Patient information: uses, side effects, how to take - Enbumyst

What is the most important information I should know about ENBUMYST?

ENBUMYST is a diuretic that causes fluid loss and may lead to abnormalities with blood electrolytes and body energy systems (metabolic). Too much fluid loss can lead to dehydration and decreased blood volume and increase your risk of blood clots. Blood abnormalities may include decreased salts (electrolytes), and increased nitrogen, glucose and uric acid. The chance of getting these abnormalities is higher in people who are elderly, use higher doses, or who do not get enough electrolytes by mouth. Your healthcare provider should do blood tests to check for these abnormalities during treatment with ENBUMYST.
You should not use ENBUMYST if you have severe electrolyte loss until it gets better.

Tell your healthcare provider if you get any of the following signs or symptoms:

unusual thirst
dizziness or lightheadedness
weakness or tiredness
fast heart rate
dry mouth or tongue
sudden pain, redness or swelling in your joints, especially your big toe (gout)
pain, swelling, redness, or warmth in your leg

shortness of breath
fast breathing
high blood sugar
dark urine
skin is pale, tight, cool or clammy
muscle cramps
confusion

See " What are the possible side effects of ENBUMYST?" for more information about side effects.

What is ENBUMYST?

ENBUMYST is a prescription medicine used in adults to treat swelling caused by too much fluid in the body (edema) from congestive heart failure, liver disease and kidney disease, including a kidney problem called nephrotic syndrome.

It is not known if ENBUMYST is safe and effective in children.

Who should not use ENBUMYST?

Do not use ENBUMYST if you:

have very low or no urine production
are allergic to bumetanide or to any of the ingredients in ENBUMYST. See the end of this Patient Information for a complete list of ingredients in ENBUMYST.

Before using ENBUMYST, tell your healthcare provider about all your medical conditions, including if you:

have low levels of salts (electrolytes) in your blood, or are on a low-salt diet
have diarrhea
have diabetes
have nasal problems including a runny nose, nasal congestion, nasal polyps, history of injury such as a broken nose, or any past nasal surgery
are pregnant or plan to become pregnant. It is not known if ENBUMYST will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if ENBUMYST passes into your breast milk. If you use ENBUMYST and breastfeed, watch your baby for signs of urinating more than usual, dehydration, or unusual sleepiness, drowsiness, or sluggishness.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

ENBUMYST and other medicines may affect each other, causing side effects, and may affect the way each other works.

Especially tell your healthcare provider if you take or use:

other nasal sprays
water pills (diuretics)
lithium
probenecid

indomethacin
antibiotic medicines called aminoglycosides
medicines to treat high blood pressure

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use ENBUMYST?

Read the Instructions for Use that come with ENBUMYST for detailed information about how to use the device.
Use ENBUMYST exactly as your healthcare provider tells you to. Talk to your healthcare provider or pharmacist if you have questions about how to use ENBUMYST.
ENBUMYST is for use in the nose only.
Each ENBUMYST device has 1 spray of medicine and cannot be reused. Do not test or prime (pre-spray) the device.
ENBUMYST comes in a carton with 12 devices. Use the following number of nasal spray devices for your prescribed dose:

Prescribed Dose

Number of Nasal Spray Devices

0.5 mg

1 device

1 mg

2 devices

1.5 mg

3 devices

2 mg

4 devices

Your healthcare provider will prescribe the dose of ENBUMYST that is right for you.
ENBUMYST is for short term use only for a single treatment course (episode) of edema.
If you use too much ENBUMYST call your healthcare provider right away.

What are the possible side effects of ENBUMYST?

ENBUMYST may cause serious side effects, including:

See "What is the most important information I should know about ENBUMYST?"
Worsening kidney function. Your healthcare provider may stop treatment if your kidney function gets worse.
Ear damage (ototoxicity) including ringing in the ears (tinnitus) or hearing loss, especially in people with severe kidney problems, taking higher than recommended doses, with low levels of protein in the blood, and when used with certain other medicines.

The most common side effects of ENBUMYST include:

low levels of fluid in the body
headache
muscle cramps
dizziness

low blood pressure
nausea
abnormal brain functioning in people with certain liver problems

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ENBUMYST.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ENBUMYST?

Store ENBUMYST at room temperature between 59°F to 77°F (15°C to 25°C).
Do not freeze.

Keep ENBUMYST and all medicines out of the reach of children.

General information about the safe and effective use of ENBUMYST.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ENBUMYST for a condition for which it was not prescribed. Do not give ENBUMYST to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ENBUMYST that is written for health professionals.

What are the ingredients in ENBUMYST?

Active Ingredient: bumetanide

Inactive Ingredients: benzyl alcohol (0.5 mg per 0.1 mL spray), carboxymethylcellulose sodium, mannitol, potassium hydroxide (pH modifier), hydrochloric acid (to adjust pH) and water for injection.

Manufactured for Corstasis Therapeutics Inc., 3891 Ranchero Drive, Suite 150, Ann Arbor, MI 48108

For more information about ENBUMYST, call 1-877-300-5339 or visit ENBUMYST.com.

Enbymyst _™

(bumetanide nasal spray)

0.5 mg per device

This Instructions for Use contains Information on how to use ENBUMYST

Talk to your healthcare provider on how to use ENBUMYST.
Read this Instructions for Use before using ENBUMYST.

Storing ENBUMYST

Store in carton at room temperature of 59°F to 77°F (15°C to 25°C).
Do not freeze.
Keep ENBUMYST and all medicines out of the reach of children.

Important Information You Need to Know Before Using ENBUMYST

For use in the nose only.
Each blister contains 1 device. Do not remove from blister until ready to use.
Check the expiration date. Do not use past the expiration date on the blister or if the device appears damaged.
Do not test, prime (pre-spray), or reuse the device. Each device can only be sprayed 1 time.
Refer to the table and only remove the number of devices needed for your prescribed dose (up to 4).

Dose	Number of Nasal Spray Devices
0.5 mg	1 device
1 mg	2 devices
1.5 mg	3 devices
2 mg	4 devices

INSTRUCTIONS FOR USE

Step 1	Remove Device from Blister
	Before first device use only, blow your nose gently to clear both nostrils. Remove the number of blisters needed for your prescribed dose from the carton. Peel back the tab with the triangle to open the blister and remove the device.
Step 2	Properly Hold Device
	Hold ENBUMYST with your thumb on the bottom of the plunger and your index and middle fingers on either side of the nozzle. Do not press the plunger yet.
Step 3	Insert Device into Nose
	Tilt your head back slightly. Gently insert the tip of the nozzle into one nostril until your fingers on either side of the nozzle are against the bottom of your nose.
Step 4	Press Plunger Firmly
	Gently press the other nostril with your finger to keep it closed. Make sure that the tip of the device is pointed straight into the nose and not against the side (wall) of the nose. Slowly breath through the open nostril. Press the plunger firmly to give the dose of ENBUMYST.
Step 5	Remove and Dispose of Device
	Remove ENBUMYST nasal spray from the nostril after giving the dose. Dispose of (throw away) the used device and blister in the household trash.
Dose Completion	Alternate Nostrils
	If your prescribed dose requires more than 1 ENBUMYST device, repeat Steps 1 to 5 to complete your dose. Alternate each time between your right and left nostrils. Note: Do not blow your nose. Keep your head tilted back for approximately 1 minute before using another device. This will allow the medicine to go into your nasal passage without dripping out.