Arformoterol

Arformoterol Tartrate Inhalation Solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ( 1.1 ) Important limitations of use: Arformoterol Tartrate Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. ( 1.2 , 5.2 ) Arformoterol Tartrate Inhalation Solution is not indicated to treat asthma. …

• The recommended dose of Arformoterol Tartrate Inhalation Solution is one 15 mcg unit-dose vial administered twice daily (morning and evening) by nebulization
• A total daily dose of greater than 30 mcg (15 mcg twice daily) is not recommended
• Arformoterol Tartrate Inhalation Solution should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor (see the accompanying Patient Information )
• Arformoterol Tartrate Inhalation Solution should not be swallowed
• Arformoterol Tartrate Inhalation Solution should be stored refrigerated in foil pouches
• After opening the pouch, unused unit-dose vials should be returned to, and stored in, the pouch
• An opened unit-dose vial should be used right away
• If the recommended maintenance treatment regimen fails to provide the usual response, medical advice should be sought immediately, as this is often a sign of destabilization of COPD
• Under these circumstances, the therapeutic regimen should be reevaluated and additional therapeutic options should be considered
• No dose adjustment is required for patients with renal or hepatic impairment
• However, since the clearance of Arformoterol Tartrate Inhalation Solution is prolonged in patients with hepatic impairment, they should be monitored closely
• The drug compatibility (physical and chemical), efficacy, and safety of Arformoterol Tartrate Inhalation Solution when mixed with other drugs in a nebulizer have not been established. …

Arformoterol Tartrate Inhalation Solution is supplied as a sterile solution for nebulization in low-density polyethylene unit-dose vials. Each 2 mL vial contains 15 mcg of arformoterol equivalent to 22 mcg of arformoterol tartrate. Inhalation Solution (unit-dose vial for nebulization): 15 mcg/2 mL solution ( 3 )

• Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ) with each new prescription and refill
• The complete text of the Patient Information is reprinted at the end of this document
• Patients should be given the following information: Serious Asthma-Related Events, Acute Exacerbations or Deteriorations Patients should be informed that long-acting beta 2 -adrenergic agonists, such as Arformoterol Tartrate Inhalation Solution, when used as monotherapy [without an inhaled corticosteroid], increase risk of serious asthma-related events, including asthma-related death. …

• Arformoterol Tartrate Inhalation Solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product
• Use of a LABA, including Arformoterol Tartrate Inhalation Solution, without an inhaled cortisteroid is contraindicated in patients with asthma [see Warnings and Precautions ]
• Arformoterol Tartrate Inhalation Solution is not indicated
• For the treatment of asthma. …

Other adrenergic drugs may potentiate effect. Use with caution. ( 5.3 , 7.1 ) Xanthine derivatives, steroids, diuretics, or non-potassium sparing diuretics may potentiate hypokalemia or ECG changes. Use with caution. ( 5.7 , 7.2 , 7.3 ) MAO inhibitors, tricyclic antidepressants and drugs that prolong the QTc interval may potentiate effect on the cardiovascular system. Use with extreme caution. ( 7.4 ) Beta-blockers may decrease effectiveness. May block bronchodilatory effects of beta-agonists. Use with caution and only when medically necessary. …

LABA as monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. ( 5.1 ) Do not initiate Arformoterol Tartrate Inhalation Solution in acutely deteriorating patients. ( 5.2 ) Do not use for relief of acute symptoms. Concomitant short-acting beta2-agonists can be used as needed for acute relief. ( 5.2 ) Do not exceed the recommended dose. Excessive use of Arformoterol Tartrate Inhalation Solution, or use in conjunction with other medications containing long-acting beta2-agonists, can result in clinically significant cardiovascular effects, and may be fatal. ( 5.3 , 5.5 ) Life-threatening paradoxical bronchospasm can occur. …

Long-acting beta2-adrenergic agonists, such as Arformoterol Tartrate, as monotherapy (without inhaled corticosteroids) for asthma increase the risk of asthma-related events. Arformoterol Tartrate Inhalation Solution is not indicated for the treatment of asthma [see Warnings and Precautions (5.1 )]. Most common adverse reactions (≥2% incidence and more common than placebo) are pain, chest pain, back pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheral edema and lung disorder. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Fosun Pharma USA Inc. at 1-866-611-3762 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

IN SPECIFIC POPULATIONS Hepatic Impairment Use with caution in patients with hepatic impairment. ( 8.6 ) 8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women. Arformoterol Tartrate Inhalation Solution should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the fetus. …

The expected signs and symptoms associated with overdosage of Arformoterol Tartrate Inhalation Solution are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms listed under ADVERSE REACTIONS . Signs and symptoms may include angina, hypertension or hypotension, tachycardia, with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia. …

There were no reported cases of abuse or evidence of drug dependence with the use of Arformoterol Tartrate Inhalation Solution in the clinical trials.

Prenez-le dès que vous y pensez, sauf s'il est presque l'heure de la dose suivante. Dans ce cas, sautez la dose oubliée. Ne prenez jamais deux doses à la fois pour compenser. Vérifiez votre notice, certains médicaments font exception.