Glycopyrrolate And Formoterol Fumarate Interactions

Brand names: Bevespi Aerosphere

Route: Respiratory (Inhalation)

Contraindications

4 CONTRAINDICATIONS BEVESPI AEROSPHERE is contraindicated in: • use of a long-acting beta 2 -adrenergic agonist (LABA), including formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE, without an inhaled corticosteroid, in patients with asthma [see Warnings and Precautions (5.1) ]. BEVESPI AEROSPHERE is not indicated for the treatment of asthma. • patients with hypersensitivity to glycopyrrolate, formoterol fumarate, or to any component of the product [see Warnings and Precautions (5.5) ]. • 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 )

Pregnancy & Breastfeeding

8.1 Pregnancy 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, administered by the oral route in rats and rabbits, caused structural abnormalities at 1500 and 61,000 times the MRHDID, respectively. Formoterol fumarate was also embryocidal, increased pup loss at birth and during lactation, and decreased pup weight in rats at 110 times the MRHDID. These adverse effects generally occurred at large multiples of the MRHDID when formoterol fumarate was administered by the oral route to achieve high systemic exposures. No structural abnormalities, embryocidal, or developmental effects were seen in rats that received inhalation doses up to 350 times the MRHDID. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Labor or Delivery : There are no well-controlled human trials that have investigated the effects of BEVESPI AEROSPHERE on preterm labor or labor at term. Because beta 2 -agonists may potentially interfere with uterine contractility, BEVESPI AEROSPHERE should be used during labor only if the potential benefit justifies the potential risk. Data Animal Data Glycopyrrolate In an embryo-fetal developme

7 interactions on record