Arformoterol tartrate

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Arformoterol tartrate
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Black Box Warning

WARNING: ASTHMA RELATED DEATH
See full prescribing information for complete Boxed Warning.
* Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including arformoterol, the active ingredient in BROVANA Inhalation Solution. The safety and efficacy of BROVANA Inhalation Solution in patients with asthma have not been established. All LABA, including BROVANA Inhalation Solution, are contraindicated in patients with asthma without use of a long-term asthma control medication.

Overview

Arformoterol tartrate is a {{{drugClass}}} that is FDA approved for the treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include pain, chest pain, back pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheral edema and lung disorder..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Maintenance Treatment of COPD

Important Limitations of Use 

Arformoterol tartrate inhalation Solution is not indicated to treat asthma. The safety and effectiveness of arformoterol tartrate  inhalation  Solution in asthma have not been established.

Dosage

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.

BROVANA Inhalation Solution should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor (see the accompanying MEDICATION GUIDE). BROVANA Inhalation Solution should not be swallowed. BROVANA 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 BROVANA Inhalation Solution is prolonged in patients with hepatic impairment, they should be monitored closely.

The drug compatibility (physical and chemical), efficacy, and safety of BROVANA Inhalation Solution when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of BROVANA 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 BROVANA Inhalation Solution delivered from non-compressor based nebulizer systems have not been established.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Arformoterol tartrate in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Arformoterol tartrate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Arformoterol tartrate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Arformoterol tartrate in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Arformoterol tartrate in pediatric patients.

Contraindications

  • Condition1

Warnings

WARNING: ASTHMA RELATED DEATH
See full prescribing information for complete Boxed Warning.
* Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including arformoterol, the active ingredient in BROVANA Inhalation Solution. The safety and efficacy of BROVANA Inhalation Solution in patients with asthma have not been established. All LABA, including BROVANA Inhalation Solution, are contraindicated in patients with asthma without use of a long-term asthma control medication.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Arformoterol tartrate in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Arformoterol tartrate in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Arformoterol tartrate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Arformoterol tartrate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Arformoterol tartrate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Arformoterol tartrate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Arformoterol tartrate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Arformoterol tartrate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Arformoterol tartrate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Arformoterol tartrate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Arformoterol tartrate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Arformoterol tartrate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Arformoterol tartrate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Arformoterol tartrate in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Arformoterol tartrate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Arformoterol tartrate in the drug label.

Pharmacology

There is limited information regarding Arformoterol tartrate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Arformoterol tartrate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Arformoterol tartrate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Arformoterol tartrate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Arformoterol tartrate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Arformoterol tartrate in the drug label.

How Supplied

Storage

There is limited information regarding Arformoterol tartrate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Arformoterol tartrate in the drug label.

Precautions with Alcohol

  • Alcohol-Arformoterol tartrate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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