"The US Food and Drug Administration (FDA) has expanded the indication for the short-acting beta-agonist albuterol sulfate inhalation powder (ProAir RespiClick, Teva) to children aged 4 to 11 years, the company announced today.
SURFAXIN (lucinactant) Intratracheal Suspension is a sterile, non-pyrogenic pulmonary surfactant intended for intratracheal use only. It is a synthetic formulation consisting of phospholipids, a fatty acid, and sinapultide (KL4 peptide), a 21-amino acid hydrophobic synthetic peptide. The chemical names, structures, and empirical formulas of the 4 active components of SURFAXIN are:
Sinapultide (KL4 acetate)
Chemical Name: L-Lysyl-L-leucyl-L-leucyl-L-leucyl-L-leucyl-L-lysyl-L-leucyl-L-leucyl-L-leucyl-L-leucyl-L-lysyl-L-leucyl-L-leucyl-L-leucyl-L-leucyl-L-lysyl-L-leucyl-L-leucyl-L-leucyl-L-leucyl-L-lysine, acetate
Empirical Formula: C126H238N26O22 Molecular Weight: 2469.46
Chemical Name: 1,2-dipalmitoyl-sn-glycero-3-phosphocholine
Empirical Formula: C40H80NO8P Molecular Weight: 734.06
Chemical Name: 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol, sodium salt
Empirical Formula: C40H76O10PNa Molecular Weight: 771.00
Chemical Name: Palmitic acid (hexadecanoic acid)
Empirical Formula: C16H32O2 Molecular Weight: 256.43
SURFAXIN is a white to off-white opaque gel-like suspension at 2° to 8°C (36° to 46°F), which becomes a free-flowing suspension upon warming for 15 minutes in a dry block heater set at 44°C (111°F). Each mL of SURFAXIN provides 30 mg phospholipids (22.50 mg DPPC and 7.50 mg POPG, Na), 4.05 mg PA, and 0.862 mg sinapultide in tromethamine and sodium chloride. Glacial acetic acid is used to adjust the pH of the buffer to 7.4 (range 7.0 to 8.0). SURFAXIN contains no preservatives.
What are the possible side effects of lucinactant (Surfaxin)?
Lucinactant causes few side effects. There is a possibility that the baby will have breathing difficulties during the lucinactant treatment, and these problems may require further treatment by health care professionals. Your baby will remain under constant supervision during treatment with lucinactant.
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...
Last reviewed on RxList: 3/16/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Surfaxin Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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