Enbumyst

Enbumyst is an FDA-registered drug product whose active ingredient is BUMETANIDE. It is labelled by Corstasis USA LLC taken by nasal and marketed as a human prescription drug product. Identifiers on file: NDC 84388-005, application NDA219500, label effective 20260827. It is one of 32 FDA drug label records sharing the active ingredient BUMETANIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BUMETANIDE are most often described in connection with: treatment edema, congestive heart, failure hepatic, renal disease, nephrotic syndrome, usage enbumyst, loop diuretic. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 )

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 more than one nasal spray, alternate between right and left nostrils. Refer patients and caregivers to the Instructions for Use for detailed administration instructions.

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 )

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 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. Adverse Reactions in Studies with Oral Bumetanide 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 Most common adverse reactions (incidence > 0.5%) are hypovolemia, headache, muscle cramps, dizziness, hypotension, nausea and encephalopathy (in patients with pre-existing liver disease). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Corstasis Therapeutics at 1-877-300-5339 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FDA lists 32 drug label records with BUMETANIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Enbumyst used for?
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 )

Who makes Enbumyst?
Corstasis USA LLC is the labeler of record for Enbumyst. 32 FDA label records share the active ingredient BUMETANIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Enbumyst come in?
administered by nasal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Enbumyst prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BUMETANIDE?
Yes. 32 FDA drug label records list BUMETANIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Enbumyst been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.