Patient information: uses, side effects, how to take - Deluxe Dental Emergency Kit

What is the most important information I should know about epinephrine injection?

1. Epinephrine injection contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen within minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes. Symptoms of an anaphylaxis may include:

trouble breathing
wheezing
hoarseness (changes in the way your voice sounds)
hives (raised reddened rash that may itch)
severe itching
swelling of your face, lips, mouth, or tongue
skin rash, redness, or swelling
fast heartbeat
weak pulse
feeling very anxious
confusion
stomach pain
losing control of urine or bowel movements (incontinence)
diarrhea or stomach cramps
dizziness, fainting, or “passing out” (unconsciousness)

2. Always carry your epinephrine injection with you because you may not know when anaphylaxis may happen. Talk to your healthcare provider if you need additional units to keep at work, school, or other locations. Tell your family members, caregivers, and others where you keep your epinephrine injection and how to use it before you need it. You may be unable to speak in an allergic emergency.

3. When you have an allergic emergency (anaphylaxis)

Use epinephrine injection right away.
Get emergency medical help right away. You may need further medical attention. You may need to use a second epinephrine injection if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.

What is epinephrine injection?

Epinephrine injection is a disposable, prefilled automatic injection device (auto-injector) used to treat life-threatening, allergic emergencies including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies. Each device contains a single dose of epinephrine.
Epinephrine injection is for immediate self (or caregiver) administration and does not take the place of emergency medical care. You should get emergency medical help right away after using epinephrine injection.
Epinephrine injection is for people who have been prescribed this medicine by their healthcare provider.
The epinephrine injection 0.3 mg auto-injector is for patients who weigh 66 pounds or more (30 kilograms or more).
The epinephrine injection 0.15 mg auto-injector is for patients who weigh about 33 to 66 pounds (15 to 30 kilograms).
It is not known if epinephrine injection is safe and effective in children who weigh less than 33 pounds (15 kilograms).

Before using epinephrine injection, tell your healthcare provider about all your medical conditions, especially if you:

have heart problems or high blood pressure
have diabetes
have thyroid problems
have asthma
have a history of depression
have Parkinson's disease
have any other medical conditions
are pregnant or plan to become pregnant. It is not known if epinephrine will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if epinephrine passes into your breast milk.

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

Especially tell your healthcare provider if you take certain asthma medicines.

Epinephrine injection and other medicines may affect each other, causing side effects. Epinephrine injection may affect the way other medicines work, and other medicines may affect how epinephrine injection works.

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

Use your epinephrine injection for treatment of anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or the medicine you take.

How should I use epinephrine injection?

Each epinephrine injection contains only 1 dose of medicine.
Epinephrine injection should only be injected into the middle of the outer thigh (upper leg). It can be injected through clothing, if needed.
Read the Instructions for Use at the end of this Patient Information Leaflet for information about the right way to use epinephrine injection.
Your healthcare provider will show you how to safely use epinephrine injection.
Use epinephrine injection exactly as your healthcare provider tells you to use it. You may need to use a second epinephrine injection if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.
Caution: Never put your thumb, fingers, or hand over the red tip. Never press or push the red tip with your thumb, fingers, or hand. The needle comes out of the red tip. Accidental injection into finger, hands, or feet may cause a loss of blood flow to those areas. If this happens, go immediately to the nearest emergency room. Tell the healthcare provider where on your body you received the accidental injection.
Your epinephrine injection comes packaged in a carton containing 1 or 2 epinephrine injection.
You may request a separate Trainer, that comes packaged with instructions. Additional video instructions on the use of epinephrine injection are available from www.epinephrineautoinject.com. The epinephrine injection, USP auto-injector Trainer has a beige color. The beige epinephrine injection Trainer contains no medicine and no needle. Practice with your epinephrine injection Trainer before an allergic emergency happens to make sure you are able to safely use the real epinephrine injection in an emergency. Always carry your real epinephrine injection with you in case of an allergic emergency.
Do not drop the carrying case or epinephrine injection. If the carrying case or epinephrine injection is dropped, check for damage and leakage. Throw away (dispose of) epinephrine injection and the carrying case, and replace if damage or leakage is noticed or suspected.

What are the possible side effects of epinephrine injection?

Epinephrine injection may cause serious side effects.

Epinephrine injection should only be injected into the middle of your outer thigh (upper leg). Do not inject epinephrine injection into your:
- veins
- buttocks
- fingers, toes, hands or feet.

If you accidentally inject epinephrine injection into any other part of your body, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection.

Rarely, people who use epinephrine injection may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following at an injection site:
- redness that does not go away
- swelling
- tenderness
- the area feels warm to the touch

Cuts on the skin, bent needles, and needles that remain in the skin after the injection, have happened in young children who do not cooperate and kick or move during an injection. If you inject a young child with epinephrine injection, hold their leg firmly in place before and during the injection to prevent injuries. Ask your healthcare provider to show you how to properly hold the leg of a young child during an injection.

If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use epinephrine injection. Talk to your healthcare provider about all your medical conditions.

Common side effects of epinephrine injection include:

faster, irregular or “pounding” heartbeat
sweating
headache
weakness
shakiness
paleness
feelings of over excitement, nervousness, or anxiety
dizziness
nausea or vomiting
breathing problems

These side effects may go away with rest. 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 epinephrine injection. For more information, ask your healthcare provider or pharmacist.

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 epinephrine injection?

Store epinephrine injection at room temperature between 68°F to 77° F (20°C to 25° C).
Protect from light.
Do not expose to extreme heat or cold. For example, do not store in your vehicle’s glove box and do not store in the refrigerator or freezer.
Examine the contents in the clear viewing window of your epinephrine injection periodically. The solution should be clear. If the solution is discolored (pinkish or brown), cloudy or contains solid particles, replace the unit.
Always keep your epinephrine injection in the carrying case to protect it from damage. The carrying case is not waterproof.
The two blue end caps help to prevent accidental injection. Do not remove the blue end caps until you are ready to use epinephrine injection.
Your epinephrine injection has an expiration date. Replace it before the expiration date.
Throw away (dispose of) expired, unwanted, or unused epinephrine injections in an FDA-cleared sharps disposal container. Do not throw away epinephrine injection in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- Made of heavy-duty plastic,
- Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- Upright and stable during use,
- Leak-resistant, and
- Properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal Visit the FDA’s website (https://www.fda.gov/drugs/safe-disposal-medicines/disposal- unused-medicines-what-you-should-know) for more information about how to throw away (dispose of) unused, unwanted or expired medicines.

Keep epinephrine injection and all medicines out of the reach of children.

General information about the safe and effective use of epinephrine injection:

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use epinephrine injection for a condition for which it was not prescribed. Do not give epinephrine injection to other people.

This Patient Information Leaflet summarizes the most important information about epinephrine injection. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about epinephrine injection that is written for health professionals.

What are the ingredients in epinephrine injection?

Active Ingredient: epinephrine

Inactive Ingredients: sodium chloride, chlorobutanol, sodium bisulfite, hydrochloric acid and sodium hydroxide, and water.

For more information and video instructions on the use of epinephrine injection go to www.epinephrineautoinject.com or call 1-877-835-5472.

Important Information

The epinephrine injection 0.3 mg has a yellow colored label.
The epinephrine injection 0.15 mg has an orange colored label.
The epinephrine injection Trainer has a beige color, and contains no medicine and no needle.
Your epinephrine injection is designed to work through clothing.
The two blue end caps on epinephrine injection help to prevent accidental injection of the device. Do not remove the blue end caps until you are ready to use it.
Only inject into the middle of the outer thigh (upper leg). Never inject into any other part of the body.
Never put your thumb, fingers, or your hand over the red tip. The needle comes out of the red tip.
If an accidental injection happens, get medical help right away.
Do not place patient information or any other foreign objects in carrier with the epinephrine injection, as this may prevent you from removing the auto-injector for use.

This Patient Information has been approved by the U.S. Food and Drug Administration

Rev. 02-2021-03

Instructions for Use

EPINEPHRINE injection (ep-in-eph-rine)

for intramuscular or subcutaneous use

For allergic emergencies (anaphylaxis)

Read this Instructions for Use carefully before you use epinephrine injection and each time you get a refill. There may be new information. Before you need to use your epinephrine injection, make sure your healthcare provider shows you the right way to use it. Parents, caregivers, and others who may be in a position to administer epinephrine injection should also understand how to use it well. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. If you have any questions, ask your healthcare provider.

Your epinephrine injection

Step 1. Prepare epinephrine injection for injection

Remove epinephrine injection from its protective carrying case.
Pull off blue end caps. You will now see a red tip. Grasp the epinephrine injection in your fist with the red tip pointing downward. See Figure A.

Note:

The needle comes out of the red tip.
To avoid an accidental injection, never put your thumb, fingers, or hand over the red tip. If an accidental injection happens, get medical help right away.

Step 2. Administer epinephrine injection

If you are administering epinephrine injection to a young child, hold the leg firmly in place and limit movement prior to and while administering an injection.
Put the red tip against the middle of the outer thigh (upper leg) at a 90° angle (perpendicular) to the thigh.
Press down hard and hold firmly against the thigh for approximately 10 seconds to deliver the medicine. See Figure B.

Only inject into the middle of the outer thigh. Do not inject into any other part of the body.
Remove epinephrine injection from the thigh.
Massage the area for 10 seconds.
Check the red tip. The injection is complete and you have received the correct dose of the medicine if you see the needle sticking out of the red tip. If you do not see the needle repeat Step 2.

Step 3. Get emergency medical help right away. You may need further medical attention. You may need to use a second epinephrine injection if symptoms continue or recur.

Step 4. After use Disposal

Carefully cover the needle with the carrying case.

Lay the labeled half of the carrying case cover down on a flat surface. Use one hand to carefully slide the end of the epinephrine injection needle first, into the labeled carrying case cover. See Figure C.

After the needle is inside the labeled cover, push the unlabeled half of the carrying case cover firmly over the non-needle end of the epinephrine injection . See Figure D.

Take your used epinephrine injection with you when you go to see a healthcare provider.
Tell the healthcare provider that you have received an injection of epinephrine. Show the healthcare provider where you received the injection.
Give your used epinephrine injection to the healthcare provider for inspection and proper disposal.
Ask for a refill, if needed.

Note:

Epinephrine injection is a single-use injectable device that delivers a fixed dose of epinephrine. Epinephrine injection cannot be reused. Do not attempt to reuse epinephrine injection after the device has been activated. It is normal for most of the medicine to remain in the auto-injector after the dose is injected. The correct dose has been administered if you see the needle sticking out of the red tip.
A separate epinephrine injection Trainer is available. The epinephrine injection Trainer has a beige color. The beige epinephrine injection Trainer contains no medicine and no needle. Practice with your epinephrine injection Trainer, but always carry your real epinephrine injection in case of an allergic emergency.
If you will be administering epinephrine injection to a young child, ask your healthcare provider to show you how to properly hold the leg in place while administering a dose.
Do not try to take epinephrine injection.

For more information and video instructions on the use of epinephrine injection, go to www.epinephrineautoinject.com or call 1-877-835-5472.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Hospira, Inc.

McPherson, KS 67460

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Revised 02-2021-03

INSTRUCTIONS FOR USE

Albuterol Sulfate (al-BYOO-ter-ole)

Inhalation Aerosol with Dose Indicator

Read this Instructions for Use before you start using Albuterol Sulfate Inhalation Aerosol and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment. Your doctor should show you how your child should use Albuterol Sulfate Inhalation Aerosol.

Important Information:

Albuterol Sulfate Inhalation Aerosol is for oral inhalation use only.
Take Albuterol Sulfate Inhalation Aerosol exactly as your doctor tells you to.

Albuterol Sulfate Inhalation Aerosol comes as a canister with a dose indicator. The dose indicator is located on the top of the canister that fits into an actuator (See Figure A). The dose indicator display window will show you how many puffs of medicine you have left. A puff of medicine is released each time you press the center of the dose indicator.

Do not use the Albuterol Sulfate Inhalation Aerosol actuator with a canister of medicine from any other inhaler.
Do not use the Albuterol Sulfate Inhalation Aerosol canister with an actuator from any other inhaler.

Figure A

Before you use Albuterol Sulfate Inhalation Aerosol for the first time make sure that the pointer on the dose indicator is pointing to the right of the “200” inhalation mark in the dose indicator display window (See Figure A) .

Each canister of Albuterol Sulfate Inhalation Aerosol contains 200 puffs of medicine. This does not include the sprays of medicine used for priming your inhaler.

The dose indicator display window will continue to move after every 10 puffs.
The number in the dose indicator display window will continue to change after every 20 puffs.
The color in the dose indicator display window will change to red, as shown in the shaded area, when there are only 20 puffs of medicine left in your inhaler (See Figure B) . This is when you need to refill your prescription or ask your doctor if you need another prescription for Albuterol Sulfate Inhalation Aerosol.

Figure B

Before using your Albuterol Sulfate Inhalation Aerosol for the first time, you should prime your inhaler. If you do not use your Albuterol Sulfate Inhalation Aerosol for more than 2 weeks, you should re-prime it before use.

Remove the cap from the mouthpiece (See Figure C ). Check inside the mouthpiece for objects before use.
Make sure the canister is fully inserted into the actuator.
Hold the inhaler in an upright position away from your face and shake the inhaler well.
Press down fully on the center of the dose indicator to release a spray of medicine. You may hear a soft click from the dose indicator as it counts down during use.
Repeat the priming step 3 more times to release a total of 4 sprays of medicine. Shake the inhaler well before each priming spray.
After the 4 priming sprays, the dose indicator should be pointing to 200. There are now 200 puffs of medicine left in the canister.
Your inhaler is now ready to use.

Using your Albuterol Sulfate Inhalation Aerosol inhaler:

Step 1: Shake the inhaler well before each use. Remove the cap from the mouthpiece (See Figure C ). Check inside the mouthpiece for objects before use. Make sure the canister is fully inserted into the actuator.

Figure C

Step 2: Breathe out as fully as you comfortably can through your mouth. Hold the inhaler in the upright position with the mouthpiece pointing towards you and place the mouthpiece fully into the mouth (See Figure D ). Close your lips around the mouthpiece.

Figure D

Step 3: While breathing in deeply and slowly, press down on the center of the dose indicator with your index finger until the canister stops moving in the actuator and a puff of medicine has been released (See Figure D ). Then stop pressing the dose indicator.

Step 4: Hold your breath as long as you comfortably can, up to 10 seconds. Remove the inhaler from your mouth, and then breathe out.

Step 5: If your doctor has prescribed additional puffs of Albuterol Sulfate Inhalation Aerosol, wait 1 minute then shake the inhaler well. Repeat steps 3 through 5 in the section “ Using your Albuterol Sulfate Inhalation Aerosol inhaler”.

Step 6: Replace the cap right away after use.

Cleaning your Albuterol Sulfate Inhalation Aerosol inhaler:

It is very important that you keep the mouthpiece clean so that medicine will not build up and block the spray through the mouthpiece. Clean the mouthpiece 1 time each week or if your mouthpiece becomes blocked (See Figure F ).

Step 1: Remove the canister from the actuator and take the cap off the mouthpiece. Do not clean the metal canister or let it get wet.

Step 2: Wash the mouthpiece through the top and bottom with warm running water for 30 seconds (See Figure E ).

Figure E

Step 3: Shake off as much water from the mouthpiece as you can.

Step 4: Look in the mouthpiece to make sure any medicine buildup has been completely washed away. If the mouthpiece is blocked with buildup, little to no medicine will come out of the mouthpiece (See Figure F ). If there is any buildup, repeat Steps 2 through 4 in the section “ Cleaning your Albuterol Sulfate Inhalation Aerosol inhaler”.

Figure F

Step 5: Let the mouthpiece air-dry such as overnight ( Figure G). Do not put the canister back into the actuator if it is still wet.

Figure G

Step 6: When the mouthpiece is dry, put the canister back in the actuator and put the cap on the mouthpiece.

Note: If you need to use your Albuterol Sulfate Inhalation Aerosol inhaler before it is completely dry, put the canister back in the actuator and shake the inhaler well. Press down on the center of the dose indicator 2 times to release a total of 2 sprays into the air, away from your face. Take your dose as prescribed then clean and air-dry your inhaler as described in the section “ Cleaning your Albuterol Sulfate Inhalation Aerosol inhaler”.

How should I store Albuterol Sulfate Inhalation Aerosol?

Store Albuterol Sulfate Inhalation Aerosol at room temperature between 59°F and 77°F (15°C and 25°C).
Store with the mouthpiece down.
Avoid exposing Albuterol Sulfate Inhalation Aerosol to extreme heat and cold.
Do not puncture or burn the canister.
Keep your Albuterol Sulfate Inhalation Aerosol inhaler and all medicines out of the reach of children.

Developed and Manufactured by:

Kindeva Drug Delivery L.P.

Northridge, CA 91324, USA

Distributed by:

Sandoz Inc.

Princeton, NJ 08540

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 12/2020

Patient Information

**Nitroglycerin (nahy-truh-glis-er-in)**

Sublingual Tablets, USP

Read this information carefully before you start nitroglycerin sublingual tablets and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor. If you have any questions about nitroglycerin sublingual tablets, ask your doctor. Your doctor will know if nitroglycerin sublingual tablets are right for you.

What are Nitroglycerin Sublingual Tablets?

Nitroglycerin sublingual tablets are type of medicine known as an organic nitrate and is a vasodilating agent. It is used to treat a type of chest pain called angina.

What is Angina?

Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back. Nitroglycerin sublingual tablets can relieve this pain.

Who should not use Nitroglycerin Sublingual Tablets?

Do not use nitroglycerin sublingual tablets if you are allergic to organic nitrates (like the active ingredient in nitroglycerin).

You should not take nitroglycerin sublingual tablets if you have the following conditions:

very recent heart attack
severe anemia
increased pressure in the head

Do not take nitroglycerin sublingual tablets with drugs for erectile dysfunction, like VIAGRA^®(sildenafil citrate), CIALIS^®(tadalafil), or LEVITRA^®(vardenafil hydrochloride), as this may lead to extreme lowering of your blood pressure.

Do not take nitroglycerin sublingual tablets if you take medicines called guanylate cyclase stimulators which include riociguat, a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.

What should I tell my doctor before taking Nitroglycerin Sublingual Tablets?

Before using nitroglycerin sublingual tablets, tell your doctor if:

You are taking any medicines that are used to treat angina, heart failure, or an irregular heartbeat.
You are taking any medicines that reduce blood pressure.
You are taking any diuretics (water pills).
You are taking medicines that can cause dry mouth such as tricyclic antidepressants (e.g. amitriptyline, desipramine, doxepin), anticholinergic drugs, or any antimuscarinic drugs (e.g. atropine).
You are taking ergotamine or similar drugs for migraine headaches.
You are taking aspirin.
You are taking any medicines for erectile dysfunction.
You are pregnant or plan to become pregnant.
You are breastfeeding.

How should I take Nitroglycerin Sublingual Tablets?

Do not chew, crush, or swallow nitroglycerin sublingual tablets.
You should sit down when taking nitroglycerin sublingual tablets and use caution when you stand up. This eliminates the possibility of falling due to lightheadedness or dizziness.
One tablet should be dissolved under the tongue or in the oral cavity at the first sign of chest pain.
The dose may be repeated approximately every 5 minutes, until the chest pain is relieved.
If the pain persists after a total of 3 tablets in a 15-minute period, or is different than you typically experience, call your doctor or seek emergency help.
Nitroglycerin sublingual tablets may be used 5 to 10 minutes prior to activities that might cause chest pain.
You may feel a burning or tingling sensation in your mouth when you take nitroglycerin sublingual tablets.

What should I avoid while taking Nitroglycerin Sublingual Tablets?

Do not breastfeed. It is not known if nitroglycerin will pass through your milk.
Do not consume alcohol while taking nitroglycerin sublingual tablets, as this can lower your blood pressure.
Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.

What are the possible side effects of Nitroglycerin Sublingual Tablets?

Nitroglycerin sublingual tablets may cause the following side effects:

headache
vertigo (a major symptom of balance disorder)
dizziness
weakness
heart palpitations (unusual awareness of the heartbeat)
low blood pressure upon rising from a seated position
nausea and vomiting
sweating
paleness
fainting
flushing (warm or red condition of your skin)
other skin reactions that may be severe

Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of nitroglycerin sublingual tablets. For a complete list, ask your doctor or pharmacist.

How do I store Nitroglycerin Sublingual Tablets?

Nitroglycerin sublingual tablets should be kept in the original glass container and tightly capped after each use to prevent loss of tablet potency.

Store nitroglycerin sublingual tablets at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

General advice about Nitroglycerin Sublingual Tablets

Sometimes doctors will prescribe a medicine for a condition that is not included in the patient information leaflets. Only use nitroglycerin sublingual tablets the way your doctor told you to. Do not give nitroglycerin sublingual tablets to other people, even if they have the same symptoms you have. They may harm them.

You can ask your pharmacist or doctor for information about nitroglycerin sublingual tablets, or you can call Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115.

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