Information for Physicians
Click below to view a 22 minute video on hyponatremia and its prevalence, sequelae, mortality, treatment options, the use of oral urea and the associated guidelines.
Presented by Kris Vijay MD, MS FACP, FACC
Get ure-Na for your hospital, institution, or clinic patients.
Frequently Asked Questions
A: ure-Na may be covered by health insurance through Prior Authorization. If ure-Na is not covered by insurance, it may be a tax deductible qualified medical expense.
If not covered by insurance, ure-Na an be purchased direct or ordered at most retail pharmacies. Patient't comfortable ordering online can purchase on this site. Patients not comfortable purchasing online can order by calling 1-844-980-9933. Best price is usually found purchasing direct. If a patient wants to purchase from a retail pharmacy it can be ordered and typically received overnight. The pharmacist can find ure-Na under item #:62530-0000-11.
When initiating a Prior Auth, please note that ure-Na is packaged in 8 count boxes. If a patient is on 15g/day the dispensing request on the PA will be ure-Na 8 count x 4. If the patient is on 15g/BID (30g/day) the dispensing request will be ure-Na 8 count x 8.
For patients with VA benefits, ure-Na is on the VANF (VA National Formulary). Ure-Na is listed as: UREA 15GM/PKT/PWDR,ORAL.
A: Ask the inpatient pharmacy to order ure-Na from their pharmacy wholesaler. ure-Na is currently available through McKesson, Cardinal, AmerisourceBergen and Morris and Dickson. McKesson item #: 3572344. Cardinal item # 5286018. AmerisourceBergen item # 10173267 or 619114. Morris and Dickson item # 942680.
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.
A: ure-Na is pharmaceutical grade (USP) urea with a proprietary flavor and taste 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).
A: ure-Na is a medical food used to treat euvolemic and hypervolemic hyponatremia, including SIADH.
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) http://www.eje-online.org/content/170/3/G1.full.pd... UpToDate has also reviewed the use of urea in hyponatremia and has recommendations on dosing.(click for link) http://www.uptodate.com/contents/overview-of-the-treatment-of-hyponatremia-in-adults
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.
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.).
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.
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.
A: As each patients therapeutic needs are different, this determination will need to be made by the health care provider
A: The European Guidelines* recommend the use of urea in moderate to profound hyponatremia.
A: Mild GI upset has been seen in a minority of patients taking urea.
A: Urea is not nephrotoxic or hepatotoxic like other therapeutic options for the management of hyponatremia.
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)
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.
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.