DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Curosurf (Poractant Alfa) - Warnings and Precautions

 
 



WARNINGS

CUROSURF is intended for intratracheal use only.

THE ADMINISTRATION OF EXOGENOUS SURFACTANTS, INCLUDING CUROSURF, CAN RAPIDLY AFFECT OXYGENATION AND LUNG COMPLIANCE. Therefore, infants receiving CUROSURF should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes. CUROSURF should only be administered by those trained and experienced in the care, resuscitation, and stabilization of pre-term infants.

TRANSIENT ADVERSE EFFECTS SEEN WITH THE ADMINISTRATION OF CUROSURF INCLUDE BRADYCARDIA, HYPOTENSION, ENDOTRACHEAL TUBE BLOCKAGE, AND OXYGEN DESATURATION. These events require stopping Curosurf administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing may proceed with appropriate monitoring.

PRECAUTIONS

General

Correction of acidosis, hypotension, anemia, hypoglycemia, and hypothermia is recommended prior to CUROSURF administration.

Surfactant administration can be expected to reduce the severity of RDS but will not eliminate the mortality and morbidity associated with other complications of prematurity.

Sufficient information is not available on the effects of administering initial doses of CUROSURF other than 2.5 mL/kg (200 mg/kg), subsequent doses other than 1.25 mL/kg (100 mg/kg), administration of more than three total doses, dosing more frequently than every 12 hours, or initiating therapy with CUROSURF more than 15 hours after diagnosing RDS. Adequate data are not available on the use of CUROSURF in conjunction with experimental therapies of RDS, e.g., high-frequency ventilation.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies to assess potential carcinogenic and reproductive effects of CUROSURF, or other surfactants, have not been conducted.

Mutagenicity studies of CUROSURF, which included the Ames test, gene mutation assay in Chinese hamster V79 cells, chromosomal aberration assay in Chinese hamster ovarian cells, unscheduled DNA synthesis in HELA S3 cells, and in vivo mouse nuclear test, were negative.

Page last updated: 2006-04-07

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017