Betadine, vaginal suppositories 200 mg 14 pcs

Pharmacotherapeutic group:antiseptic

ATX code: G01AX11

Pharmacological properties

Pharmacodynamics

Povidone iodine is a complex of iodine and polyvinylpyrrolidone polymer that releases iodine within a certain time after application. Elemental iodine (I₂) has a strong germicidal effect. In in vitro experiments it rapidly destroys bacteria, viruses, fungi and some protozoa. Its mechanism of action is as follows: free iodine has a rapid germicidal effect and the polymer is a depot for iodine. When in contact with skin or mucous membranes, ever-increasing amounts of iodine are released from the polymer. Iodine reacts with the oxidized -SH and -OH groups of amino acids that make up the enzymes and structural proteins of microorganisms, inactivating or destroying these proteins, leading to the death of the microorganisms.

The majority of microorganisms are killed by in vitro exposure in less than 1 minute, with the main destructive effect occurring in the first 15 to 30 seconds, with iodine discolored. Therefore, the intensity of the brown color is an indicator of efficacy. Resistance to the drug is unknown.

Antimicrobial spectrum of action: the active substance of Betadine vaginal suppositories effectively targets and destroys a wide range of microorganisms such as Gram positive and Gram negative bacteria (bactericidal effect), viruses (virucidal effect), fungi (fungicidal effect), some protozoa (protozocidal effect) and spores (sporocidal effect).

Pharmacokinetics

absorption

No data on systemic absorption.

Evacuation

Predominantly by the kidneys.

Povidone

The absorption and even more so the excretion of povidone by the kidneys depends on its molecular weight. Because its molecular weight is between 35,000 and 50,000, retention in the body is to be expected.

Indications

Vaginitis, Herpes, Trichomoniasis, thrush (candidiasis)

• Acute or chronic vaginitis (mixed non-specific infections), bacterial vaginosis (caused by Gardnerella vaginalis), candidiasis, infection caused by Trichomonas vaginalis. Vaginal infections after antibiotic or steroid therapy.
• Prevention before surgical or diagnostic interventions in the vagina.

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Active ingredient

Povidone-Yodine

Composition

Active ingredient: 200 mg povidone iodine (corresponds to 18-24 mg of active iodine) in each vaginal suppository. Excipient: macrogoal 1000 2800 mg.

How to take, the dosage

Intravaginal (For insertion into the vagina).
In order to maximize the release of the active ingredient and to prevent the development of local irritation it is recommended to moisten the suppository with water and insert it deep into the vagina in the evening before going to bed. If during the application of the vaginal suppository menstruation occurs, the treatment should be continued without interruption for the period prescribed.

Inject one suppository deep into the vagina: for acute vaginitis once a day for seven days; in more severe cases or if the treatment is not sufficiently effective it may be continued for additional seven days once a day. In cases of persistent long-term infections the treatment may be longer and the vaginal suppositories may be used twice a day.
For preoperative prevention of complications of infectious genesis in gynecology the drug is administered intravaginally 2 times a day (in the morning and in the evening before going to bed) for 1-7 days.
If after treatment no improvement occurs or symptoms worsen or new symptoms appear, consult a physician. Use the drug only for the indications, according to the route of administration and in the dosage indicated in the instructions for use.

To use

Separate one suppository from the band by tearing along the perforation of the V-shaped cut

Remove the suppository from the blister by pulling both ends of the foil in opposite directions at the same time

Remove the suppository from the blister.

Interaction

The povidone-iodine complex is effective in the pH range of 2 – 7. Interaction of the complex with proteins and other unsaturated organic substances reduces its effectiveness. You should not use the drug with other disinfectants and antiseptics containing oxidants, alkalis and cationic surfactants. If you use the above mentioned or other drugs (including over-the-counter ones), consult your doctor before using Betadine. The oxidizing effect of povidone iodine can lead to false positives in various diagnostic tests (e.g. determination of haemoglobin in stool or urine or glucose in urine). During the use of povidone iodine, iodine uptake by the thyroid gland may decrease, which may affect the results of some diagnostic tests (e.g., thyroid scintigraphy, protein-bound iodine and radioactive iodine determination) or make planned thyroid iodotherapy impossible. In order to obtain objective results after long-term treatment with povidone iodine, a break should be taken before scintigraphy.

Special Instructions

In prolonged use of the drug, skin irritation, contact dermatitis or hypersensitivity may occur. In case of signs of local irritation and hypersensitivity, the use of the drug should be discontinued.

In patients with thyroid diseases, such as goiter, nodular goiter and other non-acute thyroid diseases, administration of significant amounts of iodine may cause hyperthyroidism. In such patients, the use of Betadine vaginal suppositories should be limited in time. If signs of hyperthyroidism develop at the end of treatment, patients should have their thyroid function monitored.

The drug should not be used before and after scintigraphy, or during treatment of thyroid carcinoma with radioactive iodine (see Contraindications).

Particular caution should be used with regular use in patients with impaired renal function.

Principal use of Betadine Vaginal Suppositories should be avoided if patients are receiving lithium supplements.

Precaution is recommended for virgins when using the vaginal suppositories.

The suppositories have spermicidal properties, so they are not recommended for women who are planning to become pregnant.

We also recommend sanitary pads during the course of treatment. After contact with the drug, eye contact should be avoided.

Children and adolescents

The use of Betadine vaginal suppositories is contraindicated for girls under the age of adolescence.

Influence on the ability to drive vehicles, machinery

The drug does not affect the ability to drive vehicles or engage in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions.

Synopsis

Torpedo-shaped homogeneous suppositories of dark brown color.

Contraindications

• High sensitivity to povidone-iodine and other ingredients of the drug;
• disorders of thyroid function (hyperthyroidism) (see Special indications;
• other acute diseases of the thyroid gland. Special Indications);
• other acute thyroid disorders;
• During dermatitis herpetiformis;
• before or during the use of radioiodine for thyroid carcinoma or scintigraphy;
• pregnancy and lactation;
• the use of Betadine vaginal suppositories is contraindicated in girls under the age of adolescence.

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Side effects

Itching, hyperemia at the injection site, allergic reactions. If you experience or worsen any of the side effects mentioned in the instructions, or if you notice any other side effects not mentioned in the instructions, please inform your doctor.

Overdose

When using the drug in accordance with the instructions for use, overdose is unlikely. In case of overuse iodine intoxication is possible, which is characterized by the following symptoms: metallic taste in the mouth, increased salivation, burning or pain in the mouth or throat, eye irritation and edema, skin reactions, gastrointestinal disorders and diarrhea, renal disorders and anuria, circulatory failure, laryngeal edema with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatriemia. Treatment: symptomatic and supportive therapy with special attention to electrolyte balance, renal and thyroid function.

Pregnancy use

The use of povidone iodine during pregnancy and during breastfeeding is contraindicated because the absorbed iodine passes through the placenta and is excreted into the breast milk. In addition, the fetus and the newborn are hypersensitive to iodine. Breast milk has a higher concentration of iodine than blood serum. Iodine use may cause hypothyroidism in the fetus or newborn with increased concentration of thyrotropic hormone (TSH). It may be necessary to monitor the child’s thyroid function. In children, the possibility of accidental ingestion or ingestion should be prevented.

Fertility

Vaginal suppositories may have spermicidal effects, so their use is not recommended during pregnancy planning.

Similarities

Povidone-Iodine, Iodoxide, Braunodine B.Brown