AdultPediatricNot indicatedDosage 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 >10% Transient bradycardia (12%) 1-10% O2 desaturation (10%) <1% Apnea Endotracheal tube blockage Endotracheal tube reflux Hypotension Hypercarbia Hypertension/hypotension Sepsis Vasoconstriction 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 Category: Not applicable Lactation: Not applicablePregnancy 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. 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 No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. 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