Enbumyst .5 mg/.1mL
bumetanide · SPRAY · Corstasis USA LLC
Enbumyst is a nasal spray containing bumetanide, a loop diuretic used to remove excess fluid from the body in patients with conditions like heart failure, liver disease, or kidney disease. This prescription medication works by increasing urine production to help reduce swelling and improve breathing.
Key Facts
- Brand Name
- Enbumyst
- Generic Name
- bumetanide
- NDC Code (Product)
84388-005- Manufacturer
- Corstasis USA LLC
- Strength
- .5 mg/.1mL
- Dosage Form
- SPRAY
- Route
- NASAL
- Marketing Status
- Application #
- NDA219500
- Drug Class
- Loop Diuretic [EPC]
- Marketing Start
- 09/12/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ENBUMYST is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome in adults. ENBUMYST is a loop diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including nephrotic syndrome in adults. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION ENBUMYST is for nasal route only. ( 2 ) Individualize dosage based on patient response. The recommended total daily dosage of ENBUMYST is 0.5 mg to 2 mg administered once daily. ( 2.1 ) ENBUMYST is not intended for chronic use; replace with oral diuretics as soon as practical. ( 2.1 ) 2.1 Recommended Dosage 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. 2.2 Administration Instructions ENBUMYST is for nasal use only. Each ENBUMYST unit is for single use and delivers 0.5 mg bumetanide upon actuation. Do not prime or attempt to reuse ENBUMYST for more than one administration. Administer ENBUMYST directly into the nose and not against the wall of the nose. If prescribed dose requires …
Contraindications
4 CONTRAINDICATIONS Bumetanide is contraindicated in: Patients with anuria. Patients in hepatic coma. Patients with a history of a hypersensitivity reaction to bumetanide. Reactions have included anaphylaxis and anaphylactoid reactions. Anuria. ( 4 ) Hepatic coma. ( 4 ) History of hypersensitivity to bumetanide. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Lithium may reduce renal clearance of bumetanide and add a high risk of lithium toxicity. ( 7 ) Probenecid reduces both the natriuresis and hyperreninemia. ( 7 ) Indomethacin blunts the increase in urine volume and sodium excretion. ( 7 ) Drugs with ototoxic potential: avoid parenteral bumetanide in patients receiving aminoglycoside antibiotics. ( 7 ) Drugs with nephrotoxic potential: the simultaneous administration of ENBUMYST with drugs of nephrotoxic potential should be avoided. ( 7 ) Antihypertensive effects may be potentiated by bumetanide. ( 7 ) 7.1 Effects of Other Drugs on Bumetanide Lithium 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 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. Indomethacin Concurrent therap…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Fluid, electrolyte, and metabolic abnormalities [see Warnings and Precautions (5.1) ] Worsening Renal Function [see Warnings and Precautions (5.2) ] Ototoxicity [see Warnings and Precautions (5.3) ] Potential Altered Absorption in Patients with Nasal Mucosal or Structural Abnormalities [see Warnings and Precautions (5.4) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ENBUMYST is supported by clinical trials and postmarketing reports of oral bumetanide, as well as open-label, single- and repeat-dose studies of ENBUMYST in healthy subjects. Adverse Reactions in Two Clinical Pharmacology Studies with ENBUMYST in Adult 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 subj…
Frequently Asked Questions
What is Enbumyst used for?
Enbumyst is a nasal spray containing bumetanide, a loop diuretic used to remove excess fluid from the body in patients with conditions like heart failure, liver disease, or kidney disease. This prescription medication works by increasing urine production to help reduce swelling and improve breathing.
Is Enbumyst a controlled substance?
Enbumyst is not classified as a controlled substance by the DEA.
What is the generic name for Enbumyst?
The generic name for Enbumyst is bumetanide. There are 12 other brand versions of bumetanide.
What is the NDC code for Enbumyst .5 mg/.1mL?
The NDC (National Drug Code) for Enbumyst .5 mg/.1mL is 84388-005, listed by Corstasis USA LLC.