New Release: Alpha testing version has been released.

Beractant

R07A - Other respiratory system products ATC R07AA02 Unknown approved 1991 Parenteral

JFDA label: Survanta Vial 8ml

Mechanism of Action

— Surfactant agent

Indications

Approved

  • Respiratory distress syndrome

Contraindications

Source: Lexicomp

  • There are no contraindications listed in the manufacturer's labeling Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Other (2)

Very Common Cardiovascular: Bradycardia (transient)

Common Respiratory: Oxygen desaturation

Dosing

Source: Lexicomp

(For additional information see "Beractant: Pediatric drug information") Respiratory distress treatment: Premature neonates: Limited data available in premature neonates 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 (AAP [Polin 2014]). The need for additional doses is determined by evidence of continuing respiratory distress; if the neonate is still intubated and requiring 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 (AAP [Polin 2014]). 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 (AAP [Polin 2014]). 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.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.

Warnings & Precautions

Source: Lexicomp

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 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.

Pregnancy & Lactation

Pregnancy

Beractant is only indicated for use in premature neonates

Lactation

Beractant is only indicated for use in premature neonates

Monitoring

Clinical pearlContinuous ECG and arterial or transcutaneous measurement of systemic oxygen and carbon dioxide during administration; arterial blood gases

Biology & Pharmacokinetics

Pharmacokinetics

Registered Products (4)

BrandForm / strengthPackAgentCitizen (JOD)
BLES Vial 27 mg/1 ml, 176-500 mcg/ml 5 ml pack varies ALTHAER DRUG STORE
BLES Vial 27 mg/1 ml, 176-500 mcg/ml 3 ml pack varies ALTHAER DRUG STORE
Survanta Vial 25 mg/ml 1 vial pack varies Sukhtian Group
Survanta Vial Vial 25 mg/ml 1 vial pack varies Hussam Al Nmer Drug Store