Hypertonic Saline

DRUG DESCRIPTION

3% and 5% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents. Composition, ionic concentration, osmolarity, and pH are shown in Table 1.

Table 1

	size (mL)	Composition (g/L)	Ionic Concentration (mEq/L)		*Osmolarity (mOsmol/L) (calc)	pH
		Sodium Chloride USP (NaCl)	Sodium	Chloride
3% Sodium Chloride Injection, USP	500	30	513	513	1027	5.0 (4.5 to 7.0)
5% Sodium Chloride Injection, USP	500	50	856	856	1711	5.0 (4.5 to 7.0)
*Normal physiological osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions ( ≥ 600 mOsmol/L) may cause vein damage.

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl
chloride (PL 146 Plastic). The amount of water that can permeate from inside
the container into the overwrap is insufficient to affect the solution significantly.
Solutions in contact with the plastic container can leach out certain of its
chemical components in very small amounts within the expiration period, e.g.,
di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety
of the plastic has been confirmed in tests in animals according to USP biological
tests for plastic containers as well as by tissue culture toxicity studies.