Classifications: lung surfactant; Therapeutic:lung surfactant
Pregnancy Category: Not applicable
25 mg/mL suspension
Beractant is a sterile pulmonary surfactant. Endogenous pulmonary surfactant lowers surface tension on alveolar surfaces
during respiration and stabilizes the alveoli against collapse at resting pressures. Deficiency of surfactant causes respiratory
distress syndrome (RDS) in premature infants.
Beractant lowers minimum surface tension and restores pulmonary compliance and oxygenation in premature infants.
Prevention and treatment of RDS in premature infants, especially those weighing <1250 g.
Infants weighing <600 g or >1750 g; treatment of RDS in adults.
Nosocomial infections; bovine protein hypersensitivity.
Route & Dosage
Neonate: Intratracheal Instill 100 mg/kg (4 mL/kg) birth weight through endotracheal tube, may repeat no more frequently than q6h (max: 4 doses
in the first 48 h of life)
- Place refrigerated drug at room temperature for at least 20 min or warm in the hand for at least 8 min. Do not use artificial
- Give to premature infants weighing less than 1250 g, or who have a surfactant deficiency, preferably within 15 min of birth.
- Give to infants requiring mechanical ventilation and with RDS confirmed by x-ray examination, within 8 h of birth.
- Suction infant before administration of beractant.
- Note: Drug color should be white to light brown. If drug has settled, swirl vial gently to suspend.
- Administer using a No. 5 French end-hole catheter inserted into the endotracheal tube.
- Follow specific dosing procedure recommended by the manufacturer. Carefully read and follow exactly accompanying drug administration
- Do not suction for 1 h after drug is administered unless signs of significant airway obstruction occur.
- Unopened vials warmed to room temperature will not lose potency if refrigerated within 8 h of warming. Drug should not be
warmed and returned to refrigerator more than once.
- Note: Vials are for single use only. Discard unused drug in opened vials.
- Store unopened vials inside carton to protect from light and refrigerated at 2°8° C (36°46°
F) until ready to use.
Adverse Effects (≥1%)CV: Transient bradycardia. Respiratory: Oxygen desaturation. Other:
Increased probability of posttreatment nosocomial sepsis in surfactant-treated infants was observed in the controlled clinical
trials but was not associated with increased mortality.
Absorbed from the alveolus into lung tissue, where it can be extensively catabolized and reutilized for further phospholipid
synthesis and secretion. Onset:
0.54 h. Peak:
2 h. Duration:
4872 h; may need multiple doses to sustain improvement. Distribution:
Not distributed to the systemic circulation. Metabolism:
Surfactant is recycled and metabolized exclusively in the lungs. Elimination:
Recycling may be a dominant metabolic pathway by which surfactant is taken up by type II pneumocytes and reused. Half-Life:
Assessment & Drug Effects
- Monitor heart rate, color, chest expansion, facial expressions, oximeter, and endotracheal tube patency and position, during
administration. Most adverse effects occur during dosing.
- Monitor frequently with arterial or transcutaneous measurement of systemic oxygen and CO2.
- Note: Rales and moist breath sounds may occur transiently following drug administration. These do not necessarily indicate a need