POTASSIUM PHOSPHATES- potassium phosphate, monobasic and potassium phosphate, dibasic injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MONOBASIC POTASSIUM PHOSPHATE (UNII: 4J9FJ0HL51) (POTASSIUM CATION - UNII:295O53K152, PHOSPHATE ION - UNII:NK08V8K8HR), DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR, POTASSIUM CATION - UNII:295O53K152)

Available from:

Hospira, Inc.

INN (International Name):

POTASSIUM PHOSPHATE, MONOBASIC

Composition:

POTASSIUM PHOSPHATE, MONOBASIC 224 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Potassium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of potassium (K+ 4.4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.     Safety has not been established for parenteral nutrition in pediatric patients due to the risk of aluminum toxicity. (See WARNINGS) Potassium phosphate is contraindicated in diseases where high potassium, high phosphorus or low calcium levels may be encountered.

Product summary:

Potassium Phosphates Injection, USP is supplied as follows: NDC 0409-7295-01 Tray containing 25 vials 45 mM (3 mM P/mL) containing 66 mEq K+ (4.4 mEq/mL) NDC 0409-7295-11 15 mL Single-dose Fliptop Vial Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

unapproved drug other

Summary of Product characteristics

POTASSIUM PHOSPHATES- POTASSIUM PHOSPHATE, MONOBASIC AND POTASSIUM
PHOSPHATE, DIBASIC INJECTION, SOLUTION, CONCENTRATE
HOSPIRA, INC.
_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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POTASSIUM PHOSPHATES INJECTION, USP
POTASSIUM
PHOSPHATES
INJECTION, USP
3 MM P/ML AND 4.4 MEQ K /ML
_FOR ADDITIVE USE ONLY AFTER DILUTION IN I.V. FLUIDS_
FLIPTOP VIAL
RX ONLY
DESCRIPTION
Potassium Phosphates Injection, USP 3 mM P/mL (millimoles/mL) is a
sterile,
nonpyrogenic, _concentrated solution_ containing a mixture of mono-
and dibasic
potassium 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 milliliter contains 224 mg of monobasic potassium phosphate,
anhydrous and
236 mg of dibasic potassium phosphate, anhydrous. One mM of phosphorus
weighs 31
mg and the product provides 93 mg (approximately 3 mM) of
phosphorus/mL, plus
170.3 mg (4.4 mEq) of potassium/mL. NOTE: 1 mM P=1 mM PO .
It contains no bacteriostat, antimicrobial agent or added buffer. The
osmolar
concentration is 7.4 mOsmol/mL (calc.). The solution is intended as an
alternative to
sodium phosphate to provide phosphorus for addition to large volume
infusion fluids for
intravenous use.
Monobasic Potassium Phosphate, NF (monopotassium phosphate), anhydrous
is
chemically designated KH PO , colorless crystals or white granular
powder freely soluble
in water.
Dibasic Potassium Phosphate, USP (dipotassium phosphate), anhydrous is
chemically
designated K HPO , white granules very soluble in water.
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