Azmasol Plus120 Metered Inhalations

Azmasol Plus is an inhaled combination medicine containing a short-acting beta-2 agonist (salbutamol) and an inhaled corticosteroid (budesonide), used in the management of asthma and other reversible airway obstruction. Because Azmasol Plus combines rapid symptom relief with anti-inflammatory control in a single inhaled formulation, the approved way to use it depends on the specific product and prescriber's instructions.

Established / approved use

• As-needed relief and prevention of bronchoconstriction, and reduction of the risk of asthma exacerbations, in adult and adolescent patients (18 years and older) with asthma, when Azmasol Plus is prescribed as an as-needed rescue combination inhaler.

Guideline-supported / product-dependent use

• Some formulations of Azmasol Plus are used as part of a maintenance-and-reliever regimen, while other products are intended only as an add-on reliever alongside a separately prescribed regular maintenance therapy. Always follow the specific product's labeling and your physician's instructions.

Common clinical practice (adjunct/off-label use)

• Combined nebulization of salbutamol and budesonide solutions is widely used in hospital and emergency settings for acute exacerbations of asthma and, in select cases, chronic obstructive pulmonary disease (COPD), to provide rapid bronchodilation together with an anti-inflammatory effect; this use of Azmasol Plus should be directed and monitored by a physician.

Azmasol Plus is not indicated as the primary treatment for a severe, rapidly deteriorating asthma attack requiring emergency care, nor as a substitute for a regular controller therapy prescribed separately, unless the specific product is labeled for that purpose.

Each dose of Salbutamol + Budesonide contains salbutamol (as salbutamol sulfate), a short-acting beta-2 adrenergic agonist, together with micronized budesonide, a corticosteroid, formulated for oral inhalation. The exact strength per actuation or per nebulizer respule varies between products (for example, combination metered-dose inhalers deliver salbutamol and budesonide in fixed microgram amounts per puff, while nebulizer solutions supply milligram quantities per dose); refer to the specific pack/label of the product dispensed for its exact strength.

Azmasol Plus is a fixed combination of two medicines that work together to manage asthma symptoms: salbutamol is a short-acting beta-2 agonist (SABA) that relaxes airway smooth muscle to relieve bronchospasm within minutes, and budesonide is an inhaled corticosteroid (ICS) that reduces airway inflammation, swelling, and mucus production over time. By combining a fast-acting bronchodilator with an anti-inflammatory agent, Azmasol Plus is designed to provide both quick symptom relief and a degree of anti-inflammatory protection with each use, depending on the specific product's approved dosing pattern.

Combination bronchodilator (short-acting beta-2 agonist) and inhaled corticosteroid; Azmasol Plus belongs to the anti-asthmatic combination inhalation therapy class.

Salbutamol + Budesonide combines two complementary mechanisms of action.

Salbutamol component

Salbutamol selectively stimulates beta-2 adrenergic receptors on bronchial smooth muscle, activating adenylate cyclase and increasing intracellular cyclic AMP (cAMP). This relaxes bronchial smooth muscle, producing bronchodilation and rapid relief of bronchospasm, typically within about 5 minutes, with effects lasting roughly 4-6 hours.

Budesonide component

Budesonide is a corticosteroid with potent local anti-inflammatory activity. It diffuses across cell membranes, binds to the glucocorticoid receptor, and modulates gene transcription to reduce production of inflammatory cytokines, decrease eosinophil and mast cell activity, and reduce airway hyperresponsiveness and mucosal oedema. Its anti-inflammatory benefit develops over hours to days with regular or repeated use rather than providing immediate symptom relief.

Together, the two components of Salbutamol + Budesonide provide immediate bronchodilation alongside a corticosteroid effect that reduces underlying airway inflammation.

Shake the inhaler well before use. Prime the inhaler before first use and if it has not been used for 7 days or more, or after it has been dropped or cleaned, as per the product's instructions. Breathe out fully, place the mouthpiece in the mouth, and inhale slowly and deeply while actuating the device, then hold the breath for about 10 seconds before exhaling. Wait about 1 minute between the two inhalations of a single dose if the label instructs this. Rinse the mouth with water and spit it out after each use of Azmasol Plus to reduce the risk of oral thrush and hoarseness. For nebulizer solutions, administer via a properly functioning nebulizer as instructed by a healthcare provider, and clean the nebulizer equipment as directed.

Azmasol Plus has the following clinically significant drug interactions:

• Beta-blockers (especially non-selective agents): may block the bronchodilator effect of the salbutamol component and can provoke severe bronchospasm; concurrent use should generally be avoided in patients with asthma.
• Other sympathomimetic/beta-agonist medicines: concurrent use with other short-acting beta-agonists or sympathomimetic agents may increase the risk of cardiovascular side effects (tachycardia, arrhythmia); avoid additional short-acting beta-agonist bronchodilators unless directed by a physician.
• Non-potassium-sparing diuretics (e.g., loop or thiazide diuretics): the salbutamol component can lower serum potassium; combined use may worsen diuretic-induced hypokalemia and increase the risk of ECG changes - monitor potassium levels.
• Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants: may potentiate the cardiovascular effects of the salbutamol component; use with caution, particularly within 2 weeks of MAOI use.
• Digoxin: salbutamol may lower serum digoxin concentrations, and salbutamol-induced hypokalemia may increase susceptibility to digoxin toxicity; monitor as clinically indicated.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): may substantially increase systemic exposure to the budesonide component, raising the risk of corticosteroid-related side effects, including adrenal suppression; concurrent use should be avoided or requires close monitoring.

Inform your physician or pharmacist of all other medicines you are taking before using Azmasol Plus.

Side effects of Azmasol Plus arise from its two components.

Common side effects

• Tremor, nervousness, headache
• Palpitations, increased heart rate (tachycardia)
• Throat irritation, cough, hoarseness (dysphonia)
• Oral/oropharyngeal candidiasis (thrush) - reduced by rinsing the mouth after use
• Muscle cramps

Less common but important side effects

• Paradoxical bronchospasm (worsening of wheeze immediately after use) - discontinue Azmasol Plus and seek medical attention if this occurs
• Hypokalemia (low blood potassium), particularly with high or frequent doses
• Hyperglycemia (mild elevation of blood sugar)
• Signs of hypersensitivity such as rash, urticaria, angioedema, or bronchospasm
• With prolonged, high-dose use: features of systemic corticosteroid effect (adrenal suppression, reduced bone mineral density, growth suppression in children, cataracts, or glaucoma) - see Precautions and Warnings

Report persistent or severe side effects from Azmasol Plus to your physician.

Azmasol Plus should be used during pregnancy only if clearly needed, and the potential benefit justifies the potential risk to the fetus; uncontrolled asthma itself poses a well-recognized risk to both mother and fetus, so inhaled asthma therapy, including Azmasol Plus, is generally continued during pregnancy under close medical supervision rather than stopped. Available human data have not identified a clear pattern of drug-related birth defects, but this cannot rule out all risk, and use should always be directed by a physician.

For breastfeeding, it is not known in detail whether the individual components of Azmasol Plus pass into breast milk in clinically significant amounts; because inhaled doses produce relatively low systemic exposure, use during breastfeeding may be considered if clearly needed, but only under medical advice, weighing the benefit of treating maternal asthma against any unknown risk to the infant.

Use Azmasol Plus with the following precautions:

• Worsening asthma / overreliance on the reliever component: an increasing need for extra doses of Azmasol Plus, or reduced effectiveness, may signal worsening asthma control; seek prompt medical review and do not simply increase the dose beyond the maximum recommended.
• Paradoxical bronchospasm: if wheezing or breathing difficulty worsens immediately after use, stop use of Azmasol Plus and seek medical attention promptly.
• Cardiovascular effects: the salbutamol component can cause increased heart rate, palpitations, and blood pressure/ECG changes; use with caution in patients with cardiovascular disease, arrhythmias, or hypertension.
• Hypokalemia: use with caution in patients at risk of low potassium (e.g., those on diuretics, with severe airway obstruction, or hypoxia); monitor potassium as clinically indicated.
• Local corticosteroid effects: oral thrush and hoarseness can occur with the budesonide component; rinse the mouth with water after each use.
• Systemic corticosteroid effects with prolonged/high-dose use: long-term use of the budesonide component, especially at higher doses, may cause adrenal suppression, reduced bone mineral density, growth suppression in children and adolescents, and increased risk of cataracts or glaucoma; use the lowest effective dose for the shortest necessary duration with regular medical follow-up.
• Immunosuppression / infection risk: the corticosteroid component may reduce resistance to infection; caution is needed in patients exposed to chickenpox, measles, tuberculosis, or other active infections, and live vaccines should be discussed with a physician before use.
• Not for acute severe asthma attacks requiring emergency care: Azmasol Plus is not a substitute for emergency treatment of a severe asthma attack; seek immediate medical care if symptoms are severe or rapidly worsening.

Overdose of Azmasol Plus may cause symptoms related to excess beta-agonist stimulation, such as marked tachycardia, palpitations, tremor, arrhythmias, chest pain, high or low blood pressure, seizures, low blood potassium (hypokalemia), high blood sugar, and metabolic acidosis; with very high or prolonged doses of the corticosteroid component, features of excess corticosteroid exposure (such as adrenal suppression) may also occur. If overdose of Azmasol Plus is suspected, seek immediate medical attention or contact a poison control center/emergency services; do not attempt to manage a suspected overdose at home, and bring the product packaging with you if possible.

Store Azmasol Plus at room temperature (below 30°C), away from direct sunlight, heat, and moisture. Do not puncture, break, or burn the inhaler canister, and avoid exposing it to temperatures above 50°C, as pressurized canisters can burst if heated. Keep out of reach and sight of children. Discard the product according to the expiry date and any dose-counter instructions on the label.

Elderly: Azmasol Plus can generally be used in older adults using standard adult dosing, with extra caution in those with cardiovascular disease.

Pediatric patients: safety and efficacy of this fixed-dose combination have not been established in patients younger than 18 years; use in children should follow a physician's specific guidance, who may prefer separate, age-appropriate formulations of the individual components instead.

Renal impairment: no well-established dose adjustment is required; use with routine monitoring.

Hepatic impairment: significant hepatic impairment may increase systemic exposure to the budesonide component; use Azmasol Plus with caution and physician supervision in such patients.

Pregnancy and breastfeeding: see Pregnancy and Lactation.

The duration of treatment with Azmasol Plus is individualized by the prescribing physician. When used for as-needed symptom relief, there is no fixed treatment duration, but excessive or increasing use over time should prompt medical review. When used as part of a regular maintenance regimen, treatment is generally continued long-term for ongoing asthma control, with periodic reassessment of dose and continued need by a physician.

Short-acting beta-2 adrenergic agonist (SABA) combined with an inhaled corticosteroid (ICS); anti-asthmatic bronchodilator-corticosteroid combination.

The salbutamol component of Salbutamol + Budesonide acts as a selective beta-2 adrenergic receptor agonist, stimulating adenylate cyclase to raise intracellular cyclic AMP, which relaxes bronchial smooth muscle and produces rapid bronchodilation. The budesonide component is a glucocorticoid that binds intracellular glucocorticoid receptors, altering gene transcription to reduce the synthesis of pro-inflammatory mediators and suppress recruitment and activation of inflammatory cells in the airway, thereby reducing airway inflammation, mucosal oedema, and bronchial hyperresponsiveness over time.

The fixed-dose combination Azmasol Plus has not been established as safe and effective in children and adolescents younger than 18 years, and dedicated pediatric dosing for this combination is not well established. Where inhaled salbutamol and budesonide are used in children (typically as separate products, including nebulizer solutions for acute wheeze/asthma exacerbations under hospital or physician supervision), dosing is individualized by age/weight and must be directed and monitored by a pediatrician. Long-term use of the inhaled corticosteroid component in children should use the lowest effective dose, with growth monitored periodically, because of the possibility of a small effect on growth velocity.