Survanta

Drug overview for SURVANTA (beractant):

Generic name: BERACTANT
Drug class: Lung Surfactants
Therapeutic class: Respiratory Therapy Agents

Beractant is an exogenous pulmonary surfactant preparation.

No enhanced Uses information available for this drug.

DRUG IMAGES

SURVANTA 25 MG/ML VIAL

The following indications for SURVANTA (beractant) have been approved by the FDA:

Indications:
Prevention of respiratory distress syndrome in the newborn
Respiratory distress syndrome in the newborn

Professional Synonyms:
Congenital alveolar dysplasia prophylaxis
Congenital alveolar dysplasia
Hyaline membrane disease prophylaxis
Hyaline membrane disease
Idiopathic respiratory distress syndrome prophylaxis
Idiopathic respiratory distress syndrome
IRDS prophylaxis
Neonatal respiratory distress syndrome prophylaxis
Neonatal respiratory distress syndrome
Perinatal respiratory distress syndrome prophylaxis
Perinatal respiratory distress syndrome
Pulmonary hypoperfusion syndrome of newborn prophylaxis
Pulmonary hypoperfusion syndrome of newborn
RDS of newborn prophylaxis
RDS of newborn
Respiratory distress syndrome of newborn prophylaxis
Respiratory distress syndrome of newborn
Respiratory distress syndrome prophylaxis

The following dosing information is available for SURVANTA (beractant):

Dosing
Administration
Dosing Information
Generic

Dosage of beractant is expressed in terms of phospholipids. Each dose of beractant consists of 100 mg of phospholipids per kg of birthweight.

The recommended intratracheal (administered via a catheter inserted into an endotracheal tube) dosage of beractant for prevention of RDS in premature neonates with low birthweight or in those with evidence of an endogenous surfactant deficiency is 100 mg of phospholipids (4 mL of Survanta(R)) per kg of birthweight as soon as possible (preferably within 15 minutes) after birth and intubation. The recommended intratracheal dosage of the drug for active (rescue) treatment of RDS in neonates having radiographic evidence of the disease and requiring mechanical ventilation also is 100 mg of phospholipids per kg of birthweight; the first dose should be administered as soon as possible following initiation of mechanical ventilation, preferably within 8 hours of birth. Transient episodes of bradycardia and decreased oxygen saturation may occur during dosing; if they occur, the dosing procedure should be interrupted, and appropriate measures to alleviate the condition initiated.

Once stabilization occurs, dosing can be resumed.

Following an initial dose of beractant, the need for additional doses of the drug is determined by evidence of continuing respiratory distress. If there is evidence of continuing distress, the manufacturer states that doses of 100 mg of phospholipids per kg of birthweight (the neonate should not be reweighed) can be repeated no more frequently than every 6 hours; however, the manufacturer states that no more than 4 doses of beractant should be administered during the first 48 hours of life. The manufacturer states that the safety and efficacy of doses other than 100 mg/kg, regimens exceeding 4 doses or involving administration more frequently than every 6 hours, or administration beyond 48 hours of age have not been determined.

The manufacturer's labeling should be consulted for more detailed dosing information.

Beractant is intended for intratracheal administration only using specialized techniques. The manufacturer's labeling and/or specialized references should be consulted for guidelines on administration techniques. Beractant should be administered by or under the supervision of clinicians experienced in intubation, ventilatory management, and general care of premature neonates since the drug can rapidly affect oxygenation and pulmonary compliance.

Arterial or transcutaneous measurement of systemic oxygen and carbon dioxide should be performed frequently in neonates receiving the drug. Careful clinical observation and other measures to avoid hyperoxia are essential.

No dosing information available.

No generic dosing information available.

Moderate List
No disease contraindications

The following adverse reaction information is available for SURVANTA (beractant):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 12 severe adverse reactions.

More Frequent	Less Frequent
Bradycardia	Apnea Endotracheal tube blockage Hypercapnia Hypertension Hypotension Pallor Peripheral vasoconstriction Pulmonary hemorrhage Sepsis

Rare/Very Rare
Pneumonia Seizure disorder

There are 0 less severe adverse reactions.

The following precautions are available for SURVANTA (beractant):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

No enhanced Pregnancy information available for this drug.

No enhanced Lactation information available for this drug.

No enhanced Geriatric Use information available for this drug.

Respiratory distress syndrome in the newborn
P22.0	Respiratory distress syndrome of newborn