INGALIPT-N

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT INGALIPT-N (Ingaliptum-N)

Composition:

Active substances: soluble streptocide, sulfathiazole sodium hexahydrate;

1 can contains 0.75 g of soluble streptocide and 0.75 g of sulfathiazole sodium hexahydrate;

Excipients: thymol, peppermint oil, eucalyptus oil, glycerin, 96% ethanol, polysorbate 80, sucrose, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical properties: clear liquid, light yellow to dark yellow in color, with a characteristic odor.

Pharmacotherapeutic group.
Agents acting on the respiratory system. Preparations used for throat disorders. Antiseptics. Miscellaneous antiseptics.

ATC code R02A A20.

Pharmacological Properties

Pharmacodynamics

Ingalipt-N exerts antibacterial and anti-inflammatory effects, as well as cooling and distracting actions. The combination of these pharmacological properties provides comprehensive pathogenetic therapy for inflammatory diseases of the upper respiratory tract and the oral mucosa. Ingalipt-N does not produce ulcerogenic or general toxic effects on the body.

Pharmacokinetics

Ingalipt-N is intended for local inhalation use and creates a therapeutic concentration primarily at the site of inflammation. Sulfonamides (soluble streptocide and norsulfazole sodium) are partially absorbed into the systemic circulation, reversibly binding to plasma proteins: soluble streptocide binds by 12–14%, norsulfazole sodium by 55%. During biotransformation, acetylated forms of sulfonamides are formed, which are excreted by the kidneys. The half-life (T_1/2) of soluble streptocide is 10 hours, and that of norsulfazole sodium is 1.2 hours.

Clinical characteristics.

Indications.

Local treatment of infectious and inflammatory diseases of the ear, nose, throat, and oral mucosa (tonsillitis, pharyngitis, laryngitis, aphthous and ulcerative stomatitis).

Contraindications.

Hypersensitivity to components of the medicinal product, history of severe toxic-allergic reactions to sulfonamides.

Interaction with other medicinal products and other forms of interaction.

If you are taking any other medicinal products, you must consult your doctor regarding the possibility of continuing treatment with this drug!

Possible reduction of the antimicrobial effect of the drug when used concomitantly with derivatives of para-aminobenzoic acid (procaine, anestezin, tetracaine).

Special precautions for use.

Before using the medication, individuals prone to allergies should consult a physician!

Do not use the medication beyond the recommended period without consulting a doctor!

Always inform your doctor about any previous reaction to medications of this group.

Avoid contact of the medication with the eyes.

Before first use, press the nozzle up to 7 times until a fine mist appears. If no spray is observed, repeat the procedure once again.

Before using the medication, it is recommended to rinse the mouth with warm boiled water. Remove necrotic deposits from affected areas of the oral cavity (ulcers, erosions) using sterile swabs.

After spraying the medication into the oral cavity, refrain from eating for 15–30 minutes.

After use, remove the oral spray nozzle from the stem and rinse it with warm water. Replace the protective cap on the bottle to prevent contamination.

When using the medication in children, it should be noted that a single dose delivered in 1–2 sprays contains 0.0076–0.0152 ml of ethanol (96%), which corresponds per dose to: for children aged 3–5 years (body weight 15–21 kg) 0.0004–0.0013 ml/kg; for children aged 6–12 years (body weight 21–38 kg) 0.0002–0.0007 ml/kg.

Since the medicinal product contains sucrose, it should not be administered to patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency.

Use during pregnancy or breastfeeding.

The use of the medication during pregnancy or breastfeeding is possible under medical supervision after benefit-risk assessment and with strict adherence to the recommended dosing regimen.

Effect on the ability to drive or operate machinery.

The medication does not affect the ability to drive or operate machinery; however, drivers should be aware of the potential for interference with alcohol breath test results.

Administration and Dosage.

For topical application to the oral and nasopharyngeal mucous membranes by spraying in adults and children aged 3 years and older.

Adults: spray 3–4 times daily.

Children aged 3 years and older: spray 1–2 times daily, unless otherwise directed by a physician.

The duration of treatment depends on the course of the disease and usually lasts 3–10 days.

The frequency and duration of use should be individually determined by a physician depending on the severity of the condition!

Instructions for using the aerosol canister.

1. Remove the protective cap from the canister.
2. Attach the provided oral nozzle (sprayer) to the canister, ensuring it is clean.
3. Shake the canister several times and press the nozzle up to 7 times until a fine mist appears. If no spray appears, repeat the procedure.
4. Insert the free end of the sprayer into the mouth and, holding the canister upright, press the sprayer head. Administer 2–3 sprays of Ingalipt-N per session.
5. After completing the application, remove the sprayer from the canister stem and cover the canister with the protective cap to prevent contamination.
6. Keep the sprayer clean; after each use, rinse it with warm water and dry it in a warm place.

Children.

This medicinal product must not be used in children under 3 years of age. Use with caution in children aged 3 years and older due to the potential risk of reflex bronchospasm caused by eucalyptus and peppermint essential oils. Treatment of children should be carried out under medical supervision.

Overdose.

Cases of overdose have not been reported. Overdose may result in an intensification of adverse effects.

Treatment: discontinue the drug, rinse the oral cavity with warm boiled water.

Symptomatic therapy.

Side effects.

Immune system: allergic reactions, including angioneurotic edema, bronchospasm.

Skin: rashes, itching, urticaria, swelling at the site of contact.

Gastrointestinal system: nausea, vomiting, local effects (burning sensation in the mouth, lump in the throat or irritation).

Other: general weakness, difficulty breathing.

If any adverse events or unusual reactions occur, consult a physician regarding further use of the medication.

Shelf life. 2 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C. Keep out of reach of children and away from fire.

Packaging.

30 g in an aluminum aerosol can with a spray dispenser and protective cap.

Availability.

Over-the-counter.

Manufacturer.

LLC "Micropharm".

Ukraine, 61013, Kharkiv, Shevchenko St., 20.

Location of manufacturer and its business address.

Ukraine, 61013, Kharkiv, Shevchenko St., 20.