Cytra-2 Oral Solution

Generic Name: sodium citrate and citric acid
Dosage Form: oral liquid

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.

Cytra-2 Oral Solution A Sugar-Free Systemic Alkalizer

Cytra-2

Oral Solution
Rx Only
NDC 60258-001-16


DESCRIPTION
Cytra-2 Oral Solution 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.

CYTRA-2 contains in each teaspoonful (5 mL):
Sodium Citrate Dihydrate......................500 mg
Citric Acid Monohydrate.......................334 mg

Each mL contains 1 mEq Sodium Ion, and is equivalent to 1 mEq Bicarbonate (HC03).

INACTIVE INGREDIENTS:

propylene glycol, sorbitol, polyethylene glycol, sodium benzoate, sodium saccharin, grape flavor, and purified water.

Cytra-2 Oral 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 for Cytra-2 Oral Solution

Cytra-2 Oral Solution 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.

Cytra-2 Oral Solution 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

Contraindicated in patients with sodium-restricted diets, with severe renal impairment, or known hypersensitivity to any of the ingredients.

Precautions

Cytra-2 Oral Solution 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

Cytra-2 Oral Solution 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.

Cytra-2 Oral Solution Dosage and Administration

Cytra-2 Oral Solution should be administered by diluting in water, followed by additional water, if desired.  SHAKE WELL BEFORE USING.

For Systemic Alkalization:
Usual Adult Dosage:  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 is Cytra-2 Oral Solution Supplied

Cytra-2 Oral Solution is a (colorless, grape flavor) solution and is supplied in the following oral dosage form:  NDC 60258-001-16 (16 fl oz bottles).

STORAGE

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

To report a serious adverse event or to obtain product information, contact
800-856-4393.

Manufactured for:
Cypress Pharmaceutical, Inc.
Madison, MS  39110

I351   GSL     Rev. 12/11

PRODUCT PACKAGING

The packaging below represents the labeling currently used:

Principal display panel and side panel for 473 mL label:

NDC  60258-001-16

CYTRA-2
ORAL SOLUTION
(SODIUM CITRATE AND CITRIC
 ACID ORAL SOLUTION USP)

500 mg/334 mg per 5 mL


A SUGAR-FREE SYSTEMIC ALKALIZER

EACH TEASPOONFUL (5 mL) CONTAINS:
SODIUM CITRATE DIHYDRATE.......................500 mg
CITRIC ACID MONOHYDRATE.........................334 mg

Each mL contains 1 mEq Sodium Ion, and is equivalent
to 1 mEq Bicarbonate (HC03).

Rx Only

SHAKE WELL BEFORE USE

CYPRESS
PHARMACEUTICAL, INC.

16 fl oz (473 mL)

INDICATIONS AND USAGE:
Cytra-2 Oral Solution is a stable systemic alkalizer in a palatable sugar-free base.  It is useful in the management of metabolic acidosis especially when the administration of potassium salts is undesirable or contraindicated.

DOSAGE AND ADMINISTRATION:  Cytra-2 Oral Solution should be administered by diluting in water, followed by additional water, if desired.  SHAKE WELL BEFORE USING.
Usual Adult Dosage:  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 Dosage:  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, take as a single dose, or as directed by a physician.

See attached insert for full prescribing information.

STORAGE: Keep tightly closed.  Store at controlled room temperature, 20°- 25°C (68°- 77°F).  Protect from excessive heat or 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 child-resistant closure.

To report a serious adverse event or to obtain product information, call 1-800-856-4393.

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.


Manufactured for:  Cypress Pharmaceutical, Inc., Madison MS 39110        L651        Rev. 12/11








CYTRA-2 
sodium citrate and citric acid liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60258-001
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Trisodium Citrate Dihydrate (Sodium Cation) Trisodium Citrate Dihydrate 500 mg  in 5 mL
Citric Acid Monohydrate (Bicarbonate Ion) Citric Acid Monohydrate 334 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Propylene Glycol  
Sorbitol  
Polyethylene Glycol  
Sodium Benzoate  
Saccharin Sodium  
Water  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:60258-001-16 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2008
Labeler - Cypress Pharmaceutical, Inc. (790248942)
Revised: 02/2012
 
Cypress Pharmaceutical, Inc.
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