Fenoterol Uses, Dosage, Side Effects & Warnings | DrugsAtlas
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DRUG NAME: Fenoterol
Therapeutic Class: Bronchodilator
Subclass: Short-acting β2-adrenergic agonist (SABA)
Speciality: Pulmonology
Schedule (India): Schedule H
Route(s): Inhalation (MDI, nebuliser solution)
Formulations Available in India:
- Inhalation aerosol (MDI): Fenoterol 100 mcg per actuation (200 actuations per canister)
- Nebuliser solution: Fenoterol hydrobromide 500 mcg/mL solution for inhalation (2 mL ampoule)
- Fixed-dose combination nebuliser solution: Fenoterol 500 mcg + Ipratropium bromide 250 mcg per 2 mL
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
▶ 1. Acute Bronchospasm in Bronchial Asthma and COPD
A. Nebulisation Route:
| Parameter | Recommendation |
|
Starting dose
|
0.5 mg (1 mL of 500 mcg/mL solution) diluted with 2–3 mL normal saline |
|
Titration
|
Increase to 1 mg per dose if inadequate response after 20–30 minutes |
|
Usual maintenance dose
|
0.5–1 mg every 4–6 hours |
|
Maximum dose
|
2 mg per single dose; 8 mg/day |
Clinical Notes:
- Usually combined with ipratropium bromide for synergistic bronchodilation in emergency settings
- Continuous nebulisation not recommended routinely
- Monitor heart rate and oxygen saturation during acute management
B. Metered-Dose Inhaler (MDI) Route:
| Parameter | Recommendation |
|
Starting dose
|
100 mcg (1 puff) |
|
Titration
|
May increase to 200 mcg (2 puffs) if needed |
|
Usual maintenance dose
|
100–200 mcg per dose as required |
|
Maximum dose
|
400 mcg per dose; 800 mcg/day (8 puffs/day) |
Clinical Notes:
- Use with spacer device for optimal drug delivery
- Rescue use only — not for regular preventive therapy
- Reassess asthma control if using >2 times per week
▶ 2. Intermittent Asthma — Rescue Therapy
| Parameter | Recommendation |
|
Starting dose
|
100 mcg (1 puff) MDI with spacer |
|
Titration
|
Not applicable — use as needed |
|
Usual maintenance dose
|
100–200 mcg per episode |
|
Maximum dose
|
400 mcg per dose; 800 mcg/day |
Clinical Notes:
- Not for chronic or preventive use
- Overuse (>2–3 times/week) indicates poor asthma control — reassess need for inhaled corticosteroid
- Patients should carry rescue inhaler at all times
▶ 3. Exercise-Induced Bronchospasm (Temporary Prophylaxis)
| Parameter | Recommendation |
|
Starting dose
|
100–200 mcg (1–2 puffs) MDI |
|
Timing
|
15–30 minutes before anticipated exertion |
|
Titration
|
Not applicable |
|
Maximum dose
|
200 mcg per occasion |
Clinical Notes:
- Short-term prophylactic use only
- Duration of protection: approximately 2–4 hours
- If frequently required, reassess baseline asthma control and consider regular controller therapy
Secondary Indications — Adults Only (Off-label)
| Indication | Dosing | Duration | Notes |
|
Tocolysis (acute preterm labour) — OFF-LABEL
|
IV: 100 mcg over 10 minutes initially, then continuous infusion 1–3 mcg/min, titrated to uterine response | Short-term emergency use only (24–48 hours maximum) | Specialist only — obstetric units. Historical use; largely superseded by nifedipine and atosiban. Associated with significant maternal cardiovascular effects. Evidence basis: Historical case series; not current standard of care |
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India)
▶ 1. Acute Bronchospasm / Asthma Exacerbation — Nebulisation
| Age Group | Starting Dose | Titration | Usual Maintenance | Maximum Dose |
|
<6 years
|
0.05–0.1 mg/kg diluted in 2–3 mL saline | Repeat after 20–30 min if needed | 0.05–0.1 mg/kg every 4–6 hours | 0.5 mg/dose |
|
6–12 years
|
0.5 mg (1 mL) diluted in 2–3 mL saline | Increase to 1 mg if inadequate response | 0.5–1 mg every 4–6 hours | 1 mg/dose |
|
>12 years (Adolescents)
|
0.5 mg diluted in 2–3 mL saline | As per adult protocol | 0.5–1 mg every 4–6 hours | 2 mg/dose |
▶ 2. Rescue Therapy for Intermittent Asthma — MDI with Spacer
| Age Group | Dose | Frequency | Maximum |
|
Children 4–12 years
|
100 mcg (1 puff) via spacer | As needed for symptoms | 400–600 mcg/day (4–6 puffs) |
|
Adolescents >12 years
|
100–200 mcg (1–2 puffs) | As needed | 800 mcg/day |
Clinical Notes:
- Always use with valved holding chamber (spacer) in children
- Supervise inhaler technique at each visit
- Reassess controller therapy if rescue use exceeds 2 times/week
Secondary Indications — Paediatrics (Off-label)
Not commonly used off-label in paediatric population. Tocolysis indication not applicable to paediatrics.
Safety Monitoring (Paediatric):
- Heart rate monitoring during and after nebulisation
- Observe for tremor, restlessness, paradoxical bronchospasm
- SpO2 monitoring in acute settings
- Serum potassium if repeated high-dose nebulisation
Age Restrictions:
- Not recommended below 6 months of age except under respiratory specialist supervision in PICU setting
- MDI with spacer preferred over nebulisation in children >4 years for mild-moderate symptoms
RENAL ADJUSTMENT
| Renal Function | Recommendation |
| Mild–Severe impairment | No dosage adjustment required |
| Haemodialysis | No adjustment; minimal systemic absorption via inhalation route |
HEPATIC ADJUSTMENT
| Child-Pugh Class | Score | Recommendation |
|
Class A (Mild)
|
5–6 points | No dose adjustment required |
|
Class B (Moderate)
|
7–9 points | No dose adjustment required |
|
Class C (Severe)
|
10–15 points | Use with caution; monitor for increased systemic effects if high-dose nebulisation required |
Clinical Notes:
- Fenoterol is not primarily hepatically metabolised
- Inhaled administration results in minimal systemic exposure
- Caution advised only with high-dose or prolonged nebulisation in severe hepatic dysfunction
CONTRAINDICATIONS
- Known hypersensitivity to fenoterol, other beta-agonists, or formulation components
- Tachyarrhythmias (e.g., paroxysmal supraventricular tachycardia, uncontrolled atrial fibrillation)
- Hypertrophic obstructive cardiomyopathy (HOCM)
- First trimester pregnancy if used for tocolysis (off-label)
- Severe untreated thyrotoxicosis
CAUTIONS
- Ischaemic heart disease or significant cardiovascular disease
- Hypertension — poorly controlled
- Cardiac arrhythmias — history of
- Hyperthyroidism — may exacerbate symptoms
- Diabetes mellitus — may cause hyperglycaemia, especially with high doses
- Hypokalaemia risk — particularly with concurrent corticosteroids, xanthines, or diuretics
- Narrow-angle glaucoma — nebulised delivery may precipitate acute attack if mist contacts eyes (especially when combined with anticholinergics)
- Phaeochromocytoma
- Severe asthma — paradoxical bronchospasm risk
PREGNANCY
| Aspect | Details |
|
Overall safety
|
Limited human data; inhaled use likely low-risk due to minimal systemic absorption |
|
When to use
|
When short-acting beta-agonist is clearly indicated for acute bronchospasm; benefit outweighs potential risk |
|
Preferred alternatives
|
Salbutamol (more extensive safety data in pregnancy) |
|
Tocolysis use
|
Discouraged — nifedipine or atosiban preferred; if used, only under specialist inpatient supervision |
|
Monitoring required
|
Maternal: heart rate, blood pressure, blood glucose. Fetal: continuous fetal heart rate monitoring if used for tocolysis |
LACTATION
| Aspect | Details |
|
Compatibility
|
Likely compatible with breastfeeding when used by inhalation |
|
Expected levels in milk
|
Low — minimal systemic absorption from inhaled route |
|
Preferred alternatives
|
Salbutamol (wider safety data in lactation) |
|
Infant monitoring
|
Usually not required with standard inhaled doses; observe for irritability or tachycardia if maternal high-dose use |
ELDERLY
| Aspect | Recommendation |
|
Starting dose
|
Same as adults — 100 mcg MDI or 0.5 mg nebulised |
|
Titration
|
Slower titration; allow longer intervals between doses |
|
Extra risks
|
Increased sensitivity to cardiovascular effects (tachycardia, palpitations, arrhythmias); tremor more pronounced; underlying cardiac disease may be unmasked |
|
Monitoring
|
Heart rate and rhythm; blood pressure; watch for angina symptoms |
|
Practical tips
|
Prefer MDI with spacer to ensure adequate drug deposition; assess inhaler technique regularly |
MAJOR DRUG INTERACTIONS
| Interacting Drug | Effect/Risk | Management |
|
Non-selective beta-blockers (propranolol, carvedilol, labetalol)
|
Antagonise bronchodilator effect; may precipitate bronchospasm | Avoid combination; if beta-blocker essential, use cardioselective agent (bisoprolol, metoprolol) |
|
MAO inhibitors (phenelzine, tranylcypromine, linezolid)
|
Potentiate sympathomimetic effects; risk of hypertensive crisis | Avoid combination or use with extreme caution; monitor BP closely |
|
Tricyclic antidepressants (amitriptyline, imipramine)
|
Potentiate cardiovascular effects | Use with caution; monitor heart rate and rhythm |
|
QT-prolonging drugs (azithromycin, haloperidol, ondansetron, amiodarone)
|
Additive risk of QT prolongation and arrhythmias, especially with hypokalaemia | Monitor ECG if combination unavoidable; correct electrolytes |
MODERATE DRUG INTERACTIONS
| Interacting Drug | Effect/Risk | Management |
|
Loop diuretics (furosemide)
|
Additive hypokalaemia risk | Monitor serum potassium; supplement as needed |
|
Thiazide diuretics
|
Additive hypokalaemia risk | Monitor potassium levels |
|
Theophylline/aminophylline
|
Potentiated bronchodilation but also increased tachycardia, tremor, and hypokalaemia risk | Monitor heart rate and potassium; may need to reduce doses |
|
Systemic corticosteroids
|
Additive hypokalaemia and hyperglycaemia | Monitor electrolytes and blood glucose with prolonged co-administration |
|
Digoxin
|
Hypokalaemia from beta-agonist may increase digoxin toxicity risk | Monitor potassium and digoxin levels |
|
Other sympathomimetics (salbutamol, adrenaline)
|
Additive cardiovascular effects | Avoid concurrent use if possible; if essential, monitor closely |
COMMON ADVERSE EFFECTS
- Tremor (especially hands)
- Palpitations
- Tachycardia
- Nervousness/restlessness
- Headache
- Dizziness
- Mouth/throat dryness or irritation (inhaled use)
- Muscle cramps
SERIOUS ADVERSE EFFECTS
| Adverse Effect | Notes |
| Paradoxical bronchospasm | Requires immediate discontinuation; provide alternative bronchodilator |
| Cardiac arrhythmias (SVT, atrial fibrillation) | More common with high doses or in patients with underlying cardiac disease |
| Severe hypokalaemia | Especially with high-dose nebulisation combined with steroids/xanthines; may precipitate arrhythmias |
| Lactic acidosis | Rare; associated with high-dose or continuous nebulisation in severe asthma |
| Myocardial ischaemia | In patients with underlying coronary artery disease |
| Hypersensitivity reactions | Rare; discontinue immediately |
MONITORING REQUIREMENTS
| Timing | Parameters |
|
Baseline
|
Heart rate, blood pressure, serum potassium (especially in combination therapy), blood glucose in diabetics |
|
During acute use
|
Heart rate, SpO2, symptom relief, respiratory rate; watch for paradoxical bronchospasm |
|
Repeated/continuous nebulisation
|
ECG if cardiac risk factors present; serum potassium every 6–12 hours |
|
Long-term asthma management
|
Frequency of rescue inhaler use (marker of control); ensure adequate ICS adherence; reassess if SABA use >2 times/week |
BRANDS AVAILABLE IN INDIA
- Berotec® (Boehringer Ingelheim)
- Fenoterol combinations with ipratropium:
-
- Duolin® (Cipla) — Fenoterol 500 mcg + Ipratropium 250 mcg nebuliser solution
- Combivent® equivalent preparations
Note: Fenoterol monotherapy products have limited availability; combination products with ipratropium are more commonly stocked.
PRICE RANGE (INR)
| Formulation | Price Range | Notes |
| MDI 100 mcg/actuation (200 doses) | ₹120–₹180 per inhaler | Brand-dependent |
| Nebuliser solution 500 mcg/mL (2 mL ampoule) | ₹15–₹25 per ampoule | Mono-ingredient |
| Combination nebuliser solution (Fenoterol + Ipratropium) | ₹25–₹40 per ampoule | More commonly available |
- Not listed in NLEM India
- Price not DPCO-controlled
- Available through retail and hospital pharmacies
CLINICAL PEARLS
- Combination preferred — Fenoterol is rarely used as monotherapy; combination with ipratropium bromide (e.g., Duolin-type products) provides synergistic bronchodilation and is standard practice in acute exacerbations.
- SABA overuse is a red flag — Rescue inhaler use >2–3 times/week indicates inadequate asthma control; reassess and optimise inhaled corticosteroid therapy.
- Shorter duration than LABAs — Fenoterol provides acute relief (4–6 hours) only; do not substitute for maintenance therapy with formoterol or salmeterol.
- Eye protection during nebulisation — Wash nebuliser mask thoroughly after use, especially when combined with ipratropium, to prevent ocular deposition and risk of acute angle-closure glaucoma.
- Salbutamol may be preferred — In elderly and cardiac patients, salbutamol has a more established safety profile; consider switching if cardiovascular concerns arise.
- Potassium vigilance — High-dose or repeated nebulisation, especially combined with corticosteroids or xanthines, can cause significant hypokalaemia — monitor and supplement as needed.
TAGS
fenoterol; SABA; short-acting beta-agonist; asthma exacerbation; COPD rescue; inhaled bronchodilator; nebuliser; paediatric asthma; ipratropium combination; bronchospasm; Schedule H
VERSION
RxIndia v0.9 — 28 Feb 2026
REFERENCES
- CDSCO approved product information
- Indian Pharmacopoeia 2018
- National Formulary of India 2021
- AIIMS Paediatric Asthma Protocol
- API Textbook of Medicine 2022
- Indian Academy of Pediatrics (IAP) Respiratory Guidelines
- ICMR Asthma & COPD Guidance
- WHO Essential Medicines List (paediatric supportive data)
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Clinical Responsibility
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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