1 suppository contains
- active ingredient – povidone – iodine 200.0 mg (equivalent to active iodine 17-24 mg),
- excipient – macrogol 1000.
The degree of absorption of povidone and its excretion by the kidneys depends on the average molecular weight (mixture). For substances with a molecular weight above 35,000-50,000, a delay in the body is possible. The fate of absorbed iodine or iodide in the body is basically the same as that of iodine administered in any other way. Excreted mainly through the kidneys.
The active substance of the Betadine ointment – povidone-iodine is a complex of iodine and a polymer of polyvinylpyrrolidone, from which iodine is released for some time after the use of the drug and a constant concentration of active free iodine is provided. Free iodine (I2) has a strong bactericidal effect. In in vitro studies , it quickly destroys bacteria, viruses, fungi and some protozoa. Upon contact with the skin or mucous membranes, the polymer releases ever-increasing amounts of iodine.
Free iodine reacts with oxidizable SH or OH groups of amino acid units of enzymes and structural proteins of microorganisms, inactivating and destroying these enzymes and proteins. In vitro , most microorganisms are killed within less than one minute, with the greatest bactericidal effect observed within 15-30 seconds. Drug resistance is unknown.
Betadine’s spectrum of action includes Gram-positive and Gram-negative bacteria (bactericidal), viruses (virucidal), fungi (fungicidal), some protozoa (protozoocidal) and spores (sporicidal).
Indications for use
Acute and chronic vaginal infections (vaginitis):
– mixed infections
– non-specific infections (bacterial vaginosis, Gardenerella vag .)
– fungal infections ( Candida albicans ), including candidiasis, due to treatment with antibiotics and steroid drugs
– trichomoniasis ( Trichomonas vaginalis) (if necessary, combined systemic treatment should be carried out).
Preoperative and postoperative treatment (for the purpose of prevention) before and after vaginal surgery, as well as obstetric and diagnostic procedures.
Dosage and administration
For intravaginal administration.
The suppository is recommended to use in the evening, before going to bed. The Betadine suppository is removed from the shell and inserted deep into the vagina. To maximize the dissolution of the active substance and prevent local irritation, it is recommended to moisten the suppository with water before administration.
In acute vaginitis, it is used 1-2 times a day for 7 days, in subacute and chronic vaginitis, 1 time a day at bedtime for 14 days (possibly longer). During treatment with suppositories, the use of sanitary pads is recommended. The drug should be used daily. There is no need to interrupt treatment during menstruation.
Rare (≥ 1/10,000 – < 1/1,000)
– contact dermatitis with the formation of psoriasis-like red small bullous elements, erythema, itching
Very rare (<1/10,000)
– anaphylactic reaction
– hyperthyroidism (sometimes accompanied by tachycardia or restlessness) may occur in patients with pre-existing thyroid disease after the use of iodine in significant amounts (for example, with long-term use of povidone-iodine to treat wounds or burns)
Frequency not known (frequency cannot be determined from available data)
– hypothyroidism (may develop with prolonged use with the treatment of large surfaces)
– changes in serum electrolytes and osmolarity**, metabolic acidosis**
– acute renal failure**
– chemical skin burn***
** – can be observed after the use of iodine in significant quantities (for example, in the treatment of burns)
*** – can be observed before surgery if the patient “gets wet” in Betadine solution
– hypersensitivity to iodine and other components of the drug
– hyperthyroidism or other severe thyroid dysfunction
– Duhring’s dermatitis herpetiformis
– state before and after the use of radioactive iodine in the treatment of hyperthyroidism (until complete recovery)
– girls who have not reached puberty
– before and after therapy and scintigraphy using radioactive iodine
The povidone-iodine complex has antimicrobial activity in the pH range of 2.0-7.0. Interaction with proteins and other unsaturated organic substances reduces its effectiveness.
Regular use of Betadine should be avoided in patients receiving lithium preparations.
During the use of povidone-iodine, the uptake of iodine by the thyroid gland may decrease, which may affect the results of some diagnostic tests (for example, thyroid scintigraphy, protein-bound iodine determination, radioactive iodine measurements), and may also interact with iodine preparations used for the treatment of thyroid diseases. To obtain undistorted research results after long-term therapy with povidone-iodine, it is recommended to withstand a sufficiently long period of time (1-2 weeks) without this drug.
Due to the oxidizing properties of povidone-iodine, its traces in some types of tests using toluidine or guaiac resin to detect occult blood (hemoglobin) in the stool, as well as blood or glucose in the urine, can lead to false positive results.
In case of skin irritation, contact dermatitis or hypersensitivity, the drug should be discontinued.
Do not heat the drug before use.
Significant amounts of iodine can cause hyperthyroidism in patients with impaired thyroid function (eg, nodular colloid or endemic goiter). In such patients, the use of Betadine vaginal suppositories should be limited in time and area of the treated skin surface. If symptoms of hyperthyroidism occur during treatment, thyroid function should be checked.
Particular caution should be observed with regular use of the drug in patients with previously diagnosed chronic renal failure.
The drug should not be used before and after scintigraphy, as well as during the treatment of thyroid carcinoma with radioactive iodine.
Pregnancy and lactation
The use of povidone-iodine during pregnancy and breastfeeding is contraindicated, since the absorbed iodide ions pass through the placental barrier and are excreted into breast milk. The use of the drug during pregnancy can cause the development of transient hypothyroidism with an increase in the level of thyroid-stimulating hormone in the fetus and newborn. It may be necessary to study the function of the thyroid gland in a child.
Features of the effect of the drug on the ability to drive vehicles and work with mechanisms
Does not affect
The following symptoms are characteristic of acute iodine intoxication : a metallic taste in the mouth, increased salivation, a burning sensation or pain in the mouth or throat; irritation and swelling of the eyes; skin reactions; gastrointestinal disorders and diarrhea; impaired renal function and anuria; circulatory failure; laryngeal edema with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.
Treatment : symptomatic and supportive therapy with special control of electrolyte balance, kidney and thyroid function.
Store between 5°C and 15°C, in a cool dry place.
Keep out of the reach of children!
Shelf life – 5 years
Do not use after the expiration date.