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Urea (systemic): Drug information

Urea (systemic): Drug information
(For additional information see "Urea (systemic): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Ure-Na
Pharmacologic Category
  • Medical Food
Dosing: Adult
Syndrome of inappropriate antidiuretic hormone secretion–associated hyponatremia, treatment and/or maintenance therapy

Syndrome of inappropriate antidiuretic hormone secretion–associated hyponatremia, treatment and/or maintenance therapy:

Note: May consider in patients who do not respond to fluid restriction or are unable to be fluid restricted, or to maintain serum sodium level after successful treatment of symptomatic hyponatremia (Ref). Goal of initial therapy is to achieve a 24-hour increase in serum sodium concentration by 4 to 6 mEq/L (maximum serum sodium increase: 8 mEq/L in any 24-hour period), which is sufficient to improve most symptoms of hyponatremia. However, if patient is symptomatic (acute or chronic hyponatremia), it is recommended to increase serum sodium by 4 to 6 mEq/L within the first 6 hours, then maintain serum sodium at a constant level for the remainder of the 24-hour period. In chronic severe hyponatremia, overcorrection or too rapid correction increases the risk of iatrogenic osmotic demyelination syndrome (Ref).

Oral: Initial: 15 to 30 g daily in 1 or 2 divided doses; titrate dose based on clinical response in increments of 15 g at weekly intervals; maximum daily dose: 60 g/day (Ref). For treatment goals, refer to "Note."

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Endocrine & metabolic: Hypernatremia

Gastrointestinal: Mildly upset stomach

Contraindications

There are no contraindications listed in the manufacturer’s labeling.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Powder for Solution, Oral:

Ure-Na: 15 g (8s) [lemon-lime flavor]

Administration: Adult

Mix each 15 g dose with 3 to 4 ounces of water or juice.

Use: Labeled Indications

Syndrome of inappropriate antidiuretic hormone secretion–associated hyponatremia, treatment and/or maintenance therapy: A medical food for the management of hyponatremia (euvolemic and hypervolemic).

Note: A medical food is formulated to be administered enterally under the supervision of a physician and is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation. Medical foods are not drugs and, therefore, are not subject to any FDA regulatory requirements that specifically apply to drugs (eg, requirement for written/oral prescription prior to dispensing, premarket review or approval, proof of safety and efficacy).

Medication Safety Issues
Sound-alike/look-alike issues:

Ure-Na may be confused with hydroxyurea

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Monitoring Parameters

Serum sodium

Mechanism of Action

Urea normalizes serum sodium levels by inducing osmotic excretion of free water. Urea also ameliorates hyponatremia in syndrome of inappropriate antidiuretic hormone secretion by a more specific effect, diminishing the natriuresis in association with increased medullary urea content.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (ES) Spain: Urea nm;
  • (PR) Puerto Rico: Ure na;
  • (PT) Portugal: Urea nm
  1. ACMP Dossier: Ure-Na. Phoenix, AZ: Nephcentric; received November 2016.
  2. Lockett J, Berkman KE, Dimeski G, Russell AW, Inder WJ. Urea treatment in fluid restriction-refractory hyponatraemia. Clin Endocrinol (Oxf). 2019;90(4):630-636. doi:10.1111/cen.13930 [PubMed 30614552]
  3. Nervo A, D'Angelo V, Rosso D, et al. Urea in cancer patients with chronic SIAD-induced hyponatremia: old drug, new evidence. Clin Endocrinol (Oxf). 2019;90(6):842-848. doi:10.1111/cen.13966 [PubMed 30868608]
  4. Rondon-Berrios H. Urea for chronic hyponatremia. Blood Purif. 2020;49(1-2):212-218. doi:10.1159/000503773 [PubMed 31851974]
  5. Soupart A, Coffernils M, Couturier B, Gankam-Kengne F, Decaux G. Efficacy and tolerance of urea compared with vaptans for long-term treatment of patients with SIADH. Clin J Am Soc Nephrol. 2012;7(5):742-747. doi:10.2215/CJN.06990711 [PubMed 22403276]
  6. Sterns RH. Overview of the treatment of hyponatremia in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 4, 2021a.
  7. Sterns RH. Treatment of hyponatremia: syndrome of inappropriate antidiuretic hormone secretion (SIADH) and reset osmostat. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 4, 2021b.
  8. Verbalis JG, Goldsmith SR, Greenberg A, et al. Diagnosis, evaluation, and treatment of hyponatremia: expert panel recommendations. Am J Med. 2013;126(10)(suppl 1):S1-S42. doi:10.1016/j.amjmed.2013.07.006 [PubMed 24074529]
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