Arformoterol Tartrate Inhalation Solution

ARFORMOTEROL TARTRATE INHALATION SOLUTION

Manufacturer: Ritedose Pharmaceuticals, LLC

Score: 141.0

Quick Summary

Arformoterol Tartrate Inhalation Solution is a long-acting beta 2-adrenergic agonist (beta 2-agonist) indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The recommended dose is one 15 mcg unit-dose vial administered twice daily by nebulization. The drug is not indicated for the treatment of asthma and is contraindicated in patients with a history of hypersensitivity to arformoterol or racemic formoterol. Common adverse reactions include pain, chest pain, back pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheral edema, and lung disorder.

Key Clinical Findings and Indications

Maintenance treatment of bronchoconstriction in patients with COPD
Long-term, twice daily administration
Not indicated for the treatment of asthma

Important Safety Information

Warning

Arformoterol Tartrate Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease

Contraindications

History of hypersensitivity to arformoterol, racemic formoterol, or any other components of the product
Use of a LABA, including Arformoterol Tartrate Inhalation Solution, without an inhaled corticosteroid is contraindicated in patients with asthma

Adverse Reactions

Pain
Chest pain
Back pain
Diarrhea
Sinusitis
Leg cramps
Dyspnea
Rash
Flu syndrome
Peripheral edema
Lung disorder

Dosing Recommendations

General Guidance

No dose adjustment is required for patients with renal or hepatic impairment

COPD

Adult Dose

One 15 mcg unit-dose vial administered twice daily by nebulization

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

There are no adequate and well-controlled studies in pregnant women
Arformoterol Tartrate should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the fetus

Nursing Mothers

Pediatric Use

The safety and efficacy of Arformoterol Tartrate Inhalation Solution in pediatric patients have not been established
This disease does not occur in children

Geriatric Use

Of the 873 patients who received Arformoterol Tartrate Inhalation Solution in two placebo-controlled clinical studies in adults with COPD, 391 (45%) were 65 years of age or older
No overall differences in safety or effectiveness were observed between these subjects and younger subjects