POTASSIUM CITRATE AND CITRIC ACID- potassium citrate and citric acid monohydrate solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

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Fachinformation Fachinformation (SPC)
25-01-2023

Wirkstoff:

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

Verfügbar ab:

PAI Holdings, LLC

INN (Internationale Bezeichnung):

POTASSIUM CITRATE

Zusammensetzung:

POTASSIUM CITRATE 1100 mg in 5 mL

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Potassium Citrate and Citric Acid Oral Solution USP 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 l

Produktbesonderheiten:

Potassium Citrate and Citric Acid Oral Solution USP (clear pink to red colored; berry-citrus flavored) is supplied in the following oral dosage form: NDC 0121-0676-16: 16 fl oz (473 mL) bottle Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from excessive heat and freezing.

Berechtigungsstatus:

unapproved drug other

Fachinformation

                                POTASSIUM CITRATE AND CITRIC ACID- POTASSIUM CITRATE AND CITRIC ACID
MONOHYDRATE SOLUTION
PAI HOLDINGS, 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._
----------
POTASSIUM CITRATE AND CITRIC ACID ORAL SOLUTION USP
RX ONLY
DESCRIPTION
Potassium Citrate and Citric Acid Oral Solution USP is a stable and
pleasant-tasting 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 1100 mg
CITRIC ACID Monohydrate 334 mg
Each mL contains 2 mEq potassium ion and is equivalent to 2 mEq
bicarbonate (HCO
).
Inactive Ingredients: FD&C Red No. 40, flavoring, polyethylene glycol,
propylene glycol,
purified water, sodium benzoate, and sorbitol solution.
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 USP 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, a
                                
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