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Curosurf

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Curosurf

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Acute Changes In Oxygenation And Lung Compliance

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.

Administration-Related Adverse Reactions

Transient adverse reactions associated with 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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Studies to assess potential carcinogenic effects of CUROSURF have not been conducted.

Poractant alfa was negative for genotoxicity in the following assays: bacterial reverse mutation assay (Ames test), gene mutation assay in Chinese hamster V79 cells, chromosomal aberration assay in Chinese hamster ovary cells, unscheduled DNA synthesis in HELA S3 cells, and in vivo mouse micronucleus assay.

No studies to assess reproductive effects of CUROSURF have been performed.

Use In Specific Populations

Pediatric Use

CUROSURF is indicated for the rescue treatment, including the reduction of mortality and pneumothoraces, of Respiratory Distress Syndrome (RDS) in premature infants [see INDICATIONS AND USAGE and DOSAGE ADMINISTRATION].

The safety and efficacy of CUROSURF in the treatment of full term infants or older pediatric patients with respiratory failure has not been established.

Last reviewed on RxList: 10/27/2014
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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Report Problems to the Food and Drug Administration

 

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