Windel Plus

Indications

The inhalation solution containing Salbutamol sulfate and Ipratropium bromide is designed to manage reversible bronchospasm associated with obstructive airway diseases. This medication is particularly beneficial for patients who require more than one bronchodilator for effective symptom relief.

• Always consult a registered physician before using this medication.

Description

This inhalation solution incorporates two active bronchodilators: Salbutamol Sulfate and Ipratropium Bromide. Salbutamol Sulfate acts as a beta2-adrenergic agonist, promoting relaxation of the airway smooth muscle. It effectively relaxes smooth muscle from the trachea to the terminal bronchioles and offers protection against various bronchoconstrictor stimuli. Meanwhile, Ipratropium Bromide is a quaternary ammonium compound with anticholinergic properties that inhibits vagally mediated reflexes by blocking acetylcholine, the neurotransmitter released from the vagus nerve. This action prevents the rise of intracellular cyclic guanosine monophosphate (cGMP) levels due to acetylcholine’s interaction with muscarinic receptors on bronchial smooth muscle. The bronchodilation induced by Ipratropium Bromide is primarily localized to the lungs and is non-systemic, ensuring minimal side effects. The concurrent release of Salbutamol and Ipratropium enhances the overall bronchodilatory effect, resulting in superior efficacy without an increased risk of adverse reactions compared to individual agents.

Pharmacology

Ipratropium Bromide is rapidly absorbed following inhalation, with systemic bioavailability estimated to be less than 10% of the administered dose. Renal excretion accounts for approximately 46% of the dose following intravenous administration, with a terminal elimination half-life of around 1.6 hours. The elimination half-life of both the drug and its metabolites is about 3.6 hours, and Ipratropium Bromide does not cross the blood-brain barrier.

Salbutamol Sulfate is also swiftly and thoroughly absorbed via both inhalation and oral routes. Peak plasma concentrations are typically reached within three hours of administration, and it is primarily excreted unchanged in the urine within 24 hours. Its elimination half-life is approximately four hours, with about five percent of plasma concentrations crossing the blood-brain barrier.

Co-nebulization of Ipratropium Bromide and Salbutamol Sulfate has been shown not to enhance systemic absorption, ensuring that the additive effects arise from their combined local action within the lungs.

Dosage

The Salbutamol sulfate and Ipratropium bromide inhalation solution, provided in ampoules, can be administered using a suitable nebulizer or an intermittent positive pressure ventilator.

• Adults (including the elderly): Use one 3 ml ampoule in the nebulizer four times a day. An additional two treatments may be administered daily if necessary.
• Children: Dosage and usage must be determined by a healthcare professional.

Patients should seek immediate medical attention in cases of acute or rapidly worsening dyspnoea, especially if additional inhalations do not yield sufficient improvement.

• Always consult a registered physician before using this medication.

Administration

1. Twist off the top of the ampoule, holding it upright.
2. Squeeze the necessary amount of the nebulizer solution into the nebulizer chamber.
3. Follow the physician’s instructions if dilution is required.

• Always consult a registered physician before using this medication.

Interactions

Concurrent use of other beta-mimetics, systemically absorbed anticholinergics, and xanthine derivatives may amplify side effects.

• Treatment with xanthine derivatives, glucocorticosteroids, and diuretics may heighten beta-agonist-induced hypokalaemia, particularly in patients with severe airway obstruction.
• Hypokalaemia can increase the risk of arrhythmias in patients receiving digoxin; therefore, serum potassium levels should be monitored.
• Beta-blockers may significantly reduce the bronchodilator effect.
• Caution is advised when administering beta-adrenergic agonists to patients taking monoamine oxidase inhibitors or tricyclic antidepressants, as the effects of beta agonists may be intensified.
• Inhalation of halogenated hydrocarbon anesthetics like halothane, trichloroethylene, and enflurane may increase the cardiovascular side effects associated with beta agonists.

Contraindications

This medication is contraindicated in individuals with hypertrophic obstructive tachyarrhythmia and those with a history of hypersensitivity to atropine, its derivatives, or any component of the product.

Side Effects

Common side effects associated with this bronchodilator solution may include fine tremors of skeletal muscles, nervousness, and, less frequently, tachycardia, dizziness, palpitations, or headaches, particularly in sensitive individuals.

Serious hypokalaemia may occur with prolonged or high-dose beta2 agonist therapy. Other potential side effects include coughing, local irritation, and, in rare instances, inhalation-induced bronchospasm. As with other beta-mimetics, nausea, vomiting, sweating, weakness, and muscle cramps may occur. Rare cases may present with decreased diastolic blood pressure, increased systolic blood pressure, and arrhythmias, especially at higher doses. Psychological alterations have also been reported in some individuals undergoing inhalation therapy with beta-mimetics.

Common non-respiratory side effects related to anticholinergic use may include dry mouth and dysphonia. Isolated cases of ocular complications, such as mydriasis, increased intraocular pressure, angle-closure glaucoma, and eye pain, have been noted when aerosolized Ipratropium Bromide escapes into the eyes. Rare instances of gastrointestinal motility disturbances and urinary retention may occur, though these are reversible.

Pregnancy & Lactation

This medication falls under Pregnancy Category C. Animal studies with Salbutamol Sulfate have indicated potential teratogenic effects, and it remains uncertain whether this medication poses risks to the fetus. There is no documented evidence of abnormalities in women taking Salbutamol during pregnancy, but it should only be used if the benefits outweigh the risks. Caution is advised before childbirth due to Salbutamol’s potential to inhibit uterine contractions.

Both Salbutamol Sulfate and Ipratropium Bromide may be excreted in breast milk, and their effects on neonates remain unknown. While lipid-insoluble quaternary bases typically do not pass into breast milk significantly, caution should still be exercised when administering this solution to nursing mothers.

Precautions & Warnings

In cases of acute or rapidly worsening dyspnoea, immediate medical consultation is essential. Rare hypersensitivity reactions, including urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema, may occur following administration of this solution.

Overdose Effects

Overdosage effects are primarily linked to Salbutamol, as acute overdosage of Ipratropium Bromide is unlikely due to its limited systemic absorption after inhalation or oral administration.

Symptoms of overdose may include tachycardia, anginal pain, hypertension, hypotension, palpitations, tremors, widened pulse pressure, arrhythmias, and flushing.

Therapeutic response: The administration of sedatives and tranquilizers may be necessary in severe cases. Beta-receptor blockers, preferably beta1-selective, can serve as specific antidotes; however, careful dosing adjustments are crucial in patients with bronchial asthma to avoid exacerbating bronchial obstruction.

Therapeutic Class

Combined bronchodilators

Storage Conditions

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