beractant (Rx)Brand and Other Names:Survanta

 
 
 

Dosing & Uses

AdultPediatric

Not indicated

Dosage Forms & Strengths

intratracheal suspension

  • 25mg/mL
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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
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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

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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

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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.

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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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Images

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Formulary

FormularyPatient Discounts

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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.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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