Primatene Mist (Inhalation)

Epinephrine inhalation is used for temporary relief of mild symptoms of a weak type of asthma, known as intermittent asthma (for example, chest tightness, trouble breathing).

This medicine is available with your doctor's prescription and over the counter.

It is very important that your doctor checks your or your child's progress at regular visits to make sure that this medicine is working well and to look for any side effects.

Talk to your doctor if your symptoms do not improve or if they get worse. Your asthma may be getting worse if:

• You are not better in 20 minutes.
• You need more than 8 inhalations in 24 hours.
• You have more than 2 asthma attacks in a week.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the past 14 days.

This medicine may cause high blood pressure, which may increase your risk for heart attack or stroke. Contact your doctor immediately if you experience chest pain or discomfort, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, slurred speech, or weakness.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor must weigh the risks of taking the medicine against the benefits it may provide. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how epinephrine inhalation affects children younger than 12 years of age. Its safety and effectiveness in this age group have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the effectiveness of epinephrine inhalation.

Breast Feeding

There are no sufficient studies on women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits against the possible risks before using this medicine during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. In some cases, your doctor may need to adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been identified based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may adjust some of your other medicines.

• Dihydroergotamine
• Isocarboxazid
• Linezolid
• Phenelzine
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Benperidol
• Bromperidol
• Bucindolol
• Carteolol
• Carvedilol
• Clomipramine
• Desipramine
• Dibenzepin
• Digoxin
• Dilevalol
• Dixyrazine
• Doxepin
• Droperidol
• Entacapone
• Ergonovine
• Fexofenadine
• Fluphenazine
• Furazolidone
• Haloperidol
• Halothane
• Imipramine
• Iobenguane I 123
• Iproniazid
• Levalbuterol
• Levobunolol
• Lofepramine
• Loxapine
• Melitracen
• Melperone
• Methdilazine
• Methotrimeprazine
• Methylene Blue
• Methylergonovine
• Metipranolol
• Metopimazine
• Milnacipran
• Moperone
• Nadolol
• Nialamide
• Nortriptyline
• Opicapone
• Opipramol
• Oxprenolol
• Penbutolol
• Perazine
• Periciazine
• Perphenazine
• Pindolol
• Pipamperone
• Piperazine
• Pipotiazine
• Practolol
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propiomazine
• Propranolol
• Protriptyline
• Rasagiline
• Rocuronium
• Safinamide
• Selegiline
• Sotalol
• Terfenadine
• Tertatolol
• Thiethylperazine
• Thioproperazine
• Thioridazine
• Tianeptine
• Timolol
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimipramine
• Zavegepant

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both may be the best option for you. If both are prescribed, your doctor may adjust the dose or frequency of one or both.

• Labetalol

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines can also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Make sure to inform your doctor if you have any of the following medical issues:

• Diabetes or
• Enlarged prostate or
• Glaucoma, narrow-angle or
• Heart disease or history of or
• Hypertension (high blood pressure) or
• Seizures or
• Thyroid problems or
• Trouble urinating—Use with caution. May worsen these conditions.

Along with its needed effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Blurred vision
• chest pain or discomfort
• confusion
• difficulty in speaking
• dizziness
• double vision
• headache
• inability to move the arms, legs, or facial muscles
• inability to speak
• nausea
• nervousness
• pain or discomfort in the arms, jaw, back, or neck
• pounding in the ears
• seizures
• slow or fast heartbeat
• slow speech
• sweating
• tremors
• vomiting

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:

Incidence not known

• Difficulty sleeping

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.

In the U.S.

• Adrenalin
• Primatene Mist

In Canada

• Bronkaid Mistometer

Available Dosage Forms:

• Aerosol Liquid

Therapeutic Class: Bronchodilator

Pharmacologic Class: Sympathomimetic

Chemical Class: Alkylarylamine

Follow the instructions on the medicine label if you are using this medicine without a prescription.

This medicine should come with patient instructions. Read and follow these instructions carefully. Ask your pharmacist if you have any questions.

To use the inhaler:

• Before using the inhaler, activate it first by shaking then test spraying into the air away from your face 4 separate times.
• Shake and spray into the air once each time you take a dose.
• Remove the cap and look at the mouthpiece to make sure it is clean.
• To inhale this medicine, breathe out fully and try to get as much air out of your lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.
• Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down on the top of the canister once.
• Hold your breath for as long as you can.
• Release your finger and remove the inhaler from your mouth, then exhale slowly.
• If your symptoms are still not relieved after at least 1 minute, take a second inhalation.
• Wash your inhaler by removing the red cap and container. Run water through both ends of the mouthpiece for 30 seconds. Shake off as much water as you can. Air dry overnight. If you need to use the inhaler but it is still wet, shake off the excess water before using.
• The container of the inhaler contains a spray indicator. This will tell you how much medicine you have left. The spray indicator changes every after 20 sprays. Replace your inhaler as soon as the display reads "20".
• Do not use this medicine to treat other breathing problems, without first checking with your doctor.
• Avoid food or drinks that contain caffeine.
• Avoid supplements that contain, or claim to have, stimulant effects.

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 inhalation dosage form (aerosol):For relief of asthma symptoms: Adults and children 12 years of age and older—1 to 2 inhalations for each dose. Wait at least 1 minute between each inhalation. Wait at least 4 hours between doses. Do not use more than 8 inhalations in 24 hours. Children younger than 12 years of age—Use and dose must be determined by your doctor.

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 canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

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.

Throw the inhaler away if the spray indicator displays "0" or if it has expired.

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