Beractant: Indication, Dosage, Side Effect, Precaution

This information is not country-specific. Please refer to the Myanmar prescribing information.

Generic Medicine Info

Indications and Dosage

Endotracheal
Neonatal respiratory distress syndrome

Child: Dose is expressed in terms of phospholipids; each mL contains beractant equivalent to 25 mg phospholipids (4 mL contains 100 mg phospholipids). As treatment in premature neonates: Initially, 100 mg phospholipids/kg (4 mL/kg) given as soon as possible after the diagnosis of RDS is confirmed by radiographic or clinical findings, preferably within 8 hours of birth. If necessary, the dose may be repeated at intervals of at least 6 hours for up to a Max of 4 doses within the 1st 48 hours of life. As prophylaxis in premature neonates at risk of developing RDS with evidence of surfactant deficiency: Initially, 100 mg phospholipids/kg (4 mL/kg) given as soon as possible after birth, preferably within 15 minutes. If necessary, the dose may be repeated at intervals of at least 6 hours for up to a Max of 4 doses within the 1st 48 hours of life. Doses are administered via an endotracheal tube. Specific methods of administration may vary depending on the ventilation technique. Refer to detailed product guidelines for instructions on administration.

Special Precautions

Marked improvements in lung oxygenation and compliance may occur within minutes of administration; frequent and appropriate adjustments to oxygen delivery and ventilator settings may be required to avoid hyperoxia. Premature neonates. Use of beractant in neonates <600 g or >1,750 g birth weight has not been evaluated in controlled clinical trials.

Adverse Reactions

Significant: Transient bradycardia and oxygen desaturation; increased risk of nosocomial sepsis (post-treatment); transient rales and moist breath sounds; endotracheal tube obstruction by mucous secretions.
General disorders and administration site conditions: Rarely, pallor.
Nervous system disorders: Intracranial haemorrhage.
Respiratory, thoracic and mediastinal disorders: Pulmonary haemorrhage. Rarely, hypocapnia, hypercapnia, apnoea, endotracheal tube reflux.
Vascular disorders: Rarely, hypertension, hypotension, vasoconstriction.

Monitoring Parameters

Closely monitor continuous ECG and arterial or transcutaneous systemic oxygen and CO₂ measurements during administration; arterial blood gases after administration.

Action

Description: 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.
Onset: Improved oxygenation: Within minutes.
Pharmacokinetics:
Distribution: Rapidly distributes to the alveolar surfaces.

Storage

Store between 2-8°C. Do not freeze. Protect from light. Do not shake. Recommendations on the stability and storage of unopened vials once warmed may vary between countries. Refer to detailed product guidelines.

MIMS Class

Other Drugs Acting on the Respiratory System

References

Anon. Beractant. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 07/03/2022.

Anon. Beractant. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/03/2022.

Buckingham R (ed). Pulmonary Surfactants. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/03/2022.

Survanta 25 mg/mL Suspension (AbbVie Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 07/03/2022.

Survanta Suspension (AbbVie Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/03/2022.

Disclaimer: This information is independently developed by MIMS based on Beractant from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com