survanta
Pharmaranks rates Survanta 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Survanta (Beractant) is a medication used to treat Premature Infant, Newborn Respiratory Distress Syndrome.
Beractant · by Abbvie
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
What is Survanta?
From the FDA label:SURVANTA ® contains beractant, a pulmonary surfactant, which is a natural bovine lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins (SP) to which colfosceril palmitate (dipalmitoylphosphatidylcholine), palmitic acid, and tripalmitin are added to standardize the composition and to mimic surface-tension lowering properties of natural lung surfactant. The resulting composition provides 25 mg/mL of phospholipids (including 11.0-15.5 mg/mL of disaturated phosphatidylcholine), 0.5-1.75 mg/mL of triglycerides, 1.4-3.5 mg/mL of free fatty acids, and less than 1 mg/mL of SP (including SP-B, a 79-amino acid protein, and SP-C, a 35-amino acid peptide). SURVANTA (beractant) intratracheal suspension is a sterile, preservative-free, non-pyrogenic off-white to light brown liquid supplied in single-dose glass vials for intratracheal use only. Each vial contains 4 mL (100 mg phospholipids) or 8 mL (200 mg phospholipids). Each mL of SURVANTA contains 25 mg of phospholipids. It is suspended in 0.9% sodium chloride solution and heat-sterilized. SURVANTA contains no preservatives. Sodium hydroxide or hydrochloric acid may be added to adjust the pH. The pH is approximately 6.2 to 7.6.
How to use
Important Administration Instructions For intratracheal administration only. SURVANTA should be administered by or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants. The administration of SURVANTA is facilitated if one person administers the dose while another person positions and monitors the infant. Before administering SURVANTA, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering SURVANTA. The infant should be allowed to stabilize before proceeding with dosing. Administer SURVANTA intratracheally by instillation through a 5 French end-hole catheter. Recommended Dosage Each dose of SURVANTA is 100 mg of phospholipids/kg birth weight (4 mL/kg). In the prevention strategy, in premature infants with evidence of surfactant deficiency, give the first dose of SURVANTA as soon as possible, preferably within 15 minutes of birth. To treat infants with RDS confirmed by radiographic and clinical findings, give the first dose of SURVANTA as soon as possible, preferably by 8 hours of age. Four doses of SURVANTA can be administered in the first 48 hours of life. Doses should be given no more frequently than every 6 hours. The need for additional doses of SURVANTA is determined by evidence of continuing…
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. Table 3. All Controlled Studies Concurrent Event SURVANTA (%) Control (%) P -Value a Patent ductus arteriosus 46.9 47.1 0.814 Intracranial hemorrhage 48.1 45.2 0.241 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 Necrotizing enterocolitis 6.1 5.3 0.427 Apnea 65.4 59.6 0.283 Severe apnea 46.1 42.5 0.114 Post-treatment sepsis 20.7 16.1 0.019 Post-treatment infection…
Warnings
Important safety information
SURVANTA can rapidly affect oxygenation and lung compliance within minutes of administration of SURVANTA. Therefore, its use should be restricted to a highly supervised clinical setting with immediate availability of clinicians experienced with intubation, ventilator management, and general care of premature infants. Infants receiving SURVANTA should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide. During the dosing procedure, transient episodes of bradycardia and decreased oxygen saturation have been reported. If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure.
Who should not take Survanta
None
Overdose — what happens if you take too much
Overdosage with SURVANTA has not been reported. Based on animal data, overdosage might result in acute airway obstruction. Treatment should be symptomatic and supportive. Rales and moist breath sounds can transiently occur after SURVANTA is given, and do not indicate overdosage. Endotracheal suctioning or other remedial action is not required unless clear-cut signs of airway obstruction are present.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
May treat (source: NIH RxClass)
Dosage forms
Suspension
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Survanta treat?
- Survanta (Beractant) may be used to treat premature infant, newborn respiratory distress syndrome, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Survanta rated?
- pharmaranks gives Survanta a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Survanta?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Survanta. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Survanta?
- Survanta is marketed by Abbvie. You can see Abbvie's full profile, rating, and other products on pharmaranks.
- Is Survanta a brand-name or generic drug?
- Survanta is a brand-name product with the active ingredient Beractant.
- Is Survanta available over the counter?
- No. Survanta is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Survanta come in?
- Survanta is currently marketed as suspension, per the FDA's National Drug Code Directory.
- Is Survanta FDA-registered?
- Survanta is on record with the U.S. FDA under application number BLA020032. You can verify this on its official FDA label.
- Has Survanta been recalled by the FDA?
- Survanta has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Survanta safe?
- There's no single safe-or-not verdict. pharmaranks gives Survanta a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Survanta?
- Survanta's side effects are taken directly from its FDA label. From the label: 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 th… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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survanta
72/100