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YUPELRI® INHALATION SOLUTION 175MCG/3ML [SIN16336P]
Active ingredients: YUPELRI® INHALATION SOLUTION 175MCG/3ML
Last updated 26 October 2025
Product Info
YUPELRI® INHALATION SOLUTION 175MCG/3ML
[SIN16336P]
Product information
Active Ingredient and Strength | REVEFENACIN - 175 MCG/3 ML |
Dosage Form | SOLUTION |
Manufacturer and Country | THE RITEDOSE CORPORATION (TRC) - UNITED STATES |
Registration Number | SIN16336P |
Licence Holder | MYLAN PHARMACEUTICALS PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | R03BB08 |
1 INDICATIONS AND USAGE
YUPELRI inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
2 DOSAGE AND ADMINISTRATION
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug 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 sections 8.5, 8.7, Clinical Pharmacology (12.3) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].
The drug compatibility (physical and chemical), efficacy, and safety of YUPELRI when mixed with other drugs in a nebulizer have not been established.
4 CONTRAINDICATIONS
YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product.