Yox-teva

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT Jox-Teva (Jox-Teva)

Composition:

Active substances: povidone-iodine, allantoin;

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

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

Pharmaceutical form.

Oromucosal spray.

Main physicochemical characteristics: clear or slightly opalescent red-brown liquid, which is completely soluble in water.

Pharmacotherapeutic group.

Medicinal products used in throat disorders. Antiseptics.

ATC code R02A A20.

Pharmacological Properties.

Pharmacodynamics.

Povidone-iodine is a disinfecting agent belonging to the group of iodine-containing substances. Upon contact with the skin or mucous membranes, it releases organic iodine, which exerts a broad spectrum of antimicrobial activity through direct action on microbial proteins. It acts partially bactericidal against gram-positive and gram-negative cocci and bacilli, certain anaerobic bacteria, yeasts or saccharomycetes, protozoa, and some viruses.

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

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 pass 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 combination therapy 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 function disorders;
• Decompensated heart failure;
• Renal function impairment;
• 2 weeks before and after diagnostic procedures or therapy involving radioactive iodine.

Interaction with other medicinal products and other types of interactions.

The drug should not be combined with other antiseptic agents for the oral cavity and pharynx, especially hydrogen peroxide.

Due to its oxidizing properties, povidone-iodine may interfere with the results of certain diagnostic tests, such as occult blood detection in feces or urine, or glucose detection in urine. The use of the drug may lead to false-positive results in hemotests. It may also 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 receiving lithium therapy, as concomitant use may lead to a synergistic hypothyroid effect.

Povidone-iodine should not be used simultaneously with agents 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 concurrently with these substances.

All interactions are visually manifested by discoloration of the solution, indicating reduced drug efficacy.

The drug should not be used simultaneously with mercury-containing disinfectants; enzyme-containing ointments; or benzoin tincture. The drug is incompatible with oxidizing agents, alkali metal salts, and substances with an 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 this product simultaneously with other antiseptic medicinal products intended for use in the oral cavity and throat.

Povidone iodine may be used in laryngitis only in exceptional cases.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose (the product contains 18.6% ethanol). The product does not contain sugar.

Use with caution in patients with hepatic insufficiency. In such patients, transaminase levels may increase; therefore, monitoring of serum transaminase 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 (more than 14 days) use 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 potential 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 with eyes! If the product comes into contact with eyes, rinse thoroughly with water.

The product may cause discoloration of the mucous membranes of the oral cavity, 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.

If possible, dentures and similar devices should be removed from the mouth before applying the product.

The medicinal product contains propylene glycol. It may cause irritation of mucous membranes.

Do not heat the product before use.

Use during pregnancy or breastfeeding.

Pregnancy

There is no experience with the 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 during delivery or application to the skin during pregnancy). Therefore, povidone iodine must not be used during pregnancy.

Breastfeeding

Iodine may pass into breast milk. Concentrations of iodine detected in the blood and urine of breastfed infants were many times higher than those observed in their mothers who used povidone iodine. High concentrations of iodine 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 or operating machinery.

The use of this product does not affect or has a negligible effect on the ability to drive vehicles or operate other machinery.

Method of Administration and Dosage

The spray is intended for topical application to the mucous membranes of the oral cavity and pharynx.

The medication is administered in measured doses from the bottle equipped with a mechanical pump and an oral applicator (Fig. A1 or A2).

If the oral applicator is in a polyethylene bag, cut the bag with scissors or another suitable tool and remove the applicator (Fig. B2).

Before use, rinse the oral applicator with warm water and inspect it for damage. Do not use a damaged applicator.

Remove the protective cap from the mechanical pump. Attach the applicator to the bottle (Fig. B3).

Press the pump 2–3 times until the solution reaches the dispenser and begins to spray upon pressing.

Insert the applicator tube into the oral cavity, hold your breath, and press twice, directing the spray each time to the corresponding area of the throat on the right and left sides. Hold the bottle vertically during administration.

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), administering 1–3 sprays on each side (right and left) or directly onto the affected area. There should be at least 4 hours between administrations.

The spray should not be used more than 6 times per day.

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

Children

Indicated for treatment in children aged 8 years and older.

Children aged 8 to 12 years should use the medication under medical supervision.

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

Overdose

Overdose has not been reported with correct topical application of the medication to the oral cavity or pharynx. However, acute poisoning may occur if the iodine solution is swallowed. Patients may 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 may also occur.

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 have been reported. Inhalation of iodine vapors in animals resulted in respiratory depression due to laryngeal and glottic 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 freshly prepared starch solution. (To prepare the starch solution: place 2 g of starch in a porcelain cup and mix thoroughly with 8 mL of cool purified water. Add 90 mL of boiling purified water. Heat the mixture with constant stirring until boiling (0.5–1 minute), and continue heating until it thickens and becomes lighter in color. Cool to room temperature (25 °C) before administration.) If the esophagus is not damaged, gastric lavage may be performed. Additionally, activated charcoal and a 1% or 5% sodium thiosulfate solution should be administered to reduce iodine to iodide. Osmotic diuresis may be used to eliminate absorbed substance. There is currently no reported experience with dialysis. No specific antidote is available.

Side effects.

The frequency of adverse reactions was assessed as follows: 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 product: 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, renal dysfunction, diarrhea) after long-term use.

Shelf life.

3 years.

Storage conditions.

Keep in the original packaging to protect from moisture.

Keep out of reach and sight of children.

Packaging.

30 ml in a bottle with a mechanical spray pump; 1 bottle with an oral applicator in a carton.

Availability.

Over-the-counter (without prescription).

Manufacturer.

Teva Czech Industries s.r.o.

Manufacturer's address and place of business.

Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic.