SODIUM PHOSPHATES monobasic monohydrate and dibasic anhydrous injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

sodium phosphate, monobasic, monohydrate (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR)

Available from:

Cardinal Health

INN (International Name):

sodium phosphate, monobasic, monohydrate

Composition:

sodium phosphate, monobasic, monohydrate 276 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM PHOSPHATES- SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM
PHOSPHATE,
DIBASIC ANHYDROUS INJECTION, SOLUTION
CARDINAL HEALTH
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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SODIUM PHOSPHATES INJECTION, USP(3 MM PHOSPHORUS/ML 4 MEQ
SODIUM/ML)OSMOLARITY 7 MOSMOL/ML
RX ONLY
CAUTION: FOR INTRAVENOUS USE ONLY MUST BE DILUTED PRIOR TO ADMINISTRATION
DESCRIPTION:
Sodium Phosphates Injection, USP is a sterile, nonpyrogenic,
concentrated solution containing a mixture
of monobasic and dibasic sodium phosphate in Water for Injection. It
must be diluted prior to
administration.
Each mL of the solution consists of two phosphate salts provided as
follows:
INGREDIENT (S)
PHOS PHORUS
SODIUM
Monobasic Sodium
Phosphate
Monohydrate - 276 mg
93 mg
or
92 mg
or
Dibasic Sodium
Phosphate
Anhydrous – 142 mg
3 mM
4 mEq
The solution contains no bacteriostatic agent or other preservative.
The solution is intended to provide phosphate ion: (PO
) for addition to large volume infusion fluids
for intravenous use. Unused portions should be discarded.
CLINICAL PHARMACOLOGY:
Phosphorus in the form of organic and inorganic phosphate has a
variety of important biochemical
functions in the body and is involved in many significant metabolic
and enzyme reactions in almost all
organs and tissues. It exerts a modifying influence on the steady
state of calcium levels, a buffering
effect on acid-base equilibrium and a primary role in the renal
excretion of hydrogen ion.
Phosphorus is present in plasma and other extracellular fluid, in cell
membranes and intracellular fluid,
as well as in collagen and bone. Phosphorus in the extracellular fluid
is primarily in inorganic form, and
plasma levels may vary somewhat with age.
The ratio of disodium phosphate and monosodium phosphate in the
extracellular fluid is 4:1 (80% :
20%) at the normal pH of 7.4. This buffer ratio varies with the pH,
but owing to i