Ingamist

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT INGAMIST (INGAMIST)

Composition:

Active substance: acetylcysteine;

1 ml contains acetylcysteine 100 mg;

Excipients: disodium edetate, sodium hydroxide, water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear, colorless liquid with a slight sulfur odor.

After opening the ampoule, a faint pink-violet tint may appear upon prolonged exposure to air.

Pharmacotherapeutic group. Mucolytic agent. ATC code R05C B01.

Pharmacological Properties

Pharmacodynamics

Acetylcysteine liquefies sputum. The presence of sulfhydryl groups in the structure of acetylcysteine promotes cleavage of disulfide bonds of acidic mucopolysaccharides in sputum, resulting in depolymerization of mucoproteins and reduction of mucus viscosity. The drug retains activity in the presence of purulent sputum.

Acetylcysteine exerts an antioxidant effect due to the presence of a nucleophilic thiol (SH) group, which readily donates hydrogen and neutralizes oxidative radicals.

The protective mechanism of acetylcysteine is based on the ability of its reactive sulfhydryl groups to bind free radicals.

Acetylcysteine easily penetrates into the cell, where it is deacetylated to L-cysteine, which is used for the synthesis of intracellular glutathione.

Glutathione is a highly reactive tripeptide, a potent antioxidant and cytoprotective agent that captures endogenous and exogenous free radicals and toxins. Acetylcysteine prevents depletion and promotes increased synthesis of intracellular glutathione, which participates in cellular redox processes, thereby supporting detoxification of harmful substances.

Pharmacokinetics

After intravenous administration of 600 mg of acetylcysteine, the maximum plasma concentration is 300 mmol/L, and the plasma half-life is 2 hours. Total clearance is 0.21 L/h/kg, and the volume of distribution at steady state is 0.34 L/kg. Acetylcysteine penetrates into the extracellular space and is distributed predominantly in the liver, kidneys, lungs, and bronchial secretions. Acetylcysteine and its metabolites are primarily excreted by the kidneys.

Clinical characteristics.

Indications.

Acute and chronic respiratory tract diseases associated with increased mucus production.

Contraindications.

Hypersensitivity to acetylcysteine or to any other components of the drug, peptic ulcer of the stomach and duodenum in the stage of exacerbation, hemoptysis, pulmonary hemorrhage.

Interaction with other medicinal products and other types of interactions.

Studies on interactions with other medicinal products have been conducted only in adults.

Concomitant administration of nitroglycerin and acetylcysteine may lead to pronounced hypotension and dilation of the temporal artery. If concomitant use of nitroglycerin and acetylcysteine is necessary, the patient must be under medical supervision for the development of hypotension, which may be severe. The patient should be warned about the possibility of headache.

Acetylcysteine should not be administered simultaneously with antitussive agents, as suppression of the cough reflex may enhance bronchial secretion retention.

Ingamist can be used concomitantly with conventional bronchodilators and vasoconstrictors.

Available information on the interaction of antibiotics with acetylcysteine, obtained from in vitro studies, indicates reduced antibiotic activity after mixing the two substances. Therefore, mixing antibiotics with acetylcysteine solution is not recommended.

Laboratory parameters

Acetylcysteine may alter the results of quantitative colorimetric determination of salicylates and the determination of ketones in urine.

Special precautions for use.

Patients suffering from bronchial asthma should be under medical supervision during treatment with Inhamest. If bronchospasm develops, acetylcysteine administration must be discontinued immediately and appropriate treatment initiated.

Inhamest should be administered with particular caution to patients with peptic ulcer disease in the active phase or in medical history, especially when concomitantly taking other medicinal products that irritate the gastric mucosa.

Administration of acetylcysteine, particularly in aerosol form, may initially liquefy secretions from bronchial glands and increase their volume. If the patient is unable to effectively expectorate sputum, postural drainage or bronchoaspiration should be performed to prevent sputum accumulation.

The medicinal product must be administered intravenously under strict medical supervision. Adverse effects following intravenous administration of acetylcysteine may occur more frequently if the drug is administered too rapidly or in high doses. Therefore, it is recommended to strictly follow the instructions provided in the section "Administration and dosage".

Use of acetylcysteine in doses indicated for the treatment of poisoning may prolong prothrombin time (decrease prothrombin index, increase INR).

The sulfurous odor that appears upon opening the Inhamest ampoule is a characteristic smell of the active substance and does not in any way affect the possibility of using the medicinal product.

The acetylcysteine solution, when stored in opened ampoules or transferred into nebulization equipment, may rarely develop a slight violet coloration, which does not affect the efficacy or tolerability of the medicinal product.

The medicinal product contains 1.9 mmol (43 mg) of sodium per dose (in one ampoule). Caution should be exercised when administering to patients on a sodium-restricted diet.

For intravenous and intramuscular administration, the ampoule should be opened immediately before use. For topical application, partial use of the ampoule content is possible: the remaining solution may be used (under appropriate storage conditions) within 24 hours, but only for topical application; reuse of the remaining injectable solution is prohibited.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, acetylcysteine may be used only if the expected benefit to the mother outweighs the potential risk to the fetus or infant, and under direct medical supervision.

Ability to influence reaction rate while driving or operating machinery.

There are no data confirming effects on reaction speed.

Method of Administration and Dosage

Local Administration

Inhalation administration: for adults – 1 ampoule 1–2 times daily as prescribed by a physician for 5–10 days; for children aged 6 years and older – up to 1 ampoule 1–2 times daily as prescribed by a physician for 5–10 days.

Endobronchial administration: for adults and children aged 6 years and older – up to 1 ampoule 1–2 times daily.

Systemic Administration

Intramuscular administration

For adults – 1 ampoule of 300 mg 1–2 times daily administered deep intramuscularly.

Intravenous administration

The medicinal product should be administered slowly by intravenous infusion in 0.9% sodium chloride solution or 5% glucose solution.

For adults – 1 ampoule of 300 mg 1–2 times daily.

Children.

For intramuscular and intravenous administration, the drug must not be used in children.

For local administration, the medicinal product may be prescribed to children aged 6 years and older.

Overdose

Intravenous administration

Symptoms

Symptoms of overdose are similar to those of adverse reactions but more severe in intensity.

Treatment

Treatment requires immediate discontinuation of the drug and implementation of symptomatic therapy and resuscitation measures. There is no specific antidote. Dialysis is effective.

Local administration

Symptoms

Cases of overdose have not been reported. High doses of the drug may trigger excessive production of bronchopulmonary secretions, potentially leading to airway obstruction.

Treatment

Perform bronchoaspiration.

Adverse reactions.

The adverse effects listed below have been reported during post-marketing use; their frequency is unknown (cannot be estimated based on available data):

Inhalation use

Parenteral administration

In very rare cases, serious skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been observed during the use of acetylcysteine.

In most cases, there was suspicion that the above-mentioned mucocutaneous syndromes might have been caused by concomitant use of at least one other medicinal product. If mucocutaneous changes occur, medical advice must be sought and administration of acetylcysteine should be discontinued immediately.

Reduced platelet aggregation during acetylcysteine administration has been confirmed by some studies. The clinical significance of these findings is currently not established.

Shelf life. 2 years.

Storage conditions.

Store at a temperature not exceeding 30 °C in the original packaging. An opened ampoule intended for topical use may be stored in the refrigerator for up to 24 hours.

Keep out of reach of children.

Incompatibility.

The Ingamist solution must not come into contact with rubber or metal surfaces.

It is recommended to use glass or plastic equipment for inhalations; after use, the equipment should be rinsed with water.

Packaging.

3 ml in amber glass ampoules; 5 ampoules in a blister pack; 2 blister packs in a carton.

Prescription status. Prescription only.

Manufacturer.

LLC "Yuria-Pharm".

Manufacturer's address and location of business activity.

108, Kozbirska Street, Cherkasy, Cherkasy region, 18030, Ukraine. Tel.: (044) 281-01-01.