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All price changes →Indications & Uses
Phospholipids (Alveofact) is indicated for the prevention and treatment of Respiratory Distress Syndrome (RDS), also known as hyaline membrane disease, in premature infants. For prevention, in premature infants under 1250 g birthweight, or with evidence of surfactant deficiency, give it as soon as possible, preferably within 15 minutes of birth. For rescue, in infants with RDS confirmed by X-ray who need mechanical ventilation, give it as soon as possible, preferably by 8 hours of age. Results from clinical studies suggest that little benefit is likely when infants have completed a prenatal course of corticosteroids, unless they develop RDS within the first 6 to 8 hours of life. The results for outborn and inborn infants were not analysed separately in the clinical trials. Outborn infants were distributed equally between the treatment groups and were not considered likely to bias the estimation of treatment effect. So there does not appear to be any evidence that outborn infants respond less well to treatment with the medicine.
Pharmacology
Pulmonary surfactant is made naturally in the body. It lowers surface tension on the surfaces of the alveoli while a person breathes, and it keeps the alveoli from collapsing at resting transpulmonary pressures. Premature infants who lack enough surfactant develop Respiratory Distress Syndrome (RDS). Phospholipids replace the missing surfactant and bring back surface activity in the lungs of these infants.
In vitro, Phospholipids lowered minimum surface tension to less than 8 dynes/cm every time they were tested, on both the pulsating bubble surfactometer and the Wilhelmy Surface Balance. In vivo, single doses of Phospholipids improved lung pressure-volume measurements, lung compliance and oxygenation in premature rabbits and sheep.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Phospholipids are for intratracheal administration only. They should be given by clinicians experienced in intubation, ventilator management and the general care of premature infants, or under their supervision.
Oxygenation can improve markedly within minutes of administration of Phospholipids. So frequent and careful clinical observation and monitoring of systemic oxygenation are essential to avoid hyperoxia.
Each dose is 100 mg of phospholipid/kg birth weight (4 mL/kg). The Phospholipids Dosage Chart shows the total dosage for a range of birth weights.
Four doses can be given in the first 48 hours of life. Doses should be given no more frequently than every 6 hours.
Side Effects
With phospholipids, the reported effects on the respiratory system are lung consolidation, blood from the endotracheal tube, deterioration after weaning, respiratory decompensation, subglottic stenosis, paralyzed diaphragm and respiratory failure. Cardiovascular effects include hypotension, hypertension, tachycardia, ventricular tachycardia, aortic thrombosis, cardiac failure and cardio-respiratory arrest. Increased apical pulse, persistent foetal circulation, air embolism and total anomalous pulmonary venous return have also been reported. In the gut, the problems are abdominal distension, haemorrhage, intestinal perforations, volvulus, bowel infarct, loading intolerance, hepatic failure and stress ulcer. Kidney effects are renal failure and haematuria. Blood-related effects are coagulopathy, thrombocytopenia and disseminated intravascular coagulation. In the central nervous system, seizures have been seen. Endocrine and metabolic effects are adrenal haemorrhage, inappropriate ADH secretion and hyperphosphataemia. Inguinal hernia is listed under the musculoskeletal effects, and fever and deterioration are listed as general (systemic) effects.
Cautions & Contraindications
Warnings & Precautions
Phospholipids are for intratracheal use only. They can quickly affect oxygenation and lung compliance, so they should be used only in a closely supervised clinical setting. Clinicians experienced in intubation, ventilator management and the general care of premature infants must be available immediately. Infants receiving Phospholipids should be monitored often, with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide. During dosing, short episodes of bradycardia and decreased oxygen saturation have been reported. If either happens, stop the dosing procedure and take appropriate measures to relieve the condition. Once the infant is stable, resume dosing. General: Rales and moist breath sounds can occur for a short time after administration. Endotracheal suctioning or other remedial action is not necessary unless there are clear signs of airway obstruction. An increased probability of post-treatment nosocomial sepsis was seen in Phospholipids-treated infants in the controlled clinical trials (See Table). This increased risk of sepsis was not linked to increased mortality among these infants. The causative organisms were similar in treated and control infants, and there was no significant difference between the groups in the rate of post-treatment infections other than sepsis. Use of Phospholipids in infants of less than 600 g birth weight or greater than 1750 g birth weight has not been evaluated in controlled trials. There is also no controlled experience with Phospholipids used together with experimental therapies for RDS (eg. high-frequency ventilation or extracorporeal membrane oxygenation). No information is available on the effects of doses other than 100 mg Alveofacts / kg, more than four doses, dosing more often than every 6 hours, or giving the medicine after 48 hours of age.
Overdose
No case of overdose with Phospholipids has been reported. Animal data suggest that an overdose might cause acute airway obstruction, so treatment should be symptomatic and supportive. After Phospholipids is given, rales and moist breath sounds can appear for a short time. These don't mean an overdose has happened. Endotracheal suctioning or any other remedial action isn't needed unless there are clear signs of airway obstruction.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store unopened Phospholipids vials in a refrigerator at 2 to 8°C, and protect them from light. Keep the vials in their carton until you are ready to use them. Each vial is for single use only, so upon opening, discard any unused drug.
Common questions about Survanta 25 mg/ml
What is Survanta 25 mg/ml Intratracheal Suspension?
Survanta 25 mg/ml Intratracheal Suspension is a medicine that contains Phospholipids. It is made by Unimed Unihealth Pharmaceuticals Ltd. It belongs to the Cholagogues group of medicines.
What is Survanta used for?
Phospholipids (Alveofact) is indicated for the prevention and treatment of Respiratory Distress Syndrome (RDS), also known as hyaline membrane disease, in premature infants. For prevention, in premature infants under 1250 g birthweight, or with evidence of surfactant deficiency, give it as soon as possible, preferably within 15 minutes of birth.
What are the side effects of Survanta?
With phospholipids, the reported effects on the respiratory system are lung consolidation, blood from the endotracheal tube, deterioration after weaning, respiratory decompensation, subglottic stenosis, paralyzed diaphragm and respiratory failure. Cardiovascular effects include hypotension, hypertension, tachycardia, ventricular tachycardia, aortic thrombosis, cardiac failure and cardio-respiratory arrest.
What happens if I take too much Survanta?
No case of overdose with Phospholipids has been reported. Animal data suggest that an overdose might cause acute airway obstruction, so treatment should be symptomatic and supportive. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Survanta?
Store unopened Phospholipids vials in a refrigerator at 2 to 8°C, and protect them from light. Keep the vials in their carton until you are ready to use them.
Do I need a prescription for Survanta?
Survanta is a prescription (Rx) medicine. Take it as your doctor advises.