FARCOLIN RESPIRATOR SOLUTION 20ML

Indications

Approved Uses

Relief and prevention of bronchospasm in reversible obstructive airway disease (e.g., asthma) and in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Dosage & Administration

Dosing by Condition

Bronchospasm (asthma/COPD) via nebuliser: Adults and adolescents: 2.5 mg (0.5 mL of 0.5% solution) diluted, 3-4 times daily as needed; may increase to 5 mg per dose in more severe cases. Children: typically 2.5 mg per dose (younger children may require lower doses per specialist direction). Severe acute asthma: repeated 2.5-5 mg doses or continuous nebulisation only under medical supervision.

Initial Dose

2.5 mg (0.5 mL of 0.5% solution) diluted to 2.5-3 mL with normal saline via nebuliser

Maintenance Dose

Used on an as-needed basis for symptom relief, not for routine maintenance.

Maximum Dose

Typical nebulized dose: 2.5-5 mg per treatment; usual maximum is 4 treatments/day (i.e., up to ~20 mg/day) unless under close medical supervision (e.g., severe exacerbation) where higher doses may be used with monitoring.

Children's Dosage

Children 2 to 12 years of age-0.63 to 1.25 mg in the nebulizer 3 or 4 times per day as needed. Children younger than 2 years of age-Use and dose must be determined by your child's doctor.

Dose Adjustment Notes

Use the lowest effective dose and titrate to response; use caution in cardiovascular disease, hyperthyroidism, and diabetes, and monitor for tachycardia and hypokalemia with high doses or frequent use.

How to Take

For inhalation use only via a nebuliser. Measure the prescribed dose of FARCOLIN 0.5% (5 mg/mL) and dilute with sterile 0.9% sodium chloride to an appropriate nebuliser fill volume (commonly 2.5-4 mL total), then nebulise via mouthpiece/face mask until the mist stops. Do not swallow or inject; discard any remaining diluted solution after use.

How to Prepare

Albuterol sulfate inhalation solution is supplied as a single-dose, ready-to-use vial containing 3 mL of solution. No mixing or dilution is needed.

Side Effects

Common Side Effects

Tremor, headache, tachycardia, palpitations, muscle cramps; may cause hypokalemia (especially with high doses/frequent nebulisation).

Side Effect Frequency

Very common (>10%): tremor, tachycardia. Common (1-10%): palpitations, headache, muscle cramps, peripheral vasodilation, mild hypokalemia. Uncommon (<1%): paradoxical bronchospasm, arrhythmias, hypersensitivity reactions, hyperglycemia

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to salbutamol or any excipients; 'threatened abortion' is not a standard contraindication for inhaled/nebulized salbutamol.

Warnings & Precautions

Use caution in cardiovascular disease/arrhythmias, hypertension, hyperthyroidism, diabetes; monitor for hypokalemia (especially with high doses or with diuretics/systemic steroids/xanthines); increasing use indicates worsening control needing reassessment; discontinue immediately if paradoxical bronchospasm occurs; not a substitute for anti-inflammatory controller therapy in persistent asthma.

Age Restriction

No fixed minimum age in labeling; nebulized salbutamol can be used in children (including <4 years and infants) under physician supervision with age/weight-appropriate dosing.

Drug Interactions

Interaction Severity

MAJOR: Non-selective beta-blockers (e.g., propranolol) may antagonize effect and precipitate bronchospasm. MODERATE: MAOIs/TCAs may potentiate cardiovascular effects; loop/thiazide diuretics, systemic corticosteroids, and xanthines (e.g., theophylline) increase hypokalemia risk; digoxin-hypokalemia may increase arrhythmia risk. MINOR/ADDITIVE: Other sympathomimetics increase adrenergic adverse effects.

Special Populations

Children

Children 2 to 12 years of age-0.63 to 1.25 mg in the nebulizer 3 or 4 times per day as needed. Children younger than 2 years of age-Use and dose must be determined by your child's doctor.

Storage & Patient Advice

Preparation Instructions

Albuterol sulfate inhalation solution is supplied as a single-dose, ready-to-use vial containing 3 mL of solution. No mixing or dilution is needed.

Overdose

Overdose may cause tachycardia/palpitations, tremor, hypokalemia, hyperglycemia, lactic/metabolic acidosis, and arrhythmias; management is supportive, stop/reduce salbutamol, correct electrolytes (especially K+), ECG monitoring, and consider a cardioselective beta-blocker cautiously under specialist care.

Patient Counseling

Use only by nebuliser for inhalation; do not swallow or inject. Dilute with normal saline as directed and use the correct measured volume (0.5% = 5 mg/mL). This is a quick-relief medicine; if you need it more often than prescribed or relief is short-lived/worsening, seek medical review urgently. Common effects include tremor and fast heartbeat; seek help for chest pain, severe palpitations, or worsening wheeze after use. Clean the nebuliser as instructed. Store below 30°C and protect from light.

Monitoring Requirements

Monitor symptom relief and lung function (PEF/FEV1) and observe for paradoxical bronchospasm; with high-dose/frequent nebulisation or interacting drugs, monitor heart rate/BP and serum potassium, and consider glucose monitoring in diabetics.

Pharmacology

Mechanism of Action

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

Product Information

Available Dosage Forms

Nebuliser solution, metered-dose inhaler, dry powder inhaler, tablets, syrup, solution for injection

Composition per Dose

Each 1 mL: 5 mg salbutamol (as salbutamol sulfate) - 0.5% w/v solution

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Symptom Target

Wheezing & Shortness of Breath

Sedating

No

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