What is Auvi-Q?

Auvi-Q injection contains epinephrine, a chemical that narrows blood vessels and opens airways in the lungs. These effects can reverse severe low blood pressure, wheezing, severe skin itching, hives, and other symptoms of an allergic reaction.

Auvi-Q injection is used to treat severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens. Epinephrine is also used to treat exercise-induced anaphylaxis.

Auvi-Q auto-injectors may be kept on hand for self-injection by a person with a history of an severe allergic reaction. This medicine is for use in adults and children who weigh at least 16.5 pounds (7.5 kilograms).

Warnings

Seek emergency medical attention after any use of Auvi-Q to treat a severe allergic reaction. After the injection you will need to receive further treatment and observation.

Before using this medicine

Before using Auvi-Q, tell your doctor if any past use of this medicine caused an allergic reaction to get worse.

To make sure Auvi-Q is safe for you, tell your doctor if you have ever had:

• heart disease or high blood pressure;
• asthma;
• Parkinson’s disease;
• depression or mental illness;
• a thyroid disorder; or
• diabetes.

Having an allergic reaction while pregnant or nursing could harm both mother and baby. You may need to use epinephrine during pregnancy or while you are breastfeeding. Seek emergency medical attention right away after using the injection.

If possible during an emergency, tell your medical caregivers if you are pregnant or breastfeeding.

How should I use Auvi-Q?

The Auvi-Q auto-injector device is a disposable single-use system. Follow all directions on your prescription label and read all medication guides or instruction sheets. Do not inject this medicine if you do not understand these instructions. Use the medicine exactly as directed. Ask your doctor or pharmacist if you do not understand these instructions.

Use an auto-injector only one time. Do not try to reinsert an auto-injector a second time. If the needle is bent from the first use, it may cause serious injury to your skin.

Do not give this medicine to a child without medical advice.

Auvi-Q is injected into the skin (subcutaneously) or muscle (intramuscularly) of your outer thigh. In an emergency, this injection can be given through your clothing.

Your medicine may also come with a “trainer pen.” The trainer pen contains no medicine and no needle. It is only for non-emergency use to practice giving yourself an Auvi-Q injection.

Do not remove the safety cap until you are ready to use the auto-injector. Never put your fingers over the injector tip when removing the safety cap or after the safety cap has been removed.

To use an Auvi-Q auto-injector:

Auvi-Q contains an electronic voice instruction system to help guide you through each step of your injection. If the voice instructions do not work for any reason, use Auvi-Q as directed in the steps below. It will still work during an allergic reaction emergency.

1. Pull Auvi-Q up from the outer case.
2. Pull Red safety guard down and off of Auvi-Q. To reduce the chance of an accidental injection, do not touch the black base of the auto-injector, which is where the needle comes out. If an accidental injection happens, get medical help right away. Note that the red safety guard is made to fit tight. Pull firmly to remove.
3. Place black end of Auvi-Q against the middle of the outer thigh (through clothing, if needed), then push firmly until you hear a click and hiss sound, and hold in place for 2 seconds. Only inject into the middle of the outer thigh. Do not inject into any other part of the body. If you are administering Auvi-Q to a young child or infant, hold the leg firmly in place while administering an injection.The needle automatically retracts after the injection is complete, so the needle will not be visible after the injection. Auvi-Q includes a 2-second countdown after it is activated, then the voice instruction will indicate the injection is complete.
4. Seek emergency medical attention after any use of epinephrine to treat a severe allergic reaction.The effects of epinephrine may wear off after 10 or 20 minutes. You will need to receive further treatment and observation.

Do not use Auvi-Q if it has changed colors or has particles in it, or if the expiration date on the label has passed. Call your pharmacist for a new prescription.

Store at room temperature away from moisture, heat, and light. Do not refrigerate or freeze this medication, and do not store it in a car.

Do not reuse a needle or syringe. Use only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

Since epinephrine is used when needed, it does not have a daily dosing schedule.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include numbness or weakness, severe headache, blurred vision, pounding in your neck or ears, sweating, chills, chest pain, fast or slow heartbeats, severe shortness of breath, or cough with foamy mucus.

What should I avoid while using Auvi-Q?

Do not inject epinephrine into a vein or into the muscles of your buttocks, or it may not work as well. Inject it only into the fleshy outer portion of the thigh.

Accidentally injecting epinephrine into your hands or feet may result in a loss of blood flow to those areas, and resulting numbness.

Uses for formoterol

Formoterol is used together with other medicines (eg, inhaled corticosteroids) to treat asthma and prevent bronchospasm in patients with asthma. When used regularly every day, inhaled formoterol decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Formoterol is also used for the long-term maintenance treatment of air flow blockage in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (wheezing or difficulty with breathing).

Formoterol belongs to the family of medicines known as bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

Formoterol is also used to prevent troubled breathing or wheezing caused by exercise (exercise-induced bronchospasm or EIB).

This medicine is available only with your doctor’s prescription.

Before using formoterol

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of formoterol inhalation powder in children 5 years of age and older. Safety and efficacy have not been established for children younger than 5 years of age.

Formoterol inhalation solutionis not indicated for use 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 formoterol in the elderly. However, elderly patients are more likely to have age-related heart or blood vessel disease, which may require caution in patients receiving formoterol.

Breast Feeding

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.

Interactions with Medicines

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.

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

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.

• Acebutolol
• Adagrasib
• Alfuzosin
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Atenolol
• Azithromycin
• Bedaquiline
• Bemetizide
• Bendroflumethiazide
• Benzthiazide
• Betaxolol
• Bisoprolol
• Bumetanide
• Buprenorphine
• Buserelin
• Carteolol
• Carvedilol
• Celiprolol
• Ceritinib
• Chloroquine
• Chlorothiazide
• Chlorpromazine
• Chlorthalidone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clopamide
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Cyclopenthiazide
• Cyclothiazide
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Diazoxide
• Dibenzepin
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Esmolol
• Ethacrynic Acid
• Etozolin
• Etrasimod
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Furosemide
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Indapamide
• Inotuzumab Ozogamicin
• Isocarboxazid
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Labetalol
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levobunolol
• Levofloxacin
• Linezolid
• Lofepramine
• Lofexidine
• Lumefantrine
• Macimorelin
• Mefloquine
• Melitracen
• Methacholine
• Methadone
• Methotrimeprazine
• Methyclothiazide
• Methylene Blue
• Metipranolol
• Metolazone
• Metoprolol
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nadolol
• Nafarelin
• Nebivolol
• Nelfinavir
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Opipramol
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxprenolol
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Penbutolol
• Pentamidine
• Perphenazine
• Phenelzine
• Phenobarbital
• Pimavanserin
• Pindolol
• Pipamperone
• Piretanide
• Pitolisant
• Polythiazide
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Procarbazine
• Prochlorperazine
• Promethazine
• Propafenone
• Propranolol
• Protriptyline
• Quetiapine
• Quinethazone
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Rasagiline
• Relugolix
• Ribociclib
• Risperidone
• Ritonavir
• Safinamide
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tianeptine
• Timolol
• Tolterodine
• Toremifene
• Torsemide
• Tranylcypromine
• Trazodone
• Trichlormethiazide
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Xipamide
• Zotepine
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

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:

• Acute asthma attack or
• COPD attack, severe—Should not be used if you are having an acute asthma attack, severe COPD attack, or if symptoms of an asthma or COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute asthma or COPD attack.
• Allergy to milk proteins or lactose intolerance—Use with caution. The capsule form of this medicine contains lactose (milk sugar) and milk proteins.

• Angina (severe chest pain) or
• Diabetes or
• Heart or blood vessel disease (eg, aneurysm) or
• Heart rhythm problems (eg, arrhythmia, QT prolongation) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (an overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Ketoacidosis (high ketones in the blood) or
• Pheochromocytoma (adrenal gland problem) or
• Seizures—Use with caution. May make these conditions worse.

Proper use of formoterol

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than recommended on the label, unless otherwise directed by your doctor. Using the medicine more often may increase the chance of serious unwanted effects.

Inhaled formoterol is used to prevent asthma or COPD attacks. It is not used to relieve an attack that has already started. For relief of an asthma or COPD attack that has already started, you should use another medicine. If you do not have another medicine to use, or if you have any questions about this, check with your doctor.

In order for this medicine to help prevent asthma or COPD attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

Do not stop using this medicine or other asthma or COPD medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

The formoterol inhalation solution should be used with a jet nebulizer that is connected to an air compressor with good air flow. The inhalation solution comes with a patient information leaflet and patient instructions. Read and follow the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the nebulizer, ask your doctor to show you what to do. Also, ask your doctor to check how you use the inhaler to make sure you are using it properly.

To use the inhalation solution in the nebulizer:

• Use the medicine immediately after opening the foil pouch.
• Twist the cap off the vial and squeeze all the medicine in the nebulizer medicine cup.
• Do not mix Perforomist® inhalation solution with other medicines in the nebulizing machine.
• Connect the nebulizer to the face mask or mouthpiece, then connect the nebulizer to the compressor.
• To inhale the medicine, place the mouthpiece in your mouth, then turn on the compressor. Breathe in deeply and steadily until no more mist is formed in the nebulizer reservoir.
• Use the nebulizer for about 9 minutes, or until the medicine in the nebulizer cup is gone.
• Clean all the parts of the nebulizer after each use.

Formoterol inhalation powder is used with a special inhaler and usually comes with a Medication Guide and patient instructions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check how you use the inhaler to make sure you are using it properly.

To use the formoterol inhalation powder:

• Dry your hands before handling this medicine.
• Open the foil pouch containing a blister card of capsules. Do not remove a capsule until you are ready for a dose.
• Place the capsule only in the capsule-chamber in the base of the inhaler. Do not swallow the capsule and do not place a capsule directly into the mouthpiece.
• Hold the mouthpiece of the inhaler upright and press both buttons at the same time. Press the buttons only once. You should hear a click as the capsule is being pierced.
• Breathe out fully. Do not exhale into the mouthpiece.
• Tilt your head slightly backwards. Keep the inhaler level, with the blue buttons to the left and right. Place the mouthpiece in your mouth then close your lips around the mouthpiece.
• Breathe in quickly and deeply.
• Remove the inhaler from your mouth. Hold your breath as long as you can and then exhale.
• Open the inhaler after using it, and remove and discard the empty capsule. Do not leave the used capsule inside the chamber.
• Close the mouthpiece and then replace the cover.
• Do not wash the inhaler. Keep it dry.
• Do not use a spacer with this medicine.
• You may reuse your inhaler. But use a new inhaler with each refill of your medicine.
• Do not use the inhaler for this medicine with any other medicine.

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 (powder):
  • For preventing an asthma attack:
    • Adults and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation every 12 hours.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
  • For preventing exercise-induced bronchospasm (EIB):
    • Adults and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation at least 15 minutes before exercise, as needed.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
  • For maintenance treatment of COPD:
    • Adults and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation every 12 hours.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
• For inhalation dosage form (solution):
  • For maintenance treatment of COPD:
    • Adults—20 micrograms (mcg) (1 vial) in the nebulizer 2 times a day (morning and evening). Do not use more than 2 vials (40 mcg) per day.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store Foradil® capsules at room temperature, away from heat, light, or moisture. Keep capsules stored in the blister packaging, and do not remove from blister until right before use.

Store the Perforomist® solution in the refrigerator. You may also keep it at room temperature, away from direct heat or light for up to 3 months. Throw away any unused solution after 3 months.

Precautions while using formoterol

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly. Blood tests may be needed to check for any unwanted effects.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Tell your doctor if you are also using other medicines for your COPD. Your doctor may want you to stop using the medicine and use it only during a severe COPD attack. Follow your doctor’s instructions on how you should take your medicine.

This medicine should not be used if you are having a severe COPD attack, or if symptoms of a COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.

This medicine should not be used together with similar inhaled medicines such as arformoterol (Brovana), budesonide/formoterol (Symbicort®), indacaterol (Arcapta® Neohaler®), salmeterol (Serevent®), or salmeterol/fluticasone (Advair®).

This medicine should only be used as an additional treatment for patients who cannot be treated with other asthma medicines (such as inhaled corticosteroids) or for asthma patients that require two medicines, including formoterol. Ask your doctor if you have any questions.

Talk to your doctor or get medical care right away if:

• Your or your child’s symptoms do not improve after using this medicine for 1 week or if they become worse.
• Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often (eg, you use 1 whole canister of your short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of your short-acting inhaler for 2 or more days in a row).
• You have a significant decrease in your peak flow when measured as directed by your doctor.

You or your child may also be using an anti-inflammatory medicine, such as a steroid, together with this medicine. Do not stop using the anti-inflammatory medicine even if your asthma seems better, unless you are told to do so by your doctor.

Although this medicine decreases the number of asthma episodes, this medicine may also increase the chances of a severe asthma episode when they do occur. Be sure to read about these risks in the Medication Guide and talk to your doctor or pharmacist about any questions or concerns that you have.

Perforomist® may increase the risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma who take this medicine without an inhaled steroid medicine. Talk to your doctor if you have concerns about this.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child has a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Perforomist® may cause heart or blood vessel problems, including heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or weight gain.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have more than one of the following symptoms: convulsions (seizures), decreased urine, dry mouth, increased thirst, irregular heartbeat, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, shortness of breath, or unusual tiredness or weakness.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

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 of formoterol

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:

More common

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• hoarseness
• loss of voice
• runny or stuffy nose
• sneezing
• sore throat
• unusual tiredness or weakness

Less common

• Chest pain or discomfort
• cough-producing mucous
• dry throat
• labored breathing
• pain or tenderness around the eyes and cheekbones
• tender, swollen glands in the neck
• tightness in the chest
• trauma
• trouble with swallowing
• voice changes

Rare

• Decreased urine
• dry mouth
• fainting
• fast, pounding, or irregular heartbeat or pulse
• increased thirst
• loss of appetite
• noisy breathing
• seizures

Incidence not known

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• hives, itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sweating

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Arm, back, or jaw pain
• chest tightness or heaviness
• diarrhea
• general feeling or discomfort or illness
• increased hunger
• increased urination
• loss of consciousness
• muscle pain
• muscle spasm or jerking of all extremities
• nausea
• no blood pressure or pulse
• numbness or tingling in the hands, feet, or lips
• palpitations or pounding in the ears
• pounding or racing heartbeat or pulse
• slow heartbeat
• stopping of the heart
• sudden loss of consciousness
• trouble sleeping
• 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:

Less common

• Agitation
• back pain
• increased mucous in the throat and lungs
• leg cramps
• muscle cramps
• redness of the skin
• restlessness
• shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

Uses for formoterol

Formoterol is used together with other medicines (eg, inhaled corticosteroids) to treat asthma and prevent bronchospasm in patients with asthma. When used regularly every day, inhaled formoterol decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Formoterol is also used for the long-term maintenance treatment of air flow blockage in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (wheezing or difficulty with breathing).

Formoterol belongs to the family of medicines known as bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

Formoterol is also used to prevent troubled breathing or wheezing caused by exercise (exercise-induced bronchospasm or EIB).

This medicine is available only with your doctor’s prescription.

Before using formoterol

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.

Buy vitamins and supplements

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of formoterol inhalation powder in children 5 years of age and older. Safety and efficacy have not been established for children younger than 5 years of age.

Formoterol inhalation solutionis not indicated for use 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 formoterol in the elderly. However, elderly patients are more likely to have age-related heart or blood vessel disease, which may require caution in patients receiving formoterol.

Breast Feeding

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.

Interactions with Medicines

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.

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

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.

• Acebutolol
• Adagrasib
• Alfuzosin
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Atenolol
• Azithromycin
• Bedaquiline
• Bemetizide
• Bendroflumethiazide
• Benzthiazide
• Betaxolol
• Bisoprolol
• Bumetanide
• Buprenorphine
• Buserelin
• Carteolol
• Carvedilol
• Celiprolol
• Ceritinib
• Chloroquine
• Chlorothiazide
• Chlorpromazine
• Chlorthalidone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clopamide
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Cyclopenthiazide
• Cyclothiazide
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Diazoxide
• Dibenzepin
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Esmolol
• Ethacrynic Acid
• Etozolin
• Etrasimod
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Furosemide
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Indapamide
• Inotuzumab Ozogamicin
• Isocarboxazid
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Labetalol
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levobunolol
• Levofloxacin
• Linezolid
• Lofepramine
• Lofexidine
• Lumefantrine
• Macimorelin
• Mefloquine
• Melitracen
• Methacholine
• Methadone
• Methotrimeprazine
• Methyclothiazide
• Methylene Blue
• Metipranolol
• Metolazone
• Metoprolol
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nadolol
• Nafarelin
• Nebivolol
• Nelfinavir
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Opipramol
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxprenolol
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Penbutolol
• Pentamidine
• Perphenazine
• Phenelzine
• Phenobarbital
• Pimavanserin
• Pindolol
• Pipamperone
• Piretanide
• Pitolisant
• Polythiazide
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Procarbazine
• Prochlorperazine
• Promethazine
• Propafenone
• Propranolol
• Protriptyline
• Quetiapine
• Quinethazone
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Rasagiline
• Relugolix
• Ribociclib
• Risperidone
• Ritonavir
• Safinamide
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tianeptine
• Timolol
• Tolterodine
• Toremifene
• Torsemide
• Tranylcypromine
• Trazodone
• Trichlormethiazide
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Xipamide
• Zotepine
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

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:

• Acute asthma attack or
• COPD attack, severe—Should not be used if you are having an acute asthma attack, severe COPD attack, or if symptoms of an asthma or COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute asthma or COPD attack.
• Allergy to milk proteins or lactose intolerance—Use with caution. The  capsule form of this medicine contains lactose (milk sugar) and milk proteins.

• Angina (severe chest pain) or
• Diabetes or
• Heart or blood vessel disease (eg, aneurysm) or
• Heart rhythm problems (eg, arrhythmia, QT prolongation) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (an overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Ketoacidosis (high ketones in the blood) or
• Pheochromocytoma (adrenal gland problem) or
• Seizures—Use with caution. May make these conditions worse.

Proper use of formoterol

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than recommended on the label, unless otherwise directed by your doctor. Using the medicine more often may increase the chance of serious unwanted effects.

Inhaled formoterol is used to prevent asthma or COPD attacks. It is not used to relieve an attack that has already started. For relief of an asthma or COPD attack that has already started, you should use another medicine. If you do not have another medicine to use, or if you have any questions about this, check with your doctor.

In order for this medicine to help prevent asthma or COPD attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

Do not stop using this medicine or other asthma or COPD medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

The formoterol inhalation solution should be used with a jet nebulizer that is connected to an air compressor with good air flow. The inhalation solution comes with a patient information leaflet and patient instructions. Read and follow the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the nebulizer, ask your doctor to show you what to do. Also, ask your doctor to check how you use the inhaler to make sure you are using it properly.

To use the inhalation solution in the nebulizer:

• Use the medicine immediately after opening the foil pouch.
• Twist the cap off the vial and squeeze all the medicine in the nebulizer medicine cup.
• Do not mix Perforomist® inhalation solution with other medicines in the nebulizing machine.
• Connect the nebulizer to the face mask or mouthpiece, then connect the nebulizer to the compressor.
• To inhale the medicine, place the mouthpiece in your mouth, then turn on the compressor. Breathe in deeply and steadily until no more mist is formed in the nebulizer reservoir.
• Use the nebulizer for about 9 minutes, or until the medicine in the nebulizer cup is gone.
• Clean all the parts of the nebulizer after each use.

Formoterol inhalation powder is used with a special inhaler and usually comes with a Medication Guide and patient instructions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check how you use the inhaler to make sure you are using it properly.

To use the formoterol inhalation powder:

• Dry your hands before handling this medicine.
• Open the foil pouch containing a blister card of  capsules. Do not remove a capsule until you are ready for a dose.
• Place the capsule only in the capsule-chamber in the base of the inhaler. Do not swallow the capsule and do not place a capsule directly into the mouthpiece.
• Hold the mouthpiece of the inhaler upright and press both buttons at the same time. Press the buttons only once. You should hear a click as the capsule is being pierced.
• Breathe out fully. Do not exhale into the mouthpiece.
• Tilt your head slightly backwards. Keep the inhaler level, with the blue buttons to the left and right. Place the mouthpiece in your mouth then close your lips around the mouthpiece.
• Breathe in quickly and deeply.
• Remove the inhaler from your mouth. Hold your breath as long as you can and then exhale.
• Open the inhaler after using it, and remove and discard the empty  capsule. Do not leave the used capsule inside the chamber.
• Close the mouthpiece and then replace the cover.
• Do not wash the inhaler. Keep it dry.
• Do not use a spacer with this medicine.
• You may reuse your inhaler. But use a new inhaler with each refill of your medicine.
• Do not use the inhaler for this medicine with any other medicine.

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 (powder):
  • For preventing an asthma attack:
    • Adults and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation every 12 hours.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
  • For preventing exercise-induced bronchospasm (EIB):
    • Adults and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation at least 15 minutes before exercise, as needed.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
  • For maintenance treatment of COPD:
    • Adults and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation every 12 hours.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
• For inhalation dosage form (solution):
  • For maintenance treatment of COPD:
    • Adults—20 micrograms (mcg) (1 vial) in the nebulizer 2 times a day (morning and evening). Do not use more than 2 vials (40 mcg) per day.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store Foradil® capsules at room temperature, away from heat, light, or moisture. Keep capsules stored in the blister packaging, and do not remove from blister until right before use.

Store the Perforomist® solution in the refrigerator. You may also keep it at room temperature, away from direct heat or light for up to 3 months. Throw away any unused solution after 3 months.

Precautions while using formoterol

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly. Blood tests may be needed to check for any unwanted effects.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Tell your doctor if you are also using other medicines for your COPD. Your doctor may want you to stop using the medicine and use it only during a severe COPD attack. Follow your doctor’s instructions on how you should take your medicine.

This medicine should not be used if you are having a severe COPD attack, or if symptoms of a COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.

This medicine should not be used together with similar inhaled medicines such as arformoterol (Brovana), budesonide/formoterol (Symbicort®), indacaterol (Arcapta® Neohaler®), salmeterol (Serevent®), or salmeterol/fluticasone (Advair®).

This medicine should only be used as an additional treatment for patients who cannot be treated with other asthma medicines (such as inhaled corticosteroids) or for asthma patients that require two medicines, including formoterol. Ask your doctor if you have any questions.

Talk to your doctor or get medical care right away if:

• Your or your child’s symptoms do not improve after using this medicine for 1 week or if they become worse.
• Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often (eg, you use 1 whole canister of your short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of your short-acting inhaler for 2 or more days in a row).
• You have a significant decrease in your peak flow when measured as directed by your doctor.

You or your child may also be using an anti-inflammatory medicine, such as a steroid, together with this medicine. Do not stop using the anti-inflammatory medicine even if your asthma seems better, unless you are told to do so by your doctor.

Although this medicine decreases the number of asthma episodes, this medicine may also increase the chances of a severe asthma episode when they do occur. Be sure to read about these risks in the Medication Guide and talk to your doctor or pharmacist about any questions or concerns that you have.

Perforomist® may increase the risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma who take this medicine without an inhaled steroid medicine. Talk to your doctor if you have concerns about this.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child has a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Perforomist® may cause heart or blood vessel problems, including heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or weight gain.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have more than one of the following symptoms: convulsions (seizures), decreased urine, dry mouth, increased thirst, irregular heartbeat, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, shortness of breath, or unusual tiredness or weakness.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

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 of formoterol

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:

More common

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• hoarseness
• loss of voice
• runny or stuffy nose
• sneezing
• sore throat
• unusual tiredness or weakness

Less common

• Chest pain or discomfort
• cough-producing mucous
• dry throat
• labored breathing
• pain or tenderness around the eyes and cheekbones
• tender, swollen glands in the neck
• tightness in the chest
• trauma
• trouble with swallowing
• voice changes

Rare

• Decreased urine
• dry mouth
• fainting
• fast, pounding, or irregular heartbeat or pulse
• increased thirst
• loss of appetite
• noisy breathing
• seizures

Incidence not known

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• hives, itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sweating

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Arm, back, or jaw pain
• chest tightness or heaviness
• diarrhea
• general feeling or discomfort or illness
• increased hunger
• increased urination
• loss of consciousness
• muscle pain
• muscle spasm or jerking of all extremities
• nausea
• no blood pressure or pulse
• numbness or tingling in the hands, feet, or lips
• palpitations or pounding in the ears
• pounding or racing heartbeat or pulse
• slow heartbeat
• stopping of the heart
• sudden loss of consciousness
• trouble sleeping
• 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:

Buy vitamins and supplements

Less common

• Agitation
• back pain
• increased mucous in the throat and lungs
• leg cramps
• muscle cramps
• redness of the skin
• restlessness
• shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

Uses for levalbuterol

Levalbuterol is used to prevent or treat bronchospasm in patients with asthma and other lung diseases.

Levalbuterol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor’s prescription.

Before using levalbuterol

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 levalbuterol solution and solution concentrate in children younger than 6 years of age, and levalbuterol aerosol in children younger than 4 years of age. Safety and efficacy have not been established in these age groups.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levalbuterol in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving levalbuterol.

Breast Feeding

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.

Interactions with Medicines

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 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.

• Acebutolol
• Albuterol
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Arotinolol
• Atenolol
• Befunolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Bopindolol
• Bucindolol
• Bupranolol
• Butriptyline
• Carteolol
• Carvedilol
• Celiprolol
• Clomipramine
• Desipramine
• Dibenzepin
• Dilevalol
• Dothiepin
• Doxepin
• Epinephrine
• Esmolol
• Fenoterol
• Hexoprenaline
• Imipramine
• Iprindole
• Labetalol
• Landiolol
• Levobunolol
• Lofepramine
• Melitracen
• Mepindolol
• Methacholine
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Nortriptyline
• Opipramol
• Oxprenolol
• Penbutolol
• Pindolol
• Practolol
• Propizepine
• Propranolol
• Protriptyline
• Sotalol
• Talinolol
• Tertatolol
• Tianeptine
• Timolol
• Trimipramine
• Tulobuterol

Interactions with Food/Tobacco/Alcohol

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:

• Diabetes or
• Heart disease or
• Heart rhythm problems (eg, arrhythmia, QT prolongation) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Seizures, history of—Use with caution. May make these conditions worse.
• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper use of levalbuterol

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. Also, do not stop using this medicine or any other asthma medicine that you are taking without telling your doctor. To do so may increase the chance for breathing problems.

The levalbuterol inhalation solution and inhalation solution concentrate should be used with a jet nebulizer that is connected to an air compressor with good air flow. The inhalation solution and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the inhalation solution or solution concentrate in the nebulizer:

• Open the pouch and remove one vial.
• Check the liquid in the vial. It should be clear or colorless. Do not use it if is discolored.
• Open the vial and place the inhalation solution in the medicine reservoir or nebulizer cup on the machine. If you are using the solution concentrate, mix it first with sterile normal saline before placing it on the reservoir.
• Connect the nebulizer to the face mask or mouthpiece.
• Use the face mask or mouthpiece to breathe in the medicine.
• Use the nebulizer for about 5 to 15 minutes, or until the medicine in the nebulizer cup is gone.
• Clean all the parts of the nebulizer after each use.
• Do not use if solution becomes cloudy.
• Do not mix another inhalation medicine with levalbuterol in the nebulizer, unless told to do so by your doctor.

For patients using levalbuterol inhalation aerosol:

• The levalbuterol aerosol canister provides about 200 inhalations, depending on the size of the canister your doctor ordered. You should try to keep a record of the number of inhalations you use so you will know when the canister is almost empty. This canister, unlike some other aerosol canisters, cannot be floated in water to test its fullness.
• When you use the inhaler for the first time, or if you have not used it in a while, the inhaler may not deliver the right amount of medicine with the first puff. Test or prime the inhaler before using it.
• Shake the inhaler well immediately before each use.
• Take the cap off the actuator (or mouthpiece). Inspect the actuator for the presence of foreign objects and make sure that the canister is seated in the actuator before each use.
• Prime the inhaler by releasing 4 test sprays in the air, away from your face. The inhaler will now be ready to provide the right amount of medicine when you use it.
• Breathe out fully through your mouth, expelling as much air from your lungs as possible. Place the mouthpiece fully into your mouth, holding the inhaler in the mouthpiece-down position and closing your lips around it.
• While breathing in deeply and slowly through your mouth, fully depress the top of the metal canister with your middle finger. Immediately after the puff is delivered, release your finger from the canister and remove the inhaler from your mouth.
• Hold your breath for 10 seconds, if possible.
• If your doctor has prescribed more than a single inhalation/puff, wait 1 minute between inhalations. Then, shake the inhaler well and repeat.
• Replace the cap on the mouthpiece after each use.
• Clean the actuator or mouthpiece at least once a week.
• Wash the actuator through the top and bottom with warm running water for 30 seconds at least once a week.

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 preventing or treating bronchospasm:
  • For inhalation aerosol dosage form:
    • Adults and children 4 years of age and older—Two puffs every 4 to 6 hours. In some patients one puff every 4 hours may be enough.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.
  • For inhalation solution dosage form (used with a nebulizer):
    • Adults and children 12 years of age and older—At first, 0.63 milligrams (mg) in the nebulizer 3 times a day, every 6 to 8 hours per day. Some patients may need to start at 1.25 mg in the nebulizer 3 times a day.
    • Children 6 to 11 years of age—0.31 mg in the nebulizer 3 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 0.63 mg 3 times a day.
    • Children younger than 6 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.

If your dosing schedule is different from all of the above and you miss a dose of this medicine, or if you have any questions about this, check with your doctor.

Storage

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.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Keep the inhalation solution in the foil pouch until you are ready to use it. The rest of the vials in the pouch should be used within 2 weeks after the foil pouch has been opened.

Use the inhalation solution concentrate vial right away after opening the foil pouch.

Throw away the canister after either 200 sprays have been used. Ask your pharmacist if you are not sure. Do not place the canister in water to see if the canister is full (float test).

Precautions while using levalbuterol

If you will be using this medicine for a long time, it is important that your doctor check your or your child’s progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine should not be used together with other similar inhaled medicines, such as albuterol (Accuneb®), isoproterenol (Isuprel®), metaproterenol (Alupent®), pirbuterol (Maxair®), or terbutaline (Brethaire®).

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you or your child have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

Talk to your doctor or get medical help right away if:

• Your or your child’s symptoms do not improve or they become worse after using this medicine.
• Your inhaler does not seem to be working as well as usual and you need to use it more often.

You or your child may also be taking an antiinflammatory medicine, such as a steroid (cortisone-like medicine), together with this medicine. Do not stop taking the antiinflammatory medicine, even if your asthma seems better, unless you are told to do so by your doctor.

Levalbuterol may cause serious types of allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child develop a skin rash, hives, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you or your child have more than one of the following symptoms: convulsions (seizures), decreased urine, dry mouth, increased thirst, irregular heartbeat, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, trouble breathing, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

Side Effects of levalbuterol

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:

More common

• Fast heartbeat

Less common

• Chest pain or tightness
• dizziness
• feeling “faint”
• lightheadedness
• troubled breathing

Incidence not known

• Confusion
• cough
• difficult or labored breathing
• difficulty swallowing
• drowsiness
• extra heartbeat
• fainting
• fast, pounding, slow, or irregular heartbeat or pulse
• hives, welts, itching, or rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• nausea
• noisy breathing
• rapid, deep breathing
• redness of the skin
• restlessness
• stomach cramps
• unusual tiredness or weakness
• vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Chest pain
• dizziness
• dry mouth
• general feeling of discomfort or illness
• headache
• impaired consciousness
• irregular or fast heartbeat
• lightheadedness
• nausea
• nervousness
• seizures
• sleeplessness
• sweating
• tremor

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:

More common

• Accidental injury (in children 4 to 11 years of age)
• anxiety
• body aches or pain
• chills
• congestion
• cough
• dryness or soreness of the throat
• fever
• general aches and pains
• headache
• hoarseness
• increased cough
• leg cramps
• loss of appetite
• migraines or other headaches
• muscle tightness
• nervousness
• runny or stuffy nose

Less common

• Abnormal growth filled with fluid or semisolid material
• blemishes on the skin
• blood in the urine
• bloody nose
• burning, dry, or itching eyes
• burning or stinging of the skin
• cough producing mucus
• cramps
• diarrhea
• difficulty having a bowel movement
• discharge from the eye
• dry mouth or throat
• ear pain
• excessive tearing
• eye itch
• heavy menstrual bleeding
• muscle pain
• night sweats
• numbness or decreased sensitivity of the hand
• pain
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• pimples
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• stomach pain
• tingling sensation in the arms or legs
• vaginal yeast infection
• weight loss

What is neffy?

neffy (epinephrine nasal spray) is used to treat severe allergic reactions, including anaphylaxis, in adults and children 4 years of age and older who weigh 33 lbs (15 kg) or more. 

• Each neffy nasal spray for severe allergic reactions contains 1 dose of epinephrine.
• There are 2 strengths:
  • 1 mg/0.1 mL of epinephrine per spray for children 33-66 lbs (15-30 kg) 
  •  2 mg/0.1 mL of epinephrine per spray for patients 66 lbs (30 kg) or greater.
• Administer right away.
• Can be self-administered or a caregiver can give it.

How does neffy work?

neffy’s mechanism of action for anaphylaxis is the same as epinephrine injections. It activates both alpha and beta receptors, which results in the following effects:

• relaxes smooth muscle in the airways to help with breathing
• narrows blood vessels and redirects blood flow to vital organs, such as the heart
• maintains adequate blood pressure and increases heart rate
• relaxes smooth muscles of the stomach and intestine to relieve digestive symptoms.

neffy FDA approval

neffy gained FDA approval on August 9, 2024, and is the first needle-free treatment for severe allergic reactions.

neffy cost

Eligible patients with commercial insurance pay as little as $25 with a neffy Copay card.

If you are uninsured or insured but without any government or commercial drug coverage for neffy and need help paying for it, you may be able to receive it at no cost through the neffy Connect Support Program.

neffy side effects

The most common side effects of neffy are:

• throat irritation
• tingling nose
• headache
• nasal discomfort
• feeling over excitement, nervousness, or anxiety
• tingling sensation
• fatigue
• shakiness
• runny nose
• itchy nose
• sneezing
• stomach pain
• pain in the gums of teeth
• numbness in the mouth
• nasal congestion
• dizziness
• nausea
• vomiting.

Serious side effects and warnings

Always carry neffy with you because you may not know when anaphylaxis may happen. You should carry 2 neffy devices with you because you may need a second neffy nasal spray if symptoms continue or come back.

Talk to your healthcare provider about additional neffy nasal sprays to keep at work, school, or other locations. Tell your family members, caregivers, and others where you keep your neffy nasal spray and how to use it before you need it. You may be unable to speak in an allergic emergency. When you have an allergic emergency (anaphylaxis)

• Use neffy right away.
• Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after using neffy. Before you receive neffy, your healthcare provider should talk to you about when to get emergency help.

neffy may aggravate angina or affect the heartbeat in people with heart disease.

neffy contains a sulfite but this should not stop people allergic to sulfites from using it. Talk to your healthcare provider about this.

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 neffy. Talk to your healthcare provider about all your medical conditions.

• You should still use neffy to treat anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or the medicine you take.

It is not known if neffy is safe and effective in children who weigh less than 33 pounds (15 kilograms).

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of neffy. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Before using neffy

People with certain nasal conditions, such as nasal polyps or a history of nasal surgery, should talk to their healthcare provider before using neffy because these conditions may affect the absorption of neffy.

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

• have nasal problems including nasal polyps, a history of injury such as a broken nose, or any past nasal surgery
• have heart problems
• have kidney problems
• have low potassium levels in your blood
• have Parkinson’s disease
• have thyroid problems
• have high blood pressure
• have diabetes
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if neffy will harm your unborn baby.

Breastfeeding

It is not known if neffy passes into your breast milk.

How should I use neffy?

Read the neffy Instructions for Use for detailed information about how to use the neffy nasal spray. Use neffy exactly as your healthcare provider tells you to use it. Talk to your healthcare provider or pharmacist if you have questions about the use of neffy.

• neffy is for use in the nose only. Do not spray in the eyes or mouth.
• Each neffy nasal spray has 1 dose of medicine and cannot be reused. Do not test or prime (pre-spray) the device.
• Your neffy comes in a carton with 2 nasal sprays. You may need to use a second neffy nasal spray if symptoms continue or get worse.
• You should always carry 2 neffy nasal sprays with you.

neffy dosing information

neffy is for use in the nose only.

• neffy is given as 1 dose in either nostril.
• If a second dose of neffy is needed, it should be given in the same nostril, starting 5 minutes after the first dose.
• Do not sniff during or after receiving a dose of neffy.

If any liquid drips out of the nose, you may not receive the full dose of medicine.

If your symptoms continue or get worse, give a second dose of neffy in the same nostril, starting 5 minutes after the first dose.

Get emergency help for further treatment of the anaphylactic episode, if needed, after using neffy. Before you receive neffy, your healthcare provider should talk to you about when to get emergency help.

Symptoms of anaphylaxis

Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes. Symptoms of 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).

What other drugs will affect neffy?

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 or use:

• other nasal sprays
• water pills (diuretics)
• medicines to treat depression such as tricyclic antidepressants or monoamine oxidase inhibitors (MAO inhibitors)
• medicines to treat abnormal heartbeats (arrhythmias) such as cardiac glycosides
• medicines to treat Parkinson’s disease such as catechol-O-methyl-transferase inhibitors (COMT inhibitors) and ergot alkaloids
• medicines for heart disease including alpha-blockers (such as phentolamine) and beta-blockers (such as propranolol)
• medicines for thyroid disease such as levothyroxine sodium
• medicines used in labor
• medicines to treat allergies such as diphenhydramine, tripelennamine, or chlorpheniramine (antihistamines).

neffy may affect the way other medicines work, and other medicines may affect how neffy works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. See the neffy Prescribing Information for a full list of interactions.

neffy storage

Store neffy at room temperature between 68°F to 77°F (20°C to 25°C).

• Do not freeze. If neffy freezes, the device will not spray.

Your neffy has an expiration date. Replace neffy before the expiration date.

Keep out of the reach of children.

neffy ingredients

Active Ingredient: epinephrine 2 mg.

Inactive Ingredients: benzalkonium chloride, disodium edetate, n-dodecyl beta-D-maltoside, sodium chloride, sodium metabisulfite, and hydrochloric acid or sodium hydroxide to adjust pH, in water for injection.

Each neffy nasal spray contains 1 mg/0.1 mL or 2 mg/0.1 mL of epinephrine per spray.

Who makes neffy?

neffy is made by ARS Pharmaceuticals a pharmaceutical company based in San Diego, California. They specialize in the development of innovative drug delivery technologies, particularly focusing on emergency treatments.

What is albuterol inhalation?

Albuterol is a bronchodilator that relaxes muscles in the airways and increases air flow to the lungs.

Albuterol inhalation is used to treat or prevent bronchospasm, or narrowing of the airways in the lungs, in people with asthma or certain types of chronic obstructive pulmonary disease (COPD). It is also used to prevent exercise-induced bronchospasm.

Albuterol inhalation is for use in adults and children who are at least 4 years old. Always follow your doctor’s directions when giving albuterol to a child.

Warnings

It is important to keep albuterol on hand at all times. Get your prescription refilled before you run out of medicine completely. Keep using all of your other medications as prescribed by your doctor.

Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor. An increased need for medication could be an early sign of a serious asthma attack.

Only use albuterol as prescribed by your physician. An overdose of albuterol can be fatal. Seek emergency medical attention or call the Poison Help line . An overdose of albuterol can be fatal. Seek emergency medical attention or call the Poison Help line .

Before taking this medicine

You should not use this medicine if you are allergic to albuterol. You should not use ProAir RespiClick if you are allergic to milk proteins.

Albuterol may increase the risk of death or hospitalization in people with asthma, but the risk in people with obstructive airway disease or chronic obstructive pulmonary disease (COPD) is not known.

To make sure albuterol inhalation is safe for you, tell your doctor if you have:

• heart disease, high blood pressure, congestive heart failure;
• a heart rhythm disorder;
• a seizure disorder such as epilepsy;
• diabetes;
• overactive thyroid; or
• low levels of potassium in your blood.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether albuterol will harm an unborn baby. However, having uncontrolled asthma during pregnancy may increase the risk of premature birth, low birth weight, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of preventing bronchospasm may outweigh any risks to the baby.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of albuterol on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How should I use albuterol inhalation?

Use albuterol inhalation exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use albuterol inhalation in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

You may need to prime your albuterol inhaler device before the first use. Your medicine comes with directions for priming if needed. You may also need to shake your albuterol device just before each use.

Keeping your inhaler clean is important to ensure you are receiving the medication. Clean the plastic actuator with the canister removed at least once a week. Your medicine comes with directions for properly cleaning your device.

Follow all medication instructions very carefully.

Do not allow a young child to use albuterol inhalation without help from an adult.

The usual dose of albuterol inhalation is 2 inhalations every 4 to 6 hours. To prevent exercise-induced bronchospasm, use 2 inhalations 15 to 30 minutes before you exercise. The effects of albuterol inhalation should last about 4 to 6 hours.

Seek medical attention if you think your asthma medications are not working as well. An increased need for medication could be an early sign of a serious asthma attack.

Use the dose counter on your albuterol inhaler device and get your prescription refilled before you run out of medicine completely. Always use the new inhaler device provided with your refill. Do not float a medicine canister in water to see if it is empty.

ProAir HFA, Proventil HFA, or Ventolin HFA must be shaken before each use. You do not need to shake ProAir RespiClick before using.

Follow all product instructions on how to clean your albuterol inhaler device and mouthpiece. Do not try to clean or take apart the ProAir RespiClick inhaler device.

Asthma is often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice.

Store at room temperature away from moisture, heat, or cold temperatures.

Keep the albuterol canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of albuterol can be fatal.

Overdose symptoms may include dry mouth, tremors, chest pain, fast or irregular heartbeat, nausea, general ill feeling, seizure (convulsions), feeling light-headed or fainting.

What should I avoid while using albuterol inhalation?

Rinse with water if this medicine gets in your eyes.

Albuterol inhalation side effects

Get emergency medical help if you have signs of an allergic reaction to albuterol: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;
• chest pain, fast heart rate, pounding heartbeats or fluttering in your chest;
• pain or burning when you urinate;
• increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
• signs of low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling.

Common albuterol side effects may include:

• chest pain, fast or pounding heartbeats;
• upset stomach, vomiting;
• painful urination;
• dizziness;
• feeling shaky or nervous;
• headache, back pain, body aches; or
• cough, sore throat, sinus pain, runny or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect albuterol inhalation?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• any other inhaled medicines or bronchodilators;
• digoxin;
• a diuretic or “water pill”;
• an antidepressant – amitriptyline, desipramine, imipramine, doxepin, nortriptyline, and others;
• a beta blocker – atenolol, carvedilol, labetalol, metoprolol, propranolol, sotalol, and others; or
• a MAO inhibitor – isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine, and others or methylene blue injection

This list is not complete. Other drugs may interact with albuterol inhalation, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What is albuterol inhalation?

Albuterol is a bronchodilator that relaxes muscles in the airways and increases air flow to the lungs.

Albuterol inhalation is used to treat or prevent bronchospasm, or narrowing of the airways in the lungs, in people with asthma or certain types of chronic obstructive pulmonary disease (COPD). It is also used to prevent exercise-induced bronchospasm.

Albuterol inhalation is for use in adults and children who are at least 4 years old. Always follow your doctor’s directions when giving albuterol to a child.

Warnings

It is important to keep albuterol on hand at all times. Get your prescription refilled before you run out of medicine completely. Keep using all of your other medications as prescribed by your doctor.

Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor. An increased need for medication could be an early sign of a serious asthma attack.

Only use albuterol as prescribed by your physician. An overdose of albuterol can be fatal. Seek emergency medical attention or call the Poison Help line . An overdose of albuterol can be fatal. Seek emergency medical attention or call the Poison Help line .

Before taking this medicine

You should not use this medicine if you are allergic to albuterol. You should not use ProAir RespiClick if you are allergic to milk proteins.

Albuterol may increase the risk of death or hospitalization in people with asthma, but the risk in people with obstructive airway disease or chronic obstructive pulmonary disease (COPD) is not known.

To make sure albuterol inhalation is safe for you, tell your doctor if you have:

• heart disease, high blood pressure, congestive heart failure;
• a heart rhythm disorder;
• a seizure disorder such as epilepsy;
• diabetes;
• overactive thyroid; or
• low levels of potassium in your blood.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether albuterol will harm an unborn baby. However, having uncontrolled asthma during pregnancy may increase the risk of premature birth, low birth weight, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of preventing bronchospasm may outweigh any risks to the baby.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of albuterol on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How should I use albuterol inhalation?

Use albuterol inhalation exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use albuterol inhalation in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

You may need to prime your albuterol inhaler device before the first use. Your medicine comes with directions for priming if needed. You may also need to shake your albuterol device just before each use.

Keeping your inhaler clean is important to ensure you are receiving the medication. Clean the plastic actuator with the canister removed at least once a week. Your medicine comes with directions for properly cleaning your device.

Follow all medication instructions very carefully.

Do not allow a young child to use albuterol inhalation without help from an adult.

The usual dose of albuterol inhalation is 2 inhalations every 4 to 6 hours. To prevent exercise-induced bronchospasm, use 2 inhalations 15 to 30 minutes before you exercise. The effects of albuterol inhalation should last about 4 to 6 hours.

Seek medical attention if you think your asthma medications are not working as well. An increased need for medication could be an early sign of a serious asthma attack.

Use the dose counter on your albuterol inhaler device and get your prescription refilled before you run out of medicine completely. Always use the new inhaler device provided with your refill. Do not float a medicine canister in water to see if it is empty.

ProAir HFA, Proventil HFA, or Ventolin HFA must be shaken before each use. You do not need to shake ProAir RespiClick before using.

Follow all product instructions on how to clean your albuterol inhaler device and mouthpiece. Do not try to clean or take apart the ProAir RespiClick inhaler device.

Asthma is often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice.

Store at room temperature away from moisture, heat, or cold temperatures.

Keep the albuterol canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Overdose symptoms may include dry mouth, tremors, chest pain, fast or irregular heartbeat, nausea, general ill feeling, seizure (convulsions), feeling light-headed or fainting.

What should I avoid while using albuterol inhalation?

Rinse with water if this medicine gets in your eyes.

Albuterol inhalation side effects

Get emergency medical help if you have signs of an allergic reaction to albuterol: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;
• chest pain, fast heart rate, pounding heartbeats or fluttering in your chest;
• pain or burning when you urinate;
• increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
• signs of low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling.

Common albuterol side effects may include:

• chest pain, fast or pounding heartbeats;
• upset stomach, vomiting;
• painful urination;
• dizziness;
• feeling shaky or nervous;
• headache, back pain, body aches; or
• cough, sore throat, sinus pain, runny or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect albuterol inhalation?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• any other inhaled medicines or bronchodilators;
• digoxin;
• a diuretic or “water pill”;
• an antidepressant – amitriptyline, desipramine, imipramine, doxepin, nortriptyline, and others;
• a beta blocker – atenolol, carvedilol, labetalol, metoprolol, propranolol, sotalol, and others; or
• a MAO inhibitor – isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine, and others or methylene blue injection

This list is not complete. Other drugs may interact with albuterol inhalation, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide