Survanta

Approved and Clinically Accepted Uses:

• Parenteral Nutrition:
• Used as emulsifying agents in intravenous lipid emulsions to provide essential fatty acids and calories in patients requiring total parenteral nutrition (TPN).
• Liver Disorders (Supportive Use):
• Adjunctive therapy in chronic liver diseases such as:
• Fatty liver disease (alcoholic and non-alcoholic)
• Chronic hepatitis
• Liver fibrosis and early cirrhosis
• Neurological Support (Adjunctive Use):
• Supportive treatment in:
• Age-related cognitive decline
• Alzheimer's disease
• Mild cognitive impairment
• Respiratory Distress Syndrome (Neonates):
• Component of exogenous pulmonary surfactant replacement therapy in premature neonates with RDS.
• Cosmetic and Dermatological Applications:
• Used topically for skin hydration, repair of the skin barrier, and as delivery vehicles in transdermal formulations.
• Cardiovascular Support (Nutritional Supplements):
• Supportive role in managing dyslipidemia and cardiovascular risk factors when used in combination formulations.

Parenteral (IV Lipid Emulsion – Adults):

• Dose: 1–2 g/kg/day based on total energy requirements.
• Infusion rate: Should not exceed 0.11 g/kg/hour.
• Maximum dose: Up to 2.5 g/kg/day (as fat component).
• Administer over 12–24 hours via central or peripheral vein.

Oral (Phosphatidylcholine – Hepatic Support):

• Dose: 600–1800 mg/day in divided doses.
• Taken with meals to improve absorption.

Oral (Phosphatidylserine – Cognitive Support):

• Dose: 100 mg 2–3 times daily.
• Duration: Up to 12 weeks, based on clinical response.

Pediatric (IV Lipid Emulsion):

• Neonates and children: 1–3 g/kg/day (adjusted for age, clinical condition, and tolerance).

Elderly:

• Standard adult dosing generally applies.
• Monitor liver function and lipid profile closely.

Renal/Hepatic Impairment:

• Hepatic: Use caution; monitor liver enzymes, especially with prolonged IV use.
• Renal: No specific dose adjustments required, but monitor triglycerides and metabolic status.

Topical:

• Apply a thin layer to the affected skin once or twice daily.
• Avoid contact with eyes and mucous membranes.

Phospholipids are essential components of biological membranes. When administered, they integrate into cellular membranes, improving membrane fluidity, permeability, and function. In the liver, phospholipids help restore damaged hepatocyte membranes and enhance bile flow. In neurons, phospholipids like phosphatidylserine support synaptic integrity, neurotransmitter function, and neuroprotection. In IV lipid emulsions, phospholipids act as emulsifiers, allowing safe intravenous administration of fats by forming stable oil-in-water emulsions. In neonates, exogenous phospholipids in surfactant therapy reduce alveolar surface tension, improving lung expansion and oxygenation.

• Absorption (Oral):
• Phospholipids are hydrolyzed in the gastrointestinal tract and absorbed as fatty acids, glycerol, and choline.
• Resynthesized into phospholipids in enterocytes and liver cells.
• Distribution:
• Incorporated into cell membranes, particularly in the liver, brain, heart, and skeletal muscle.
• Metabolism:
• Metabolized in the liver via phospholipase enzymes.
• Choline is converted to betaine or acetylcholine.
• Fatty acid components are oxidized or stored.
• Excretion:
• Metabolites excreted in urine (choline) and feces (fatty acids).
• Half-life:
• Varies; generally short due to rapid utilization in membrane synthesis.

• Pregnancy:
• No formal FDA pregnancy category for natural phospholipids.
• Generally considered safe when used in nutritional or therapeutic doses.
• No evidence of teratogenicity in humans.
• Lactation:
• Safe for use during breastfeeding.
• Naturally present in breast milk and contributes to infant development.
• No known adverse effects on breastfed infants.
• Note: Caution with high-dose IV use; monitor liver function and triglyceride levels in pregnant or lactating women.

• Primary Class: Nutritional Agent

Subclasses:

• Lipid Emulsifier (parenteral nutrition)
• Hepatoprotective Agent (oral phosphatidylcholine)
• Neurotropic Supplement (phosphatidylserine)
• Pulmonary Surfactant Component (neonatal care)
• Cosmeceutical Agent (topical formulations)

• Hypersensitivity to soy, egg products, or any formulation component
• Severe hyperlipidemia or lipid metabolism disorders
• Acute pancreatitis associated with hypertriglyceridemia
• Uncontrolled sepsis (when using IV lipids)
• Severe hepatic insufficiency (relative contraindication)

• Lipid Overload Syndrome: Rare but serious condition involving hepatosplenomegaly, anemia, thrombocytopenia; monitor infusion rate and liver function.
• Soy or Egg Allergy: Phospholipids are often derived from soy or egg; hypersensitivity reactions may occur.
• Hepatic Monitoring: Long-term IV use may cause cholestasis or elevated transaminases.
• Triglyceride Monitoring: Required during high-dose IV lipid therapy.
• Neonatal Use: Requires careful dosage adjustment and metabolic monitoring.

Common:

• Gastrointestinal:
• Bloating, nausea, mild diarrhea (oral use)
• Skin (Topical):
• Mild irritation or rash
• IV Use:
• Fever, hyperlipidemia, elevated liver enzymes, nausea

Serious or Rare:

• Hypersensitivity reactions (rash, bronchospasm, anaphylaxis)
• Fat overload syndrome (dyspnea, hepatomegaly, metabolic acidosis)
• Coagulopathy or thrombocytopenia with prolonged parenteral use
• Pulmonary embolism (if administered too rapidly IV)

• Anticoagulants (e.g., Warfarin):
• High-dose phospholipids may interfere with coagulation; monitor INR
• Cholinergic Medications:
• Theoretical enhancement of effects with phosphatidylcholine or phosphatidylserine
• Corticosteroids:
• May increase lipid metabolism and influence lipid emulsions’ safety
• Alcohol:
• Chronic alcohol use may deplete endogenous phospholipid levels
• CYP450 Enzymes:
• Phospholipids do not significantly inhibit or induce CYP enzymes

• ASPEN/ESPEN 2024 Guidelines:
• Support inclusion of structured lipid emulsions with phospholipids in parenteral nutrition for optimal fatty acid delivery and reduced inflammation.
• Liver Disease Management:
• European liver societies recommend phosphatidylcholine supplementation in fatty liver disease as adjunctive therapy.
• Cognitive Function Research:
• Ongoing studies highlight potential benefits of phosphatidylserine in memory and cognitive health in elderly populations.

IV Lipid Emulsions:

• Store at 2°C to 8°C
• Do not freeze
• Protect from light
• Use immediately after opening; discard unused portion

Oral Capsules/Tablets:

• Store at 20°C to 25°C
• Keep in a dry place, protected from heat and humidity

Topical Formulations:

• Store at room temperature
• Avoid freezing
• Keep container tightly closed when not in use