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ENBUMYST contains bumetanide, a loop diuretic. Chemically, bumetanide is 3-(butylamino)-4- phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder with a calculated molecular weight of 364.42 g/mol, and the following structural formula:
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ENBUMYST is supplied as a unit dose nasal spray containing 0.5 mg of bumetanide (equivalent to about 0.554 mg of potassium salt of bumetanide) per 0.1 mL. ENBUMYST contains the following inactive ingredients: benzyl alcohol (0.5 mg per 0.1 mL spray), carboxymethylcellulose sodium (viscosity control agent), mannitol, potassium hydroxide (pH modifier), hydrochloric acid (to adjust pH) and water for injection.
ENBUMYST is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome in adults.
Each unit dose nasal spray contains 0.5 mg of bumetanide. The usual total daily dosage of ENBUMYST is 0.5 mg to 2 mg once daily. The number of nasal spray devices needed for a single dose depends upon the prescribed dose. Individualize dosage based on patient response up to a maximum dose of 2 mg/day.
ENBUMYST is not intended for chronic use and should be replaced with oral diuretics as soon as practical.
ENBUMYST can be substituted at approximately a 1:40 ratio to oral furosemide and a 1:20 ratio to intravenous furosemide.
Nasal spray: 0.5 mg bumetanide per 0.1 mL spray in a unit-dose nasal spray.
ENBUMYST is a clear colorless solution, supplied as 6 or 12 pack cartons containing unit dose nasal sprays as shown in Table 1. Each unit dose nasal spray delivers 0.5 mg bumetanide.
Table 1: Available Packaging Configurations| Description | Package Configuration | NDC |
| 6-pack carton | Six (6) blister packages each with a unit dose nasal spray | NDC 84388-005-06 |
| 12-pack carton | Two (2) 6-pack cartons containing twelve (12) blister packages each with a unit dose nasal spray | NDC 84388-005-12 |
Store at room temperature 59°F to 77°F (15°C to 25°C). Short-term excursions permitted between 39°F to 104°F (4°C to 40°C). Do not freeze. Dispense in the original sealed carton.
Manufactured for Corstasis Therapeutics,
3535 Executive Terminal Drive,
Henderson, NV 89042
Copyright © 2025 Corstasis Therapeutics.
All rights reserved
The following clinically significant adverse reactions are described elsewhere in the labeling:
The safety of ENBUMYST is supported by clinical trials and post-marketing reports of oral bumetanide, as well as open-label, single- and repeat-dose studies of ENBUMYST in healthy subjects.
In open-label studies of ENBUMYST in healthy subjects (n = 84), the most common adverse reaction that occurred with ENBUMYST was hypovolemia (4.8%) [see Warnings and Precautions (5.1)]. Headache occurred in 3% of subjects. There were no adverse reactions specifically associated with the nasal route of administration such as nasal irritation or pain. There was a single case of nasal dryness.
The following adverse reactions were identified in clinical studies or postmarketing reports with the use of oral bumetanide. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most frequent clinical adverse reactions considered probably or possibly related to oral bumetanide are muscle cramps (seen in 1.1% of treated patients), dizziness (1.1%), hypotension (0.8%), headache (0.6%), nausea (0.6%) and encephalopathy (in patients with pre-existing liver disease) (0.6%). One or more of these adverse reactions have been reported in approximately 4.1% of patients treated with bumetanide.
The following additional adverse reactions have been reported with bumetanide.
Blood and Lymphatic System Disorders: Deviations in hemoglobin, prothrombin time, hematocrit, WBC and differential counts, thrombocytopenia
Cardiac Disorders: Chest pain, electrocardiogram changes
Ear and Labyrinth Disorders: Ear discomfort, impaired hearing, vertigo
Gastrointestinal Disorders: Abdominal pain, diarrhea, dry mouth, GI upset, vomiting
General Disorders and Administration Site Conditions: Fatigue, weakness
Investigations: Changes in LDH, total serum bilirubin, serum proteins, SGOT, SGPT, alkaline phosphatase, cholesterol, creatinine clearance, urinary glucose, and urinary protein
Metabolism and Nutrition Disorders: Dehydration
Musculoskeletal and Connective Tissue Disorders: Arthritic pain, musculoskeletal pain
Nervous System Disorders: Asterixis
Renal and Urinary Disorders: Renal failure
Reproductive System and Breast Disorders: Erectile dysfunction, nipple tenderness, premature ejaculation
Respiratory, Thoracic and Mediastinal Disorders: Hyperventilation
Skin and Subcutaneous Tissue Disorders: Pruritus, rash, Stevens-Johnson syndrome, sweating, toxic epidermal necrolysis
Lithium should generally not be given with diuretics (such as bumetanide) because they reduce its renal clearance and add a high risk of lithium toxicity.
Probenecid should not be administered concurrently with bumetanide. Pretreatment with probenecid reduces both the natriuresis and hyperreninemia produced by bumetanide. This antagonistic effect of probenecid on bumetanide natriuresis is not due to a direct action on sodium excretion but is probably secondary to its inhibitory effect on renal tubular secretion of bumetanide.
Concurrent therapy with bumetanide is not recommended. Indomethacin blunts the increases in urine volume and sodium excretion seen during bumetanide treatment and inhibits the bumetanide-induced increase in plasma renin activity.
Especially in the presence of impaired renal function, the use of parenterally administered bumetanide in patients to whom aminoglycoside antibiotics are also being given should be avoided, except in life- threatening conditions.
Monitor renal function. Concomitant use may worsen renal function and increase the risk of nephrotoxicity.
Bumetanide may potentiate the effect of various antihypertensive drugs, necessitating a reduction in the dosage of these drugs.
Interaction studies in humans have shown no effect on digoxin blood levels.
Interaction studies in humans have shown bumetanide to have no effect on warfarin metabolism or on plasma prothrombin activity.
Included as part of the PRECAUTIONS section.
Bumetanide may cause fluid, electrolyte, and metabolic abnormalities such as hypovolemia, hypokalemia, azotemia, hyponatremia, hypochloremic alkalosis, hypomagnesemia, hypocalcemia, hyperglycemia, or hyperuricemia, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during bumetanide therapy.
Bumetanide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue bumetanide [see Clinical Pharmacology (12.3)].
Tinnitus and hearing loss (usually reversible) have been reported with loop diuretics, including bumetanide. Reports indicate that ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.
ENBUMYST has not been assessed in individuals with nasal mucosal or structural abnormalities. Avoid use in patients with significant nasal mucosal or structural abnormalities, such as acute episodes of rhinitis or congestion due to any cause. Consider alternative products or therapies in such patients.
Bumetanide was devoid of mutagenic activity in various strains of Salmonella typhimurium when tested in the presence or absence of an in vitro metabolic activation system. An 18-month study showed an increase in mammary adenomas of questionable significance in female rats receiving oral doses of 60 mg/kg/day (approximately 290 times a 2 mg/day human dose, based on BSA). A repeat study at the same doses failed to duplicate this finding.
Reproduction studies were performed to evaluate general reproductive performance and fertility in rats at oral dose levels of 10 mg/kg/day, 30 mg/kg/day, 60 mg/kg/day or 100 mg/kg/day. The pregnancy rate was slightly decreased in the treated animals; however, the differences were small and not statistically significant.
Overdosage can lead to acute profound water loss, volume and electrolyte depletion, dehydration, reduction of blood volume and circulatory collapse with a possibility of vascular thrombosis and embolism. Electrolyte depletion may be manifested by weakness, dizziness, mental confusion, anorexia, lethargy, vomiting and cramps. Treatment consists of replacement of fluid and electrolyte losses by careful monitoring of the urine and electrolyte output and serum electrolyte levels.
Bumetanide is contraindicated in:
Bumetanide primarily inhibits the reabsorption of sodium and chloride in the proximal and distal tubules and in the loop of Henle. The high degree of diuresis is largely due to the unique site of action. The action on the distal tubule is independent of any inhibitory effect on carbonic anhydrase and aldosterone.
Following administration of ENBUMYST, the onset of diuresis occurs in less than 60 minutes. Peak activity is reached between 0.75 and 1.5 hours. At a maximum dose of 2 mg, diuresis is largely complete within 4 hours. Bumetanide decreases uric acid excretion and increases serum uric acid.
In a study in 68 healthy adults, the effect of 2 mg ENBUMYST on diuresis, natriuresis and potassium urine excretion over 0 to 8 hours and 0 to 24 hours was similar to that of 2 mg bumetanide oral tablet and 2 mg bumetanide IV injection.
In a study in healthy adults, the exposure (Cmax and AUC) of 2 mg ENBUMYST was similar to that of 2 mg bumetanide oral tablet. The exposure of 2 mg ENBUMYST was approximately 11% (Cmax) and 65-67% (AUC) relative to that of 2 mg bumetanide IV injection.
Bumetanide median time to maximum concentration (Tmax) is 1.0 hour following nasal administration of ENBUMYST.
Bumetanide exhibits high plasma protein binding in the range of 94% to 96%.
Bumetanide is eliminated rapidly in humans following both oral and parenteral (intravenous or intramuscular) administration, with a half-life of 1 to 1.5 hours. ENBUMYST demonstrated a half-life of approximately 3 hours in healthy adult subjects.
Mass balance studies using carbon-14 labeled bumetanide in healthy adults identified metabolites formed by oxidation of the N-butyl side chain. These metabolites were detected in both urine and bile.
Following oral administration of carbon-14 labeled bumetanide to healthy adults, 81% of the administered radioactivity was recovered in urine, with 45% excreted as unchanged drug. Biliary excretion accounted for 2% of the administered dose.
In a group of ten geriatric subjects between the ages of 65 and 73 years, total bumetanide clearance was significantly lower (1.8 ± 0.3 mL/min*kg) compared with younger subjects (2.9 ± 0.2 mL/min*kg) after a single oral bumetanide 0.5 mg dose. Maximum plasma concentrations were higher in geriatric subjects (16.9 ± 1.8 ng/mL) compared with younger subjects (10.3 ± 1.5 ng/mL). Urine flow rate and total excretion of sodium and potassium were increased less in the geriatric subjects compared with younger subjects, although potassium excretion and fractional sodium excretion were similar between the two age groups. Nonrenal clearance, bioavailability, and volume of distribution were not significantly different between the two groups.
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Advise patients on appropriate administration, including the number of devices to use [see Dosage and Administration (2)].
Advise lactating women treated with ENBUMYST to monitor their breastfed infant for excessive urine output, dehydration, and lethargy [see Use in Specific Populations (8.2)].
Manufactured for Corstasis Therapeutics, 3535 Executive Terminal Drive, Henderson, NV 89042 Copyright © 2025 Corstasis Therapeutics. All rights reserved
Manufactured for Corstasis Therapeutics,
3535 Executive Terminal Drive,
Henderson, NV 89042
Copyright © 2025 Corstasis Therapeutics. All rights reserved.
For more information about ENBUMYST, call 1-877-300-5339 or visit ENBUMYST.com.
