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sodium phosphates injection, USP Description

DESCRIPTION

Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection.

The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted.

Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate).

One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO4. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc).

The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use.

It is provided as a 15 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit.

Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH2PO4• H2O, white, odorless crystals or granules freely soluble in water.

Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na2HPO4, colorless or white granular salt freely soluble in water.

The semi-rigid container is 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.

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