NOT FOR USE IN NEWBORNS
Heparin Lock Flush Solution, USP is a sterile, nonpyrogenic, hypertonic
preparation of heparin sodium injection, USP with sodium chloride in water
Each milliliter (mL) contains: Heparin sodium, 10 or 100 USP units
(derived from porcine intestinal mucosa); sodium chloride 9 mg; edetate
disodium, anhydrous 0.1 mg added as a stabilizer; and benzyl alcohol 9
mg added as preservative in water for injection. Headspace nitrogen gassed.
May contain sodium hydroxide for pH adjustment. pH 6.5 (5.0 to 7.5). The
osmolar concentrations of these solutions are 392 mOsmol/L (calc). Repeated
withdrawals may be made from the multiple-dose vial.
Heparin Lock Flush Solution, USP is intended for maintenance of potency
of intravenous injection devices only and is not to be used for anticoagulant
Heparin Sodium, USP is a heterogenous group of straight-chain anionic
mucopolysaccharides, called glycosaminoglycans having anticoagulant properties.
Although others may be present, the main sugars occurring in heparin are:
(1) a-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-a-0-glucose
6-sulfate, (3) b-0-glucuronic acid, (4) 2-acetamido-2-deoxy-a-D-glucose,
and (5) a-L-iduronic acid. These sugars
are present in decreasing amounts, usually in the order (2)>(1)>(4)>(3)>(5),
and are joined by glycosidic linkages, forming polymers of varying sizes.
Heparin is strongly acidic because of its content of covalently linked
sulfate and carboxylic acid groups. In heparin sodium the acidic protons
of the sulfate units are partially replaced by sodium ions. The potency
is determined by a biological assay using a USP reference standard based
on units of heparin activity per milligram.
Sodium Chloride, USP is chemically designated NaCl, a white crystalline
compound freely soluble in water.
The semi-rigid vials are fabricated from a specially formulated polyolefin.
It is a copolymer of ethylene and propylene. The safety of the plastic
has been confirmed by tests in animals according to USP biological standards
for plastic containers. The container requires no vapor barrier to maintain
the proper drug concentration.