SODIUM CITRATE AND CITRIC ACID- sodium citrate and citric acid monohydrate solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

SODIUM CITRATE (UNII: 1Q73Q2JULR) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL), ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)

Tillgänglig från:

Pharmaceutical Associates, Inc.

INN (International namn):

SODIUM CITRATE

Sammansättning:

SODIUM CITRATE 500 mg in 5 mL

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Sodium Citrate and Citric Acid Oral Solution USP is an effective alkalinizing agent. It is useful in those conditions where long-term maintenance of an alkaline urine is desirable, and is of value in the alleviation of chronic metabolic acidosis, such as results from chronic renal insufficiency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is undesirable or contraindicated. This product is also useful for buffering and neutralizing gastric hydrochloric acid quickly and effectively. Sodium Citrate and Citric Acid Oral Solution USP is 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 the recommended dosage. This product is highly palatable, pleasant tasting, and tolerable, even when administered for long periods. Patients on sodium-restricted diets or with s

Produktsammanfattning:

Sodium Citrate and Citric Acid Oral Solution USP (colorless, grape flavor) is supplied in the following oral dosage forms: NDC 0121-0595-16: 16 fl oz (473 mL) bottle NDC 0121-0595-15: 15 mL unit dose cup. Case contains 100 unit-dose cups of 15 mL (NDC 0121-0595-00), packaged in 10 trays of 10 unit-dose cups each. NDC 0121-1190-30: 30 mL unit dose cup. Case contains 100 unit-dose cups of 30 mL (NDC 0121-1190-00) packaged in 10 trays of 10 unit-dose cups each. .

Bemyndigande status:

unapproved drug other

Produktens egenskaper

SODIUM CITRATE AND CITRIC ACID- SODIUM CITRATE AND CITRIC ACID
MONOHYDRATE SOLUTION
PHARMACEUTICAL ASSOCIATES, 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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SODIUM CITRATE AND CITRIC ACID ORAL SOLUTION USP
A Sugar-Free Systemic Alkalizer
DESCRIPTION
Sodium Citrate and Citric Acid Oral Solution USP is a stable and
pleasant-tasting systemic
alkalizer containing sodium citrate and citric acid in a sugar-free
base. It is a
nonparticulate neutralizing buffer.
Sodium Citrate and Citric Acid Oral Solution USP contains in each
teaspoonful (5 mL):
SODIUM CITRATE Dihydrate 500 mg (0.34 Molar)
CITRIC ACID Monohydrate 334 mg (0.32 Molar)
Each mL contains 1 mEq sodium ion and is equivalent to 1 mEq
bicarbonate (HCO3).
Sodium citrate contains the following inactive ingredients: flavoring,
polyethylene glycol,
propylene glycol, purified water, sodium benzoate, and sorbitol
solution.
CLINICAL PHARMACOLOGY
Sodium citrate is absorbed and metabolized to sodium 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 sodium citrate is excreted in the urine unchanged.
INDICATIONS AND USAGE
Sodium Citrate and Citric Acid Oral Solution USP is an effective
alkalinizing agent. It is
useful in those conditions where long-term maintenance of an alkaline
urine is desirable,
and is of value in the alleviation of chronic metabolic acidosis, such
as results from
chronic renal insufficiency or the syndrome of renal tubular acidosis,
especially when the
administration of potassium salts is undesirable or contraindicated.
This product is also
useful for buffering and neutralizing gastric hydrochloric acid
quickly and effectively.
Sodium Citrate and Citric Acid Oral Solution USP is concentrated, and
when administered
after meals and before b