Taro-Epinephrine Auto-Injector: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What this medication is used for:

Taro-Epinephrine Auto-Injector is indicated for the emergency treatment of anaphylaxis and are intended for people determined to be at risk for serious allergic reactions and for people with a history of anaphylactic reactions.

Taro-Epinephrine Auto-Injector should be used immediately to treat yourself or your child when experiencing a severe allergic reaction. This is emergency treatment. It does not replace seeing a doctor or going to the hospital.

Anaphylaxis is the term for a severe, life-threatening allergic reaction. A severe allergic reaction occurs when a person is exposed to an allergen (an allergy-causing substance). When the allergen enters the body it triggers the releases of chemicals that can lead to life-threatening symptoms.

Some common allergens include:

• foods like peanuts, tree nuts, shellfish, fish, milk, eggs and wheat
• insect stings like those from bees, wasps, hornets, yellow jackets and fire ants
• insect bites like those from mosquitos and black flies
• certain medicines
• latex
• other allergens (a substance that causes allergies)

These severe allergic reactions can also be caused by exercise, asthma or by unknown causes.

Those who are considered to be at a higher risk of anaphylaxis include people:

• who have previously experienced allergic reactions or anaphylaxis
• who suffer from asthma

• who have food allergies

  Anaphylaxis affects multiple body systems: skin, upper and lower respiratory system, intestinal tract, heart and blood vessels.

  The most common warning symptoms of anaphylaxis are:

  • Hives and swelling

Typical symptoms of anaphylaxis include:

• Swelling of the throat, lips, tongue, or the area around the eyes
• Hives
• Difficulty breathing or swallowing
• Wheezing and cough
• Metallic taste or itching in the mouth
• Flushing, itching, or redness of the skin
• Stomach cramps, nausea, vomiting, or diarrhea
• Increased heart rate
• Decreased blood pressure
• Chest pain
• Irregular heart beat
• Paleness
• Sudden feeling of weakness
• Feeling faint
• Anxiety or an overwhelming sense of doom
• Collapse
• Loss of consciousness

What it does:

Taro-Epinephrine Auto-Injector contains epinephrine, which is the medication that helps to decrease your body’s allergic reaction.

Some of the ways it works include:

• Relaxing the muscles in your airways so you can breathe more easily
• Helping to reverse the rapid and dangerous decrease in blood pressure
• Relaxing the muscles in your stomach, intestines, and bladder

What the medicinal ingredient is:

Epinephrine.

What the nonmedicinal ingredients are:

Hydrochloric acid, sodium chloride, sodium metabisulfite, and water for injection.

What dosage forms it comes in:

Taro-Epinephrine Auto-Injector: Unidose 0.3 mg epinephrine auto-injector

Taro-Epinephrine Auto-Injector: Unidose 0.15 mg epinephrine auto-injector

Taro-Epinephrine Auto-Injector comes in disposable, prefilled automatic injection device.

Taro-Epinephrine Auto-Injector is single-use injectable devices that deliver a fixed dose of epinephrine.

WARNINGS AND PRECAUTIONS

BEFORE you obtain Taro-Epinephrine Auto-Injector

talk to your doctor or pharmacist about all of your medical conditions, especially if you have:

• heart disease
• irregular heartbeat
• high blood pressure
• diabetes
• thyroid conditions
• narrow-angle glaucoma
• depression or other mental disease
• Parkinson’s disease
• severe kidney disease
• a tumor on the adrenal gland
• a tumor in the prostate gland
• very high calcium levels in your blood
• very low potassium levels in your blood
• asthma
• previously had an allergic reaction
• an allergy to any of the ingredients in this medication

• also notify your doctor and pharmacist if you are pregnant or breast feeding

Taro-Epinephrine Auto-Injector is the first line emergency treatment for severe, life-threatening allergic reactions even if you have the above conditions.

Other warnings you should know about:

General: If have you had a severe, life-threatening allergic reaction in the past, you are at a higher risk for having one again. You should carry Taro-Epinephrine Auto-Injector with you at all times. You or your child should also wear some form of medical identification bracelet or necklace.

Using Taro-Epinephrine Auto-Injector does not replace seeing a doctor or going to the hospital. You must get medical help right away after you or your child has used it.

Patients with Asthma: if you or your child has asthma, and it is not controlled properly, you are at a higher risk of having breathing problems when you have a severe allergic reaction.

Taro-Epinephrine Auto-Injector contains metabisulfite. This can cause allergic reactions and bronchospasms in those with a history of asthma.

You should follow your doctor’s instructions carefully on when you or child can use Taro-Epinephrine Auto-Injector.

Injection site: You should ONLY inject Taro-Epinephrine Auto-Injector into the outer side of your upper thigh - into the muscle (see Proper Use of this Medication).

Do not inject it into the:

• Vein (intravenously (IV))
• Buttocks
• hands, fingers, feet and toes

If you do, it can either cause dangerously high blood pressure or you or your child may not get the effect of the emergency treatment that you or they need.

If you accidentally inject it into any of these areas, go right away to the nearest hospital (emergency room) for further treatment.

If you inject a young child with Taro-Epinephrine Auto-Injector hold their leg firmly in place and limit movement 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 injection.

If you have a thick layer of fat under your skin the epinephrine in Taro-Epinephrine Auto-Injector may not reach your muscle tissue. In some cases this might make Taro-Epinephrine Auto-Injector not work as well.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with Taro-Epinephrine Auto-Injector include:

• Heart rhythm medicine, such as digoxin or quinidine (another name for digoxin is digitalis)
• Diuretic medicines ("water pills")
• MAO inhibitors (MAOI), such as selegilline, isocarboxazid, phenelzine sulfate, or tranylcypromine
• Tricyclic antidepressants, such as amitriptyline, doxepin, nortriptyline
• Antihistamines, such as chlorpheniramine, tripelennamine, or diphenhydramine
• Beta-adrenergic blocking drugs, such as propranolol
• Alpha-adrenergic blocking drugs, such as phentolamine
• Ergot alkaloids and phenothiazines
• Isoproterenol, orciprenaline, salbutamol and LABAs
• Thyroid medications (e.g. sodium levothyroxine)
• Cocaine

PROPER USE OF THIS MEDICATION

If you have been told by your doctor that you are at risk for an anaphylactic reaction, carry your Taro-Epinephrine Auto-Injector with you at all times.

When your doctor prescribes Taro-Epinephrine Auto-Injector, you must make sure you understand the reason it has been prescribed for you. You should be confident that you know exactly how and when to use it.

Use Taro-Epinephrine Auto-Injector exactly how your doctor or pharmacist has told you. Ask to have the instructions repeated to you if you are unsure about how to use it. It is recommended that your family members, carers or teachers are also instructed in the correct use of Taro-Epinephrine Auto-Injector.

There is a training device (Trainer) which you can use to practice.

If you have been stung by an insect, try to remove the stinger with your fingernails. Do not squeeze, pinch or push the stinger deeper into the skin.

If possible, put an ice pack on the area of the sting. Keep yourself warm and avoid exercise.

For allergic reactions caused by foods make sure you remove any remaining food from the mouth immediately.

IMPORTANT NOTE:

Severe, life-threatening allergic reactions (anaphylaxis) can result in death if not treated immediately.

Talk to your doctor about the warning signs and symptoms of anaphylaxis and when to use Taro-Epinephrine Auto-Injector.

Inject Taro-Epinephrine Auto-Injector right away if you experience any of the symptoms of a severe allergic reaction, such as swelling of the throat, lips, tongue or around the eyes, trouble breathing or swallowing. You must get medical help right away after using Taro-Epinephrine Auto-Injector. You can:

• call 911 and get taken to the hospital OR
• you can have someone take you (or you can take your child) to the nearest hospital emergency room

If you or your child do not feel better or get worse you can inject another dose of Taro-Epinephrine Auto-Injector 5 to 15 minutes after the first injection.

Do not inject more than 2 injections right after each other.

Usual dose:

Taro-Epinephrine Auto-Injector (0.3 mg) should be used for adults and children weighing 30 kg or more.

Taro-Epinephrine Auto-Injector (0.15 mg) should be used for children weighing between 15 kg to 30 kg. For children weighing less than 15 kg, call 911.

DIRECTIONS FOR USE

Taro-Epinephrine Auto-Injector

Caution

• Remove Taro-Epinephrine Auto-Injector from carrier tube before use.
• Never put thumb, fingers or hand over black injector tip.
• Never press or push black injector tip with thumb, fingers, or hand. The injection needle comes out of black injector tip.
• Do not remove safety cap (green 0.15 mg Unidose or yellow 0.3 mg Unidose) until ready to use.
• Remove safety cap (green 0.15 mg Unidose or yellow 0.3 mg Unidose) by pulling straight up (Do not bend or twist off the safety cap).

Note: The following instructions contain images using the Training Taro-Epinephrine Auto-Injector device; for demonstration purposes the viewing window of the training device is larger than the viewing window of the actual Taro-Epinephrine Auto-Injector.

To Take Taro-Epinephrine Auto-Injector out of the Carrier Tube

To Open:

1. 1. UNSCREW the Carrier Cap (green 0.15 mg Unidose or yellow 0.3 mg Unidose) from the Clear Carrier Tube.

1. 2. TIP the carrier tube and slide the Taro-Epinephrine Auto-Injector out.

Taro-Epinephrine Auto-Injector

To Use Taro-Epinephrine Auto-Injector

1. 1.

   GRASP Taro-Epinephrine Auto-Injector in your dominant hand (the one you use to write with) with your thumb closest to the grey activation button.

   1. 2.

      PULL off the safety cap (green 0.15 mg Unidose or yellow 0.3 mg Unidose).

      Never put thumb, fingers, or hand over black injector tip.

   2. 3. PLACE black injector tip onto outer thigh. Inject into your thigh, even through clothing, if necessary. Do not inject into your hands, feet, or buttock.

PRESS firmly until injector tip is completely depressed (pushed in).

PUSH grey button until it ‘clicks’ to begin the delivery and hold on thigh for several seconds.

1. 4. LIFT the injector straight away from your thigh after the window turns blue. The Black Needle Safety Guard will lock over the needle when Taro-Epinephrine Auto-Injector is removed from the thigh.

.

1. 5.

   Massage injected area if desired. If the needle is still visible, do not attempt to reuse it. The injection is now complete.

   1. 6. If you are administering Taro-Epinephrine Auto-Injector to a young child, hold the leg firmly in place while administering the injection.
   2. 7. Seek emergency medical attention immediately even if the severe allergy symptoms seem to have subsided. Because the effects of epinephrine can wear off and there is a chance of a second reaction, it is important that you seek medical assistance or go to the emergency room immediately after using Taro-Epinephrine Auto-Injector. With a severe, long-lasting allergic reaction, you may need to administer an additional dose of epinephrine. More than two sequential doses of epinephrine should only be administered under direct medical supervision.
   3. 8.

      Even if you have sought medical help, you must stay within close proximity to a hospital or where you can easily call 911 for the next 48 hours.

      The used Taro-Epinephrine Auto-Injector with extended Black Needle Safety Guard can be placed back into the carrier tube. Give any used Taro-Epinephrine Auto-Injector to emergency responders or emergency room personnel.

      Do not attempt to reuse a Taro-Epinephrine Auto-Injector after the device has been activated.

Overdose:

Too much epinephrine can cause dangerously high blood pressure, stroke, or death.

Signs of an overdose include:

• irregular heart beat
• difficulty breathing caused by a build-up of fluid in your lungs

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Taro-Epinephrine Auto-Injector is intended to be used immediately to treat yourself or your child when suffering from a severe allergic reaction. This is emergency treatment.

After you use Taro-Epinephrine Auto-Injector always seek appropriate medical care. Taro-Epinephrine Auto-Injector does not replace seeing a doctor or going to the hospital.

The following side effects may occur after using Taro-Epinephrine Auto-Injector .

• Paleness
• Dizziness
• Weakness
• Shaking
• Headache
• Throbbing
• Restlessness
• Anxiety
• Tenseness
• Fear

Patients who have used Taro-Epinephrine Auto-Injector 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.

Serious side effects and what to do about them

This is not a complete list of side effects. For unexpected effects while taking Taro-Epinephrine Auto-Injector, talk to your doctor or pharmacist.

It is important that you seek medical assistance or go to the emergency room immediately after using Taro-Epinephrine Auto-Injector.

HOW TO STORE IT

• Store at 25°C (77°F). Do not refrigerate or freeze. Do not drop.
• Do not expose your Taro-Epinephrine Auto-Injector to direct sunlight.
• Do not keep your Taro-Epinephrine Auto-Injector in a vehicle during extremely hot or cold weather.
• Always keep your Taro-Epinephrine Auto-Injector in the carrier tube with the green safety cap (Taro-Epinephrine Auto-Injector 0.15 mg Unidose) or yellow safety cap (Taro-Epinephrine Auto-Injector 0.3 mg Unidose) to protect it from damage; however, the carrier tube is not waterproof.
• The green safety cap (Taro-Epinephrine Auto-Injector 0.15 mg Unidose) or yellow safety cap (Taro-Epinephrine Auto-Injector 0.3 mg Unidose) helps to prevent accidental injection. Keep the green safety cap (Taro-Epinephrine Auto-Injector 0.15 mg Unidose) or yellow safety cap (Taro-Epinephrine Auto-Injector 0.3 mg Unidose) until you need to use Taro-Epinephrine Auto-Injector.
• Occasionally inspect your Taro-Epinephrine Auto-Injector solution through the viewing window. Replace your Taro-Epinephrine Auto-Injector if it is discolored or contains solid particles (precipitate) or if there are any signs of leakage. The solution should be clear.
• Discard if there are any signs of damage to the carrier or the Taro-Epinephrine Auto-Injector.
• Do not attempt to take the Taro-Epinephrine Auto-Injector apart. Replace your Taro-Epinephrine Auto-Injector before the expiration date or after you use it.
• Talk to your pharmacist or physician about how to properly dispose of your expired Taro-Epinephrine Auto-Injector.
• Do not place this Consumer Information or any other objects in the carrier tube with your Taro-
• Epinephrine Auto-Injector, as this may prevent you from removing your Taro-Epinephrine Auto-Injector, quickly for use.
• Keep out of reach and sight of children.

Reporting Side Effects

MORE INFORMATION

If you want more information about

Taro-Epinephrine Auto-Injector:

• Talk to your healthcare professional
• Find the full Prescribing Information that is prepared for healthcare professionals and includes this Part III: Consumer Information by visiting the Health Canada website: (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp; the manufacturer’s website www.taro.ca, or by calling 1-800-268-1975.

Taro Pharmaceuticals Inc.

130 East Drive, Brampton

Ontario L6T 1C1

Last revised: December 1, 2020