Proventil

Albuterol is a prescription medication used to treat bronchospasm (narrowing of airways) in people who have reversible obstructive airway disease. It may also used to prevent exercise-induced bronchospasm. Albuterol belongs to a group of drugs called beta agonists. These cause the smooth muscle of the airways to relax, making it easier to breathe.

Albuterol comes as a tablet, a syrup, and an extended release tablet to take by mouth. The tablets and syrup are usually taken three or four times a day. The extended release tablets are usually taken once every 12 hours. 

Albuterol also comes as a solution to be inhaled into the mouth using a nebulizer and is usually used 3 or 4 times a day.

This medication also comes as aerosol to inhale by mouth using an inhaler. When the aerosol is used to treat or prevent symptoms of lung disease, it is usually used every 4 to 6 hours as needed. When the aerosol is used to prevent breathing difficulty during exercise, it is usually used 15 to 30 minutes before exercise.

Common side effects include fast heartbeat, shakiness, and nervousness.

Inhalational:

• Albuterol aerosol spray is a prescription medication used in people 4 years of age and older to:
  • treat or prevent bronchospasm (narrowing of airways) in people who have reversible obstructive airway disease (asthma)
  • prevent exercise induced bronchospasm (narrowing of airways)
• Albuterol solution for nebulization is a prescription medication used for the relief of bronchospasm (narrowing of airways) in patients 2 to 12 years of age with asthma

Oral:

• Albuterol immediate- and extended-release tablets are used for the relief of bronchospasm (narrowing of airways) in adults and children 6 years of age and older with reversible obstructive airway disease (asthma).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• A-S Medication Solutions LLC

• Cheshire Pharm. Systems

• Compumed Pharmaceuticals, Inc.

• Dispensing Solutions, Inc.

• Lake Erie Medical DBA Quality Care Products LLC

• Merck Sharp & Dohme Corp.

• Pharma Pac (A Service Of H.J. Harkins Co., Inc.)

• Physician Partner

• Physicians Total Care, Inc.

• Quality Care Pharmaceuticals

• Quality Care Products, LLC

• Rebel Distributors Corp..

• Schering Corporation

• Schering Plough Corporation

• Southwood Pharm., Inc.

Inhalational/Oral:

Albuterol may cause serious side effects. See "Albuterol Precautions" section.

The most common side effects of albuterol include:

• your heart feels like it is pounding or racing (palpitations)
• chest pain
• fast heart rate
• shakiness
• nervousness
• headache
• dizziness
• sore throat
• runny nose

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

These are not all of the possible side effects of albuterol. For more information, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Albuterol and other medicines may affect each other and cause side effects. Albuterol may affect the way other medicines work, and other medicines may affect the way albuterol works.

Especially tell your doctor if you take:

• other inhaled medicines or asthma medicines
• beta blocker medicines
• diuretics
• digoxin
• monoamine oxidase inhibitors
• tricyclic antidepressants

This is not a complete list of albuterol drug interactions. Ask your doctor or pharmacist for more information.

Inhalational/Oral:

Albuterol may cause serious side effects, including:

• worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens stop using albuterol and call your doctor or get emergency help right away. Paradoxical bronchospasm is more likely to happen with your first use of a new canister of medicine.
• heart problems including faster heart rate and higher blood pressure
• possible death in people with asthma who use too much albuterol
• allergic reactions. Call your doctor right away if you have the following symptoms of an allergic reaction:
  • itchy skin
  • swelling beneath your skin or in your throat
  • rash
  • worsening trouble breathing
• low potassium levels in your blood
• worsening of other medical problems in people who also use albuterol including increases in blood sugar

Do not use albuterol if you are allergic to albuterol sulfate or any of the ingredients in albuterol. 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of albuterol there are no specific foods that you must exclude from your diet when receiving albuterol.

Before you use albuterol, tell your doctor if you:

• have heart problems
• have high blood pressure (hypertension)
• have convulsions (seizures)
• have thyroid problems
• have diabetes
• have low potassium levels in your blood
• are pregnant or plan to become pregnant. It is not known if albuterol will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if albuterol passes into your breast milk. Talk to your doctor about the best way to feed your baby if you are using albuterol.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. 

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Albuterol falls into category C. There are no good studies that have been done in humans with albuterol. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed. 

It is not known if albuterol crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using albuterol.

Use albuterol exactly as your doctor tells you to use it.

Inhalational:

• Aerosol Spray
  • If your child needs to use albuterol, watch your child closely to make sure your child uses the inhaler correctly. Your doctor will show you how your child should use albuterol.
  • Each dose of albuterol should last up to 4 hours to 6 hours.
  • Do not increase your dose or take extra doses of albuterol without first talking to your doctor.
  • Get medical help right away if albuterol no longer helps your symptoms.
  • Get medical help right away if your symptoms get worse or if you need to use your inhaler more often.
  • While you are using albuterol, do not use other inhaled rescue medicines and asthma medicines unless your doctor tells you to do so.
  • Call your doctor if your asthma symptoms like wheezing and trouble breathing become worse over a few hours or days. Your doctor may need to give you another medicine (for example, corticosteroids) to treat your symptoms.
• Solution for Nebulization
  • The albuterol for nebulization is usually taken 3 or 4 times daily, as needed. More frequent use is not recommended.
  • Use the entire contents of one unit-dose vial. Adjust the flow rate to deliver albuterol over 5 to 15 minutes.
  • To control recurring bouts of bronchospasm, using albuterol for nebulization on a regular basis works best.
  • If the medication does not seem to be working, seek medical advice immediately. This is often a sign of seriously worsening asthma.
  • Efficacy and safety of this medication, when mixed with other drugs in a nebulizer, have not been determined.
  • The safety and efficacy of this medication have been established with the Pari LC Plus nebulizer and Pari PRONEB compressor. The safety and efficacy of albuterol for nebulization with other nebulizer systems have not been determined.
  • Albuterol for nebulization should be used with a jet nebulizer connected to an air compressor with adequate air flow. It should also be used with a mouthpiece or suitable face mask.

Oral

• The regular release tablets and syrup are usually taken three or four times a day.
• Albuterol extended release tablets must be swallowed whole with the aid of liquids.
• Do not crush or chew extended release tablets.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Syrup

• Adults And Children Over 14 Years Of Age: The usual starting dosage for adults and children over 14 years of age is 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or four times a day.
• Children 6 To 14 Years Of Age: The usual starting dosage for children 6 to 14 years of age is 2 mg (1 teaspoonful) three or four times a day.
• Children 2 To 6 Years Of Age: Dosing in children 2 to 6 years of age should be initiated at 0.1 mg/kg of body weight three times a day. This starting dosage should not exceed 2 mg (1 teaspoonful) three times a day.

Aerosol

• Treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms
  • The usual dosage for adults and children 12 years of age and older is 2 inhalations repeated every 4 to 6 hours
  • In some, 1 inhalation every 4 hours may be sufficient. More frequent use or a larger number of inhalations is not recommended.
  • For maintenance therapy or prevention of exacerbation of bronchospasm, 2 inhalations, 4 times a day should be sufficient.
  • If a previously effective dosage fails to provide the usual response, this may be a sign of worsening asthma and requires reevaluation of the treatment regimen.
• ​Exercise-Induced Bronchospasm Prevention
  • ​The usual dosage for adults and children 12 years and older is 2 inhalations, 15 minutes before exercise.

Solution for Nebulization

• The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of AccuNeb (albuterol for nebulization) taken 3 or 4 times daily, as needed, by nebulization.
• To take 1.25 mg or 0.63 mg of albuterol, use the entire contents of one vial (3 mL of 1.25 mg or 0.63 mg inhalation solution). Adjust nebulizer flow rate to deliver AccuNeb (albuterol for nebulization) over 5 to 15 minutes.
• Patients 6 to 12 years of age with more severe asthma, weight >40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Extended Release Tablets

• Adults and Children over 12 years of age - The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.
• Children 6 to 12 years of age - The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Regular Release Tablets

• Adults and Children Over 12 Years of Age - The usual starting dosage for adults and children 12 years and older is 2 or 4 mg three or four times a day.
• Children 6 to 12 Years of Age - The usual starting dosage for children 6 to 12 years of age is 2 mg three or four times a day.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Inhalational:

Albuterol aerosol spray

• Do not use the inhaler after the expiration date, which is on the packaging it comes in.
• Store between 15° and 25° C (59° and 77° F). Avoid exposure to extreme heat and cold. For best results, canister should be at room temperature. Store the inhaler with the mouthpiece down. Shake well before each spray.
• Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator.
• It is very important to keep the plastic actuator clean so the medicine will not build-up and block the spray. Do not try to clean the metal canister or let it get wet. The inhaler may stop spraying if it is not cleaned correctly. Wash the actuator at least once a week with warm water and let it air-dry completely.
• As with all aerosol medications, it is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks. Prime by releasing four “test sprays” into the air, away from your face.

A) Albuterol aerosol spray

• Before you reach 200 sprays, you should refill your prescription or ask your doctor if you need another prescription for albuterol HFA.
• Throw the inhaler away when you have used 200 sprays. You should not keep using the inhaler after 200 sprays even though the canister may not be completely empty because you cannot be sure you will receive any medicine.

B) Albuterol aerosol spray- with dose counter

• Discard albuterol inhaler when the counter reads 000 or 12 months after it is taken out of the foil pouch, whichever comes first.
• When the counter reads 020, contact your pharmacist for a refill or talk to your doctor to determine whether a prescription refill is needed.
• Never try to alter the numbers or remove the counter from the metal canister.
• Never immerse the canister in water to determine the amount of drug remaining in the canister.

Albuterol for nebulization

• ​Store at room temperature.
• Protect from light and excessive heat.
• Store vials in protective foil pouch at all times. Once removed from the foil pouch, use vial(s) within 1 week. Discard the vial if the solution is not colorless.
• Keep out of the reach of children.

Tablets

• Dispense in a well-closed, light-resistant container.
• Replace cap securely after each opening.
• Store at room temperature.

Syrup

• Store at controlled room temperature 15° to 30°C (59° to 86°F).
• Dispense in a tight, light-resistant container as defined in the USP/NF.
• Keep this and all drugs out of the reach of children.