Iprasol Nebuliser Solution

Indications

The inhalation solution of Salbutamol Sulfate and Ipratropium Bromide is designed to address reversible bronchospasm associated with obstructive airway conditions in patients who need more than one bronchodilator.

Description

This inhalation solution combines two potent bronchodilators: Salbutamol Sulfate and Ipratropium Bromide. Salbutamol Sulfate, a beta2-adrenergic agonist, induces relaxation of the airway smooth muscles, ranging from the trachea to the terminal bronchioles, and defends against bronchoconstrictor challenges. Ipratropium Bromide, an anticholinergic quaternary ammonium compound, works by blocking the action of acetylcholine, reducing vagally mediated reflexes. This action prevents an increase in cyclic guanosine monophosphate (cyclic GMP) in bronchial smooth muscle, providing localized bronchodilation primarily within the lungs. When used together, Salbutamol and Ipratropium offer enhanced bronchodilation by acting on both beta2-adrenergic and muscarinic receptors, with synergistic effects superior to those of each agent used alone, while minimizing adverse effects.

Pharmacology

Ipratropium Bromide, following inhalation, is minimally absorbed systemically, with a bioavailability of less than 10%. Renal excretion accounts for approximately 46% of the dose after intravenous administration, with a terminal elimination half-life of about 1.6 hours. It does not cross the blood-brain barrier.

Salbutamol Sulfate is absorbed rapidly and completely via inhalation or oral administration, with peak plasma concentrations occurring within three hours. It is excreted unchanged in the urine within 24 hours, with a half-life of about 4 hours. Salbutamol crosses the blood-brain barrier to a small extent.

Co-nebulization of Ipratropium Bromide and Salbutamol Sulfate does not enhance systemic absorption of either drug; the added efficacy is due to their combined local action on the lungs.

Dosage

For adults (including the elderly): Administer one 3 ml ampoule of the inhalation solution via a nebulizer four times daily, with up to two additional treatments if required. For children: Dosage should be determined by a healthcare provider. Patients experiencing acute or worsening dyspnoea should seek medical attention if additional inhalations do not provide sufficient relief.

Administration

1. Twist off the ampoule top while holding it upright.
2. Squeeze the required amount of solution into the nebulizer chamber.
3. Dilute if necessary as per physician’s instructions.

Interactions

Concurrent use with other beta-mimetics, systemically absorbed anticholinergics, or xanthine derivatives may intensify side effects. Beta-agonist-induced hypokalaemia may be exacerbated by xanthine derivatives, glucocorticosteroids, and diuretics. Monitoring of serum potassium levels is recommended in such cases. Co-administration with beta-blockers may reduce bronchodilator effectiveness, and caution is advised when using beta-adrenergic agonists with monoamine oxidase inhibitors or tricyclic antidepressants. Inhalation of halogenated hydrocarbon anesthetics may heighten cardiovascular effects.

Contraindications

This product is contraindicated in patients with hypertrophic obstructive tachyarrhythmia or hypersensitivity to atropine, its derivatives, or any component of the formulation.

Side Effects

Common side effects include skeletal muscle tremor and nervousness. Less frequently, patients may experience tachycardia, dizziness, palpitations, or headaches, particularly if hypersensitive. Prolonged or high-dose use may lead to serious hypokalaemia. Inhalation therapy may cause cough, local irritation, or bronchospasm. Rare side effects include nausea, vomiting, sweating, muscle cramps, and potential cardiovascular effects. Anticholinergic-related adverse events may involve mouth dryness, dysphonia, and, in rare cases, ocular complications.

Pregnancy & Lactation

Pregnancy Category C. Salbutamol Sulfate has shown teratogenic effects in animal studies, and its safety during pregnancy is not well established. Use this solution during pregnancy only if the benefits outweigh the risks. Both Salbutamol Sulfate and Ipratropium Bromide may be excreted in breast milk, and caution is advised when administering to nursing women.

Precautions & Warnings

Seek immediate medical attention for acute or rapidly worsening dyspnoea. Rare hypersensitivity reactions such as urticaria, angioedema, rash, bronchospasm, or oropharyngeal oedema may occur.

Overdose Effects

Overdose effects are primarily associated with Salbutamol, as Ipratropium Bromide is minimally absorbed systemically. Symptoms of Salbutamol overdose may include tachycardia, anginal pain, hypertension, hypotension, palpitations, tremor, and flushing. Treatment involves sedatives or tranquillisers, and in severe cases, intensive therapy. Beta-receptor blockers may be used cautiously as antidotes.

Therapeutic Class

Combined Bronchodilators

Storage Conditions

Store below 30°C, away from light and moisture. Keep out of reach of children.