Beractant

Generic Name: beractant

Surfactant [EPC]Over-the-Counter (OTC)

Brand Names:

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.

Overview

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.

Uses

INDICATIONS AND USAGE SURVANTA is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.

Dosage

DOSAGE AND ADMINISTRATION Important Administration Instructions For intratracheal administration only. SURVANTA should be administered by or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants. The administration of SURVANTA is facilitated if one person administers the dose while another person positions and monitors the infant. Before administering SURVANTA, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering SURVANTA. The infant should be allowed to stabilize before proceeding with dosing. Administer SURVANTA intratracheally by instillation through a 5 French end-hole catheter.

Side Effects

ADVERSE REACTIONS The most commonly reported adverse experiences were associated with the dosing procedure. In the multiple-dose controlled clinical trials, each dose of SURVANTA was divided into four quarter-doses which were instilled through a catheter inserted into the endotracheal tube by briefly disconnecting the endotracheal tube from the ventilator. Transient bradycardia occurred with 11.9% of doses . Oxygen desaturation occurred with 9.8% of doses . Other reactions during the dosing procedure occurred with fewer than 1% of doses and included endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage, hypertension, hypocarbia, hypercarbia, and apnea.

Warnings

WARNINGS SURVANTA can rapidly affect oxygenation and lung compliance within minutes of administration of SURVANTA. Therefore, its use should be restricted to a highly supervised clinical setting with immediate availability of clinicians experienced with intubation, ventilator management, and general care of premature infants. Infants receiving SURVANTA should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide. During the dosing procedure, transient episodes of bradycardia and decreased oxygen saturation have been reported. If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure. CONTRAINDICATIONS None

Storage

HOW SUPPLIED SURVANTA (beractant) intratracheal suspension is supplied in 100 mg/4 mL single-dose glass vials (NDC 0074-1040-04) or 200 mg/8 mL single-dose glass vials (NDC 0074-1040-08). Each mL contains 25 mg of phospholipids suspended in 0.9% sodium chloride solution. The color is off-white to light brown. Store unopened vials refrigerated at 36°F to 46°F (2°C to 8°C). Do not shake.

Frequently Asked Questions

What is Beractant used for?

INDICATIONS AND USAGE SURVANTA is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.

What are the side effects of Beractant?

ADVERSE REACTIONS The most commonly reported adverse experiences were associated with the dosing procedure. In the multiple-dose controlled clinical trials, each dose of SURVANTA was divided into four quarter-doses which were instilled through a catheter inserted into the endotracheal tube by briefly disconnecting the endotracheal tube from the ventilator. Transient bradycardia occurred with 11.9% of doses . Oxygen desaturation occurred with 9.8% of doses . Other reactions during the dosing procedure occurred with fewer than 1% of doses and included endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage, hypertension, hypocarbia, hypercarbia, and apnea.

What are the important warnings for Beractant?

WARNINGS SURVANTA can rapidly affect oxygenation and lung compliance within minutes of administration of SURVANTA. Therefore, its use should be restricted to a highly supervised clinical setting with immediate availability of clinicians experienced with intubation, ventilator management, and general care of premature infants. Infants receiving SURVANTA should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide. During the dosing procedure, transient episodes of bradycardia and decreased oxygen saturation have been reported. If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure. CONTRAINDICATIONS None

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.