Asmalin Plus HFA Inhaler

✔️ Dosage and Administration of Asmalin Plus HFA Inhaler

Adults 18 years and older:

• The recommended dose is 2 inhalations as needed for asthma symptoms, providing a total of salbutamol 180 micrograms and budesonide 160 micrograms.
• Do not exceed 6 doses (12 inhalations) within 24 hours, unless otherwise directed by your doctor.
• Use the inhaler by oral inhalation exactly as instructed.

✔️ Overdose Effects

Because this inhaler contains both salbutamol and budesonide, overdose may produce effects related to either component.

Salbutamol overdose may cause:

• Tremor
• Nervousness
• Headache
• Rapid heartbeat
• Palpitations
• Blood pressure changes
• Nausea
• Dizziness
• Muscle cramps
• Hyperglycemia
• Hypokalemia
• Metabolic acidosis
• Cardiac arrhythmias
• Seizures in severe cases

✔️ Side Effects

Possible adverse effects include:

• Headache
• Tremor or nervousness
• Palpitations or increased heart rate
• Throat irritation
• Hoarseness
• Nausea
• Muscle cramps
• Oral or throat Candida (thrush) infection
• Hypokalemia
• Hypersensitivity reactions

Less common but potentially serious effects include:

• Paradoxical bronchospasm
• Significant cardiovascular effects
• Severe allergic reactions, including anaphylaxis or angioedema
• Adrenal suppression or systemic corticosteroid effects with prolonged high-dose use
• Reduced bone mineral density with long-term corticosteroid exposure
• Increased intraocular pressure, glaucoma, or cataracts

✔️ Pregnancy and Lactation

Pregnancy:
Available data have not consistently demonstrated an increased risk of major birth defects or miscarriage with inhaled salbutamol or budesonide. However, adequate controlled studies with this specific combination are limited. It should be used during pregnancy only when considered necessary by a healthcare professional.

Breastfeeding:
There are limited data regarding the effects of this combination on breastfed infants or milk production. Consult your doctor before using it while breastfeeding.

✔️ This inhaler should not be used in patients with known hypersensitivity to:

• Salbutamol
• Budesonide
• Any of the other ingredients in the formulation

✔️ Priming the Inhaler

Before first use:

1. Shake the inhaler well.
2. Release 4 sprays into the air, away from the face.
3. Shake well before each spray.

Re-priming is required if:

• The inhaler has not been used for more than 7 days.
• The inhaler has been dropped.
• The inhaler has been cleaned.

For re-priming, release 2 sprays into the air, shaking well before each spray.

Do not exceed the prescribed maximum daily dose. If asthma symptoms are not adequately controlled or you need to use the inhaler more frequently than usual, seek medical evaluation.

✔️ Precautions and Warnings

• Asthma can worsen rapidly over hours or gradually over several days. If symptoms become more frequent or severe, or if you need more inhalations than usual, seek medical evaluation promptly.
• Do not exceed the recommended maximum daily dose. Excessive use of beta₂-agonists may cause serious cardiovascular effects and other complications.
• Paradoxical bronchospasm may occur immediately after inhalation. If this happens, discontinue the inhaler and seek medical attention for alternative treatment.
• Use with caution in patients with cardiovascular disease, hypertension, diabetes mellitus, hyperthyroidism, seizure disorders, or sensitivity to sympathomimetic medicines.
• Salbutamol may cause hypokalemia, particularly at higher doses or when used with certain diuretics.
• Inhaled corticosteroids may cause oral candidiasis. Rinse the mouth with water and spit it out after use when advised.
• Long-term use of inhaled corticosteroids may affect bone mineral density, eye health, and adrenal function.
• Patients with risk factors for osteoporosis should be monitored during prolonged corticosteroid treatment.
• Long-term corticosteroid use may increase the risk of glaucoma, increased intraocular pressure, and cataracts.
• Corticosteroids can increase susceptibility to certain infections. Patients who have not had or been vaccinated against infections such as chickenpox or measles should take appropriate precautions to avoid exposure.
• Budesonide may reduce growth velocity in children. However, the safety and effectiveness of this specific inhaler have not been established in pediatric patients, and it is not indicated for children.
• Strong CYP3A4 inhibitors should be used cautiously because they may increase systemic exposure to budesonide.

✔️ This inhaler may interact with certain medicines, including:

• Strong CYP3A4 inhibitors: Medicines such as ritonavir, ketoconazole, itraconazole, clarithromycin, and other strong CYP3A4 inhibitors may increase systemic exposure to budesonide and increase corticosteroid-related adverse effects.
• Beta-blockers: May reduce the bronchodilating effect of salbutamol and may cause severe bronchospasm in susceptible patients.
• Non-potassium-sparing diuretics: May increase the risk of hypokalemia and associated ECG changes.
• Digoxin: Salbutamol may affect serum digoxin concentrations.
• MAO inhibitors and tricyclic antidepressants: May increase cardiovascular effects associated with beta-adrenergic agonists and should be used with caution.

✔️ Storage:

• Store below 30°C.
• Keep in a dry place and protect from direct sunlight and heat.
• Do not puncture, break, or burn the pressurized canister, even when empty.
• Keep out of reach of children.
• Keep away from the eyes.
• Clean the inhaler according to the manufacturer's instructions.
• Shake well before each use.
• For best results, allow the canister to reach room temperature before use.
• Use within 6 months after removal from the foil pouch, or according to the manufacturer's specified period.