Rx Item-BEVESPI AEROSPHERE 9/4.8MCG 28 INH by Astra Zeneca Pharma

For: Chronic Obstructive Pulmonary Disease

Bevespi Aerosphere (formoterol fumarate and glycopyrrolate) is a long -acting beta2-adrenergic agonist (LABA) and anticholinergic combination indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). WARNING: ASTHMA-RELATED DEATH

Long-acting beta2 -adrenergic agonists (LABAs) increase the risk of asthma-related death. Data from a large placebo-controlled US trial that compared the safety of another LABA (salmeterol) with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all LABAs, including formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE.



The safety and efficacy of BEVESPI AEROSPHERE in patients with asthma have not been established. BEVESPI AEROSPHERE is not indicated for the treatment of asthma. [see Warnings and Precautions (5.1)]

1 INDICATIONS AND USAGE

BEVESPI AEROSPHERE is a combination of glycopyrrolate and formoterol fumarate indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important Limitation of Use:BEVESPI AEROSPHERE is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions (5.1, 5.2)].

2 DOSAGE AND ADMINISTRATION

BEVESPI AEROSPHERE (glycopyrrolate/formoterol fumarate 9 mcg/4.8 mcg) should be administered as two inhalations taken twice daily in the morning and in the evening by the orally inhaled route only. Do not take more than two inhalations twice daily.

BEVESPI AEROSPHERE contains 28 or 120 inhalations per canister. The canister has an attached dose indicator, which indicates how many inhalations remain. The dose indicator display will move after every tenth actuation. When nearing the end of the usable inhalations, the color behind the number in the dose indicator display window changes to red. BEVESPI AEROSPHERE should be discarded when the dose indicator display window shows zero.

Priming BEVESPI AEROSPHERE is essential to ensure appropriate drug content in each actuation. Prime BEVESPI AEROSPHERE before using for the first time. To prime BEVESPI AEROSPHERE, release 4 sprays into the air away from the face, shaking well before each spray. BEVESPI AEROSPHERE must be re-primed when the inhaler has not been used for more than 7 days. To re-prime BEVESPI AEROSPHERE, release 2 sprays into the air away from the face, shaking well before each spray.

3 DOSAGE FORMS AND STRENGTHS

Inhalation Aerosol: BEVESPI AEROSPHERE is a pressurized metered dose inhaler that delivers 9 mcg of glycopyrrolate and 4.8 mcg of formoterol fumarate per inhalation. Two inhalations equal one dose. BEVESPI AEROSPHERE contains 28 or 120 inhalations per canister. The canister has an attached dose indicator and is supplied with a white plastic actuator with an orange dust cap.

4 CONTRAINDICATIONS

BEVESPI AEROSPHERE 9/4.8MCG
BEVESPI AEROSPHERE glycopyrrolate/formoterol fum INHALATION HFA AER AD 9/4.8MCG 28 INH by Astra Zeneca Pharma NDC No.00310-4600-39 0310-4600-39 0310460039 00310460039 UPC/GTIN No. 3-03104-60039-9 3

BEVESPI AEROSPHERE 9/4.8MCG 28 INH by As
NDC No.00310-4600-39 0310-4600-39 UPC/GTIN No. 3-03104-60039-9 MPN 37020 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA

BUDESONIDE/FORMOTEROL FUM
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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BEVESPI AEROSPHERE 9/4.8MCG
BEVESPI AEROSPHERE 9/4.8MCG 120 INH by Astra Zeneca Pharma NDC: 00310-4600-12 00310460012 UPC: 303104600122