Minerals and electrolytes
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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

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

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There have been several reports, published and unpublished, concerning nonspecific small-bowel lesions consisting of stenosis, with or without ulceration, associated with the administration of enteric-coated thiazides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.

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 SYRUP Packaging



CYTRA-3 SYRUP Packaging



CYTRA-3 SYRUP Packaging






CYTRA 3
potassium citrate monohydrate, sodium citrate dihydrate, citric acid monohydrate syrup
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:60258-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Potassium Citrate (UNII: EE90ONI6FF) (Potassium Cation - UNII:295O53K152) Potassium Citrate550 mg in 5 mL
Sodium Citrate (UNII: 1Q73Q2JULR) (Sodium Cation - UNII:LYR4M0NH37) Sodium Citrate500 mg in 5 mL
Citric Acid Monohydrate (UNII: 2968PHW8QP) (Bicarbonate Ion - UNII:HN1ZRA3Q20) Citric Acid Monohydrate334 mg in 5 mL
Product Characteristics
Color Score
ShapeSize
FlavorRASPBERRYImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60258-002-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/29/2008
Labeler - Cypress Pharmaceuticals, Inc (790248942)

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