POTASSIUM CITRATE AND CITRIC ACID solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

POTASSIUM CITRATE (UNII: EE90ONI6FF) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL), CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)

Disponible desde:

Chartwell RX, LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Potassium citrate and citric acid oral solution is an effective alkalinizing agent useful in those conditions where long-term maintenance of an alkaline urine is desirable, such as in patients with uric acid and cystine calculi of the urinary tract, especially when the administration of sodium salts is undesirable or contraindicated. In addition, it is a valuable adjuvant when administered with uricosuric agents in gout therapy, since urates tend to crystallize out of an acid urine. It is also effective in correcting the acidosis of certain renal tubular disorders where the administration of potassium citrate may be preferable. This product is highly concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes the urine without producing a systemic alkalosis in recommended dosage. It is highly palatable, pleasant tasting and tolerable, even when administered for long

Resumen del producto:

Potassium Citrate and Citric Acid Oral Solution, USP (Red color liquid with cherry flavor) is supplied in the following oral dosage form: NDC 62135-435-47: 16 fl oz (473 mL) bottle STORAGE Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from excessive heat and freezing. Manufactured for: Chartwell RX, LLC Congers, NY 10920 L71146 Rev. 12/2022

Estado de Autorización:

unapproved drug other

Ficha técnica

POTASSIUM CITRATE AND CITRIC ACID- POTASSIUM CITRATE AND CITRIC
ACID SOLUTION
CHARTWELL RX, 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 CITRATE AND CITRIC ACID ORAL SOLUTION, USP
RX ONLY
DESCRIPTION
Potassium Citrate and Citric Acid Oral Solution, USP is a stable red
colored and cherry
flavored oral systemic alkalizer containing potassium citrate and
citric acid in a sugar-
free, non-alcoholic base.
Potassium Citrate and Citric Acid Oral Solution, USP contains in each
teaspoonful (5 mL):
Potassium Citrate Monohydrate, USP 1100 mg
Citric Acid Monohydrate, USP 334 mg
Each mL contains 2 mEq potassium ion and is equivalent to 2 mEq
bicarbonate (HCO
).
Inactive Ingredients: saccharin sodium, sodium benzoate, sorbitol
solution, FD&C red #
40, purified water, and wild cherry flavor.
ACTIONS
Potassium citrate is absorbed and metabolized to potassium
bicarbonate, thus acting as
a systemic alkalizer. The effects are essentially those of chlorides
before absorption and
those of bicarbonates subsequently. Oxidation is virtually complete so
that less than 5%
of the potassium citrate is excreted in the urine unchanged.
INDICATIONS AND USAGE
Potassium citrate and citric acid oral solution is an effective
alkalinizing agent useful in
those conditions where long-term maintenance of an alkaline urine is
desirable, such as
in patients with uric acid and cystine calculi of the urinary tract,
especially when the
administration of sodium salts is undesirable or contraindicated. In
addition, it is a
valuable adjuvant when administered with uricosuric agents in gout
therapy, since urates
tend to crystallize out of an acid urine. It is also effective in
correcting the acidosis of
certain renal tubular disorders where the administration of potassium
citrate may be
preferable. This product is highly concentrated, and when administered
after meals and
before bedtime, allows