Cytra-3 Oral Syrup Prescribing Information

Drug Detail:Cytra-k (Citric acid and potassium citrate [ sit-rik-as-id-and-poe-tass-ee-um-si-trate ])

Drug Class: Minerals and electrolytes

Cytra-3 Oral Syrup Description

Rx Only
NDC 60258-002-16

DESCRIPTION
CYTRA-3 Syrup is a stable and pleasant-tasting oral systemic alkalizer containing potassium citrate, sodium citrate, and citric acid in a sugar-free, non-alcoholic base.

CYTRA-3 Syrup contains in each teaspoonful (5 mL):
Potassium Citrate Monohydrate.....550 mg
Sodium Citrate Dihydrate.....500 mg
Citric Acid Monohydrate.....334 mg

Each 1 mL contains 1 mEq potassium ion and 1 mEq sodium ion and is equivalent to 2 mEq bicarbonate (HCO3)

Inactive Ingredients:
propylene glycol, sorbitol, polyethylene glycol 400, sodium benzoate, sodium saccharin, FD and C yellow #6, raspberry flavor, and purified water.

Potassium Citrate Monohydrate has the chemical name: 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tripotassium salt, monohydrate. Its chemical structure is as follows.

Potassium Citrate Monohydrate chemical structure

Sodium Citrate Dihydrate has the chemical name: 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, trisodium salt, dihydrate. Its chemical structure is as follows.

Sodium Citrate Dihydrate chemical structure

Citric Acid Monohydrate has the chemical name: 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, monohydrate. Its chemical structure is as follows.

Citric Acid Monohydrate chemical structure

Cytra-3 Oral Syrup - Clinical Pharmacology

Potassium citrate and sodium citrate are absorbed and metabolized to potassium bicarbonate and sodium bicarbonate, thus acting as systemic alkalizers. 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 citrates are excreted in the urine unchanged.

Indications and Usage for Cytra-3 Oral Syrup

CYTRA-3 Syrup 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. 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. This product is highly concentrated and when administered after meals and before bedtime, allows one to maintain an alkaline urine 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 dosages. It is highly palatable, pleasant tasting, and tolerable, even when administered for long periods. Potassium citrate and sodium citrate do not neutralize the gastric juice or disturb digestion.

Contraindications

Severe renal impairment with oliguria or azotemia, untreated Addison's disease, or severe myocardial damage. In certain situations, when patients are on a sodium-restricted diet, the use of potassium citrate may be preferable; or, when patients are on a potassium-restricted diet, the use of sodium citrate may be preferable.

Warnings and Precautions

There have been several reports, published and unpublished, concerning nonspecific small-bowel lesions consisting of stenosis, with or without ulceration, associated with the administration of enteric-coated thiazides with potassium salts. These lesions may occur with enteric-coated potassium tablets alone or when they are used with nonenteric-coated thiazides, or certain other diuretics. These small-bowel lesions have caused obstruction, hemorrhage, and perforation. Surgery was frequently required and deaths have occurred. Based on a large survey of physicians and hospitals, both United States and foreign, the incidence of these lesions is low, and a casual relationship in man has not been definitely established. Available information tends to implicate enteric-coated potassium salts, although lesions of this type also occur spontaneously. Therefore, coated potassium-containing formulations should be administered only when indicated, and should be discontinued immediately if abdominal pain, distention, nausea, vomiting, or gastrointestinal bleeding occur.

Do not exceed recommended dosage. Discontinue use if adverse reactions occur. Should be used with caution by patients with low urinary output or reduced glomerular filtration rates unless under the supervision of a physician. Aluminum-based antacids should be avoided in these patients. Patients should be directed to dilute adequately with water and, preferably, to take each dose after meals, to minimize the possibility of gastrointestinal injury associated with oral ingestion of potassium salt perparations and to avoid saline laxative effect. Sodium salts should be used cautiously in patients with cardiac failure, hypertension, peripheral and pulmonary edema, and toxemia of pregnancy.

Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity. Periodic examination 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/Side Effects

CYTRA-3 Syrup 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 hyperkalemia or alkalosis, especially in the presence of hypocalcemia. Potassium intoxication causes listlessness, weakness, mental confusion, and tingling of extremities.

Overdosage

Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia, and convulsions. Overdosage with potassium salts may cause hyperkalemia and alkalosis, especially in the presence of renal disease.

Cytra-3 Oral Syrup Dosage and Administration

CYTRA-3 Syrup should be administered by diluting with water, followed by additional water, if desired. Palatability is enhanced if chilled before taking.

Proper dilution may help prevent gastrointestinal injury associated with the oral ingestion of concentrated potassium salt preparations.

Usual Adult Dosage: 3 to 6 teaspoonfuls (15 to 30 mL), diluted with water, for times a day, after meals and at bedtime, or as directed by a physician.
Usual Pediatric Dosage: 1 to 3 teaspoonfuls (5 to 15 mL), diluted with water, four times a day, after meals and at bedtime, or as directed by a physician.

Usual Dosage Range: 2 to 3 teaspoonfuls (10 to 15 mL), diluted with water, taken four times a day, will usually maintain a urinary pH of 6.5-7.4. 3 to 4 teaspoonfuls (15 to 20 mL), diluted with water taken four times a day, will usually maintain a urinary pH of 7.0-7.6 throughout most of the 24 hours without unpleasant side effects. To check urine pH, HYDRION Paper (pH 6.0-8.0) or NITRAZINE Paper (pH 4.5-7.5) are available and easy to use.

SHAKE WELL BEFORE USING

How is Cytra-3 Oral Syrup supplied

CYTRA-3 Syrup (orange colored, raspberry flavored) is supplied in the following oral dosage form: NDC 60258-002-16 (16 fl oz bottles).

Storage and Handling

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 child-resistant 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.

Manufactured for:
Cypress Pharmaceutical
Madison, MS 39110 I350 Rev. 09/10

PRODUCT PACKAGING

The packaging below represents the labeling currently used:

Principal Display Panel and Side Panel for 473 mL Label:

NDC 60258-002-16

CYTRA-3 SYRUP

500 mg/500 mg/ 334mg per 5 mL

A SUGAR-FREE SYSTEMIC ALKALIZER

EACH TEASPOONFUL (5 mL) CONTAINS:
POTASSIUM CITRATE MONOHYDRATE.....550 mg
SODIUM CITRATE DIHYDRATE.....500 mg
CITRIC ACID MONOHYDRATE.....334 mg

Each mL contains 1 mEq Potassium Ion and 1 mEq Sodium Ion, and
is equivalent to 2 mEq Bicarbonate (HCO3).

Note: The pH limits for this product, 4.7 - 5.4, differ from the USP limits
of 4.9 - 5.4.

Rx Only

CYPRESS PHARMACEUTICAL, INC

16 fl oz (473 mL)

INDICATIONS AND USAGE:
Cytra-3 Syrup is a stable and pleasant-tasting oral syrup containing potassium citrate, sodium citrate, and citric acid.
It is designed to aid in maintaining effective alkalinity of the urin.

DOSAGE AND ADMINISTRATION: SHAKE WELL BEFORE USING.
Usual Adult Dosage: 3 to 6 teaspoonfuls (15 to 30 mL) DILUTED with water, four times a day, after meals and at
bedtime, or as directed by a physician.
Usual Pediatric Dosage: 1 to 3 teaspoonfuls (5 to 15 mL) DILUTED with water, four times a day, after meals and
at bedtime, or as directed by a physician.

Proper dilution may help prevent gastrointestinal injury associated with the oral ingestion of concentrated potassium
salt preparation.

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.

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 FDA at 1-800-FDA-1088 (Toll Free).

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

L350 Rev. 09/10

CYTRA 3
potassium citrate monohydrate, sodium citrate dihydrate, citric acid monohydrate syrup

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:60258-002
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Potassium Citrate (UNII: EE90ONI6FF) (Potassium Cation - UNII:295O53K152)	Potassium Citrate	550 mg in 5 mL
Sodium Citrate (UNII: 1Q73Q2JULR) (Sodium Cation - UNII:LYR4M0NH37)	Sodium Citrate	500 mg in 5 mL
Citric Acid Monohydrate (UNII: 2968PHW8QP) (Bicarbonate Ion - UNII:HN1ZRA3Q20)	Citric Acid Monohydrate	334 mg in 5 mL

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60258-002-16	473 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		07/29/2008

Labeler - Cypress Pharmaceuticals, Inc (790248942)

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Cytra-3 Oral Syrup Prescribing Information

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