Azmasol Plus

Indications

This product is prescribed for the on-demand treatment or prevention of bronchoconstriction and to minimize the risk of asthma exacerbations in patients aged 18 years and older.

Pharmacology

This product combines salbutamol, a beta2-adrenergic agonist, with budesonide, a corticosteroid. It is used for the on-demand management of bronchoconstriction and to reduce exacerbation risks in asthma patients. Salbutamol works by relaxing the smooth muscles throughout the airways, while budesonide exhibits a broad spectrum of anti-inflammatory actions against various cells and mediators involved in inflammation.

Dosage & Administration

The recommended dose is 180 µg of salbutamol and 160 µg of budesonide (administered as two inhalations) taken as needed for asthma symptoms via oral inhalation. Do not exceed 6 doses (12 inhalations) within 24 hours. Before the first use, prime the inhaler by releasing four sprays into the air, ensuring you shake well before each spray. Re-prime the inhaler by releasing two sprays if it hasn’t been used for over 7 days, has been dropped, or after cleaning.

Contraindications

This product is contraindicated in patients who are hypersensitive to salbutamol, budesonide, or any other components of the formulation.

Side Effects

Potential adverse reactions include:

• Worsening of asthma
• Paradoxical bronchospasm
• Cardiovascular effects (e.g., increased heart rate, blood pressure)
• Hypersensitivity reactions (including anaphylaxis)
• Hypokalemia
• Increased susceptibility to infections
• Oral fungal infections (candidiasis)
• Bone density reduction
• Glaucoma and cataracts
• Growth inhibition in pediatric patients

Pregnancy & Lactation

Pregnancy: Adequate studies on pregnant women using this product are lacking. However, existing data from studies on salbutamol and budesonide indicate no consistent evidence of increased risk for major birth defects or miscarriage.
Lactation: There is insufficient data regarding the effects on breastfed infants or milk production.

Precautions & Warnings

Asthma symptoms may worsen acutely or gradually over time. If the need for this inhaler increases or symptoms persist, it may indicate worsening asthma, requiring medical evaluation.
This inhaler can induce life-threatening paradoxical bronchospasm. Should this occur, discontinue use immediately and seek alternative treatment.
Excessive use of this inhaler may lead to cardiovascular complications or fatal outcomes. Patients hypersensitive to salbutamol or budesonide may experience severe allergic reactions like anaphylaxis or bronchospasm.
Patients with conditions like convulsive disorders, hyperthyroidism, or diabetes should exercise caution when using this product. Long-term corticosteroid use may decrease bone mineral density, increasing the risk of osteoporosis. Additionally, prolonged use may lead to eye problems such as glaucoma and cataracts. Monitor patients periodically for these conditions.

Overdose Effects

Salbutamol: Symptoms of overdose may include excessive beta-adrenergic stimulation, manifesting as seizures, hypertension, arrhythmias, rapid heartbeat, or hypokalemia.
Budesonide: Prolonged excessive use may lead to systemic corticosteroid effects, including hypercorticism.

Therapeutic Class

Combination bronchodilators

Storage Conditions

Store in a pressurized canister. Do not puncture or incinerate, even if empty. Protect from direct sunlight, and do not store above 30°C. Keep in a dry, cool place, away from children’s reach. For optimal results, use within six months of opening the foil pouch. Shake well before each use and ensure the canister is at room temperature.