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

Westminster Pharmaceuticals, LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Potassium Citrate and Citric Acid Oral Solution USP is a (red colored; cherry flavored) oral solution and is supplied in the following oral dosage form: NDC 69367-321-16 (16 fl oz bottles). Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from excessive heat and freezing. Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Dispense in a tight, light-resistant container as defined in the USP/NF with a childresistant closure. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSAGE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Call your doctor for medical advice about side effects. You may report side effects to Westminster Pharmaceuticals, LLC at 1-844-221-7294.

Estado de Autorización:

unapproved drug other

Ficha técnica

POTASSIUM CITRATE AND CITRIC ACID- POTASSIUM CITRATE AND CITRIC ACID
MONOHYDRATE SOLUTION
WESTMINSTER PHARMACEUTICALS, 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
NDC 69367-321-16
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
cherry flavor, FD&C red #40, purified water, sodium benzoate, sodium
saccharin,
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
3
certain renal tubular disorders where the administration of potassium
citrate may be
preferable.