Azmasol Plus
Rx90 mcg+80 mcg • Metered-Dose Inhaler (MDI)
Indications & Uses
Azmasol Plus is indicated for:
Pharmacology
Salbutamol + Budesonide is a combination of salbutamol, a beta2-adrenergic agonist, and budesonide, a corticosteroid. It is used as needed to treat or prevent bronchoconstriction, and to lower the risk of exacerbations, in people with asthma who are 18 years of age and older. Salbutamol relaxes the smooth muscles of all the airways, from the trachea down to the terminal bronchioles. Budesonide works against many different cell types and mediators involved in inflammation.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The usual dose of this salbutamol and budesonide inhaler is salbutamol 180 µg and budesonide 160 ug, which comes from 2 actuations of the inhaler. You take it by oral inhalation as needed for asthma symptoms. Don't take more than 6 doses (12 inhalations) in a 24-hour period.
Prime the inhaler before you use it for the first time. To do this, release 4 sprays into the air, away from your face, and shake the inhaler well before each spray.
You need to prime it again if it hasn't been used for more than 7 days, if it has been dropped, or after cleaning. For re-priming, release 2 sprays into the air away from your face, shaking well before each spray.
Side Effects
Salbutamol + Budesonide may cause some significant side effects. These include worsening of asthma, paradoxical bronchospasm and cardiovascular effects. Hypersensitivity reactions are also possible, including anaphylaxis. Other reactions are hypokalemia, immunosuppression with a risk of infections, and oropharyngeal candidiasis. You may also see hypercorticism and adrenal suppression, a reduction in bone mineral density, and glaucoma and cataracts. In children, there may be effects on growth.
Cautions & Contraindications
Warnings & Precautions
Asthma can get worse suddenly over a few hours, or slowly over several days or longer. If symptoms carry on after a patient uses this Salbutamol + Budesonide inhaler, or if they need more doses than usual, it may be a sign that the asthma is becoming unstable. The patient and their treatment plan then need to be evaluated. The inhaler can cause paradoxical bronchospasm, which may be life threatening. If this happens after a dose, stop the inhaler immediately and start alternative therapy. Like other medicines that contain beta-adrenergic agonists, this inhaler can cause clinically significant cardiovascular effects in some patients, seen as a rise in pulse rate, blood pressure and/or other symptoms. If these effects occur, the inhaler may need to be stopped. Don't use more than the maximum daily dose, because an overdose may result. Clinically significant cardiovascular effects and deaths have been reported with excessive use of inhaled sympathomimetic drugs. Hypersensitivity reactions can occur after salbutamol sulfate and budesonide, the two components of this inhaler. Cases of anaphylaxis, angioedema, bronchospasm, oropharyngeal edema, rash and urticaria have been seen. Stop the inhaler if any of these reactions occur. As with all therapies containing sympathomimetic amines, use it with caution in patients with convulsive disorders, hyperthyroidism or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines. Beta-adrenergic agonist medicines may cause significant hypokalemia in some patients, possibly through intracellular shunting, and this has the potential to produce adverse cardiovascular effects. Patients taking medicines that suppress the immune system are more likely to get infections. Chicken pox and measles, for example, can run a more serious or even fatal course in susceptible patients who are using corticosteroids. Patients who have not had these diseases or been properly immunized should take particular care to avoid exposure. The inhaler contains budesonide, an inhaled corticosteroid (ICS). Localized infections of the mouth and pharynx with Candida albicans have occurred in patients treated with ICS agents, so patients should be monitored periodically. Budesonide will often help control asthma symptoms with less suppression of hypothalamic-pituitary-adrenal (HPA) function than therapeutically equivalent oral doses of prednisone. Bone mineral density (BMD) has decreased with long-term use of products containing ICS. Patients with major risk factors for low bone mineral content should be monitored and treated according to established standards of care. These risk factors are prolonged immobilization, family history of osteoporosis, post-menopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass. Glaucoma, increased intraocular pressure and cataracts have been reported after long-term use of ICS, including budesonide. Take caution when considering this inhaler together with long-term ketoconazole or other known strong CYP3A4 inhibitors (e.g. ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin). Adverse effects linked to higher systemic exposure to budesonide may occur. Orally inhaled corticosteroids, including budesonide, may slow growth velocity when given to pediatric patients. The safety and effectiveness of this inhaler have not been established in pediatric patients, and it is not indicated for use in this group.
Contraindications
Salbutamol + Budesonide should not be given to anyone who is hypersensitive to salbutamol, to budesonide, or to any of the excipients in the product.
Pregnancy & Breastfeeding
Pregnancy: No adequate and well-controlled studies of the Salbutamol + Budesonide inhaler have been done in pregnant women, so its risk in pregnancy is not known. Some information does exist for the two medicines separately. Epidemiological studies and postmarketing case reports of inhaled salbutamol use in pregnancy do not consistently show a risk of major birth defects or miscarriage. Reviews of budesonide use in pregnant women have not found a drug-related risk of major birth defects, miscarriage or other adverse outcomes for the mother or the baby.
Lactation: There are no data on how this inhaler affects a breastfed child or milk production.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
This inhaler contains both salbutamol and budesonide, so the overdose risks of each component apply to it.
Salbutamol: The symptoms to expect with an overdose are those of too much beta-adrenergic stimulation, or a worsening of any of the usual symptoms of that stimulation. These include seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/minute, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia and metabolic acidosis. Hypokalemia may also occur.
Budesonide: If it is used at excessive doses for a long period, systemic corticosteroid effects such as hypercorticism may occur.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
The Salbutamol + Budesonide inhaler comes in a pressurized canister. Don't puncture it, break it or burn it, even when it's empty, because it may explode. Keep it out of direct sunlight and away from heat, and don't store it above 30°C. Keep it in a dry place, protected from light, and out of the reach of children.
Clean your inhaler regularly as the directions say. Keep it away from your eyes.
Once you take the canister out of the foil pouch, use it within six months. For best results, let the canister reach room temperature before you use it, and shake it well before each use.
Drug Interactions
Common questions about Azmasol Plus 90 mcg+80 mcg
What is Azmasol Plus 90 mcg+80 mcg Metered-Dose Inhaler (MDI)?
Azmasol Plus 90 mcg+80 mcg Metered-Dose Inhaler (MDI) is a medicine that contains Salbutamol + Budesonide. It is made by Beximco Pharmaceuticals Ltd. It belongs to the Combined bronchodilators group of medicines.
What is Azmasol Plus used for?
Azmasol Plus is used for: Asthma.
What are the side effects of Azmasol Plus?
Salbutamol + Budesonide may cause some significant side effects. These include worsening of asthma, paradoxical bronchospasm and cardiovascular effects.
Can I take Azmasol Plus during pregnancy or while breastfeeding?
Pregnancy: No adequate and well-controlled studies of the Salbutamol + Budesonide inhaler have been done in pregnant women, so its risk in pregnancy is not known. Some information does exist for the two medicines separately. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Azmasol Plus?
This inhaler contains both salbutamol and budesonide, so the overdose risks of each component apply to it. Salbutamol: The symptoms to expect with an overdose are those of too much beta-adrenergic stimulation, or a worsening of any of the usual symptoms of that stimulation. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Azmasol Plus?
The Salbutamol + Budesonide inhaler comes in a pressurized canister. Don't puncture it, break it or burn it, even when it's empty, because it may explode.
Can I take other medicines with Azmasol Plus?
Some medicines can interact with Salbutamol + Budesonide, for example: Digoxin, Ritonavir. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Azmasol Plus?
Azmasol Plus is a prescription (Rx) medicine. Take it as your doctor advises.