"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
CUROSURF (poractant alfa) is intended for intratracheal use only.
THE ADMINISTRATION OF EXOGENOUS SURFACTANTS, INCLUDING CUROSURF (poractant alfa) , CAN RAPIDLY AFFECT OXYGENATION AND LUNG COMPLIANCE. Therefore, infants receiving CUROSURF (poractant alfa) should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified to respond to respiratory changes. CUROSURF (poractant alfa) 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 (poractant alfa) INCLUDE BRADYCARDIA, HYPOTENSION, ENDOTRACHEAL TUBE BLOCKAGE, AND OXYGEN DESATURATION. These events require stopping Curosurf (poractant alfa) administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing may proceed with appropriate monitoring.
Correction of acidosis, hypotension, anemia, hypoglycemia, and hypothermia is recommended prior to CUROSURF (poractant alfa) 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 (poractant alfa) 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 (poractant alfa) more than 15 hours after diagnosing RDS. Adequate data are not available on the use of CUROSURF (poractant alfa) 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 (poractant alfa) , or other surfactants, have not been conducted.
Mutagenicity studies of CUROSURF (poractant alfa) , 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.
Last reviewed on RxList: 12/4/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Curosurf Information
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