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Survanta
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  • FDA PI

Survanta

Generic name:beractant
Dosage form: intratracheal suspension
Drug class:Lung surfactants

Medically reviewed by Drugs.com. Last updated on Oct 1, 2020.

Survanta Description

Survanta® contains beractant, a pulmonary surfactant, which is a natural bovine lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins (SP) to which colfosceril palmitate (dipalmitoylphosphatidylcholine), palmitic acid, and tripalmitin are added to standardize the composition and to mimic surface-tension lowering properties of natural lung surfactant. The resulting composition provides 25 mg/mL of phospholipids (including 11.0-15.5 mg/mL of disaturated phosphatidylcholine), 0.5-1.75 mg/mL of triglycerides, 1.4-3.5 mg/mL of free fatty acids, and less than 1 mg/mL of SP (including SP-B, a 79-amino acid protein, and SP-C, a 35-amino acid peptide).

Survanta (beractant) intratracheal suspension is a sterile, preservative-free, non-pyrogenic off-white to light brown liquid supplied in single-dose glass vials for intratracheal use only. Each vial contains 4 mL (100 mg phospholipids) or 8 mL (200 mg phospholipids). Each mL of Survanta contains 25 mg of phospholipids. It is suspended in 0.9% sodium chloride solution and heat-sterilized. Survanta contains no preservatives. Sodium hydroxide or hydrochloric acid may be added to adjust the pH. The pH is approximately 6.2 to 7.6.

Survanta - Clinical Pharmacology

Endogenous pulmonary surfactant lowers surface tension on alveolar surfaces during respiration and stabilizes the alveoli against collapse at resting transpulmonary pressures. Deficiency of pulmonary surfactant causes Respiratory Distress Syndrome (RDS) in premature infants. Survanta replenishes surfactant and restores surface activity to the lungs of these infants.

Activity

In vitro, Survanta reproducibly lowers minimum surface tension to less than 8 dynes/cm as measured by the pulsating bubble surfactometer and Wilhelmy Surface Balance. In situ, Survanta restores pulmonary compliance to excised rat lungs artificially made surfactant-deficient. In vivo, single Survanta doses improve lung pressure-volume measurements, lung compliance, and oxygenation in premature rabbits and sheep.

Animal Metabolism

Survanta is administered directly to the target organ, the lungs, where biophysical effects occur at the alveolar surface. In surfactant-defi...