Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule H
Beractant is a Lung surfactant
Beractant is used in the Treatment of Respiratory distress syndrome.
Beractant is Rapidly distributed to the alveolar surfaces.
The onset of Action of Beractant: Improved oxygenation: Within minutes.
Beractant shows common side effects like Chest pain, coughing or spitting up blood, dark-colored urine, decreased appetite, fever, general feeling of tiredness
Beractant is available in the form of Suspension.
Beractant is available in India, Germany, Canada, and Italy.
Beractant, an exogenous pulmonary surfactant, is a modified bovine lung extract containing mainly phospholipids. It replaces deficient or ineffective endogenous lung surfactant in neonates with or at risk of developing respiratory distress syndrome (RDS). Beractant acts by reducing the surface tension between air and alveolar surfaces, thereby stabilizing the alveoli against collapse during respiration and increasing alveolar ventilation.
Beractant is available in the form of Suspension.
Specific administration methods may vary with the ventilation technique.
Endotracheal/Intratracheal: Allow the beractant to stand at room temperature for 20 minutes or warm in the hand for at least 8 minutes prior to administration; artificial warming methods should NOT be used. Inspect solution to verify complete mixing of the suspension; do not shake; if settling occurs during storage, gently swirl. Suction infant prior to administration.
Endotracheal: Administration through endotracheal tube using a 5-French end-hole catheter: The infant should be stable before proceeding with administration. Insert a 5-French end-hole catheter into the infant’s endotracheal tube. Administer the dose in four 1 mL/kg aliquots. Each quarter-dose is instilled over 2 to 3 seconds followed by at least 30 seconds of manual ventilation or until stable; each quarter-dose is administered with the infant in a different position; slightly downward inclination with head turned to the right, then repeat with head turned to the left; then slightly upward inclination with head turned to the right, then repeat with head turned to the left. Following administration of one full dose, withhold suctioning for 1 hour unless signs of significant airway obstruction.
Intratracheal: Administration method for spontaneously breathing newborns who do not require endotracheal intubation: Minimally invasive surfactant therapy (MIST): Limited data available: Administration via a thin catheter (2.5- to 5-French) has been suggested as a less invasive method. The catheter is placed between the vocal cords under direct laryngoscopy and the surfactant dose is administered over 1 to 3 minutes.
Beractant is used in the Treatment of Respiratory distress syndrome
Replaces deficient or ineffective endogenous lung surfactant in neonates with respiratory distress syndrome (RDS) or in neonates at risk of developing RDS. Surfactant prevents the alveoli from collapsing during expiration by lowering surface tension between air and alveolar surfaces.
Beractant is approved for use in the following clinical indications
Respiratory distress syndrome: Prevention of respiratory distress syndrome (RDS) in premature neonates with birth weight <1,250 g or with evidence of surfactant deficiency (administer within 15 minutes of birth); treatment of RDS in neonates with x-ray confirmation of RDS and requiring mechanical ventilation (administer within 8 hours of birth).
Beractant is available in the form of Suspension
- Dosage Adjustment in Hepatic impairment Patient
Mild impairment: No dosage adjustment necessary.
Moderate to severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling
● Dosage Adjustment for Pediatric Patients
Respiratory distress treatment: Premature neonates: Limited data available in premature neonates <600 g or >1,750 g:
Prophylactic therapy: Endotracheal: 4 mL/kg (100 mg phospholipids/kg) as soon as possible after birth, preferably within 15 minutes; as many as 4 doses may be administered during the first 48 hours of life, no more frequently than 6 hours apart; usually requires no more frequent dosing than every 12 hours unless surfactant is being inactivated by an infectious process, meconium, or blood . The need for additional doses is determined by evidence of continuing respiratory distress; if the neonate is still intubated and requires at least 30% inspired oxygen to maintain a PaO2 ≤80 torr. Note: For newborns who do not require mechanical ventilation for severe RDS, current guidelines recommend using CPAP immediately after birth with subsequent selective surfactant administration.
Rescue treatment: Endotracheal: 4 mL/kg (100 mg phospholipids/kg) as soon as the diagnosis of RDS is made; may repeat if needed, no more frequently than every 6 hours to a maximum of 4 doses during the first 48 hours of life; usually requires no more frequent dosing than every 12 hours unless surfactant is being inactivated by an infectious process, meconium, or blood. The need for additional doses is determined by evidence of continuing respiratory distress or if the neonate is still intubated and requiring at least 30% inspired oxygen to maintain a PaO2 ≤80 torr.
Concerns related to adverse effects:
• Mucous plugs: Marked impairment of ventilation during or shortly after dosing may indicate mucous plugging of the endotracheal tube; suctioning all neonates prior to administration may decrease the chance of endotracheal tube obstruction. Replace endotracheal tube immediately if obstruction is not removed with suctioning.
• Nosocomial sepsis: There is an increased risk of post-treatment nosocomial sepsis in treated neonates this increased risk was not associated with increased mortality.
• Transient adverse effects: Transient episodes of bradycardia and decreased oxygen saturation may occur. Discontinue dosing procedure and initiate measures to alleviate the condition; may reinstitute after the patient is stable. Rales and moist breath sounds may occur; endotracheal suctioning or other remedial action is necessary if clear-cut signs of airway obstruction are present.
Other warnings/precautions:
• Administration: Intended for endotracheal administration only.
• Appropriate use: Use in neonates with <600 grams birth weight or >1,750 grams birth weight has not been evaluated.
• Lung oxygenation/lung compliance: Produces rapid improvements in lung oxygenation and compliance that may require frequent adjustments to oxygen delivery and ventilator settings; hyperoxia may occur within minutes of administration.
• Trained personnel: Rapidly affects oxygenation and lung compliance; restrict use to a highly-supervised clinical setting with immediate availability of clinicians experienced in intubation and ventilatory management of premature neonates.
Alcohol Warning
Beractant is only indicated for use in premature neonates.
Breast Feeding Warning
Beractant is only indicated for use in premature neonates.
Pregnancy Warning
Beractant is only indicated for use in premature neonates.
Food Warning
High-fat meal may decrease the rate but not the extent of absorption. Management: May administer with meals.
- Common Adverse effects
Transient bradycardia and oxygen desaturation; increased risk of nosocomial sepsis (post-treatment); transient rales and moist breath sounds; endotracheal tube obstruction by mucous secretions.
- Less Common Adverse effects
Hypertension, hypotension, vasoconstriction.
- Rare Adverse effects
Pallor, hypocapnia, hypercapnia, apnoea, endotracheal tube reflux.
Pharmacodynamic
Beractant, an exogenous pulmonary surfactant, is a modified bovine lung extract containing mainly phospholipids. It replaces deficient or ineffective endogenous lung surfactant in neonates with or at risk of developing respiratory distress syndrome (RDS). Beractant acts by reducing the surface tension between air and alveolar surfaces, thereby stabilising the alveoli against collapse during respiration and increasing alveolar ventilation.
Pharmacokinetics
- Distribution: Rapidly distributes to the alveolar surfaces.
- https://pubmed.ncbi.nlm.nih.gov/1091001/
- https://clinicaltrials.gov/ct2/show/NCT01422915
- https://clinicaltrials.gov/ct2/show/NCT02263547
- https://www.medicines.org.uk/emc/product/128/smpc.
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1364710/
- https://reference.medscape.com/drug/colestid-Beractant -342452
- https://go.drugbank.com/drugs/DB00375
- https://www.sciencedirect.com/topics/medicine-and-dentistry/Beractant
- https://europepmc.org/article/med/6988203
