Dosing and uses of Perforomist (formoterol)
Adult dosage forms and strengths
solution for inhalation
- 20mcg/2mL
Chronic Obstructive Pulmonary Disease (COPD)
Indicated for long-term maintenance treatment of bronchoconstriction in patients with COPd
Perforomist: 20 mcg inhaled via nebulizer q12hr
Pediatric dosage forms and strengths
Safety and efficacy not established
Perforomist (formoterol) adverse (side) effects
>10%
Viral infection (17.2%)
1-10%
Bronchitis (4.6%)
Chest infection (2.7%)
Dyspnea (2.1%)
Chest pain (1.9%)
Tremor (1.9%)
Dizziness (1.6%)
Frequency not defined
Angina
Arrhythmias
Hypo/hypertension
Tachycardia
Hypokalemia
Hyperglycemia
Metabolic acidosis
Headache
Insomnia
Paradoxical bronchospasm
Severe asthma exacerbation
Postmarketing Reports
Immune system disorders: Rare reports of anaphylactic reactions, including severe hypotension and angioedema
Metabolism and nutrition disorders: Hypokalemia, hyperglycemia
Respiratory, thoracic and mediastinal disorders: Cough
Skin and subcutaneous tissue disorders: Rash
Cardiac disorders: Angina pectoris, cardiac arrhythmias (eg, atrial fibrillation, ventricular extrasystoles, tachyarrhythmia)
Investigations: Electrocardiogram QT prolonged, blood pressure increased (including hypertension)
Warnings
Black box warnings
Long-acting beta2-adrenergic agonists (LABAs) increase the risk of asthma-related death
A placebo-controlled study with another long-acting beta2-adrenergic agonist (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeteroL
The finding of an increased risk of asthma-related death with salmeterol is considered a class effect of LABAs, including formoterol, the active ingredient in Perforomist
The safety and efficacy of Perforomist in patients with asthma have not been established
All LABAs, including Perforomist, are contraindicated in patients with asthma without use of a long-term asthma control medication
Contraindications
Hypersensitivity
Tachycardia secondary to heart condition
Cautions
Coexisting conditions including cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, hypertension, aneurysm, and pheochromocytoma; convulsive disorders; thyrotoxicosis; patients who are unusually responsive to sympathomimetic amines
Risk of transient hypokalemia
May increase risk of severe, potentially fatal asthma attacks
Do not use for relief of acute COPD symptoms
Concomitant short-acting beta2-agonists can be used as needed for acute relief
Life-threatening paradoxical bronchospasm can occur; discontinue immediately
Immediate hypersensitivity reactions may occur (eg, anaphylactic reactions, urticaria, angioedema, rash, bronchospasm)
Pregnancy and lactation
Pregnancy category: C
Lactation: not known if excreted in breast milk, use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Perforomist (formoterol)
Mechanism of action
Long-acting selective beta-2 agonist
Bronchial smooth muscle relaxation
Absorption
Peak Plasma Time: 5 min
Peak Plasma Concentration: 92 pg/mL
Distribution
Protein Bound: 61-64%
Metabolism
Metabolized by CYP2D6, CYP2C19, CYP2C9, CYP2A6
Elimination
Half-Life: 10 hr
Clearance: 150 mL/min
Excretion: Urine 66%; feces 33%