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Urea (Systemic)

Generic name: urea systemic

Brand names: Ureaphil, ure-Na

Dosage Forms

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]


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.

Use: Labeled Indications

Hyponatremia: 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).


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

Dosage and Administration

Dosing: Adult

Hyponatremia: Oral: 15 to 60 g daily

Dosing: Geriatric

Refer to adult dosing.


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

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Frequency not defined.

Endocrine & metabolic: Hypernatremia

Gastrointestinal: Mildly upset stomach

Monitoring Parameters

Serum sodium

Patient Education

  • Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
  • Patient may experience nausea. Have patient report immediately to prescriber signs of fluid and electrolyte problems (mood changes, confusion, muscle pain or weakness, abnormal heartbeat, severe dizziness, passing out, fast heartbeat, increased thirst, seizures, loss of strength and energy, lack of appetite, unable to pass urine or change in amount of urine passed, dry mouth, dry eyes, or nausea or vomiting) (HCAHPS).
  • Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Source: Wolters Kluwer Health. Last updated October 14, 2019.