Dosing & Uses
Not indicated
Dosage Forms & 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
Adverse 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 & 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
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
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Formulary
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