"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
TPN is an intravenous"...
Survanta Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Survanta (beractant) Intratracheal Suspension is made from animal lung extract and is used to treat or prevent respiratory distress syndrome in newborn infants. Common side effects of Survanta include pale skin, slow heartbeat, breathing that stops (apnea), urinating less than usual, and blood in the urine.
Each dose of Survanta is 100 mg of phospholipids/kg birth weight. Talk to your doctor about your baby's individual dosage recommendation. There are no known medications that interact with Survanta. Your child will require special care in the hospital during treatment with Survanta. Talk with your doctor about special care for handling the infant and watching for side effects while Survanta is given. Survanta is not indicated for women of child bearing age and therefore should not be taken if you are pregnant or breastfeeding.
Our Survanta (beractant) Intratracheal Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Survanta in Detail - Patient Information: Side Effects
There is a possibility that the baby will have breathing difficulties during the beractant treatment, and these problems may require further treatment by health care professionals. Your baby will remain under constant supervision during treatment with beractant.
Tell your child's caregivers at once if the child has any of these serious side effects:
- pale skin;
- slow heartbeat;
- breathing that stops;
- urinating less than usual; or
- blood in the urine.
Less serious side effects include:
- noisy breathing;
- feeding or bowel problems; or
- bleeding around the endotracheal tube.
Read the entire detailed patient monograph for Survanta (Beractant)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Survanta FDA Prescribing Information: Side Effects
The most commonly reported adverse experiences were associated with the dosing procedure. In the multiple-dose controlled clinical trials, each dose of SURVANTA was divided into four quarter-doses which were instilled through a catheter inserted into the endotracheal tube by briefly disconnecting the endotracheal tube from the ventilator. Transient bradycardia occurred with 11.9% of doses. Oxygen desaturation occurred with 9.8% of doses.
Other reactions during the dosing procedure occurred with fewer than 1% of doses and included endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage, hypertension, hypocarbia, hypercarbia, and apnea. No deaths occurred during the dosing procedure, and all reactions resolved with symptomatic treatment.
The occurrence of concurrent illnesses common in premature infants was evaluated in the controlled trials. The rates in all controlled studies are in Table 3.
|Concurrent Event||All Controlled Studies|
|SURVANTA (%)||Control (%)||P-Valuea|
|Patent ductus arteriosus||46.9||47.1||0.814|
|Severe intracranial hemorrhage||24.1||23.3||0.693|
|Pulmonary air leaks||10.9||24.7||< 0.001|
|Pulmonary interstitial emphysema||20.2||38.4||< 0.001|
|aP-value comparing groups in controlled studies|
When all controlled studies were pooled, there was no difference in intracranial hemorrhage. However, in one of the single-dose rescue studies and one of the multiple-dose prevention studies, the rate of intracranial hemorrhage was significantly higher in SURVANTA patients than control patients (63.3% v 30.8%, P = 0.001; and 48.8% v 34.2%, P = 0.047, respectively). The rate in a Treatment IND involving approximately 8100 infants was lower than in the controlled trials.
More than 4300 pretreatment and post-treatment serum samples from approximately 1500 patients were tested by Western Blot Immunoassay for antibodies to surfactant-associated proteins SP-B and SP-C. No IgG or IgM antibodies were detected.
Several other complications are known to occur in premature infants. The following conditions were reported in the controlled clinical studies. The rates of the complications were not different in treated and control infants, and none of the complications were attributed to SURVANTA.
hypotension, hypertension, tachycardia, ventricular tachycardia, aortic thrombosis, cardiac failure, cardio-respiratory arrest, increased apical pulse, persistent fetal circulation, air embolism, total anomalous pulmonary venous return.
renal failure, hematuria.
Central Nervous System
To date, no long-term complications or sequelae of SURVANTA therapy have been found.
Six-month adjusted-age follow-up evaluations of 232 infants (115 treated) demonstrated no clinically important differences between treatment groups in pulmonary and neurologic sequelae, incidence or severity of retinopathy of prematurity, rehospitalizations, growth, or allergic manifestations.
Six-month adjusted age follow-up evaluations have been completed in 631 (345 treated) of 916 surviving infants. There were significantly less cerebral palsy and need for supplemental oxygen in SURVANTA infants than controls. Wheezing at the time of examination was significantly more frequent among SURVANTA infants, although there was no difference in bronchodilator therapy.
Final twelve-month follow-up data from the multiple-dose studies are available from 521 (272 treated) of 909 surviving infants. There was significantly less wheezing in SURVANTA infants than controls, in contrast to the six-month results. There was no difference in the incidence of cerebral palsy at twelve months.
Twenty-four month adjusted age evaluations were completed in 429 (226 treated) of 906 surviving infants. There were significantly fewer SURVANTA infants with rhonchi, wheezing, and tachypnea at the time of examination. No other differences were found.
Read the entire FDA prescribing information for Survanta (Beractant)
Additional Survanta Information
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