Betayod-pharmex

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BETAID-PHARMEKS (BETAID-PHARMEKS)

Composition:

Active substance: povidone-iodine;

1 suppository contains 200 mg of povidone-iodine;

Excipient: macrogol 1000.

Pharmaceutical form. Suppositories.

Main physicochemical characteristics: smooth, dark brown-colored suppositories with an iodine odor and uniform consistency. A cup-shaped depression and an air channel may be present.

Pharmacotherapeutic group. Antimicrobial and antiseptic agents used in gynecology. ATC code G01AX11.

Pharmacological Properties.

Pharmacodynamics.

Povidone-iodine is a complex of iodine and the polymer polyvinylpyrrolidone, which releases iodine over a certain period after application to the skin. Free iodine exerts a potent bactericidal effect and has a broad spectrum of antimicrobial activity against bacteria, viruses, fungi, and protozoa.

Mechanism of action: free iodine provides a rapid bactericidal effect, while the polymer acts as an iodine reservoir.

Upon contact with skin and mucous membranes, a significant amount of iodine is released from the polymer.

Iodine reacts with oxidizable sulfhydryl (SH) and hydroxyl (OH) groups of amino acids present in enzymes and structural proteins of microorganisms, thereby inactivating or destroying these proteins. Most microorganisms are destroyed in vitro within less than one minute, with the primary destructive effect occurring within the first 15–30 seconds. During this process, iodine becomes decolorized, so a change in the intensity of the brown color serves as an indicator of its effectiveness.

The active substance of the medicinal product Betayod-Farmeks, pesaries, has a broad antimicrobial spectrum of activity, namely: it acts against Gram-positive and Gram-negative bacteria (bactericidal), viruses (virucidal), fungi (fungicidal) and fungal spores (sporicidal), as well as against certain protozoa (protozoicidal).

Due to its mechanism of action, resistance to the drug, including secondary resistance during prolonged use, is not expected.

The product is water-soluble and easily washed off with water.

Prolonged application of the product to large wound surfaces or severe burns, as well as to mucous membranes, may result in the absorption of a significant amount of iodine. Usually, prolonged use of the product leads to a rapid increase in blood iodine levels. Concentrations return to baseline levels within 7–14 days after the last application.

In patients with normal thyroid gland function, increased iodine stores do not lead to clinically significant changes in thyroid hormone status.

Pharmacokinetics.

Absorption and renal excretion of povidone-iodine depend on its molecular weight, which ranges between 35,000 and 50,000, potentially leading to retention of the substance.

Absorption of povidone-iodine or iodide is similar to that of iodine from other sources.

The volume of distribution is approximately 38% of body weight. The biological half-life after vaginal administration is about 2 days. Normal total plasma iodine concentration is approximately 3.8–6 µg/dL, while inorganic iodine levels range from 0.01–0.5 µg/dL. The drug is primarily excreted via the kidneys with a clearance rate of 15–60 mL/min, depending on plasma iodine levels and creatinine clearance (normally, 100–300 µg of iodine per 1 g of creatinine).

Clinical characteristics.

Indications.

Acute and chronic vaginal infections (colpitis):

• mixed infections;
• nonspecific infections (bacterial vaginosis caused by Gardnerella vaginalis);
• fungal infections (Candida albicans);
• vaginal infections following treatment with antibiotics and steroid drugs;
• trichomoniasis (combined systemic treatment should be administered when necessary).

Preoperative prophylaxis in surgical procedures in the vagina or diagnostic procedures.

Contraindications.

• Hypersensitivity to iodine or suspected hypersensitivity, or to other components of the drug.
• Thyroid gland dysfunction (nodular colloid goiter, endemic goiter, and Hashimoto's thyroiditis).
• Before and after treatment and scintigraphy with radioactive iodine in patients with thyroid carcinoma.
• Dermatitis herpetiformis Duhring.
• Renal insufficiency.

Interaction with other medicinal products and other forms of interaction.

The povidone-iodine complex is active against microorganisms at pH 2–7.

Concomitant use of povidone-iodine and hydrogen peroxide, as well as enzymatic preparations containing silver and thallium, for wound treatment or antiseptic agents, leads to mutual reduction in efficacy.

The use of povidone-iodine simultaneously or immediately after antiseptics containing octenidine may lead to the development of dark necroses at the application sites.

Povidone-iodine must not be used with mercury-containing preparations due to the risk of forming mercuric iodide. The drug may react with proteins and unsaturated organic compounds; therefore, the effect of povidone-iodine may be counteracted by increasing its dose.

Prolonged use of the drug should be avoided in patients receiving lithium therapy.

Due to its oxidizing properties, povidone-iodine may interfere with the results of certain diagnostic tests, such as tests for occult blood in feces or urine, or glucose in urine.

When povidone-iodine is used, iodine uptake by the thyroid gland may decrease, which may affect the results of certain diagnostic tests (such as thyroid scintigraphy, determination of protein-bound iodine, measurement of radioactive iodine), or may interfere with iodine used for thyroid therapy.

Thyroid scintigraphy should be performed 1–2 weeks after discontinuation of therapy to obtain reliable results.

Special precautions for use.

The use of povidone-iodine may reduce iodine uptake by the thyroid gland, which can affect the results of certain diagnostic tests and procedures (thyroid scintigraphy, determination of protein-bound iodine, diagnostic procedures involving radioactive iodine) and may also interact with iodine-containing medications used in the treatment of thyroid disorders. Therefore, treatment with iodine preparations for thyroid disease may not be feasible. A break of at least 1–4 weeks should be made before using povidone-iodine.

The product should not be used in patients before or after radioactive iodine therapy for thyroid cancer or radioactive iodine scintigraphy.

Significant amounts of iodine may induce hyperthyroidism in patients with thyroid dysfunction (e.g., nodular colloid goiter, endemic goiter). Therefore, the use of povidone-iodine preparations should be limited in terms of duration and the skin surface area treated.

Even after completion of treatment, patients should be monitored for early signs of hyperthyroidism, and thyroid function should be controlled.

The oxidizing effect of povidone-iodine may cause corrosion of metals, whereas plastic and synthetic materials are generally resistant to povidone-iodine. In individual cases, discoloration may occur, which is usually reversible.

Povidone-iodine can be easily removed from textiles and other materials with warm water and soap. Stubborn stains should be treated with ammonia solution or sodium thiosulfate.

Excessive use of iodine may cause hyperthyroidism in patients with thyroid disorders. The use of Betayod-Farmex, solution, should be kept as short as possible in such patients. Thyroid function tests should be performed if symptoms of hyperthyroidism occur after treatment.

The regular use of Betayod-Farmex, solution, should be avoided in patients receiving lithium preparations.

The oxidizing effect of povidone-iodine may lead to false-positive results in certain diagnostic tests (such as toluidine and guaiac tests for hemoglobin and glucose in feces and urine).

Use during pregnancy or breastfeeding.

Povidone-iodine should be used only in cases strictly prescribed by a physician and in the smallest possible doses. Iodine crosses the placental barrier and may pass into breast milk, thus posing a risk of hypersensitivity to iodine in the fetus or newborn. The concentration of povidone-iodine in breast milk is higher than in blood serum. Therefore, the drug may cause hyperthyroidism or elevated thyroid hormone levels in the fetus or newborn. It is necessary to monitor thyroid function in infants.

The product is contraindicated after the second month of pregnancy and during breastfeeding. Breastfeeding must be discontinued for the duration of treatment.

Fertility.

The drug has a spermicidal effect; therefore, it is not recommended for use in women planning pregnancy.

Ability to affect reaction rate when driving vehicles or operating machinery.

Betayod-Farmex, solution, does not affect the reaction rate when driving vehicles or operating other machinery.

Method of Administration and Dosage

The drug is administered vaginally.

It is recommended to use the drug once daily for 7 days.

In the case of more severe infections, it is recommended to continue treatment for an additional 7 days. For persistent infections, the drug may be prescribed twice daily (after consultation with a physician).

Remove the suppository from its wrapper, moisten it, and insert deeply into the vagina.

During treatment with suppositories, the use of hygienic pads is recommended.

Dosage

Insert 1 suppository deeply into the vagina in the evening before bedtime. The drug should be used daily (even during menstruation).

Children

Betayod-Farmeks suppositories are not used in children.

Overdose

Symptoms of acute iodine intoxication include:

• metallic taste in the mouth, increased salivation, burning sensation or pain in the mouth or throat;
• eye irritation and swelling;
• skin reactions;
• gastrointestinal disturbances and diarrhea;
• kidney dysfunction and anuria;
• circulatory insufficiency;
• laryngeal edema with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.

Treatment: symptomatic and supportive therapy should be administered, taking into account the electrolyte balance, renal function, and thyroid gland function.

Side effects

Povidone-iodine is generally well tolerated. Local reactions are possible, although this substance is considered less irritating.

Immune system disorders: hypersensitivity, anaphylactic reactions.

Skin and subcutaneous tissue disorders: local skin hypersensitivity reactions such as contact dermatitis with psoriasis-like red, small bullous lesions. Allergic reactions including itching, redness, rash, angioedema, exfoliative dermatitis, dry skin, chemical and thermal skin burns.

If any of the above symptoms occur during treatment, the use of the product should be discontinued immediately and medical advice should be sought.

Renal and urinary disorders: impaired kidney function, acute renal failure.

Metabolism and nutrition disorders: electrolyte imbalance; metabolic acidosis.

Endocrine disorders: hyperthyroidism (sometimes with symptoms such as tachycardia or restlessness); hypothyroidism.

Prolonged use of povidone-iodine may lead to absorption of a large amount of iodine.

In some cases, iodine-induced hyperthyroidism has been reported following prolonged use of the product, primarily in patients with pre-existing thyroid gland disorders.

Adverse effects from other organs and systems have been reported only sporadically.

Pessaries have a spermicidal effect; therefore, their use is not recommended for individuals planning pregnancy.

In isolated cases, generalized acute reactions with decreased blood pressure and/or breathing difficulties (anaphylactic reactions) may occur.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature between +2 °C and +8 °C. Keep out of reach of children.

Packaging.

7 pessaries per blister, 1 or 2 blisters per cardboard box.

Availability. Over-the-counter.

Manufacturer. LLC "FARMEKS GROUP", Ukraine.

Manufacturer's address and location of business activity.

LLC "Farmeks Group", Ukraine, 08301, Kyiv region, city of Boryspil, Shevchenka Street, building 100.
Tel.: +38 (044) 391-19-19, Fax: +38 (044) 391-19-18, or via contact form at the website: http://www.pharmex.com.ua/kontakty/forma-137-o/