Sodium Citrate and Citric Acid Oral Solution USP

/Sodium Citrate and Citric Acid Oral Solution USP
Sodium Citrate and Citric Acid Oral Solution USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

Sodium Citrate and Citric Acid Oral Solution USP

ID:

fc90d0cd-35e5-4b6f-ad4f-c69e2d23adb3

Code:

34391-3

DESCRIPTION


id: 37a0c44d-f802-4ef4-a6c5-38d90b51222c
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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). INACTIVE INGREDIENTS: Flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol solution.

CLINICAL PHARMACOLOGY


id: df27a87a-c461-422c-843f-64a7da407b58
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

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


id: ef9043dd-4fea-4eb0-81ec-8c3207c46ad7
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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.

CONTRAINDICATIONS


id: 44c3e9c1-296a-4afb-b408-56c644a8fb06
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Patients on sodium-restricted diets or with severe renal impairment.

PRECAUTIONS


id: 4dea151e-88be-486b-a683-969f55ff9fd9
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9

Sodium Citrate and Citric Acid Oral Solution USP should be used with caution by patients with low urinary output unless under the supervision of a physician. This product should not be administered concurrently with aluminum-based antacids. Patients should be directed to dilute adequately with water and preferably, to take each dose after meals to avoid saline laxative effect. Sodium salts should be used cautiously in patients with cardiac failure, hypertension, impaired renal function, peripheral and pulmonary edema, and toxemia of pregnancy. Periodic examinations and determinations of serum electrolytes, particularly serum bicarbonate level, should be carried out in those patients with renal disease in order to avoid these complications.

ADVERSE REACTIONS


id: 86db6cee-228a-40f7-9904-befd9840d584
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

Sodium Citrate and Citric Acid Oral Solution USP is generally well tolerated, without any unpleasant side effects, when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of alkalosis, especially in the presence of hypocalcemia.

OVERDOSAGE


id: 45f5f2d3-809c-4431-a2b9-7635a83e7fb0
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia, and convulsions.

DOSAGE AND ADMINISTRATION


id: a0bc92e5-edc6-4c43-90e6-e4ba8daaa06a
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Sodium Citrate and Citric Acid Oral Solution USP should be taken diluted in water, followed by additional water, if desired. SHAKE WELL BEFORE USING.

As a neutralizing buffer


id: 762f7c4e-0dc8-401e-a03c-ea152a841d77
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

3 teaspoonfuls (15 mL), diluted with 15 mL water, taken as a single dose, or as directed by a physician.

HOW SUPPLIED


id: 374d3dfa-7f04-4f77-92d2-8d669d1f3e89
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Sodium Citrate and Citric Acid Oral Solution USP (colorless, grape flavor) is supplied in the following oral dosage forms: Overbagged with 5 cups per bag, (Unit dose cups of 30 mL) NDC 55154-9410-5.

PRINCIPAL DISPLAY PANEL


id: cf64bc23-d152-4ac1-84f2-32558fa14ef2
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Sodium Citrate and Citric Acid Oral Solution USP 3 g/2g per 30 mL Sugar Free 5 Cups