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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fresenius Kabi USA, LLC

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 is indicated as a source of phosphate, 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 of nutrient solutions. Potassium phosphates is contraindicated in diseases where high potassium, high phosphate or low calcium levels may be encountered.

Product summary:

Potassium Phosphates Injection, USP, 3 mmol/mL, packaged 25 per carton is available as follows: The quantity of phosphate/mL is 285 mg and the quantity of potassium/mL is 170 mg.  This product is preservative free.  Any unused portion should be discarded. 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
FRESENIUS KABI USA, LLC
_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
3 MMOL PHOSPHATE/ML AND 4.4 MEQ POTASSIUM/ML
_FOR INTRAVENOUS USE ONLY MUST BE DILUTED PRIOR TO ADMINISTRATION_
DESCRIPTION
Potassium Phosphates Injection, USP is a sterile, nonpyrogenic,
concentrated solution containing a
mixture of mono and dibasic potassium phosphate in Water for Injection
q.s. It must be diluted prior to
administration.
7.4 mOsmol/mL pH 6.2 to 6.8
Each mL of the solution consists of two phosphate salts provided as
follows:
Ingredient(s)
Phosphate
Potassium
Monobasic Potassium Phosphate – 224 mg
285 mg
(3 mmol)
170 mg
(4.4 mEq)
Dibasic Potassium Phosphate – 236 mg
–
–
The solution contains no bacteriostatic agent or other preservatives.
Unused portions should be
discarded.
The solution is intended to provide phosphate ion; (PO
) for addition to large volume infusion fluids
for intravenous use.
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
4
3-
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 tissues. Phosphate 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