Arformoterol Tartrate (2 brand names, 1 dosage form, 1 route)
Available dosage forms: SOLUTION.
Routes of administration: INHALATION.
Brand Names
- ARFORMOTEROL TARTRATE
- BROVANA
Dosage and Administration
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. The safety and efficacy of Arformoterol Tartrate Inhalation Solution have been established in clinical trials when administered using the PARI LC ® Plus nebulizer (with a face mask or mouthpiece) and the PARI DURA NEB™ 3000 compressor. The safety and efficacy of Arformoterol Tartrate Inhalation Solution delivered from non-compressor based nebulizer systems have not been established.
Contraindications
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 (5)] . Arformoterol Tartrate Inhalation Solution is not indicated for the treatment of asthma.
Adverse Reactions
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)].
Overdosage
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. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an overdose of Arformoterol Tartrate Inhalation Solution. Treatment of overdosage consists of discontinuation of Arformoterol Tartrate Inhalation Solution together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Arformoterol Tartrate Inhalation Solution. Cardiac monitoring is recommended in cases of overdosage.