Source: FDA, National Drug Code (US) Revision Year: 2019
YUPELRI inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
The recommended dose of YUPELRI inhalation solution is one 175 mcg unit‑dose vial administered once daily by nebulizer using a mouthpiece.
YUPELRI should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor (See Patient Information). The safety and efficacy of YUPELRI have been established in clinical trials when administered using the PARI LC Sprint nebulizer with a mouthpiece and the PARI Trek S compressor. The safety and efficacy of YUPELRI delivered from non‑compressor based nebulizer systems have not been established.
The YUPELRI unit-dose vial should only be removed from the foil pouch and opened IMMEDIATELY BEFORE USE. The vial and any residual content should be discarded after use.
No dosage adjustment is required for geriatric patients, or patients with renal impairment [see Clinical Pharmacology (8.5, 8.7, 12.3)].
The drug compatibility (physical and chemical), efficacy, and safety of YUPELRI when mixed with other drugs in a nebulizer have not been established.
An overdose of YUPELRI may lead to anticholinergic signs and symptoms such as nausea, vomiting, dizziness, lightheadedness, blurred vision, increased intraocular pressure (causing pain, vision disturbances, or reddening of the eye), obstipation or difficulties in voiding. In COPD patients, orally inhaled administration of YUPELRI at a once-daily dose of up to 700 mcg (4 times the maximum recommended daily dose) for 7 days was well tolerated.
Treatment of overdosage consists of discontinuation of YUPELRI along with institution of appropriate symptomatic and/or supportive therapy.
The YUPELRI solution unit-dose vial should only be removed from the foil pouch and opened IMMEDIATELY BEFORE USE. The vial and any residual content should be discarded after use.
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