Formoterol

FORADIL

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What it isLong-acting beta-2 agonist with rapid onset; maintenance treatment of asthma and COPD.

Why this oneIts rapid onset lets an inhaled-corticosteroid combination serve as both maintenance and reliever.

What limits itNever use it alone in asthma. Excess exposure causes tachycardia, tremor, and hypokalemia.

FDA-approved for

asthma/COPD (2001)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING LABAs increase the risk of asthma-related death; use only as additional therapy with a long-term asthma-control medication (e.g., inhaled corticosteroid) in patients not controlled on that alone.

FDA dosing	Population	Start	Target	Max
Asthma (with inhaled corticosteroid)	Adults and children ≥5 y	12 mcg (1 capsule) inhaled q12h	12 mcg q12h	24 mcg/day (1 capsule BID)
COPD maintenance	Adult	12 mcg (1 capsule) inhaled q12h	12 mcg q12h	24 mcg/day
Prevention of exercise-induced bronchospasm	Adults and children ≥5 y	12 mcg ≥15 min before exercise PRN	12 mcg PRN	one dose per 12 h

Renal Undefined

Hepatic Undefined

For EIB use, protection may last up to 12 hours; do not give additional doses within 12 hours.

Instructions

Oral inhalation only via AEROLIZER Inhaler; capsules must not be swallowed
Store capsules in blister; remove immediately before use
Do not exhale into the device
Do not exceed one capsule twice daily; more frequent use not recommended
For EIB, do not use additional doses within 12 hours

Contraindications

Treatment of asthma without concomitant long-term asthma-control medication (e.g., inhaled corticosteroid)

Cautions

Asthma-related death and asthma-related hospitalization (pediatric/adolescent)
Deterioration of disease/acute episodes; not for acute symptoms
Do not exceed recommended dose
Cardiovascular effects (increased pulse, blood pressure, ECG changes)
Hypokalemia and hyperglycemia
Immediate hypersensitivity reactions

Adverse reactions

Serious asthma exacerbations (higher incidence vs placebo)

Pregnancy Undefined

Lactation Undefined

NO BOXED WARNINGS

Principal riskNever as monotherapy in asthma

Cost, est. cash$30–$500/month

Generic entry2021

Classes and tags

Clinical profile

Therapeutic safety burden1 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk1 / 4

Legacy pregnancy categoryC

Defining liabilityTremor, tachycardia or anticholinergic effects; excessive beta-agonist exposure can cause hypokalemia and arrhythmia.

Mechanism of action: Formoterol ballicule

Formoterol ballicule: receptor binding, kinetics and half-life diagram

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Memory aids: mascots and interaction avatars

Formoterol mascot mnemonic cartoon — **“Formal aerosol”**

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