Instructions for Yox oral spray bottle with sprayer 30 ml
Composition
active ingredients: 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.
Dosage form
Oral spray.
Main physicochemical properties: transparent or slightly cloudy red-brown liquid, completely soluble in water.
Pharmacotherapeutic group
Medicines used for throat diseases. Antiseptics.
ATX code R02A A20.
Pharmacological properties
Pharmacodynamics.
Povidone-iodine is a disinfectant belonging to the group of iodine-containing substances. When in contact with the skin or mucous membranes, it releases organic iodine, which has a wide range of antimicrobial effects due to its direct effect on the proteins of microorganisms. It has a partially bactericidal effect on gram-positive and gram-negative cocci and bacilli, some anaerobic bacteria, yeasts or saccharomyces, protozoa and some viruses.
The drug also contains allantoin, which has an anti-inflammatory effect, which, together with povidone iodine, provides the therapeutic effect of the drug.
Pharmacokinetics.
When povidone-iodine is applied topically to intact skin, absorption of iodine is minimal. When applied orally, systemic absorption of iodine is more pronounced, which may result in interference with thyroid function. Iodine in the body is converted to iodides, which accumulate mainly in the thyroid gland and are excreted mainly by the kidneys, and in small quantities with feces, saliva, and sweat. Iodides pass through the placental barrier and enter breast milk.
Indication
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 for streptococcal tonsillitis; the first symptoms of acute respiratory viral infections.
Contraindication
Hypersensitivity to any component of the drug;
During's dermatitis herpetiformis;
hyperthyroidism, adenoma or thyroid dysfunction;
decompensated heart failure;
kidney dysfunction;
2 weeks before and after examination or therapy using 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, primarily with hydrogen peroxide.
Due to its oxidizing properties, povidone-iodine may interfere with the results of some diagnostic tests, such as the detection of occult blood in the stool or urine or glucose in the urine. The use of the drug leads to false-positive results of blood tests. May interfere with the results of some diagnostic tests (e.g. thyroid scintigraphy, determination of protein-bound iodine, measurement of radioactive iodine) or may compete with iodine used for thyroid therapy.
The administration of 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, silver sulfadiazine, due to possible partial inactivity. Povidone-iodine interacts with strong alkalis, sodium thiosulfate, sodium metabisulfite and thiomersal, therefore the drug should not be used simultaneously with these substances.
All interactions are visually manifested by discoloration of the solution, which indicates a decrease in the effectiveness of the drug.
The drug should not be used simultaneously with disinfectants containing mercury; ointments containing enzymes, or with benzoin tincture; the drug is incompatible with oxidants, alkali salts, and substances with an acidic reaction.
Application features
The drug is not intended for internal use: do not inhale or swallow the drug. If the patient's condition does not improve within 3 days or an undesirable effect or unusual sensations are observed, a doctor's consultation is necessary.
It is not advisable to use the drug simultaneously with other antiseptic drugs intended for use in the mouth and throat.
For laryngitis, the drug can be used only in exceptional cases.
This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg/dose (the product contains 18.6% ethanol). The product does not contain sugar.
The drug should be used with caution in patients with hepatic insufficiency. In such patients, transaminase levels may increase, so it is necessary to monitor their serum levels.
Since the development of hyperthyroidism cannot be excluded, long-term (more than 14 days) use of povidone-iodine or use in significant quantities in patients (especially the elderly) with latent thyroid dysfunction is permissible only after careful assessment of the expected benefit and possible risk. The condition of such patients should be monitored for early signs of hyperthyroidism and appropriate examination of thyroid function, even after discontinuation of the drug (for a period of up to 3 months).
Do not inhale or swallow the spray solution! Avoid contact with eyes! If the product gets into your eyes, rinse them with water.
The drug may discolor the mucous membrane of the oral cavity, teeth, skin and clothing. Stains on the mucous membrane, teeth and skin can be removed with alcohol. Stains on clothing can be removed by washing and rinsing with diluted ammonia (rubbing alcohol), sodium thiosulfate or soap.
If possible, dentures and similar structures should be removed from the mouth before using the drug.
The medicine contains propylene glycol. May cause irritation of mucous membranes.
Do not heat the drug 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 have used topical iodine (after vaginal application during delivery or application to the skin during pregnancy). Therefore, povidone-iodine should not be used during pregnancy.
Breast-feeding
Iodine can pass into breast milk. The detected iodine concentrations in the blood and urine of breast-fed infants were many times higher than the concentrations observed in their mothers who used povidone-iodine. High serum iodine concentrations may cause congenital hypothyroidism in breast-fed infants, therefore povidone-iodine should not be used during breast-feeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The use of the drug has no or negligible influence on the ability to drive vehicles and other mechanisms.
Method of administration and doses
Apply the spray topically to the mucous membrane of the oral cavity and pharynx.
The drug is sprayed in a dosed manner from a bottle with a mechanical sprayer and an oral applicator (Fig. A1 or A2).
If the oral applicator is in a plastic bag, cut it with scissors or another convenient tool and remove the applicator (Fig. B2).
Before use, the oral applicator should be rinsed with warm water and checked for damage. A damaged applicator should not be used.
Remove the protective cap from the mechanical sprayer. Place the applicator on the bottle (Fig. 3).
Press 2–3 times until the solution reaches the sprayer and starts spraying after pressing.
Insert the applicator tube into the oral cavity, hold your breath and press 2 times, each time directing the jet of the drug to the appropriate area of the throat cavity on the right and left. During use, the bottle should be held vertically.
Do not inhale or swallow the sprayed solution!
Adults and children over 8 years of age should apply 1-3 sprays to the right and left sides or directly to the affected area, usually 2-4 times a day (every 4 hours if necessary). At least 4 hours should elapse between applications.
The spray can be applied no more than 6 times a day.
Elderly patients and patients with hepatic insufficiency require dose adjustment (see section "Special warnings and precautions for use").
The duration of treatment depends on the nature and course of the disease and is determined by the doctor individually.
Children
Use for the treatment of children aged 8 years and over.
Children aged 8 to 12 years should use the drug under the supervision of a physician.
Children should use the drug with caution, given the possibility of laryngospasm.
Overdose
With proper local application of the drug to the oral cavity or pharynx, no overdose was observed. However, in the case of swallowing iodine solution, acute poisoning developed. Patients initially felt a metallic taste in the mouth, vomiting, stomach pain and diarrhea began. Within 1–3 days, anuria, swelling of the glottis with subsequent asphyxia, aspiration pneumonia or pulmonary edema were observed. In some cases, even severe circulatory disorders were observed.
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 brewed starch. (To brew starch, place 2 g of starch in a porcelain cup and mix well with 8 ml of cool purified water. Add 90 ml of boiling purified water. Stirring constantly, heat the mixture to a boil (0.5–1 minute) and hold until it thickens and becomes lighter. Cool to room temperature (25 °C) and consume.) If the esophagus is not damaged, gastric lavage can be performed. In addition, activated charcoal and a 1 or 5% solution of sodium thiosulfate, which ensures the reduction of iodine to iodide, should be taken. Osmotic diuresis may be performed to remove the absorbed substance. To date, no experience with dialysis has been reported. There is no specific antidote.
Side effects
The frequency of adverse events 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: allergic reactions to iodine may occur, requiring discontinuation of the drug: itching, hyperemia, urticaria. Very rare: angioedema.
General disorders and administration site conditions: uncommon: burning sensation at the application site (especially in children), pain at the application site, dry mouth.
Injury, poisoning and complications during the procedure: iodism (metallic taste in the mouth, increased salivation, swelling of the eyes, larynx, lungs, skin rash, gastrointestinal disorders, systemic side effects in the form of metabolic acidosis, hypernatremia, impaired renal function, diarrhea) after long-term use.
Expiration date
3 years.
Storage conditions
Store in original packaging to protect from moisture.
Keep out of reach of children.
Packaging
30 ml in a bottle with a mechanical sprayer; 1 bottle complete with an oral applicator in a box.
Vacation category
Without a prescription.
Producer
Teva Czech Industries s.r.o.
Location of the manufacturer and address of its place of business
Ostravska Street 305/29, Komarov, 747 70 Opava, Czech Republic.
