VIRTRATE-K- potassium citrate and citric acid monohydrate liquid 
Virtus Pharmaceuticals

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Virtrate-K

Prescription Systemic Alkalinizing Dietary Supplement1


1
This statement has not been evaluated by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure or prevent any disease.

Rx

DESCRIPTION

Virtrate-K is an orally administered prescription systemic alkalinizing dietary supplement1 and should be administered under the supervision of a licensed medical practitioner.

Virtrate-K is an effective alkalinizing agent useful in those conditions in which long-term maintenance of an alkaline urine is desirable, such as in people with uric acid and cystine calculi of the urinary tract, and especially when the administration of sodium salts is undesirable or contraindicated. It is also effective potassium citrate may be preferable to sodium citrate.

Supplement Facts
Serving Size: 1 Teaspoon (5 mL)
Amount Per Serving% Daily Value for Children Under 4 Years of Age% Daily Value for Adults and Children 4 or More Years of Age
*
Each mL contains 2 mEq Potassium Ion and is equivalent to 2 mEq Bicarbonate (HCO3).
Daily Value not established
Potassium Citrate Monohydrate1100 mg *
Citric Acid Monohydrate334 mg *

Other Ingredients: Propylene Glycol, Sorbitol, Polyethylene Glycol 400, Methylparaben, Propylparaben, Sucralose, FD&C Red #40, Natural Cherry Flavor and Purified Water.

Contains FD&C Red #40

Potassium citrate is absorbed and metabolized to potassium bicarbonate, thus it acts as a systemic alkalinizing agent.

DOSAGE AND ADMINISTRATION

Virtrate-K is highly concentrated, and when consumed after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock. When consumed as recommended, Virtrate-K alkalinizes the urine without producing a systemic alkalosis. It is highly palatable and pleasant tasting. Potassium citrate does not neutralize the gastric juice or disturb digestion.

Virtrate-K should be taken diluted in water according to directions, followed by additional water, if desired. Palatability is enhanced if chilled before taking.

Usual Adult Dose

3 to 6 teaspoonfuls (15 to 30 mL), diluted with 1 glass 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 with 1/2 glass of water, after meals and at bedtime, or as directed by a physician.

Usual Dosage Range

2 to 3 teaspoonfuls (10 to 15 mL), diluted with a glassful of 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 urinary pH, HYDRION Paper (pH 6.0-8.0) or NITRAZINE Paper (pH 4.5-7.5) are available and easy to use.

CONTRAINDICATIONS

Virtrate-K is contraindicated in people with severe renal impairment with oliguria or azotemia, untreated Addison's disease, adynamia episodica hereditaria, acute dehydration, heat cramps, anuria, severe myocardial damage, or hyperkalemia from any cause.

WARNINGS

Large doses may cause hyperkalemia and alkalosis, especially in the presence of renal disease. Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity.

PRECAUTIONS

Virtrate-K should be used with caution by people with low urinary output unless under the supervision of a physician. As with all liquids containing a high concentration of potassium, Virtrate-K should be diluted adequately with water to minimize the possibility of gastrointestinal injury associated with the oral ingestion of concentrated potassium salt preparations; if possible, take each dose after meals to avoid saline laxative effect.

ADVERSE REACTIONS

When consumed as recommended by people with normal renal function and urinary output, Virtrate-K generally has no unpleasant side effects. However, people with certain abnormal renal mechanisms should be careful to avoid development of hyperkalemia or alkalosis. Potassium intoxication causes listlessness, weakness, mental confusion, tingling of extremities, and other symptoms associated with a high concentration of potassium in the serum (hyperkalemia). Persons with renal disease should have periodic determinations of serum electrolytes in order to avoid the complications of hyperkalemia and alkalosis. These electrocardiographic abnormalities may also be observed with hyperkalemia: disappearance of the P wave, widening and slurring of QRS complex, changes of the S-T segment, tall peaked T waves.

OVERDOSAGE

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, hyperkalemia can result (see Contraindications and Warnings). Hyperkalemia, when detected, must be treated immediately because lethal levels can be reached within a few hours.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN

HOW SUPPLIED

Virtrate-K is supplied as red colored, cherry flavored liquid dispensed in 16 fl. oz. (472 mL) bottles.

STORAGE

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

Rx

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, FL 33619
1-888-848-3593

Rev. 03/15

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

VIRTUS
PHARMACEUTICALS

76439-262-16

VIRTRATE-K

Potassium Citrate and Citric Acid

Prescription Systemic Alkalinizing
Dietary Supplement*

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Rx
16 fl. oz. (473mL)

Sugar-Free
Made in the USA

Principal Display Panel - 473 mL Bottle Label
VIRTRATE-K 
potassium citrate and citric acid monohydrate liquid
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76439-262
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM CITRATE (UNII: EE90ONI6FF) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) POTASSIUM CITRATE1100 mg  in 5 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID334 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:76439-262-16472 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT05/15/201505/30/2017
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
flavor
Labeler - Virtus Pharmaceuticals (969483143)

Revised: 10/2017
 
Virtus Pharmaceuticals