Properties
What is it?
BETADINE Vaginal Suppositories Active ingredient: Povidone-iodine, 200 mg per suppository. Other ingredients: Macrogol 1000. Pharmacotherapeutic group: Antiseptic. See blog: Betadine - effective antiseptic in the form of solution, ointment, mouthwash or suppositories. Pharmacological properties: Povidone-iodine destroys microorganisms. It is effective against bacteria, fungi, spores, viruses, and protozoa. BETADINE Vaginal Suppositories help to rapidly restore the normal vaginal flora, while quickly relieving symptoms such as itching and burning. Due to this mechanism of action, resistance to the preparation, as well as secondary resistance during prolonged use, is not expected. As a result of complex formation with povidone, iodine largely loses its local irritant effect, which is characteristic of iodine alcoholic solutions, and therefore it is well tolerated by skin, mucous membranes, and wound areas. At the same time, iodine loses its color, so the intensity of the brown discoloration is an indicator of the preparation's effectiveness. Multiple applications of the preparation may be necessary after decolorization. Povidone-iodine dissolves in water and is easily washed off. Indications Acute and chronic vaginal infections (colpitis): - Mixed infections; - Non-specific infections (bacterial vaginosis, Gardenella vaginalis); - Genital herpes; - Fungal infections (Candida albicans), including candidiasis as a result of treatment with antibiotics and steroid preparations. - Trichomoniasis (if necessary, combined systemic treatment may be carried out). Preoperative and postoperative treatment of the vagina before and after surgical operations, as well as obstetric and diagnostic procedures. Contraindications - Hypersensitivity to iodine or other components of the preparation; - Hyperthyroidism or other pronounced disorders of thyroid function (symptoms: increased heart rate, anxiety), as well as after radioactive iodine treatment for hyperthyroidism until complete recovery. - Dermatitis herpetiformis Duhring. - Povidone-iodine can be used in newborns and infants up to 6 months of age only under strict indications. If necessary, thyroid function control is required. Since the development of hyperthyroidism cannot be ruled out, prolonged use (more than 14 days) or large quantities of povidone-iodine over a wide surface area (more than 10% of the body surface) is not recommended. In patients (especially the elderly) with latent thyroid disorders, its use is permissible only after careful assessment of the benefits and potential risks. These patients should be monitored for early signs of hyperthyroidism and undergo appropriate thyroid function tests even after discontinuation of the preparation (for up to 3 months). Pregnancy and breastfeeding Use of the preparation after 2 months of pregnancy, as well as during lactation, is possible only under strict indications and requires careful monitoring of the thyroid function of the mother and child. Also, accidental ingestion of suppositories by children should be avoided. In these cases, the preparation can only be used for a short period. Iodine crosses the placental barrier and is excreted in breast milk. Special instructions The use of povidone-iodine may reduce iodine uptake by the thyroid gland, which may affect the results of some tests and procedures (thyroid scintigraphy, determination of protein-bound iodine, diagnostic procedures using radioactive iodine), making it impossible to plan treatment of thyroid diseases with iodine preparations. An interval of at least 1-4 weeks should be observed after discontinuation of PVP-iodine. The oxidizing action of povidone-iodine can lead to false positive results in various diagnostic tests (e.g., determination of hemoglobin and glucose in feces and urine using toluidine and guaiac resins). The oxidizing ability of povidone-iodine can cause corrosion of metals, while plastics and synthetic materials are usually not sensitive to PVP-iodine. In isolated cases, discoloration may occur, which usually recovers. PVP-iodine is easily removed from textiles and other materials with soap and warm water. Stubborn stains may require treatment with ammonia or sodium thiosulfate. If side effects occur or if you have another illness, inform your doctor. Consult your doctor during pregnancy. Interaction with other drugs The combined use of povidone-iodine with hydrogen peroxide, as well as enzymatic preparations containing silver and taurolidine, for wound or antiseptic treatment reduces their mutual effectiveness. Povidone-iodine should not be used with mercury preparations due to the risk of forming mercury basic iodide. The preparation can react with proteins and unsaturated organic complexes, so the effect of povidone-iodine can be compensated by increasing its dose. Prolonged use of the preparation, especially for treating large surfaces, should be avoided in patients taking lithium preparations. Dosage and administration BETADINE suppositories should be removed from the wrapper and, after thorough moistening, inserted deep into the vagina. During treatment with suppositories, the use of sanitary pads is recommended. Dosage: One vaginal suppository is inserted deep into the vagina in the evening before bedtime. The preparation should be used daily (even during menstruation). If the efficacy is insufficient, the course of treatment may be extended as prescribed by the doctor, and the dose may be increased to two BETADINE vaginal suppositories daily. The duration of the course of treatment depends on the treatment results. The course of treatment is usually 7 days. Overdose After the use of a significant amount of povidone-iodine, the following symptoms may develop: anuria, circulatory failure, laryngeal edema, weak pulse or its absence, pulmonary edema, metabolic disorders. Treatment of overdose: The toxic concentration of iodine in the blood serum can be effectively reduced by peritoneal dialysis and hemodialysis. In addition, thyroid function should be monitored to rule out or detect iodine-induced hyperthyroidism at an early stage. Intoxication after ingestion: Immediate administration of food products containing starch or protein (e.g., starch dissolved in water or milk). Gastric lavage with a 5% solution of sodium thiosulfate (or intravenous administration of 10 ml of a 10% solution of sodium thiosulfate) at 3-hour intervals as needed. If a dose of BETADINE is missed, do not take a double dose to compensate for the missed dose (due to the risk of overdose). Use the recommended dose (1 suppository once or twice a day). Side effects Povidone-iodine is generally well tolerated. Hypersensitivity reactions of the skin (e.g., delayed-type allergic reactions - itching, redness, blisters) have been reported in very rare cases. Generalized acute skin reactions with decreased blood pressure and/or difficulty breathing (anaphylactic reactions) have been reported in isolated cases. Prolonged use of BETADINE solution may lead to the absorption of a significant amount of iodine. In isolated cases, individuals with a predisposition may experience iodine-induced hyperthyroidism. If any side effect occurs that is not listed in the instructions for use, consult your doctor or pharmacist. Dosage form 7 or 14 vaginal suppositories of 200 mg packed in a blister; 1 or 2 blisters are placed in a cardboard box with instructions for use. Storage conditions Store in a dry, cool place at 15°-25°C, out of reach of children! Expiration date The expiration date is indicated on the box. Do not use the preparation after the expiration date. Conditions of dispensing from the pharmacy Over-the-counter. Manufacturer Egis Pharmaceuticals PLC Hungary