FDA Label for Sodium Citrate And Citric Acid

Other

A Sugar-Free Systemic Alkalizer

Distributed by:
American Health Packaging
Columbus, OH 43217

R02/24

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 (HCO ₃).

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 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

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

Precautions

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

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.

To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

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

Dosage And Administration

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

Usual Adult Dose

2 to 6 teaspoonfuls (10 to 30 mL), diluted in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician.

Usual Pediatric Dose

1 to 3 teaspoonfuls (5 to 15 mL), diluted in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician. For children under two years of age, use is based on consultation with a physician.

As A Neutralizing Buffer

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

How Supplied

Sodium Citrate and Citric Acid Oral Solution USP (colorless, grape flavor) is supplied in the following oral dosage forms:

1.5 g/1 g in 15 mL cups packaged as 100 cups (10 x 10)
NDC 60687-832-16

3 g/2 g in 30 mL cups packaged as 100 cups (10 x 10)
NDC 60687-834-76

Storage:

Store at controlled room temperature, 20° to 25°C (68° to 77°F). Protect from freezing.

Rx ONLY

DO NOT USE IF SEAL IS BROKEN.

Package/Label Display Panel – Cup Lid – 1.5 G/1 G Per 15 Ml

Rx Only

NDC 60687- 832-44

Sodium Citrate and
Citric Acid
ORAL SOLUTION, USP

1.5 g/1 g per 15 mL

Sugar Free

Delivers 15 mL

SHAKE WELL – DILUTE AS DIRECTED
PROTECT FROM FREEZING.

See package insert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0595C150224

Package/Label Display Panel – Cup Lid – 3 G/2 G Per 30 Ml

Rx Only

NDC 60687- 834-45

Sodium Citrate and
Citric Acid
ORAL SOLUTION, USP

3 g/2 g per 30 mL

Sugar Free

Delivers 30 mL

SHAKE WELL – DILUTE AS DIRECTED
PROTECT FROM FREEZING.

See package insert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0595C300224