Survanta (beractant)

Lung Surfactants Inhalation Vial (Ml)

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Last reviewed · Source: First Databank (FDB) drug data

Overview

Beractant is an exogenous pulmonary surfactant preparation.

Beractant is an exogenous surfactant preparation. Beractant, a modified natural surfactant, is a bovine lung extract containing mostly phospholipids, which has been modified by the addition of colfosceril palmitate (dipalmitoylphosphatidylcholine, DPPC, disaturated phosphatidylcholine, dipalmitoyllecithin), palmitic acid, and tripalmitin. The resultant commercially available beractant provides 25 mg/mL of phospholipids (including 11-15.5 mg/mL of disaturated phosphatidylcholine (approximately 90% of which is colfosceril palmitate)), 1.4-3.5 mg/mL of free fatty acids, 0.5-1.75 mg/mL of triglycerides, and less than 1 mg/mL of protein.

The protein consists principally of 2 lipophilic (hydrophobic) surfactant-specific proteins (SP-B, SP-C); the hydrophilic protein, SP-35 (surfactant protein 35, apoprotein A, SAP-35, SP-A), does not appear to be present in beractant.

SumMon(R) (see Users Guide). For additional information on this drug until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the labeling be consulted for detailed information on the usual cautions, precautions, and contraindications.

Generic name: beractant
Drug class: Lung Surfactants
Therapeutic class: Respiratory Therapy Agents

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

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Indications

The following indications are listed for Survanta:

  • Prevention Of Respiratory Distress Syndrome In The Newborn
  • Respiratory Distress Syndrome In The Newborn

Also known as: Congenital Alveolar Dysplasia, Congenital Alveolar Dysplasia Prophylaxis, Hyaline Membrane Disease, Hyaline Membrane Disease Prophylaxis, Idiopathic Respiratory Distress Syndrome, Idiopathic Respiratory Distress Syndrome Prophylaxis, Irds Prophylaxis, Neonatal Respiratory Distress Syndrome, Neonatal Respiratory Distress Syndrome Prophylaxis, Perinatal Respiratory Distress Syndrome, Perinatal Respiratory Distress Syndrome Prophylaxis, Pulmonary Hypoperfusion Syndrome Of Newborn, Pulmonary Hypoperfusion Syndrome Of Newborn Prophylaxis, Rds Of Newborn, Rds Of Newborn Prophylaxis, Respiratory Distress Syndrome Of Newborn, Respiratory Distress Syndrome Of Newborn Prophylaxis, Respiratory Distress Syndrome Prophylaxis.

Dosing

Dosage of beractant is expressed in terms of phospholipids. Each dose of beractant consists of 100 mg of phospholipids per kg of birthweight.

The recommended intratracheal (administered via a catheter inserted into an endotracheal tube) dosage of beractant for prevention of RDS in premature neonates with low birthweight or in those with evidence of an endogenous surfactant deficiency is 100 mg of phospholipids (4 mL of Survanta(R)) per kg of birthweight as soon as possible (preferably within 15 minutes) after birth and intubation. The recommended intratracheal dosage of the drug for active (rescue) treatment of RDS in neonates having radiographic evidence of the disease and requiring mechanical ventilation also is 100 mg of phospholipids per kg of birthweight; the first dose should be administered as soon as possible following initiation of mechanical ventilation, preferably within 8 hours of birth. Transient episodes of bradycardia and decreased oxygen saturation may occur during dosing; if they occur, the dosing procedure should be interrupted, and appropriate measures to alleviate the condition initiated. Once stabilization occurs, dosing can be resumed.

Following an initial dose of beractant, the need for additional doses of the drug is determined by evidence of continuing respiratory distress. If there is evidence of continuing distress, the manufacturer states that doses of 100 mg of phospholipids per kg of birthweight (the neonate should not be reweighed) can be repeated no more frequently than every 6 hours; however, the manufacturer states that no more than 4 doses of beractant should be administered during the first 48 hours of life. The manufacturer states that the safety and efficacy of doses other than 100 mg/kg, regimens exceeding 4 doses or involving administration more frequently than every 6 hours, or administration beyond 48 hours of age have not been determined.

The manufacturer's labeling should be consulted for more detailed dosing information.

Drug interactions

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Contraindications

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Adverse reactions

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Precautions

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ICD codes

CodeTypeDescription
Respiratory distress syndrome in the newborn
P22.0ICD10CMRespiratory distress syndrome of newborn

ICD code information from First Databank (FDB).

Formulary status

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Last reviewed · Source: First Databank (FDB) drug data