No

Beta₂ Agonist

Prevention and treatment of bronchial asthma and bronchospasm

C

Known hypersensitivity to bitolterol

Use with caution in patients with unstable vasomotor symptoms, diabetes, hyperthyroidism, prostatic hypertrophy or a history of seizures; also use caution in the elderly and those patients with cardiovascular disorders such as coronary artery disease, arrhythmias, and hypertension; excessive use may result in cardiac arrest and death; do not use concurrently with other sympathomimetic bronchodilators

>10%: Neuromuscular & skeletal: Trembling

1% to 10%:

Cardiovascular: Flushing of face, hypertension, pounding heartbeat

Central nervous system: Dizziness, lightheadedness, nervousness

Gastrointestinal: Xerostomia, nausea, unpleasant taste

Respiratory: Bronchial irritation, coughing

<1%: Chest pain, arrhythmias, tachycardia, insomnia, paradoxical bronchospasm

Symptoms of overdose include tremor, dizziness, nervousness, headache, nausea, coughing

Treatment is symptomatic/supportive; in cases of severe overdose, supportive therapy should be instituted, and prudent use of a cardioselective beta-adrenergic blocker (eg, atenolol or metoprolol) should be considered, keeping in mind the potential for induction of bronchoconstriction in an asthmatic individual. Dialysis has not been shown to be of value in the treatment of an overdose with this agent.

Decreased effect: Beta-adrenergic blockers (eg, propranolol)

Increased effect: Inhaled ipratropium may increase duration of bronchodilation, nifedipine may increase FEV-1

Increased toxicity: MAO inhibitors, tricyclic antidepressants, sympathomimetic agents (eg, amphetamine, dopamine, dobutamine), inhaled anesthetics (eg, enflurane)

Selectively stimulates beta₂-adrenergic receptors in the lungs producing bronchial smooth muscle relaxation; minor beta₁ activity

Onset of action: Rapid

Duration of effect: 4-8 hours

Metabolism: Bitolterol, a prodrug, is hydrolyzed to colterol (active) following inhalation

Half-life: 3 hours

Time to peak serum concentration (colterol): Inhalation: Within 1 hour

Elimination: In urine and feces

Children >12 years and Adults:

Prevention of bronchospasm: 2 inhalations every 8 hours; do not exceed 3 inhalations every 6 hours or 2 inhalations every 4 hours

Administer around-the-clock rather than 3 times/day, to promote less variation in peak and trough serum levels

Assess lung sounds, pulse, and blood pressure before administration and during peak of medication; observe patient for wheezing after administration

May cause nervousness and insomnia

Concurrent use with MAOIs or TCAs may result in increased toxicity

No information available to require special precautions

No effects or complications reported

Use exactly as directed. Do not use more often than recommended. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). You may experience nervousness, dizziness, or fatigue (use caution when driving or engaging in tasks requiring alertness until response to drug is known); or dry mouth, stomach upset (frequent small meals, frequent mouth care, chewing gum, or sucking hard candy may help). Report unresolved GI upset; dizziness or fatigue; vision changes; chest pain, rapid heartbeat, or palpitations; nervousness or insomnia; muscle cramping or tremor; or unusual cough. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Self-administered nebulizer: Wash hands before and after treatment. Wash and dry nebulizer after each treatment. Twist open the top of one unit dose vial and squeeze contents into nebulizer reservoir. Connect nebulizer reservoir to the mouthpiece or face-mask. Connect nebulizer to compressor. Sit in comfortable, upright position. Place mouthpiece in your mouth or put on face-mask and turn on compressor. If face-mask is used, avoid leakage around the mask to avoid mist getting into eyes which may cause vision problems. Breath calmly and deeply until no more mist is formed in nebulizer (about 5 minutes). At this point treatment is finished.

Before using, the inhaler must be shaken well

Aerosol, oral, as mesylate: 0.8% [370 mcg/metered spray, 300 inhalations] (15 mL)

Solution, inhalation, as mesylate: 0.2% (10 mL, 30 mL, 60 mL)