Information for Physicians

Click below to view two clinical update videos presented by: Harold Szerlip MD, MS (ED) FACP, FASN FNKF, CCRP. Director, Division of Nephrology, Baylor University Medical Center, Dallas TX.

Hyponatremia: Clinical update on inpatient treatment.

Hyponatremia: Clinical update on outpatient treatment.

November 2018 CJASN published clinical study on the use of ure-Na to treat hyponatremia in the inpatient setting.

  • 15g USP Urea per pouch
  • Does not contain any NaCl
  • Mixes with only a few ounces of water or juice
  • Clinically studied & guideline supported
  • Safe, effective and cost sensitive
  • ure-Na is pronounced: you-ree-nah



Ure-Na

Ure-Na is available in a box with 8 sachets containing 15g USP urea per sachet.


Mechanism of Action of urea for the treatment of hyponatremia

Urea normalizes serum sodium by inducing osmotic excretion of free water without associated electrolyte depletion. Urea also ameliorates hyponatremia in SIADH by a more specific effect, diminishing the natriuresis in association with increased medullary urea content.


European Clinical Practice Guideline on the Diagnosis & Treatment of Hyponatremia


Dosing chart based off of the above European Guideline dose range



Independent guidance on diagnosis and treatment supporting the use of ure-Na





mOsm of NaCl versus urea



15g of urea found in 1 sachet of ure-Na equals 250 mOsm, equal to 14.7 500mg NaCl tablets or 7.35 1g NaCl tablets.

30g of urea found in 2 sachets of ure-Na equals 500 mOsm, equal to 29.4 500mg NaCl tablets or 14.7 1g NaCl tablets.


Discharging or initiating a patient on ure-Na





Ure-Na can be ordered from most retail pharmacies for next day arrival. Most retail pharmacies receive a daily shipment Monday - Friday from their pharmaceutical wholesalers where ure-Na is stocked.

We recommend the prescription or order for ure-Na includes the NDC # or UPC # so it can be found in the pharmacy ordering system.

NDC# 62530-0000-11

UPC# 862530000116

We recommend that a patient be discharged on two or three days worth of ure-Na. If a patient is discharged on a Friday, the next time most retail pharmacies will be able to get ure-Na will be Monday with their next wholesale delivery.

Ure-Na can also be ordered on this website or by calling 1-844-980-9933.
More information is available in the Buy ure-Na section of ure-na.com.



Published data on the use of ure-Na in the inpatient setting






Long term durability of urea treatment response






Patients not appropriate for ure-Na

Patients with hypovolemic hyponatremia

Patients with hyponatremia associated with adrenal insufficiency

Patients with hyperammonemia

ure-Na: BUN and Serum Creatinine

Urea is produced normally in the body by the liver. As such, it is considered safe (GRAS designation by the FDA), and does not carry nephrotoxic or hepatotoxic potential. Since the blood test for BUN measures Blood Urea Nitrogen levels, it is expected that when ure-Na is administered, an increase in BUN levels may be seen. However, this isolated increase in not indicative of kidney function, and is similar to what may be seen when individuals consume a high protein diet with production of additional amounts of urea by the liver.

Below are three data sets that report pre and post treatment serum urea or BUN as well as serum or blood creatinine.












This data has treatment lengths up to 270 days




Links to clinical data by setting






List of clinical data on the use of urea to treat hyponatremia

Click HERE to access clinical references on the use of urea to treat hyponatremia.

Inpatient access to ure-Na

Ure-Na is available in most American hospitals. If ure-Na is not available for inpatient use at the institutions where you round, please request Inpatient Pharmacy to conduct a review for addition to inpatient formulary.

Please direct Pharmacy to the Pharmacist section of ure-na.com for any pre-review questions or information they may need.



ure-Na samples

We offer ure-Na samples to licensed Health Care Providers practicing in the USA. There is a limit of 4 per HCP per order.

Click here to order samples

Insurance Coverage

Ure-Na is often covered by Health Insurance under a patient's Medical Benefit (not pharmaceutical benefit) as enteral nutrition, enteral therapy or as a medically necessary food. Plans that cover are Managed Medicare (Medicare HMO, PPO and Advantage), Commercial and some Medicaid

Unfortunately straight Medicare with or without a supplement will not cover unless ure-Na is being administered via tube feed.

While most of our patients are on ure-Na, for patients where affordability is an issue, we have a lower priced product that is stabilized and bulk packed, but is not flavor masked.

More information can be found at
UreaPro.com

Please see the Insurance section of this site for more information on insurance reimbursement options.



ure-Na ingredients

Ingredients in descending order: synthetically derived urea powder, natural flavors, maltodextrin, citric acid, calcium silicate, sucralose.


Calories in ure-Na

For some, especially people with diabetes the caloric content of ure-Na is important. Each sachet of ure-Na contains less than 15 calories. The calories are derived from the maltodextrin.


Frequently Asked Questions

Q: How do patients access ure-Na for outpatient use?

A: ure-Na may be covered by health insurance via coverage on the medical side of insurance through Prior Authorization. See the Insurance section for more information. If ure-Na is not covered by insurance, it may be a tax deductible qualified medical expense.

If needed quickly, ure-Na can be ordered at many retail pharmacies and received at the pharmacy the next day. The pharmacist can find ure-Na under item #: 62350-0000-11

If not covered by insurance, ure-Na can be purchased direct or ordered at most retail pharmacies. Patients comfortable ordering online can purchase on this site. Patients not comfortable purchasing online can order by calling 1-844-980-9933. For those paying out of pocket, best price is usually found purchasing direct.

For more information on initiating a prior authorization, please see the insurance section at the top of the home page menu.

For patients with VA benefits, ure-Na is on the VANF (VA National Formulary). Ure-Na is listed as: UREA,PWDR

Q: How do I get ure-Na for my patients in the hospital, nursing home or LTAC?

A: If ure-Na isn't already on formulary at your institutions, ask the inpatient pharmacy to add ure-Na to formulary. Inpatient pharmacy can order ure-Na from their pharmacy wholesaler.

Q: How is ure-Na dosed?

A: The European guidelines* on the use if urea recommend a dose of 0.25-0.50g/Kg (a 140lb person then would take 15.75 - 31.5g) UpToDate discusses a daily dose of 30g of urea.

Typical in-patient dosing ranges between 15-60g/day BID

Typical out-patient dosing ranges between 15-30g/day BID but doses of 60g/day BID are sometimes used. Nephcentric has also received reports from providers about having success dosing ure-Na 15g TIW.

Q: How does ure-Na work?

A: ure-Na is pharmaceutical grade (USP) synthetically derived urea with a proprietary flavor masking formula, which makes it palatable. It is known that hyponatremia is rarely a sodium deficiency, but rather an excess of water in the blood relative to sodium. Urea normalizes sodium levels in the blood by inducing water loss in the urine. This is accomplished without a risk of loss of important electrolytes like potassium, calcium and magnesium. Treatment with urea is particularly helpful in cases of SIADH (Syndrome of inappropriate ADH secretion).

Q:Which guidelines support the use of urea for the management of hyponatremia?

A: Guidelines from the European Society of Endocrinology, The European Society of Intensive Care Medicine, and The European Renal Association- EDTA support the use of urea for the management of hyponatremia:(click for link) UpToDate has also reviewed the use of urea in hyponatremia and has recommendations on dosing.(click for link)

Q: What is the efficacy of urea, how well does it raise sodium?

A: In a comparison study of urea versus vaptans, urea had similar efficacy raising serum sodium to 135 mEq/L. (Soupart A: Efficacy and Tolerance of Urea Compared with Vaptans for Long-Term Treatment of Patients with SIADH. CJASN Vol 7 May, 2012.) In another study of the use of urea in an ICU setting, urea raised serum sodium 4 mmol/L the first day of use, and 7 mmol/L in 48 hours. (Decaux et al: Treatment of euvolemic hyponatremia in the intensive care unit by urea., Critical Care 2010 14:R184.) This rate of rise is very important from a safety standpoint, because too rapid a rise of serum sodium levels can be dangerous, and even life threatening. The above study showed that the rise was within the recommended levels of raising serum sodium levels less than 9mmol/L in the first 24 hours.

Q: What are the risks of taking urea?

A: The risks of taking urea are very low. No long term toxicity has been seen. There is a very low risk of hypernatremic dehydration if your patients thirst center is intact. (Decaux G: Urea for long term treatment of syndrome of inappropriate secretion of antidiuretic hormone. BMJ Vol 283 24 Oct 1981.).

Q: How much water or juice is mixed with a 15g dose or ure-Na?

A: A 15g dose of ure-Na easily mixes into solution with as little as 3-4 ounces of water or juice. As you know, hyponatremia can be a difficult condition to manage. We recommend that ure-Na be taken under medical supervision and that the amount of water or juice that ure-Na is mixed with is determined by the health care provider.

Q: How is ure-Na packaged?

A: Each 15g dose of urea in a single serving of ure-Na is individually packaged in easy to open pouches. There are 8 pouches or doses per box.

Q: Can ure-Na be used with other therapeutic options to treat hyponatremia?

A: As each patients therapeutic needs are different, this determination will need to be made by the health care provider

Q: What degree of hyponatremia can ure-Na be used for?

A: The European Guidelines* recommend the use of urea in moderate to profound hyponatremia.

Q: What are the side effects of taking ure-Na?

A: Mild GI upset has been seen in a minority of patients taking ure-Na.

Q: Is urea nephrotoxic or hepatotoxic like other therapeutic options for the managing hyponatremia?

A: Urea is not nephrotoxic or hepatotoxic like other therapeutic options for the management of hyponatremia.

Q: Does urea have a risk of toxicity if used in the long term?

A: There is data on the use of urea in doses of 15g and 30g per day for 1 year that show no toxicity. (Soupart A:Efficacy and Tolerance of Urea Compared with Vaptans for Long Term Treatment of Patients with SIADH. CJASN Vol 7 May, 2012)

Q: What is a Medical Food?

A: Unlike supplements a medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.� Medical Foods, including ure-Na can be purchased OTC without a prescription. Ure-Na is made in the USA in an FDA inspected facility under cGMP guidelines.

Q: How does the FDA Classify urea?

A: The FDA classifies urea as GRAS or Generally Recognized As Safe. This is a designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug and Cosmetic Act (FFDCA) food additive tolerance requirements.






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