Arformoterol Tartrate

Trade Names:
Brovana
- Solution for inhalation 15 mcg

Relaxes bronchial smooth muscles.

C max is 4.3 pg/mL and occurs approximately 0.5 h after administration.

In vitro plasma protein binding is 52% to 65%.

Metabolized primarily by direct conjugation (glucuronidation) and secondarily by demethylation (CYP2D6 and, to a lesser degree, CYP2C19).

After 14 days, 67% is recovered in urine and 22% in feces.

Long-term maintenance treatment of bronchoconstriction in COPD, including bronchitis and emphysema.

History of hypersensitivity to arformoterol, racemic formoterol, or any component of the product.

Inhalation 15 mcg twice daily (morning and evening) by nebulization (max, 30 mcg/day).

Store in the protective foil pouch under refrigeration at 36° to 46°F. Protect from light and excessive heat. Once foil pouch is opened, use contents of vial immediately. Discard any vial if solution is not colorless. Unopened foil pouch also may be stored at room temperature (68° to 77°F) for up to 6 wk.

Arformoterol sympathomimetic effects may be potentiated.

Effects of both agents may be inhibited.

May potentiate the hypokalemic effect of arformoterol.

Arformoterol may potentiate these agents, increasing the risk of cardiac arrhythmias.

ECG changes and/or hypokalemia may be worsened by arformoterol.

None well documented.

Arteriosclerosis, atrial flutter, AV block, CHF, heart block, inverted T-wave, MI, QT interval prolongation, supraventricular tachycardia (less than 2%).

Agitation, cerebral infarct, circumoral paresthesia, hypokinesia, paralysis, somnolence, tremor (less than 2%).

Rash (4%); dry skin, herpes simplex, herpes zoster, skin discoloration, skin hypertrophy (less than 2%).

Abnormal vision, glaucoma (less than 2%).

Diarrhea (6%); constipation, gastritis, melena, oral moniliasis, periodontal abscess, rectal hemorrhage (less than 2%).

Breast neoplasm, calcium crystalluria, cystitis, glycosuria, hematuria, increased prostate-specific antigen, kidney calculus, nocturia, pyuria, urinary tract disorder, urine abnormality (less than 2%).

Decreased glucose tolerance, dehydration, edema, gout, hyperglycemia, hyperlipemia, hypoglycemia, hypokalemia (less than 2%).

Back pain (6%); leg cramps (4%); arthralgia, arthritis, bone disorder, neck rigidity, pelvic pain, rheumatoid arthritis, tendinous contracture (less than 2%).

Sinusitis (5%); dyspnea (4%); lung disorder, primarily pulmonary or chest congestion (2%); lung carcinoma, respiratory disorder, voice alteration (less than 2%).

Pain (8%); chest pain (7%); flu syndrome, peripheral edema (3%); abscess, allergic reaction, digitalis intoxication, fever, hernia, neoplasm, retroperitoneal hemorrhage (less than 2%).

Long-acting beta 2 -adrenergic agonists may increase the risk of asthma-related death.

Category C .

Undetermined.

Safety and efficacy not established.

Use of arformoterol in these conditions is inappropriate.

Arformoterol is not indicated for treating acute symptoms of COPD.

Can cause clinically important CV effects; therefore, use with caution in patients with CV disorders, especially coronary insufficiency, cardiac arrhythmia, and hypertension.

If paradoxical bronchospasm occurs, discontinue arformoterol and institute alternative therapy.

Immediate hypersensitivity reactions may occur.

Angina, arrhythmias, cardiac arrest, death, dizziness, dry mouth, fatigue, headache, hyperglycemia, hypertension, hypokalemia, hypotension, insomnia, malaise, metabolic acidosis, muscle cramp, nausea, nervousness, palpitation, tachycardia, tremor.

• Advise patient to read the Medication Guide before using product the first time and with each refill.
• Inform patient that arformoterol is not a rescue medication and is not to be used for the treatment of acute or deteriorating asthma.
• Advise patient that if asthma symptoms worsen immediately after using the medication to stop using it and inform health care provider immediately.
• Inform patients that arformoterol may increase the risk of asthma-related death.
• Inform patient that arformoterol is not indicated to relieve acute respiratory symptoms and not to use extra doses for this purpose. Treat acute symptoms with an inhaled, short-acting beta 2 -agonist.
• Instruct patients who have used a short-acting beta 2 -agonist on a regular basis when treatment with arformoterol was started to discontinue the regular use of the short-acting agent and use it only for symptomatic relief of acute respiratory symptoms.
• Instruct patient not to use this product more often, at higher than recommended doses, or with other long-acting beta 2 -agonists.
• Inform patient that treatment may lead to adverse reactions such as chest pain, nervousness, palpitations, rapid heart rate, or tremor.
• Instruct patient to use this product by nebulizer only and not to inject or swallow this solution.

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