BUTALIN 100/MCG INHALER 200/DOSES

Indications

Approved Uses

Treatment and prevention of bronchospasm in patients with reversible obstructive airway disease, such as asthma and chronic obstructive pulmonary disease (COPD), Prevention of exercise-induced bronchospasm.

Off-Label Uses

Adjunct treatment of acute hyperkalemia (typically via nebulized/inhaled beta-2 agonist).

Dosage & Administration

Dosing by Condition

Acute bronchospasm/asthma symptoms (adults and adolescents): 1-2 puffs (100-200 µg) as needed; may repeat every 4-6 hours as required. Exercise-induced bronchospasm prevention: 2 puffs (200 µg) 10-15 (up to 30) minutes before exercise. COPD symptom relief: 1-2 puffs up to 4 times daily as needed.

Initial Dose

100-200 mcg (1-2 puffs) per episode

Maintenance Dose

100-200 mcg (1-2 puffs) up to 4 times daily as needed

Maximum Dose

Routine PRN: 1-2 puffs (100-200 mcg) up to 4 times daily (max 8 puffs/24 h) for usual use; higher short-term dosing in acute exacerbation should follow an asthma action plan/medical supervision (e.g., repeated doses in the first hour).

Children's Dosage

Children 4 years and older: 100 mcg (1 puff) per episode, may increase to 200 mcg (2 puffs) if needed; max 4 times daily. Children under 4 years: use with spacer device under medical supervision

Dose Adjustment Notes

No routine renal or hepatic dose adjustment is required for inhaled salbutamol; use caution and the lowest effective dose in patients with cardiovascular disease/arrhythmias, hyperthyroidism, diabetes, and in those prone to hypokalemia.

How to Take

Shake well before each puff. Remove cap and check mouthpiece. Breathe out fully. Seal lips around mouthpiece. Start to breathe in slowly and deeply and press the canister once; continue inhaling fully. Hold breath about 10 seconds (or as long as comfortable), then breathe out slowly. If a second puff is needed, wait about 30-60 seconds, shake again, and repeat. Replace cap. Clean the plastic actuator/mouthpiece at least weekly (remove canister, rinse/wash actuator with warm water, air-dry completely before reassembly).

Side Effects

Common Side Effects

Tremor/shakiness, headache, palpitations, tachycardia, muscle cramps; with higher or frequent doses: hypokalemia (and sometimes transient hyperglycemia).

Side Effect Frequency

Very common (≥10%): tremor. Common (1-10%): headache, palpitations, tachycardia. Uncommon (0.1-1%): muscle cramps, mouth/throat irritation. Rare (<0.1%): hypokalemia (especially with high doses/nebules or concomitant risk factors), arrhythmias, paradoxical bronchospasm, hypersensitivity reactions; peripheral vasodilation and hyperglycemia are also uncommon-rare depending on dose and population.

Safety & Warnings

Contraindications

Hypersensitivity to salbutamol or any excipients/components of the inhaler.

Warnings & Precautions

Caution in cardiovascular disease (arrhythmias, ischemic heart disease, hypertension, heart failure), hyperthyroidism, diabetes (hyperglycemia), and in patients at risk of hypokalemia; avoid/monitor with interacting drugs; paradoxical bronchospasm requires immediate discontinuation; increasing SABA use indicates worsening asthma and need for reassessment/controller optimization.

Age Restriction

No strict minimum age in guidelines; pMDI use is age/technique dependent-typically use with spacer (and mask if needed) in young children, and ensure clinician supervision especially in <4 years.

Drug Interactions

Drug Interactions

Key interactions: non-selective beta-blockers (antagonize effect/bronchospasm risk); other sympathomimetics (additive CV effects); MAOIs/TCAs (potentiate CV effects); diuretics and systemic corticosteroids (increase hypokalemia risk); digoxin (hypokalemia may increase arrhythmia risk and can lower digoxin levels).

Interaction Severity

MAJOR: non-selective beta-blockers (e.g., propranolol) may precipitate bronchospasm and blunt bronchodilation. MODERATE: potassium-lowering agents (loop/thiazide diuretics, systemic corticosteroids) and xanthines (theophylline) increase hypokalemia risk; MAOIs/TCAs may potentiate cardiovascular effects; digoxin levels/effects may be adversely affected in the setting of hypokalemia.

Food Interaction

No restriction

Special Populations

Breastfeeding

Safe

Children

Children 4 years and older: 100 mcg (1 puff) per episode, may increase to 200 mcg (2 puffs) if needed; max 4 times daily. Children under 4 years: use with spacer device under medical supervision

Elderly

Standard adult dosing. It is advisable to initiate treatment at the lower end of the dosing range as elderly patients may be more sensitive to side effects.

Kidney Impairment

No dose adjustment required in renal impairment; use usual clinical caution in severe renal disease due to potential electrolyte/cardiac effects at high doses.

Liver Impairment

No adjustment needed.

Storage & Patient Advice

Storage Conditions

Store below 30°C. Do not freeze.

Missed Dose

Not applicable for routine missed-dose instructions because it is typically used as needed; if prescribed on a schedule, take the missed dose when remembered unless it is close to the next dose-do not double.

Stopping the Medicine

Can be stopped at any time if used PRN; however, increasing need or regular reliance should prompt medical review and optimization of controller therapy rather than simply stopping/continuing unsupervised.

Overdose

Symptoms: tremor, tachycardia/palpitations, headache, chest pain/arrhythmias, hypokalemia, hyperglycemia, lactic/metabolic acidosis; management: stop salbutamol, urgent medical assessment, supportive care with ECG/electrolytes, correct hypokalemia, consider cautious cardioselective beta-blocker if severe tachyarrhythmia/ischemia.

Patient Counseling

Reliever (rescue) inhaler for quick relief of wheeze/shortness of breath; use as needed as directed. Demonstrate correct MDI technique and advise waiting ~30-60 seconds between puffs. Seek medical review if needing it more than ~2 days/week (or increasing use), if it provides short relief, or if symptoms are severe/not improving after initial doses. Do not exceed prescribed maximum. Possible effects: tremor, fast heartbeat, headache. Store below 30°C and do not freeze (SFDA). Clean the actuator weekly and keep the cap on when not in use.

Monitoring Requirements

No routine lab monitoring is required for standard intermittent inhaler use; monitor symptom control/reliever use frequency and inhaler technique. Consider monitoring heart rate/BP and ECG in patients with cardiovascular disease or high-dose use, and serum potassium (and sometimes glucose) with high-dose/frequent use or when combined with potassium-depleting drugs.

Pharmacology

Mechanism of Action

Selective beta-2 adrenergic agonist that activates adenylate cyclase, increases intracellular cAMP, and relaxes bronchial smooth muscle to produce bronchodilation.

Onset of Action

Within 5-15 minutes.

Duration of Effect

4-6 hours.

Half-Life

3.8-6 hours.

Bioavailability

After inhalation, about 10-20% of the emitted dose reaches the lower airways; the remainder is deposited in the oropharynx and swallowed, contributing to systemic exposure after absorption/first-pass metabolism.

Metabolism

Metabolized mainly by sulfation (to an inactive 4'-O-sulfate conjugate), with first-pass metabolism relevant to the swallowed fraction after inhalation.

Excretion

Primarily renal excretion of unchanged drug and metabolites; a large proportion of an administered dose is recovered in urine within 24 hours.

Protein Binding

Approximately 10%.

Product Information

Available Dosage Forms

For salbutamol (INN): pressurised inhalation (pressurised metered-dose inhaler); nebuliser solution/respirator solution; oral tablets; oral syrup/solution; solution for injection (IV/IM).

Composition per Dose

Each actuation: 100 mcg salbutamol (as salbutamol sulfate)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Symptom Target

Bronchospasm

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 13-08-2026