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beractant (Survanta)

 

Classes: Lung Surfactants

Dosing and uses of Survanta (beractant)

 

Adult dosage forms and strengths

Not indicated

 

Pediatric dosage forms and strengths

intratracheal suspension

  • 25mg/mL

 

Respiratory Distress Syndrome

Premature neonates

  • Prophylaxis: 100 mg phospholipids/kg (4 mL/kg) intratracheal within 15 min of birth; may administer 4 doses during the first 48 hr of life not more frequent than q6hr
  • Treatment: If RDS confirmed by x-ray, administer 100 mg phospholipids/kg (4 mL/kg) intratracheal within 8 hr of birth; may administer 4 doses during the first 48 hr of life no more frequent than q6hr
  • May administer additional doses if there is evidence of respiratory distress

Administration

  • Instill through 5 French endhole catheter inserted into endotracheal tube just above carina (not into bronchus)
  • Inject each dose into catheter over 2-3 seconds
  • Each dose instilled as 4 quarter-doses, with body in different positions to assure adequate distribution, allow 30 seconds ventilation between positions
  • Store in fridge, warm to room temp, swirl to mix (no shaking!)

 

Respiratory Failure (Orphan)

Orphan designation for full-term newborns with respiratory failure caused by meconium aspiration syndrome, persistent pulmonary hypertension of the newborn, or pneumonia and sepsis

Orphan sponsor

  • Ross Laboratories; 625 Cleveland Avenue; Columbus, OH 43215

 

Respiratory Distress Syndrome (Orphan)

Orphan designation of aerosolized beractant for treatment of respiratory distress syndrome

Orphan sponsor

  • Beena G. Sood, MD, MS; Wayne State University School of Medicine; Children's Hospital fo MI; Detroit, MI 48201

 

Survanta (beractant) adverse (side) effects

>10%

Transient bradycardia (12%)

 

1-10%

O2 desaturation (10%)

 

<1%

Apnea

Endotracheal tube blockage

Endotracheal tube reflux

Hypotension

Hypercarbia

Hypertension/hypotension

Sepsis

Vasoconstriction

 

Warnings

Contraindications

None listed by the manufacturer

 

Cautions

For endotracheal administration only

Rales, moist breathing sounds may occur normally with administration

Infant may exhibit bradycardia & cyanosis

Do not chill & thaw more than once; single use vials

Lung oxygenation may improve rapidly, which in turn will require adjustments in oxygen delivery and ventilator settings

Administer only in a highly-supervised clinical setting with immediate availability of clinicians experienced in intubation and ventilatory management of premature infants

 

Pregnancy and lactation

Pregnancy category: Not applicable

Lactation: Not applicable

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Survanta (beractant)

Mechanism of action

Natural bovine pulmonary surfactant; replaces deficient endogenous lung surfactant in neonates with respiratory distress syndrome

Surfactant prevents the alveoli from collapsing during expiration by lowering surface tension between alveolar surfaces and air

 

Pharmacokinetics

Excretion: Rapid