Mastodon

Ipratropium (Solution, Aerosol) Instructions for Use

ATC Code

R03BB01 (Ipratropium bromide)

Active Substance

Ipratropium bromide (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Bronchodilator drug – m-cholinergic receptor blocker

Pharmacotherapeutic Group

Drugs for the treatment of obstructive airway diseases; other agents for inhalation administration used for the treatment of obstructive airway diseases; anticholinergic agents

Pharmacological Action

M-cholinergic receptor blocker. It is believed that the bronchodilation caused by ipratropium bromide is due to its competitive binding to m-cholinergic receptors of bronchial smooth muscles. It reduces the secretion of glands (including bronchial and digestive).

It prevents bronchoconstriction resulting from inhalation of cigarette smoke, cold air, and the action of various bronchoconstrictor substances.

When used by inhalation, it has practically no resorptive effect. The bronchodilation that occurs after inhalation of ipratropium bromide is mainly a consequence of its local and specific effect on the lungs, and not the result of its systemic action. After administration of ipratropium bromide, patients with bronchospasm due to COPD experience a significant improvement in lung function within 15 minutes, reaching a maximum in 1-2 hours and lasting up to 4-6 hours.

Pharmacokinetics

With the inhalation route of administration, ipratropium bromide is characterized by extremely low absorption from the respiratory mucosa – 10-30% of the administered dose of ipratropium bromide. Most of the dose is swallowed and enters the gastrointestinal tract.

Ipratropium bromide binds to plasma proteins to a minimal extent (less than 20%).

Ipratropium bromide is excreted mainly through the intestines. About 25% is excreted unchanged, the rest – in the form of numerous metabolites.

Ipratropium bromide does not penetrate the blood-brain barrier.

Indications

COPD (including chronic obstructive bronchitis, pulmonary emphysema), bronchial asthma of mild to moderate severity.

ICD codes

ICD-10 code Indication
J43 Emphysema
J44 Other chronic obstructive pulmonary disease
J45 Asthma
ICD-11 code Indication
CA21.Z Emphysema, unspecified
CA22.Z Chronic obstructive pulmonary disease, unspecified
CA23 Asthma

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer by inhalation only. The dose must be individualized based on the patient’s clinical condition, age, and the specific formulation prescribed.

For aerosol (metered-dose inhaler), the typical adult dose for COPD is two inhalations four times daily. Do not exceed 12 inhalations within a 24-hour period.

For solution for nebulization, the standard adult dose is 250-500 mcg administered three to four times daily. Space doses at least 4-6 hours apart.

Use the nebulizer solution undiluted. If required, mix only with sterile preservative-free saline. Discard any unused solution after the treatment is complete.

Prime the aerosol inhaler before first use or if it has not been used for more than 24 hours. Follow the specific priming instructions provided with the product.

Allow at least one minute between inhalations when multiple puffs are prescribed. Rinse your mouth with water after each inhalation to help prevent dry mouth.

This medication is not indicated for the initial treatment of acute episodes of bronchospasm where a rapid response is required. For maintenance therapy, use regularly as directed, even when feeling well.

Adverse Reactions

Infections and infestations Common – flu-like symptoms, upper respiratory tract infections; Uncommon – urinary tract infections.

Immune system disorders Uncommon – hypersensitivity, anaphylactic reactions, angioedema (Quincke’s edema).

Nervous system disorders Common – headache, dizziness.

Eye disorders Uncommon – blurred vision, mydriasis, increased intraocular pressure, glaucoma, acute eye pain, appearance of halos around objects, conjunctival hyperemia, corneal edema; Rare – accommodation disorder.

Cardiac disorders Uncommon – palpitations, supraventricular tachycardia; Rare – atrial fibrillation, increased heart rate; Frequency unknown – decreased blood pressure (hypotension).

Respiratory, thoracic and mediastinal disorders Common – pharyngeal irritation, cough, dyspnea; Uncommon – bronchospasm, paradoxical bronchospasm, laryngospasm, pharyngeal edema, dry throat, sinusitis.

Gastrointestinal disorders Common – dry mouth, nausea, gastrointestinal motility disorder; Uncommon – diarrhea, constipation, vomiting, dyspepsia, taste perversion, stomatitis.

Skin and subcutaneous tissue disorders Uncommon – rash, pruritus; Rare – urticaria.

Renal and urinary disorders Uncommon – urinary retention.

Contraindications

Hypersensitivity to ipratropium bromide, hypersensitivity to atropine and its derivatives; children and adolescents under 18 years of age.

With caution angle-closure glaucoma, urinary tract obstruction, prostatic hyperplasia, cystic fibrosis.

Use in Pregnancy and Lactation

During pregnancy, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

There are no data on the penetration of ipratropium bromide into breast milk. Ipratropium bromide should be prescribed with caution to women during breastfeeding.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

Use with caution as inhalation in patients with angle-closure glaucoma, urinary tract obstruction due to prostatic hyperplasia.

For the emergency relief of an asthma attack, monotherapy with ipratropium bromide is not recommended, since its bronchodilator effect develops later than that of beta-adrenergic agonists.

Influence on the ability to drive vehicles and mechanisms

In case of development of such adverse reactions as dizziness, accommodation disorders, mydriasis, blurred vision, it is necessary to refrain from driving vehicles and operating machinery, as well as from engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use with anticholinergic agents, an additive effect occurs.

With simultaneous use, the bronchodilator effect of beta-adrenergic agonists and xanthine derivatives is potentiated.

With simultaneous use of antiparkinsonian drugs, quinidine, tricyclic antidepressants, it is possible to enhance the anticholinergic effect of ipratropium bromide.

With simultaneous use with salbutamol, there is a risk of increased intraocular pressure and the development of acute angle-closure glaucoma, especially in predisposed patients.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Dosage Form

Bottle Rx Icon Ipratropium Inhalation solution 0.25 mg/1 ml: bottle 20 ml 1 pc.

Dosage Form, Packaging, and Composition

Solution for inhalation as a clear, colorless or almost colorless liquid.

1 ml
Ipratropium bromide monohydrate 0.261 mg,
   Equivalent to ipratropium bromide content 0.25 mg

Excipients : sodium benzoate – 0.5 mg, disodium edetate dihydrate – 0.554 mg, citric acid monohydrate – 1.64 mg, sodium hydroxide – to pH 3.4±0.1, purified water – to 1 ml.

20 ml – dark glass bottles (1) with a dropper – cardboard package.

Marketing Authorization Holder

PSK Pharma, LLC (Russia)

Dosage Form

Bottle Rx Icon Ipratropium Inhalation solution 0.25 mg/ml: bottle 20 ml 1 pc.

Dosage Form, Packaging, and Composition

Solution for inhalation colorless or almost colorless, clear.

1 ml
Ipratropium bromide monohydrate 0.261 mg,
   Equivalent to ipratropium bromide content 0.25 mg

Excipients : benzalkonium chloride – 0.1 mg, disodium edetate dihydrate – 0.5 mg, sodium chloride – 8.8 mg, hydrochloric acid – 0.66 mg, water for injections – to 1 ml.

20 ml – bottle (1) – cardboard package.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle Rx Icon Ipratropium Inhalation solution 0.25 mg/1 ml: bottle 20 ml 1 pc.

Dosage Form, Packaging, and Composition

Solution for inhalation as a clear, colorless or almost colorless liquid.

1 ml
Ipratropium bromide monohydrate 0.261 mg,
   Equivalent to ipratropium bromide content 0.25 mg

Excipients : sodium benzoate – 0.5 mg, disodium edetate dihydrate – 0.554 mg, citric acid monohydrate – 1.64 mg, sodium hydroxide – to pH 3.4±0.1, purified water – to 1 ml.

20 ml – dark glass bottles (1) with a dropper – cardboard package.

Marketing Authorization Holder

PSK Pharma, LLC (Russia)

Dosage Form

Bottle Rx Icon Ipratropium Air Metered-dose inhalation aerosol 20 mcg/dose: 200 doses canisters

Dosage Form, Packaging, and Composition

Metered-dose inhalation aerosol in the form of a colorless, clear liquid, contained in a steel canister with a metering valve.

1 dose
Ipratropium bromide monohydrate 21 mg,
   Equivalent to ipratropium bromide content 20 mcg

Excipients : citric acid – 2 mcg, ethanol – 8415 mcg, purified water – 281 mcg, 1,1,1,2-tetrafluoroethane – 47381 mcg.

200 doses – canisters – cardboard packs.

Marketing Authorization Holder

Kirov Pharmaceutical Factory, JSC (Russia)

Dosage Form

Bottle Rx Icon Ipratropium bromide Inhalation solution 0.25 mg/ml: bottle 20 ml, 25 ml, 30 ml or 50 ml 1 pc.

Dosage Form, Packaging, and Composition

Solution for inhalation colorless or almost colorless, clear.

1 ml
Ipratropium bromide monohydrate 0.261 mg,
   Equivalent to ipratropium bromide content 0.25 mg

Excipients : benzalkonium chloride – 0.1 mg, disodium edetate dihydrate – 0.5 mg, sodium chloride – 8.8 mg, hydrochloric acid solution 1M – to pH 3.4, purified water – to 1 ml.

20 ml – bottles – cardboard packs.
25 ml – bottles – cardboard packs.
30 ml – bottles – cardboard packs.
50 ml – bottles – cardboard packs.

Marketing Authorization Holder

Kirov Pharmaceutical Factory, JSC (Russia)

Dosage Form

Bottle Rx Icon Ipratropium bromide Metered-dose inhalation aerosol 20 mcg/dose: canister 200 doses

Dosage Form, Packaging, and Composition

Metered-dose inhalation aerosol : colorless or with a yellowish tint, clear solution, under pressure in a canister with a metering valve and a spray nozzle.

1 dose 1 canister
Ipratropium bromide 0.02 mg 4.8 mg
   (calculated as ipratropium bromide monohydrate) 0.021 mg 5.04 mg

Excipients : ethanol (absolute ethyl alcohol) – 9.75 mg (2340 mg per canister), citric acid monohydrate – 0.005 mg (1.2 mg per canister), triethyl citrate – 0.15 mg (36 mg per canister), propellant R-134a (1,1,1,2-tetrafluoroethane) – 55.08 mg (13219.2 mg per canister).

200 doses – aerosol canisters (1) – cardboard packs.

Marketing Authorization Holder

Fortiva Med, LLC (Republic of Belarus)

Dosage Form

Bottle Rx Icon Ipratropium Fortiva Solution for inhalation 0.25 mg/1 ml: dropper bottle 20 ml

Dosage Form, Packaging, and Composition

Solution for inhalation clear, colorless or almost colorless.

1 ml
Ipratropium bromide (as ipratropium bromide monohydrate) 0.25 mg (0.261 mg)

Excipients : benzalkonium chloride, disodium edetate dihydrate, sodium chloride, hydrochloric acid solution 1M, purified water.

20 ml – dark glass dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle Rx Icon Ipratropium-Aero Metered-dose inhalation aerosol 20 mcg/dose

Dosage Form, Packaging, and Composition

Metered-dose inhalation aerosol

1 dose
Ipratropium bromide monohydrate (calculated as Ipratropium bromide) 21 mcg (20 mcg)

(200 doses) – canisters – cardboard packs – Prescription only

Table of Contents

→ TABLE OF CONTENTS