Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D), FORMOTEROL FUMARATE (UNII: W34SHF8J2K) (FORMOTEROL - UNII:5ZZ84GCW8B)
AstraZeneca Pharmaceuticals LP
GLYCOPYRROLATE
GLYCOPYRROLATE 9 ug
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
BEVESPI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations 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)] . BEVESPI AEROSPHERE is contraindicated in: Risk Summary There are no adequate and well-controlled trials of BEVESPI AEROSPHERE or its individual components, glycopyrrolate and formoterol fumarate, in pregnant women to inform a drug-associated risk. In animal reproduction studies, glycopyrrolate alone, administered by the subcutaneous route in rats and rabbits, did not cause structural abnormalities or affect fetal survival at exposures approximately 2700 and 5400 times from the maximum recommended human daily inhalation dose (MRHDID), respectively. Glycopyrrolate had no effects on the physical, functional, and behavioral development of rat pups with exposures up to 2700 times the MRHDID. Formoterol fumarate alone, admin
BEVESPI AEROSPHERE Inhalation Aerosol: The BEVESPI AEROSPHERE canister should only be used with the BEVESPI AEROSPHERE actuator, and the BEVESPI AEROSPHERE actuator should not be used with any other inhalation drug product. The correct amount of medication in each inhalation cannot be assured after the label number of inhalations from the canister have been used, when the dose indicator display window shows zero, even though the canister may not feel completely empty. BEVESPI AEROSPHERE should be discarded when the dose indicator display window shows zero or 3 months after removal from the foil pouch, whichever comes first. Never immerse the canister into water to determine the amount remaining in the canister (“float test”). Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP]. For best results, the canister should be at room temperature before use. Shake well before using. Keep out of reach of children. CONTENTS UNDER PRESSURE Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator. Avoid spraying in eyes.
New Drug Application
AstraZeneca Pharmaceuticals LP ---------- PATIENT INFORMATION BEVESPI AEROSPHERE® (be-VES-pee AIR-oh-sfeer) (glycopyrrolate and formoterol fumarate) inhalation aerosol, for oral inhalation use What is BEVESPI AEROSPHERE? BEVESPI AEROSPHERE combines an anticholinergic, glycopyrrolate, and a long-acting beta2- adrenergic agonist (LABA) medicine, formoterol fumarate. • Anticholinergic and LABA medicines help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe. • BEVESPI AEROSPHERE is a prescription medicine used to treat COPD. COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. • BEVESPI AEROSPHERE is used long term as 2 inhalations, 2 times each day in the morning and in the evening, to improve symptoms of COPD for better breathing. • BEVESPI AEROSPHERE is not for use to treat sudden symptoms of COPD. Always have a rescue inhaler (an inhaled, short-acting bronchodilator) with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you. • BEVESPI AEROSPHERE is not for the treatment of asthma. It is not known if BEVESPI AEROSPHERE is safe and effective in people with asthma. • BEVESPI AEROSPHERE should not be used in children. It is not known if BEVESPI AEROSPHERE is safe and effective in children. Do not use BEVESPI AEROSPHERE if you: • are allergic to glycopyrrolate, formoterol fumarate, or to any of the ingredients in BEVESPI AEROSPHERE. See the end of this Patient Information leaflet for a complete list of ingredients. • have asthma. Before using BEVESPI AEROSPHERE, tell your healthcare provider about all of your medical conditions, including if you: • have heart problems • have high blood pressure • have seizures • have thyroid problems • have diabetes • have liver problems • have eye prob Přečtěte si celý dokument
BEVESPI AEROSPHERE- GLYCOPYRROLATE AND FORMOTEROL FUMARATE AEROSOL, METERED ASTRAZENECA PHARMACEUTICALS LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BEVESPI AEROSPHERE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BEVESPI AEROSPHERE. BEVESPI AEROSPHERE (GLYCOPYRROLATE AND FORMOTEROL FUMARATE) INHALATION AEROSOL, FOR ORAL INHALATION USE INITIAL U.S. APPROVAL: 2016 INDICATIONS AND USAGE BEVESPI AEROSPHERE is a combination of glycopyrrolate, an anticholinergic, and formoterol fumarate, a long-acting beta -adrenergic agonist (LABA) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1) Limitations of Use: Not indicated for the relief of acute bronchospasm or for the treatment of asthma. (1, 5.1, 5.2) DOSAGE AND ADMINISTRATION • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • • • • • ADVERSE REACTIONS Most common adverse reactions (incidence ≥2% and more common than with placebo) include: urinary tract infection and cough. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASTRAZENECA AT 1-800-236-9933 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. ® 2 For oral inhalation only. Maintenance treatment of COPD: 2 inhalations of BEVESPI AEROSPHERE twice daily by oral inhalation. (2) Inhalation aerosol: pressurized metered dose inhaler containing a combination of glycopyrrolate (9 mcg) and formoterol fumarate (4.8 mcg) per inhalation. Use of a LABA, including formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE, without an inhaled corticosteroid is contraindicated in patients with asthma. (4) Hypersensitivity to glycopyrrolate, formoterol fumarate, or to any component of this product. (4, 5.5) LABA as monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. (5.1) Do not initiate in acutely deteriorating COPD or to treat acute symptoms. ( Přečtěte si celý dokument