Clinolipid

— THERAPEUTIC CATEGORIES —
  • Parenteral nutrition

Clinolipid Generic Name & Formulations

General Description

Lipid content 0.2g/mL (mixture of refined olive oil and soybean oil [4:1]); emulsion for IV infusion; contains aluminum.

Pharmacological Class

Fatty acids.

How Supplied

Emulsion (100mL)—15; (250mL)—10; (500mL)—12; (1000mL)—6

Manufacturer

Generic Availability

NO

Mechanism of Action

Fatty acids serve as an important substrate for energy production. The most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation. Fatty acids are important for membrane structure and function, precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression.

Clinolipid Indications

Indications

To provide a source of calories and essential fatty acids in adults requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Clinolipid Dosage and Administration

Adult

Individualize. Dose based on patient’s energy expenditure, clinical status, body wt, tolerance, ability to metabolize Clinolipid, and additional energy given orally/enterally. Administer by IV infusion via central or peripheral vein. Usual dose: 1–1.5g/kg/day (max: 2.5g/kg/day); daily dosage should not exceed a max of 60% of total energy requirements. Initiate rate at max 0.5mL/min for the first 15–30mins (max: 0.5mL/kg/hr); increase gradually to required rate after 30mins. Usual infusion duration: 12–24 hours based on patient’s clinical status. If serum triglycerides (>400mg/dL): initiate at a lower dose and increase in smaller increments; check levels before each adjustment. For complete parenteral nutrition: supplement with amino acids, carbohydrates, electrolytes, vitamins and trace elements.

Children

Not established.

Clinolipid Contraindications

Contraindications

Egg, peanut, or soybean allergy. Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride >1000mg/dL).

Clinolipid Boxed Warnings

Not Applicable

Clinolipid Warnings/Precautions

Warnings/Precautions

Clinical decompensation with rapid infusion of IV lipid emulsion in neonates and infants. Risk of Parenteral Nutrition Associated Liver Disease (PNALD) and other hepatobiliary disorders; monitor liver function and consider discontinuation or dose reduction if abnormalities occur. LFTs occur. Correct severe fluid and electrolyte disorders, fluid overload states, and metabolic disorders prior to initiating. Measure serum triglycerides at baseline, with each dose increase, and regularly during therapy. Discontinue and treat if hypersensitivity reactions occur. Monitor for signs/symptoms of infection and essential fatty acid deficiency (EFAD). Severely undernourished: avoid overfeeding. Patients with pulmonary edema, heart failure: monitor fluid status closely.  Monitor fluids, electrolytes, serum osmolarity, blood glucose, kidney function, CBCs, platelets, coagulation parameters throughout treatment. Hepatic impairment. Pregnancy. Nursing mothers.

Clinolipid Pharmacokinetics

Metabolism

  • Metabolized by cells to carbon dioxide and water resulting in the generation of energy in the form of adenosine triphosphate (ATP).

Elimination

  • Carbon dioxide is expired through the lungs. Water is excreted through the kidneys or lost through evaporation/expiration through the skin, lungs, and other tissue surfaces. Some lipids (ie, phospholipids, cholesterol, and bile acids) are excreted through the biliary system.

Clinolipid Interactions

Interactions

Vitamin K content may antagonize anticoagulants (eg, coumarin, warfarin); monitor. High lipid levels in plasma may interfere with the results of certain blood tests. May precipitate if mixed with dextrose and/or amino acid solutions; check compatibility.

Clinolipid Adverse Reactions

Adverse Reactions

Nausea, vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia, abnormal LFTs; hypersensitivity reactions, infections, refeeding syndrome, PNALD, hypertriglyceridemia, aluminum toxicity (esp. preterm infants, renal impairment); rare: fat overload syndrome.

Clinolipid Clinical Trials

See Literature

Clinolipid Note

Not Applicable

Clinolipid Patient Counseling

See Literature