Ingalipt-km

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT INHALIPT-KM

Composition:

Active substances: soluble streptocide, sodium sulfathiazole hexahydrate, thymol, eucalyptus oil, peppermint oil;

30 ml of spray contains: 0.750 g of soluble streptocide, 0.750 g of sodium sulfathiazole hexahydrate, 0.015 g of thymol, 0.015 g of eucalyptus oil, 0.015 g of peppermint oil;

Excipients: ethanol (96%), sugar, glycerin, polysorbate 80, purified water.

Pharmaceutical form. Spray.

Main physicochemical properties: clear liquid ranging from light yellow to dark yellow in color, with a characteristic odor of thymol and menthol.

Pharmacotherapeutic group. Agents acting on the respiratory system. Medicinal products used in throat disorders. Antiseptics.

ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics.

The pharmacological effects of the medicinal product are due to the action of its constituent components. Soluble streptocide and sodium sulfathiazole exert antimicrobial activity against gram-positive and gram-negative bacteria causing diseases of the oral cavity and pharynx. Thymol has antiseptic, expectorant, and spasmolytic effects. Eucalyptus oil possesses anti-inflammatory and antiseptic activity. Peppermint oil exerts a moderate local anesthetic effect when applied to mucous membranes.

The combination of these components provides comprehensive pathogenetic therapy for inflammatory diseases of the mucous membranes of the oral cavity and upper respiratory tract. The medicinal product exerts anti-inflammatory, antimicrobial, and antifungal effects; it is active against gram-positive and gram-negative bacteria, as well as Candida species.

Pharmacokinetics.

Data not available.

Clinical characteristics.

Indications.

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

Contraindications.

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

Interaction with other medicinal products and other types of interactions.

If the patient is taking any other medicinal products, it is essential to consult a physician regarding the possibility of using this medicinal product!

Possible reduction of the antimicrobial effect of the drug when used simultaneously with medicinal products that are derivatives of para-aminobenzoic acid (procaine, anesthesin, dicaine).

Special precautions for use.

Before using the medicinal product, especially in case of allergy predisposition, consult a physician! Do not use the medicinal product beyond the established period without medical consultation!

Always inform the physician about any previous reactions to medications of this group.

It is prohibited for the medicinal product to get into the eyes.

Before using the medicinal product, it is recommended to rinse the oral cavity with warm boiled water. Remove necrotic deposits from affected areas of the oral mucosa (ulcers, erosions) using sterile swabs. After spraying the medication into the oral cavity, refrain from eating for 15–30 minutes.

When using the medicinal product in children, it should be taken into account that a single dose delivered per one spray contains from 0.006 mL to 0.008 mL of ethanol (96%), which corresponds to a single dose of: 0.0004 mL/kg to 0.0005 mL/kg for children aged 2–5 years (body weight 12–21 kg) and 0.0002 mL/kg to 0.0003 mL/kg for children aged 6–12 years (body weight 21–38 kg).

The medicinal product contains sugar, which should be taken into consideration by patients with diabetes mellitus and those with hereditary fructose intolerance or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding.

The use of the medicinal product during pregnancy or breastfeeding is possible only under physician supervision, after careful assessment of the benefit-risk ratio, and with strict adherence to the prescribed dosing regimen.

Effect on the ability to drive or operate machinery.

The medicinal product does not affect the ability to drive or operate machinery. However, drivers should be aware that this product may interfere with alcohol breath tests, potentially causing false-positive results.

Method of Administration and Dosage

Apply locally by spraying onto the mucous membranes of the oral cavity and pharynx. For treatment of adults and children aged 3 years and older, apply 3–4 times daily.

For treatment of children, apply locally by spraying onto the mucous membranes of the oral cavity and pharynx 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.

Frequency and duration of administration should be individually determined by a physician and depend on the severity of the condition!

Instructions for Using the Aerosol Can

1. Remove the protective cap from the can and, after ensuring the spray nozzle is clean, place it onto the valve stem.
2. Before first use, hold the can vertically and press the spray nozzle several times until the first drops of liquid appear.
3. Rinse the mouth with boiled water prior to application.
4. Direct the spray nozzle into the oral cavity toward the affected area, press the spray head 5–6 times, and evenly distribute the medication over the oral mucosa.
5. Retain the sprayed medication in the mouth for 5–7 minutes without consuming food or water.
6. After completing the spray application, always replace the protective cap on the can to prevent contamination.

Treatment course – from 3 to 10 days.

Care of the Spray Nozzle

The spray nozzle should be kept clean and washed with water—preferably daily, but no less than twice a week—as follows:

1. Thoroughly rinse the spray nozzle under warm running water.
2. Shake off excess water and dry in a warm place, avoiding exposure to high temperatures.

Children

Do not use this medication 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 conducted under medical supervision.

Overdose

Cases of overdose have not been reported. Overuse may increase the likelihood of adverse effects.

Treatment: Discontinue the medication, rinse the mouth with warm boiled water. Provide symptomatic therapy.

Adverse reactions.

Gastrointestinal tract: nausea, vomiting, local effects (burning sensation in the mouth or irritation, hyperemia of the pharyngeal mucosa).

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

Skin and subcutaneous tissue: rashes, including papular eruptions, pruritus, urticaria, swelling at the site of contact.

Other: general weakness, breathing difficulty, lump in the throat.

Shelf life. 1.5 years.

Storage conditions.

Keep out of reach of children.

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

Packaging.

30 ml in a bottle with a pump-type valve; 1 bottle with a spray nozzle and protective cap in a carton.

Availability. Over-the-counter.

Manufacturer: JSC "STOMA".

Manufacturer's address and place of business: 3, Newtona Street, Kharkiv, Ukraine, 61105.