Drugplain

Arformoterol Tartrate 15 ug/2mL

Arformoterol Tartrate · SOLUTION · Micro Labs Limited

2 Recalls on Record
Plain English

Arformoterol tartrate is a long-acting bronchodilator inhaled solution used to help open airways and improve breathing in patients with chronic obstructive pulmonary disease (COPD) or asthma. It works by relaxing muscles in the airways to make breathing easier.

Key Facts

Brand Name
Arformoterol Tartrate
Generic Name
Arformoterol Tartrate
NDC Code (Product)
42571-464
Manufacturer
Micro Labs Limited
Strength
15 ug/2mL
Dosage Form
SOLUTION
Route
RESPIRATORY (INHALATION)
Marketing Status
Application #
ANDA218555
Marketing Start
05/01/2025

Recall History

2 Recalls on Record
Class II09/29/2022

CIPLA

Lack of Assurance of Sterility: environmental monitoring failure.

TerminatedVoluntary: Firm initiated
Class II08/27/2021

Glenmark Pharmaceuticals Inc., USA

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea44 reports
fatigue27 reports
pneumonia21 reports
cough18 reports
drug ineffective18 reports
chronic obstructive pulmonary disease14 reports
asthenia13 reports
diarrhoea12 reports
oxygen saturation decreased12 reports
peripheral swelling12 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE 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. ( 1.2 ) 1.1 Maintenance Treatment of COPD Arformoterol tartrate inhalation solution is 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. Arformoterol tartrate inhalation solution is for use by nebulization only. 1.2 Important Limitations of Use Arformoterol tartrate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [ see Warnings and Precautions ( 5.2 ) …

Dosage & Administration

2 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 arfo…

Contraindications

4 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. 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. ( 4 ) Use of a LABA, including arformoterol tartrate inhalation solution, without an inhaled corticosteroid is contraindicated in patients with asthma. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS 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. ( 7.5 ) 7.1 Adrenergic Drugs If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of arformoterol may be potentiated [ see Warnings and Precautions ( 5.3 , 5.5 , 5.6 , 5.7 ) ]. 7.2 Xanthine Derivatives, Steroids, or Diuretics Concomitant treatment with methylxanthine (aminophylline, theophylline), steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists including arformoterol tartrate inhalation solution [ see Warnings and Precautions ( 5.7 ) ]. The concurrent use of intravenously or orally administered methylxanthin…

Adverse Reactions

6 ADVERSE REACTIONS Long-acting beta 2 -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 Micro Labs USA Inc., at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Beta 2 -Agonist Adverse Reaction Profile Adverse reactions to arformoterol tartrate inhalation solution are expected to be similar in nature to other beta 2 -adrenergic receptor agonists including: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia. 6.2 Clinical Trials Experience Because clinical trials are conducted under widely varying cond…

Frequently Asked Questions

What is Arformoterol Tartrate used for?

Arformoterol tartrate is a long-acting bronchodilator inhaled solution used to help open airways and improve breathing in patients with chronic obstructive pulmonary disease (COPD) or asthma. It works by relaxing muscles in the airways to make breathing easier.

Is Arformoterol Tartrate a controlled substance?

Arformoterol Tartrate is not classified as a controlled substance by the DEA.

What is the generic name for Arformoterol Tartrate?

The generic name for Arformoterol Tartrate is Arformoterol Tartrate. There are 8 other brand versions of Arformoterol Tartrate.

What is the NDC code for Arformoterol Tartrate 15 ug/2mL?

The NDC (National Drug Code) for Arformoterol Tartrate 15 ug/2mL is 42571-464, listed by Micro Labs Limited.

Product NDC

42571-464

Package NDC

42571-464-73

Other Arformoterol Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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