Brand Name
Arformoterol
View Brand InformationFDA approval date: May 31, 2021
Classification: beta2-Adrenergic Agonist
Form: Solution
What is Arformoterol?
Arformoterol Tartrate Inhalation Solution is a long-acting beta 2 -adrenergic agonist indicated for Long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease , including chronic bronchitis and emphysema.
Approved To Treat
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Brand Information
Arformoterol Tartrate Inhalation Solution (Arformoterol Tartrate)
1DOSAGE 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
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
2DOSAGE FORMS AND STRENGTHS
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.
3CONTRAINDICATIONS
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 [
4ADVERSE REACTIONS
Long-acting beta
4.1Beta -Agonist Adverse Reaction Profile
Adverse reactions to Arformoterol Tartrate Inhalation Solution are expected to be similar in nature to other beta
4.2Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
5DRUG ABUSE AND DEPENDENCE
There were no reported cases of abuse or evidence of drug dependence with the use of Arformoterol Tartrate Inhalation Solution in the clinical trials.
6OVERDOSAGE
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
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.
7DESCRIPTION
Arformoterol Tartrate Inhalation Solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol.
Arformoterol is a selective beta
The molecular weight of
Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)-formoterol L-tartrate.
Arformoterol Tartrate Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate.
Arformoterol Tartrate Inhalation Solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC
Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying
8HOW SUPPLIED/STORAGE AND HANDLING
Arformoterol Tartrate Inhalation Solution is supplied in a single strength (15 mcg of arformoterol, equivalent to 22 mcg of arformoterol tartrate) as 2 mL of a sterile solution in low-density polyethylene (LDPE) unit-dose vials overwrapped in foil. Arformoterol Tartrate Inhalation Solution is available in a shelf-carton containing 30 or 60 unit-dose vials.
NDC 73289-0072-1: Foil pouch of 1 unit-dose vial
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
The complete text of the Patient Information is reprinted at the end of this document.Patients should be given the following information:
10PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 73289-0072-1
One 2 mL Sterile Unit-Dose Vial
Arformoterol Tartrate
*Potency expressed as arformoterol
Open Foil Pouch Just Prior to Administration
Each 2 mL unit-dose vials contains 15 mcg of arformoterol (equivalent to 22 mcg arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate.
Keep out of reach of children. Rx Only.
Start Room Temp. Storage: ____________________ Use by: ____________________________
Manufactured for: Aucta Pharmaceuticals, Inc. Piscataway, NJ 08854
One 2 mL Sterile Unit-Dose Vial
Arformoterol Tartrate
*Potency expressed as arformoterol
Open Foil Pouch Just Prior to Administration
Each 2 mL unit-dose vials contains 15 mcg of arformoterol (equivalent to 22 mcg arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate.
Keep out of reach of children. Rx Only.
Start Room Temp. Storage: ____________________ Use by: ____________________________
Manufactured for: Aucta Pharmaceuticals, Inc. Piscataway, NJ 08854
NDC 73289-0072-2
Four 2 mL Sterile Unit-Dose Vials
Arformoterol Tartrate
*Potency expressed as aformoterol
After Opening the Foil Pouch, the Unused Vials Should Be Returned To, and Stored In, the Pouch.
Each 2 mL unit-dose vials contains 15 mcg of arformoterol (equivalent to 22 mcg arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate.
Protect from light and excessive heat. Store unopened pouched unit-dose vials in a refrigerator (36°F-46°F, 2°C-8°C). Unopened pouched unit dose vials can also be stored at room temperature (68°F-77°F, 20°C-25°C) for up to 6 weeks. Do not use past the expiration date or after 6 weeks storage at room temperature, whichever is sooner. Discard if solution is not colorless. Use only as directed by your physician. Do not exceed recommended dosage.
Start Room Temp. Storage: ____________________ Use by: ___________________
Manufactured for: Aucta Pharmaceuticals, Inc. Piscataway, NJ 08854
Four 2 mL Sterile Unit-Dose Vials
Arformoterol Tartrate
*Potency expressed as aformoterol
After Opening the Foil Pouch, the Unused Vials Should Be Returned To, and Stored In, the Pouch.
Each 2 mL unit-dose vials contains 15 mcg of arformoterol (equivalent to 22 mcg arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate.
Protect from light and excessive heat. Store unopened pouched unit-dose vials in a refrigerator (36°F-46°F, 2°C-8°C). Unopened pouched unit dose vials can also be stored at room temperature (68°F-77°F, 20°C-25°C) for up to 6 weeks. Do not use past the expiration date or after 6 weeks storage at room temperature, whichever is sooner. Discard if solution is not colorless. Use only as directed by your physician. Do not exceed recommended dosage.
Start Room Temp. Storage: ____________________ Use by: ___________________
Manufactured for: Aucta Pharmaceuticals, Inc. Piscataway, NJ 08854
11PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
12PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
