Description
Bumetanide nasal spray is used to treat edema (swelling) caused by congestive heart failure, liver disease, and kidney disease (eg, nephrotic syndrome).
Bumetanide belongs to a group of medicines called loop diuretics or "water pills". It works by acting on the kidneys to increase the flow of urine.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Spray
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of bumetanide nasal spray in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bumetanide nasal spray in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving bumetanide.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Desmopressin
- Methenamine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aceclofenac
- Acemetacin
- Albuterol
- Amtolmetin Guacil
- Arsenic Trioxide
- Articaine
- Aspirin
- Benzhydrocodone
- Bepridil
- Bromfenac
- Bufexamac
- Buprenorphine
- Cefepime
- Celecoxib
- Choline Salicylate
- Clonixin
- Codeine
- Dexibuprofen
- Dexketoprofen
- Diazoxide
- Diclofenac
- Diflunisal
- Digitoxin
- Dihydrocodeine
- Dipyrone
- Dofetilide
- Droperidol
- Droxicam
- Epinephrine
- Etodolac
- Etofenamate
- Etoricoxib
- Felbinac
- Fenoprofen
- Fentanyl
- Fepradinol
- Feprazone
- Floctafenine
- Flufenamic Acid
- Flurbiprofen
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Benazepril
- Captopril
- Cilazapril
- Dibekacin
- Enalapril
- Enalaprilat
- Fosinopril
- Germanium
- Ginseng
- Gossypol
- Kanamycin
- Licorice
- Lisinopril
- Moexipril
- Neomycin
- Perindopril
- Quinapril
- Ramipril
- Spirapril
- Streptomycin
- Trandolapril
- Zofenopril
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Anuria (not able to pass urine) or
- Hepatic encephalopathy (hepatic coma)—Should not be used in patients with these conditions.
- Dehydration or
- Diabetes or
- Diarrhea or
- Electrolyte imbalance (eg, hypokalemia, hyponatremia, hypomagnesemia, hypocalcemia) or
- Gout or
- Hyperglycemia (high sugar in the blood) or
- Hyperuricemia (high uric acid in the blood) or
- Hypovolemia (low blood volume) or
- Low salt diet or
- Nasal problems (eg, stuffy or runny nose, nasal polyps, history of nasal injury or surgery)—Use with caution. May make these conditions worse.
Proper Use
Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.
This medicine is for use only in the nose. Do not get any of it in your eyes or on your mouth. If it does get on these areas, rinse it off with water and call your doctor right away.
This medicine usually comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Use each nasal spray only one time. Do not reuse the spray. Do not test or prime before use.
This medicine is not for long-term use. You will be switched to an oral medicine that works the same way.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For nasal dosage form (spray):
- For edema:
- Adults—One spray in one nostril. Each spray contains 0.5 milligrams (mg) of bumetanide.
- Children—Use and dose must be determined by your doctor.
- For edema:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests will be needed to check for unwanted effects.
This medicine may cause fluid or electrolyte problems. Check with your doctor right away if you have coma, decreased urine, dizziness, dry mouth, headache, irregular heartbeat, increased thirst, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, seizures, trouble breathing, or unusual tiredness or weakness.
This medicine may cause hearing problems (eg, tinnitus). Check with your doctor right away if you have continuing ringing or buzzing or other unexplained noise in the ears, dizziness, feeling of fullness in the ears, hearing loss, loss of balance, or trouble hearing.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Agitation
- back pain
- blurred vision
- coma
- confusion
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
- drowsiness
- fever
- hallucinations
- headache
- irritability
- mood or mental changes
- seizures
- stiff neck
- sweating
- unusual tiredness or weakness
- vomiting
Rare
- Black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- chest pain
- chills
- cough
- decreased urination
- depression
- diarrhea
- dry mouth
- ear discomfort
- feeling of constant movement of self or surroundings
- hostility
- impaired hearing
- increase in heart rate
- itching
- joint or muscle pain
- lethargy
- muscle twitching
- nausea
- pinpoint red spots on the skin
- rapid breathing
- red irritated eyes
- red skin lesions, often with a purple center
- sensation of spinning
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stupor
- sunken eyes
- swelling of the face, ankles, or hands
- thirst
- unusual bleeding or bruising
- wrinkled skin
Incidence not known
- Continuing ringing or buzzing or other unexplained noise in ears
- flushed, dry skin
- fruit-like breath odor
- hearing loss
- increased hunger
- increased urination
- joint pain, stiffness, or swelling
- loss of appetite
- lower back, side, or stomach pain
- muscle pain or cramps
- numbness or tingling in the hands, feet, or lips
- stomach cramps
- swelling of the feet or lower legs
- trembling
- trouble breathing
- unexplained weight loss
- vomiting
- weak pulse
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Rare
- Decreased interest in sexual intercourse
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
- muscle or joint pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80008509
