorganisms into widespread practice, “banal” colpitis, which for half a century required the gynecologist to wearily remind the patient about the usefulness of douching with chamomile infusion, turned out to be not so “simple”. Chlamydia, mycoplasma, ureaplasma and other microorganisms forced gynecologists to comprehend the “aerobatics” of antibiotic therapy, sometimes using multi-component long-term regimens, the side effects of which in some cases are more severe than the disease being cured. Practicing gynecologists were completely misled by the appearance of the term “bacterial vaginosis.” Any descriptions of this pathological condition of the vagina are primarily intended for microbiologists, and the recommended therapeutic approaches are extremely controversial.
On the other hand, the number of sexually transmitted diseases is steadily growing, and modern social norms of behavior and the attitude of the state to the problem do not imply a future reduction in it.
Obviously, before causing an inflammatory process, the microorganism must enter and remain for some time in the place where this inflammation is localized. Antiseptics are designed to resist this process and cope with it. The effectiveness of antiseptics is mainly determined by the timely use of the antiseptic and the correctness of its selection. In gynecology, when carrying out various interventions, iodine, which has a wide spectrum of action, is most often used for these purposes. However, simply lubricating the vagina and cervix with cotton soaked in iodine before an invasive procedure is not always sufficient. To improve the quality of antiseptics, it is necessary to use such a modern product as Betadine (available in the form of vaginal suppositories, solution and ointment).
Betadine is a complex compound of iodine and polyvinylpyrrolidone (PVP), an inert synthetic polymer that acts as a carrier. Therefore, all pharmacological properties of the drug are associated only with iodine. The question immediately arises: how, in this case, does Betadine differ from cotton wool with iodine? During contact with the skin and mucous membranes, iodine, which is in combination with PVP, is released gradually, evenly, without exhibiting an irritating effect.
Iodine belongs to the group of halogen antiseptics, its spectrum of action extends to gram-positive and gram-negative bacteria, fungi, viruses and protozoa. The bactericidal effect of iodine is explained by its strong oxidizing properties; it actively interacts with the amino acids of proteins, as a result of which the quaternary structure of the protein changes and its catalytic and enzymatic activity is lost. Basically, iodine disrupts the structures of bacterial transmembrane proteins and enzymes that do not have membrane protection.
Compared to other antiseptics, Betadine has a number of significant advantages. Firstly, Betadine is more effective than other antiseptics in suppressing the proliferation of microorganisms even in large dilutions (up to 1/256). In addition, the physicochemical conditions in the site of inflammation, determined by pH, protein, blood, enzymes, have little effect on the action of Betadine. Secondly, Betadine has the widest antiviral spectrum of action, including enteroviruses, polio and herpes viruses, as well as adenoviruses and influenza viruses.
In the practice of a gynecologist, Betadine is an extremely necessary drug. The first (and main) area of application of Betadine is the prevention of postoperative complications. In particular, our experience is indicative. Before an abortion or diagnostic curettage, 80 women were prescribed Betadine for 7 days, 1 suppository 2 times a day, and immediately before the procedure, ultrasonic resonance instillation of a 10% Betadine solution into the cervical canal was performed for 2 minutes. As a result, we did not record a single case of inflammatory complications 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 antibiotics in the postoperative period.
Similar results were obtained in a study by Saratov colleagues. They were able not only to identify the effectiveness of Betadine for the prevention of inflammatory complications after medical abortion in women suffering from chronic inflammatory diseases of the pelvic organs, but also to show its advantage over another antiseptic, chlorhexidine [1].
Thus, one of the areas of application for Betadine has clearly been identified - the prevention of inflammatory diseases. However, the question of the use of Betadine for bacterial vaginosis is even more pressing, since the question of the nature of this pathological condition and rational methods of its treatment has not yet been resolved. Traditional treatment regimens for this disease sometimes themselves provoke vaginal dysbiosis.
Questions of etiology, pathogenesis and, accordingly, effective therapy for this pathological condition remain open. Contradictions begin to appear already in the issue of diagnostic criteria. Thus, Amsel’s four diagnostic signs are widely known (pH more than 4.5; white homogeneous discharge covering the entire vaginal mucosa; positive KOH test; presence of “key” cells), but there is also a Nugent scoring system [2]. This system is based on the count of bacteria in a Gram-stained smear, a defined morphology and staining pattern corresponding to Lactobacillus, Gardnerella and Mobiluncus. With a score of 7 to 10 points, a diagnosis of “bacterial vaginosis” is made, from 4 to 6 – an intermediate state of the flora, and less than 3 points – the norm. The Nugent system is used in the West along with the Amsel criteria. However, one multicenter study showed that in 11% of women diagnosed with bacterial vaginosis according to the Amsel criteria, the Nugent system did not confirm the diagnosis, and in 30% of women with bacterial vaginosis according to the Nugent system there were no Amsel criteria. In addition, in 50% of cases, bacterial vaginosis is generally asymptomatic [3].
Bacterial vaginosis cannot be classified as a sexually transmitted disease. This was convincingly shown in a study where bacterial vaginosis was detected in 12% of 52 teenage virgins and in 15% of 68 girls of the same age group who were already sexually active [4]. However, bacterial vaginosis is sexually transmitted among women during homosexual relationships. Thus, the incidence of bacterial vaginosis among lesbians is very high [5].
In our country, trigger factors for the development of bacterial vaginosis mostly include endogenous factors, while exogenous factors include factors that are, in fact, less common than bacterial vaginosis itself. In foreign literature, on the contrary, among the main trigger factors for the development of bacterial vaginosis, exogenous causes are named, such as frequent, unprotected sexual intercourse, frequent vaginal douches, changing sexual partners, wearing tight-fitting non-absorbent underwear, cunnilingus, the nature of the flora of the parotid sac in partners and other factors [2 ].
Therapy for bacterial vaginosis has remained unchanged for a long time and includes the administration of metronidazole or its analogues per os.
or 2% clindamycin or metronidazole cream per vaginal.
The beginning of the widespread use of Betadine in gynecological practice in our country has revealed its effectiveness in the treatment of bacterial vaginosis. According to N.V. Rymashevsky et al. [7]. At the same time, during therapy with Betadine, the number of lactobacilli and bifidobacteria, which are an important component of normal vaginal microbiocenosis, does not always restore independently. Therefore, in order to increase the effectiveness of treatment for bacterial vaginosis, after 7 days of using Betadine, 1 suppository 2 times a day, it is sometimes necessary to carry out the rehabilitation stage with eubiotics lacto- and bifidumbacterin intravaginally 2 times a day, 5 doses for a week.
Considering the significant role of exogenous factors in the development of bacterial vaginosis, its prevention is possible. In particular, Betadine vaginal suppositories can be used for this purpose. It is indispensable in situations of unprotected sexual intercourse or condom rupture. 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 during the premenstrual period in women with frequent relapses of bacterial vaginosis, since it is in this phase that the vaginal pH increases, which can help activate the growth of anaerobes.
In addition to the prevention and treatment of bacterial vaginosis, Betadine directly and indirectly prevents the development of other, more serious diseases. This is due to the fact that against the background of bacterial vaginosis, sensitivity to infection with various sexually transmitted infections, in particular HIV infection, increases significantly [6].
Thus, it is necessary to clearly define the main areas of application of Betadine. Firstly, Betadine, as an antiseptic, is used for the treatment and prevention of bacterial vaginosis. Secondly, Betadine is used to prevent inflammatory diseases of the pelvic organs during invasive interventions (installation of an IUD, abortion, diathermocoagulation). Thirdly, in a woman’s daily life, Betadine provides prevention of sexually transmitted infections. In addition, Betadine is a good alternative to frequent vaginal douches and douching. And one last thing. When using Betadine, it is important to remember that the earlier it is used, the less antibiotics are needed.
The list of references can be found on the website https://www.rmj.ru
Povidone-iodine
Betadine (trade name)
(Egis)
Literature:
1. Chuvashkin D.N., Mikhailov A.V., Yarovskaya N.P. Betadine in the preoperative preparation of patients suffering from chronic inflammatory diseases of the pelvic organs., Breast Cancer 2001. reprint
2. Phillip E. Hay Recurrent bacterial vaginosis, Dermatologic Clinics, Vol. 16, No. 4, Oct. 1998
3. Jane R. Schwebke Asymptomatic bacterial vaginosis: Response to therapy, Am. J. Obstet. Gynecol. Vol. 183, No. 6, Dec. 2000
4. Bump RC, Buesching WJ: Bacterial vaginosis in virginal and sexually active adolescent females: Evidence against exclusive sexual transmission. Am J Obstet Gynecol Vol.158:935, 1988
5. Berger BJ, Kolton S, Zenilman JM, et al: Bacterial vaginosis in lesbians: A sexually transmitted disease. Clin Infect Dis 21:1402, 1995
6. Draper DL, Landers DV, Krohn MA, Hillier SL et al. Levels of vaginal secretory leukocyte protease inhibitor are decreased in women with lower reproductive tract infections Am. J. Obstet. Gynecol. Vol. 183, No. 5, Nov. 2000
7. N.V. Romashevsky et al. “Experience of using Betadine (EGIS) for the correction of vaginal dysbiosis in patients of reproductive age”, Bulletin of the Russian Association of Obstetricians and Gynecologists, 2000, No. 1
