ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Beractant: Drug information

Beractant: Drug information
(For additional information see "Beractant: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Survanta
Brand Names: Canada
  • Survanta
Pharmacologic Category
  • Lung Surfactant
Dosing: Pediatric

(For additional information see "Beractant: Pediatric drug information")

Dosage guidance:

Dosage form information: 1 mL of beractant contains 25 mg of phospholipids.

Respiratory distress syndrome

Respiratory distress syndrome (RDS): Note: For newborns who do not require mechanical ventilation for severe RDS, current guidelines recommend using continuous positive airway pressure (CPAP) immediately after birth with subsequent selective surfactant administration (Ref); routine prophylactic surfactant administration is no longer recommended (Ref).

Rescue treatment:

Endotracheal administration: Note: Use for INSURE technique (INtubation-SURfactant-Extubation) or patients requiring invasive respiratory support (eg, mechanical ventilation):

Preterm neonates: Endotracheal: 4 mL/kg following a diagnosis of significant RDS; additional doses may be administered if patient remains intubated and requires at least 30% inspired fraction of oxygen (FiO2) to maintain adequate oxygenation; dosing more often than every 12 hours is typically not required unless surfactant is being inactivated by an infectious process, meconium, or blood; doses should not be given more frequently than every 6 hours; up to 4 doses may be administered if evidence of respiratory distress continues (Ref).

Prophylactic therapy: Note: Routine prophylactic surfactant administration is no longer recommended (Ref).

Preterm neonates: Endotracheal: 4 mL/kg as soon as possible after birth, preferably within 15 minutes.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined. The following occurred during the dosing procedure:

>10%: Cardiovascular: Bradycardia (transient)

1% to 10%: Respiratory: Oxygen desaturation

<1%, postmarketing, and/or case reports: Apnea, emphysema (pulmonary interstitial), hypercapnia, hypertension, hypotension, increased susceptibility to infection (post-treatment nosocomial sepsis), low blood CO2, obstruction of endotracheal tube, pallor, pneumothorax (including pneumopericardium), vasoconstriction

Contraindications

There are no contraindications listed in the manufacturer's labeling

Warnings/Precautions

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 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 <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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Intratracheal:

Survanta: Phospholipids 25 mg/mL (4 mL, 8 mL)

Generic Equivalent Available: US

No

Pricing: US

Suspension (Survanta Intratracheal)

25 mg/mL 0.9% (per mL): $114.90

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Intratracheal:

Survanta: Phospholipids 25 mg/mL (4 mL, 8 mL)

Administration: Pediatric

Specific administration method may vary with ventilation technique.

Endotracheal/Intratracheal: Allow 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. Slowly draw dose into a syringe using a 20-gauge or larger needle, taking care to avoid excessive foaming. Suction neonate prior to administration.

Endotracheal tube: Note: Utilized for INSURE (INtubation-SURfactant-Extubation) technique or patients who are mechanically ventilated.

Before administering, ensure proper placement and patency of the endotracheal tube. Patient may be suctioned prior to administration. The neonate should be stable before proceeding with administration. Insert a 5-French end-hole catheter into the neonate'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 neonate 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. Beractant has also been administered in 2 equal aliquots in 2 positions (inclined to the right and inclined to the left) as well as a single aliquot in a neutral position (Ref).

Intratracheal: Minimally invasive surfactant therapy (MIST)/less invasive surfactant administration (LISA): Administration via a thin feeding catheter (3-French to 5-French) or a semi-rigid 16-gauge vascular catheter that is placed under direct laryngoscopy has also been reported in studies. Surfactant dose is administered over 1 to 3 minutes as small boluses; administration should be slowed if apnea, bradycardia, desaturation, or surfactant reflux occurs (Ref).

Use: Labeled 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).

Medication Safety Issues
Sound-alike/look-alike issues:

Survanta may be confused with Sufenta

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Risk C: Monitor therapy

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Risk D: Consider therapy modification

Etrasimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Fexinidazole: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole. Risk X: Avoid combination

Fingolimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Fingolimod. Management: Consult with the prescriber of any bradycardia-causing agent to see if the agent could be switched to an agent that does not cause bradycardia prior to initiating fingolimod. If combined, perform continuous ECG monitoring after the first fingolimod dose. Risk D: Consider therapy modification

Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Risk C: Monitor therapy

Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Risk C: Monitor therapy

Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Ozanimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Ponesimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Ponesimod. Management: Avoid coadministration of ponesimod with drugs that may cause bradycardia when possible. If combined, monitor heart rate closely and consider obtaining a cardiology consult. Do not initiate ponesimod in patients on beta-blockers if HR is less than 55 bpm. Risk D: Consider therapy modification

Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Risk D: Consider therapy modification

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Pregnancy Considerations

Beractant is only indicated for use in premature neonates

Breastfeeding Considerations

Beractant is only indicated for use in premature neonates

Monitoring Parameters

Continuous heart rate and peripheral O2 saturation should be monitored during administration; peripheral O2 saturation, transcutaneous CO2, with confirmatory blood gas analysis as needed following administration to prevent postdosing hyperoxia and hypocarbia. If mechanically ventilated, monitor respiratory parameters to minimize volutrauma following improvement in lung compliance.

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Improved oxygenation: Within minutes

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Survanta;
  • (AR) Argentina: Survanta;
  • (AT) Austria: Survanta;
  • (AU) Australia: Survanta;
  • (BD) Bangladesh: Survanta;
  • (BE) Belgium: Survanta;
  • (BG) Bulgaria: Survanta;
  • (BR) Brazil: Survanta;
  • (CL) Chile: Survanta;
  • (CO) Colombia: Survanta;
  • (CZ) Czech Republic: Survanta;
  • (DE) Germany: Survanta;
  • (DO) Dominican Republic: Survanta;
  • (EC) Ecuador: Survanta;
  • (EG) Egypt: Survanta;
  • (ES) Spain: Survanta;
  • (FR) France: Survanta;
  • (GB) United Kingdom: Survanta;
  • (GR) Greece: Survanta;
  • (HK) Hong Kong: Survanta;
  • (HU) Hungary: Survanta;
  • (ID) Indonesia: Survanta;
  • (IN) India: Survanta;
  • (KE) Kenya: Survanta sterile;
  • (KW) Kuwait: Survanta;
  • (LB) Lebanon: Survanta;
  • (MX) Mexico: Survanta;
  • (MY) Malaysia: Survanta;
  • (NG) Nigeria: Survanta;
  • (NO) Norway: Survanta-vent;
  • (NZ) New Zealand: Survanta;
  • (PE) Peru: Survanta;
  • (PH) Philippines: Survanta;
  • (PK) Pakistan: Survanta;
  • (PL) Poland: Survanta;
  • (PR) Puerto Rico: Survanta;
  • (PT) Portugal: Survanta;
  • (PY) Paraguay: Survanta;
  • (QA) Qatar: Survanta;
  • (RU) Russian Federation: Survanta;
  • (SA) Saudi Arabia: Survanta;
  • (SE) Sweden: Survanta-vent;
  • (SG) Singapore: Survanta;
  • (SI) Slovenia: Survanta;
  • (SK) Slovakia: Survanta;
  • (TH) Thailand: Survanta;
  • (TR) Turkey: Survanta;
  • (TW) Taiwan: Survanta;
  • (UA) Ukraine: Survanta;
  • (UG) Uganda: Survanta;
  • (ZA) South Africa: Survanta
  1. Banerjee S, Fernandez R, Fox GF, et al. Surfactant replacement therapy for respiratory distress syndrome in preterm infants: United Kingdom national consensus. Pediatr Res. 2019;86(1):12-14. doi:10.1038/s41390-019-0344-5 [PubMed 30780152]
  2. Bloom BT, Clark RH; Infasurf Survanta Clinical Trial Group. Comparison of Infasurf (calfactant) and Survanta (beractant) in the prevention and treatment of respiratory distress syndrome. Pediatrics. 2005;116(2):392-399. doi:10.1542/peds.2004-2783 [PubMed 16061594]
  3. Findlay RD, Taeusch HW, Walther FJ. Surfactant replacement therapy for meconium aspiration syndrome. Pediatrics. 1996;97(1):48-52. [PubMed 8545223]
  4. Halim A, Shirazi H, Riaz S, Gul SS, Ali W. Less invasive surfactant administration in preterm infants with respiratory distress syndrome. J Coll Physicians Surg Pak. 2019;29(3):226-330. doi:10.29271/jcpsp.2019.03.226 [PubMed 30823947]
  5. Herting E, Härtel C, Göpel W. Less invasive surfactant administration: best practices and unanswered questions. Curr Opin Pediatr. 2020;32(2):228-234. doi:10.1097/MOP.0000000000000878 [PubMed 32068592]
  6. Kovey K, Barnes K, Beckett RD, Rice M. The efficacy of neutral position beractant administration in neonates. Am J Perinatol. 2018;35(13):1303-1307. doi:10.1055/s-0038-1649483 [PubMed 29734454]
  7. Kribs A, Pillekamp F, Hünseler C, Vierzig A, Roth B. Early administration of surfactant in spontaneous breathing with nCPAP: feasibility and outcome in extremely premature infants (postmenstrual age ≤27 weeks). Paediatr Anaesth. 2007;17(4):364-369. [PubMed 17359406]
  8. Lotze A, Mitchell BR, Bulas DI, Zola EM, Shalwitz RA, Gunkel JH. Multicenter study of surfactant (beractant) use in the treatment of term infants with severe respiratory failure. Survanta in Term Infants Study Group. J Pediatr. 1998;132(1):40-47. [PubMed 9469998]
  9. Ng EH, Shah V. Guidelines for surfactant replacement therapy in neonates. Paediatr Child Health. 2021;26(1):35-49. doi:10.1093/pch/pxaa116 [PubMed 33552321]
  10. Olivier F, Nadeau S, Bélanger S, et al. Efficacy of minimally invasive surfactant therapy in moderate and late preterm infants: A multicentre randomized control trial. Paediatr Child Health. 2017;22(3):120-124. doi:10.1093/pch/pxx033 [PubMed 29479196]
  11. Polin RA, Carlo WA, Committee on Fetus and Newborn, American Academy of Pediatrics. Surfactant replacement therapy for preterm and term neonates with respiratory distress. Pediatrics. 2014;133(1):156-163. [PubMed 24379227]
  12. Ramos-Navarro C, Sánchez-Luna M, Zeballos-Sarrato S, González-Pacheco N. Three-year perinatal outcomes of less invasive beractant administration in preterm infants with respiratory distress syndrome. J Matern Fetal Neonatal Med. 2020;33(16):2704-2710. doi:10.1080/14767058.2018.1557633 [PubMed 30526187]
  13. Refer to manufacturer's labeling.
  14. Survanta (beractant) [prescribing information]. North Chicago, IL; AbbVie Inc; October 2020.
  15. Sweet DG, Carnielli VP, Greisen G, et al. European consensus guidelines on the management of Respiratory distress syndrome: 2022 Update. Neonatology. 2023;120(1):3-23. doi: 10.1159/000528914 [PubMed 36863329]
  16. Wang XA, Chen LJ, Chen SM, Su PH, Chen JY. Minimally invasive surfactant therapy versus intubation for surfactant administration in very low birth weight infants with respiratory distress syndrome. Pediatr Neonatol. 2020;61(2):210-215. doi:10.1016/j.pedneo.2019.11.002 [PubMed 31818537]
Topic 9122 Version 142.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟