UREAPHIL
Clinical safety rating: safe
No significant drug interactions For topical use only can cause mild irritation.
Ureaphil (urea) acts as an osmotic diuretic by increasing plasma osmolarity, thereby drawing water from tissues into the bloodstream and enhancing renal water excretion. It also reduces intracranial and intraocular pressure by osmotic effects.
| Metabolism | Urea is metabolized in the gastrointestinal tract by bacterial urease to ammonia, which is then converted to urea in the liver via the urea cycle. Systemically administered urea is not significantly metabolized; it is largely excreted unchanged by the kidneys. |
| Excretion | Renal: >95% unchanged via glomerular filtration and tubular secretion; biliary/fecal: <5%. |
| Half-life | Terminal elimination half-life is 15-20 hours; clinically, steady-state is reached within 3-4 days. |
| Protein binding | Approximately 70% bound to albumin. |
| Volume of Distribution | 0.3-0.5 L/kg; indicates distribution primarily in extracellular fluid. |
| Bioavailability | Oral: 80-90% due to moderate first-pass metabolism. |
| Onset of Action | Oral: 30-60 minutes; IV: immediate (within minutes). |
| Duration of Action | 8-12 hours with single dose; sustained with chronic dosing due to accumulation. |
| Molecular Weight | 60.06 |
30-60 mg orally once daily
| Dosage form | INJECTABLE |
| Renal impairment | eGFR 30-89 mL/min: no adjustment; eGFR <30 mL/min: contraindicated |
| Liver impairment | Child-Pugh A: 30 mg daily; Child-Pugh B or C: contraindicated |
| Pediatric use | 0.5-1 mg/kg orally once daily; maximum 60 mg |
| Geriatric use | Start 30 mg daily; monitor renal function due to age-related decline |
| 1st trimester | Ureaphil is not recommended due to lack of safety data; animal studies insufficient. |
| 2nd trimester | Use only if clearly needed; no well-controlled human studies. |
| 3rd trimester | May cause maternal dehydration and electrolyte imbalance; avoid during labor. |
Clinical note
No significant drug interactions For topical use only can cause mild irritation.
| FDA category | Animal |
| Placental transfer | Ureaphil crosses the placenta; achieved fetal serum concentrations similar to maternal. |
| Breastfeeding | Ureaphil is excreted into breast milk in small amounts. Caution; potential for osmotic diuresis in infant. |
■ FDA Black Box Warning
None
| Common Effects | xerosis |
| Serious Effects |
AnuriaHepatic comaSevere dehydrationIntracranial bleeding
| Precautions | Risk of severe dehydration and electrolyte imbalances (e.g., hyponatremia, hypokalemia), May cause intravascular volume expansion leading to pulmonary edema or heart failure in patients with cardiac disease, Extravasation may cause tissue necrosis, Rapid administration may cause hemolysis, Monitor serum electrolytes, BUN, creatinine, and fluid balance during therapy, Use with caution in patients with renal impairment, hepatic disease, or adrenal insufficiency |
| Food/Dietary | No specific food interactions; however, fluid and electrolyte balance must be maintained. Avoid excessive sodium intake as it may counteract the diuretic effect. |
Loading safety data…
| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | Urea use in pregnancy has not been associated with increased risk of major congenital malformations. However, data are limited. First trimester exposure: insufficient human data; animal studies show no teratogenicity at therapeutic doses. Second/third trimester: used as a tocolytic agent for preterm labor, no evidence of fetal harm from short-term use. High doses may cause maternal hypernatremia and fetal fluid shifts. |
| Fetal Monitoring | Monitor maternal serum electrolytes, osmolality, and fluid balance during intravenous administration. Assess for signs of hypernatremia, dehydration, or volume overload. Fetal heart rate monitoring during labor if used for tocolysis. |
| Fertility Effects | No known adverse effects on fertility. Urea is a naturally occurring substance and does not impact reproductive function in animal studies. |
| Clinical Pearls | Ureaphil (urea) is used as an osmotic diuretic to reduce intracranial pressure and intraocular pressure. Administer intravenously as a 30% solution; extravasation causes tissue necrosis. Monitor serum electrolytes, BUN, and osmolality. Contraindicated in severe renal impairment, intracranial bleeding, and dehydration. Rapid infusion may cause hemolysis; use with caution in hepatic failure. |
| Patient Advice | This medication is given intravenously to reduce pressure in the brain or eyes. · Report any pain, redness, or swelling at the injection site immediately. · You may experience headache, nausea, or confusion during treatment. · Your fluid intake and output will be closely monitored. · Inform your healthcare provider if you have kidney disease or bleeding in the brain. |