Sodium Citrate and Citric Acid

SODIUM CITRATE AND CITRIC ACID- sodium citrate, unspecified form and anhydrous citric acid solution
Cardinal Health

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.

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).

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.

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.

For Systemic Alkalization

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:

Overbagged with 5x 30 mL unit dose cups per bag, 55154-5777-5

STORAGE:

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from freezing.

Rx ONLY

Manufactured By:
Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com

Distributed by:
Cardinal Health

Dublin, OH 43017

L53713071118

R06/16

Package/Label Display Panel

Sodium Citrate and Citric Acid Oral Solution USP

3 g/2 g per 30 mL

Sugar Free

5 Cups

bag label
(click image for full-size original)
SODIUM CITRATE AND CITRIC ACID
sodium citrate and citric acid monohydrate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5777(NDC:0121-1190)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CITRATE, UNSPECIFIED FORM (ANHYDROUS CITRIC ACID) SODIUM CITRATE, UNSPECIFIED FORM 500 mg in 5 mL
ANHYDROUS CITRIC ACID (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 334 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SORBITOL
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-5777-5 5 CUP, UNIT-DOSE in 1 BAG contains a CUP, UNIT-DOSE
1 30 mL in 1 CUP, UNIT-DOSE This package is contained within the BAG (55154-5777-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/1969
Labeler — Cardinal Health (603638201)

Revised: 06/2019 Cardinal Health

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.