Betayod plus

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BETAID PLUS (BETAIOD PLUS)

Composition:

Active substances: povidone-iodine, allantoin;

1 ml of the preparation contains povidone-iodine 85 mg, allantoin 1 mg;

Excipients: propylene glycol, menthol, citric acid, sodium citrate, ethanol 96%, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical properties: clear, slightly opalescent, reddish-brown liquid with a characteristic odor, miscible with water.

Pharmacotherapeutic group. Medicinal products used in throat disorders. Antiseptics.

ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics.

Povidone-iodine, a disinfecting agent belonging to the group of iodine-containing substances, releases organic iodine upon contact with skin or mucous membranes, which exerts a broad spectrum of antimicrobial activity through direct action on microbial proteins. It acts bactericidally, to some extent, on both Gram-positive and Gram-negative cocci and bacilli, certain anaerobic bacteria, yeasts or actinomycetes, protozoa, and some viruses.

The preparation also contains allantoin, which exerts an anti-inflammatory effect; thus, together with povidone-iodine, it contributes to the therapeutic action of the product.

Pharmacokinetics.

When povidone-iodine is applied topically to intact skin, iodine absorption is minimal. When used in the oral cavity, more pronounced systemic absorption of iodine occurs, potentially leading to interference with thyroid functions. In the body, iodine is converted into iodides, which accumulate primarily in the thyroid gland and are excreted mainly by the kidneys, as well as in small amounts in feces, saliva, and sweat. Iodides cross the placental barrier and are excreted into breast milk.

Clinical characteristics.

Indications.

Disinfection of the oral cavity and pharynx in inflammatory and infectious diseases: tonsillitis, pharyngitis, tonsillopharyngitis, tonsillitis, glossitis, and aphthous stomatitis; as part of complex treatment with antibiotics in streptococcal tonsillitis; early symptoms of acute respiratory viral infections.

Contraindications.

• Hypersensitivity to any component of the drug;
• Dermatitis herpetiformis Duhring;
• Hyperthyroidism, adenoma, or thyroid gland dysfunction;
• Decompensated heart failure;
• Renal function impairment;
• 2 weeks before and after examination or therapy with radioactive iodine.

Interaction with other medicinal products and other types of interactions.

It is not recommended to combine the drug with other antiseptic agents for the oral cavity and pharynx, especially hydrogen peroxide.

Due to its oxidizing properties, povidone-iodine may affect the results of certain diagnostic tests, such as detection of occult blood in feces or urine, or glucose in urine. The use of the drug leads to false-positive results in hemotests. It may interfere with the results of certain diagnostic tests (e.g., thyroid scintigraphy, determination of protein-bound iodine, measurement of radioactive iodine), or may compete with iodine used in thyroid therapy.

Povidone-iodine should be avoided in patients taking lithium preparations, as their concomitant use may cause a synergistic hypothyroid effect.

Povidone-iodine should not be used simultaneously with preparations containing chlorhexidine or silver sulfadiazine due to possible partial inactivation. Povidone-iodine interacts with strong alkalis, sodium thiosulfate, sodium metabisulfite, and thiomersal; therefore, the drug must not be used simultaneously with these substances.

All interactions manifest visually as discoloration of the solution, indicating reduced drug efficacy.

The drug should not be used simultaneously with disinfectants containing mercury; ointments containing enzymes; or benzoin tincture. The drug is incompatible with oxidizing agents, alkali salts, and substances with acidic reaction.

Special precautions for use

The product is not intended for internal use: do not inhale or swallow the product. If the patient's condition does not improve within 3 days or if adverse reactions or unusual sensations occur, medical advice is required.

It is not advisable to use the product simultaneously with other antiseptic medicinal products intended for use in the oral cavity and throat.

The product may be used in laryngitis only in exceptional cases.

The product contains 18.6% ethanol and is sugar-free.

The product should be used with caution in patients with hepatic insufficiency. In such patients, transaminase levels may increase; therefore, monitoring of their serum levels is necessary.

The use of povidone-iodine may interfere with thyroid scintigraphy. Povidone-iodine should not be used within 1–2 weeks prior to thyroid scintigraphy.

Since the development of hyperthyroidism cannot be excluded, prolonged use (more than 14 days) of povidone-iodine or its use in large amounts in patients (especially elderly patients) with latent thyroid dysfunction is permissible only after careful assessment of the expected benefit and possible risk. Such patients should be monitored for early signs of hyperthyroidism and appropriate evaluation of thyroid function, even after discontinuation of the product (for up to 3 months).

Do not inhale or swallow the sprayed solution. Avoid contact of the product with the eyes. If the product gets into the eyes, rinse thoroughly with water.

The product may cause discoloration of the oral mucosa, teeth, skin, and clothing. Stains on mucous membranes, teeth, and skin can be removed with alcohol. Stains on clothing can be removed by washing and rinsing with diluted ammonia (ammonium spirit), sodium thiosulfate, or soap and water.

If possible, dental prostheses and similar devices should be removed from the mouth before using the product.

Do not heat the product before use.

The medicinal product contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding

There is no experience with topical use of povidone-iodine in pregnant women. Congenital hypothyroidism or goiter has been observed in newborns whose mothers used iodine topically (after vaginal administration before delivery or application to the skin during pregnancy). Therefore, povidone-iodine must not be used during pregnancy.

Iodine can pass into breast milk. Iodine concentrations detected in the blood and urine of breastfed infants were many times higher than those observed in their mothers who used povidone-iodine. High iodine concentrations in serum may cause the development of congenital hypothyroidism in breastfed infants; therefore, povidone-iodine must not be used during breastfeeding.

Ability to affect reaction speed when driving vehicles or operating machinery

The use of the product has no effect or has a negligible effect on the ability to drive vehicles or operate machinery.

Method of Administration and Dosage.

Apply the spray locally to the mucous membranes of the oral cavity and pharynx.

The medication should be sprayed from the bottle using the oral spray device.

Remove the protective cap.

Press the pump 2–3 times until the solution reaches the spray nozzle and begins to spray.

Insert the oral spray tube into the mouth, hold your breath, and press twice, directing the spray each time toward the corresponding area of the throat on the right and left sides. During administration, the bottle must be held vertically.

Do not inhale or swallow the sprayed solution.

For adults and children aged 8 years and older, the usual dosage is 2–4 times daily; if necessary, every 4 hours.

The spray may be used no more than 6 times a day.

Dosage adjustment is required for elderly patients and patients with hepatic insufficiency (see section "Special Instructions").

The duration of treatment depends on the nature and course of the disease and is determined individually by the physician.

Children.

Use for treatment of children aged 8 years and older.

For children aged 8 to 12 years, the medication should be used under medical supervision.

Use with caution in children due to the potential risk of laryngospasm.

Overdose.

When applied correctly as a local treatment in the oral cavity or pharynx, cases of overdose have not been observed. However, ingestion of the iodine solution may lead to acute poisoning. Patients initially experience a metallic taste in the mouth, followed by vomiting, stomach pain, and diarrhea. Within 1–3 days, anuria, swelling of the glottis leading to asphyxia, aspiration pneumonia, or pulmonary edema may develop. In some cases, severe circulatory disturbances have also been observed.

In animal studies, administration of povidone-iodine caused irritation and, in some cases, damage to the gastrointestinal mucosa. Cases of pyloric stenosis, gastric necrosis, peritonitis, and sepsis were reported. Inhalation of iodine vapors in animals resulted in respiratory depression due to laryngeal and glottal edema.

Treatment is symptomatic and initially includes standard measures to prevent further absorption of the drug in the gastrointestinal tract. The patient should drink milk and prepared starch (to prepare the starch: place 2 g of starch into a porcelain cup and mix thoroughly with 8 mL of cool purified water; add 90 mL of boiling purified water; while continuously stirring, heat the mixture to boiling (0.5–1 minute) and maintain until it thickens and becomes lighter in color; cool to room temperature (25 °C) and administer). If the esophagus is not damaged, gastric lavage may be performed. Additionally, activated charcoal and a 1–5% solution of sodium thiosulfate, which converts iodine into iodide, should be administered. Osmotic diuresis may be used to eliminate absorbed substances. To date, there have been no reports on the experience of dialysis. There is no specific antidote.

Adverse reactions.

The drug is usually well tolerated.

The frequency of adverse reactions was assessed according to the following criteria: very common (> 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (< 1/10000), including isolated reports.

Immune system disorders: rare – hypersensitivity symptoms; very rare – anaphylactic shock.

Gastrointestinal disorders: uncommon – dry mouth.

Skin and subcutaneous tissue disorders: rare – possible iodine-related allergic reactions requiring discontinuation of the drug: itching, hyperemia, urticaria; very rare – angioneurotic edema.

General disorders and administration site conditions: uncommon – burning sensation at the application site (especially in children), pain at the application site, sensation of dry mouth.

Injury, poisoning and procedural complications: iodism (metallic taste in the mouth, increased salivation, swelling of eyes, larynx, lungs, skin rash, gastrointestinal disturbances, systemic adverse effects such as metabolic acidosis, hypernatremia, impaired kidney function, diarrhea) after long-term use.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

30 ml in a bottle with an oral spray device and protective cap in a carton.

Prescription status.

Over-the-counter.

Manufacturer.

LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and place of business.

Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, 22.