Salbutamol (albuterol)

Salbutamol is called albuterol in the US. The label we reviewed is for albuterol tablets taken by mouth, not for inhalers or nebulizer solutions.

The label says the tablets are for relief of bronchospasm in adults and in children aged 6 years and older with reversible obstructive airway disease.

The label also warns that bronchodilators alone may not control asthma, and early thought should be given to adding an anti-inflammatory medicine.

• Relief of bronchospasm in adults
• Relief of bronchospasm in children aged 6 years and older

The label describes albuterol as a relatively selective beta-2 adrenergic bronchodilator.

The mechanism section in the label text we reviewed is not available. The label does name it as a sympathomimetic amine.

This section covers the albuterol tablet label (2 mg and 4 mg tablets, oral route). Indian tablets, syrups, inhalers and nebulizer solutions can differ, and your prescriber decides.

For adults and children aged 12 and over, the US label gives a usual starting dose of 2 or 4 mg three or four times a day. The label says doses above 4 mg four times a day are for patients who fail to respond, up to 8 mg four times a day, with a total daily limit of 32 mg.

For children aged 6 to 12 years, the label gives a starting dose of 2 mg three or four times a day, with a limit of 24 mg a day in divided doses.

For elderly people and those unusually sensitive to beta-stimulants, the label suggests starting at 2 mg three or four times a day.

The label says the effect may last up to 8 hours or longer. It says not to raise the dose or frequency without asking your doctor, and to seek medical attention if the tablets seem less effective.

• Adults and ages 12 and over: starting dose 2 or 4 mg three or four times a day
• Ages 6 to 12: starting dose 2 mg three or four times a day
• Needing more doses than usual can signal worsening asthma

The label says salbutamol must not be used with a known allergy to albuterol or its components.

It can cause paradoxical bronchospasm, which may be life threatening. The label says to stop it immediately if this happens.

Use with caution in heart disease, including coronary insufficiency, arrhythmia and high blood pressure, and in seizure disorders, an overactive thyroid and diabetes. The label also says it may lower blood potassium.

Pregnancy: animal studies showed cleft palate and other defects, and there are no adequate studies in pregnant women. The label says to use it only if the potential benefit justifies the risk.

Breastfeeding: it is not known whether it passes into human milk, and the label asks for a decision on stopping nursing or the drug. Children: safety in children below 6 years has not been established.

• Allergy to albuterol: contraindicated
• Paradoxical bronchospasm: stop and seek help
• Heart disease, seizures, thyroid disease, diabetes: caution
• Pregnancy: only if benefit justifies risk

• Beta-blockers: may cause bronchospasm
• MAO inhibitors and tricyclics: stronger vascular effect
• Loop and thiazide diuretics: low potassium and ECG changes
• Digoxin: levels may fall
• The label says other oral sympathomimetic medicines should not usually be used together, because of effects on the heart.
• MAO inhibitors and tricyclic antidepressants, including within 2 weeks of stopping them, may strengthen the effect on blood vessels, so extreme caution is advised.
• Beta-blockers can block the lung effect and may cause severe bronchospasm in people with asthma.
• Non-potassium-sparing diuretics (loop or thiazide) can add to ECG changes and low potassium.
• Digoxin levels fell by 16% to 22% in volunteers, so digoxin levels may need checking.

No match in this label text. Ask your pharmacist about any medicine you take.

The label says an overdose gives signs of excessive beta stimulation, such as seizures, chest pain, high or low blood pressure, a very fast heartbeat, arrhythmias, tremor and low potassium.

It says cardiac arrest and even death may be linked to abuse. Treatment is to stop the medicine and give supportive care. Treat any overdose as an emergency.

The US label says to store tablets at 20 to 25 degrees C in a tight, light-resistant container.

Indian packs may carry their own storage line. Follow your pack, and keep all medicines away from children.

Salbutamol sulphate is in Schedule H (serial 443), so it is sold only on a prescription.

The National List of Essential Medicines 2022 includes salbutamol only as a 5 mg per mL nebulizer solution (page 105). We did not find the tablet in the rows we checked.

NPPA has ceiling prices for salbutamol tablets, capsules, oral liquid, inhalation and nebulizer solution, shown below.

Banned combinations: the list we checked has 14 mentions of salbutamol. Use the checker for your exact combination.

NPPA ceiling prices set the most a seller can charge per unit before local taxes. Check the pack and the seller.

Jan Aushadhi lists salbutamol 2 mg and 4 mg tablets, syrup, an inhalation product and rotacaps, plus an ipratropium inhaler combination. Combination products also contain other medicines, so read the label. We have not shown a brand price here.

• Salbutamol Tablets IP 2mg (pack 10's)
• Salbutamol Tablets IP 4 mg (pack 10's)
• Salbutamol Syrup IP 2mg per 5ml (100 ml)
• Salbutamol Inhalation IP 100mcg (200 doses)
• Salbutamol Rotacaps 200mcg (60s)