Ventolin

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.

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. 

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.

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.

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.

In the U.S.

• Proventil
• Proventil Repetabs
• Ventolin
• Volmax
• VoSpire ER

In Canada

• Apo-Salvent Inhaler

Available Dosage Forms:

• Tablet
• Syrup
• Tablet, Extended Release

Therapeutic Class: Bronchodilator

Pharmacologic Class: Sympathomimetic

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 albuterol in children 2 years of age and older.

Geriatric

No information is available on the relationship of age to the effects of albuterol in geriatric patients. However, elderly patients are more likely to have age-related heart problems, which may require caution and an adjustment in the dose for patients receiving albuterol.

Pregnancy

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.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Atomoxetine
• Clomipramine
• Desipramine
• Dibenzepin
• Doxepin
• Imipramine
• Iobenguane I 123
• Levalbuterol
• Lofepramine
• Melitracen
• Nortriptyline
• Opipramol
• Protriptyline
• Tianeptine
• Trimipramine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Digoxin

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 or blood vessel disease or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Seizure disorders—Use with caution. May make these conditions worse.

Bronchospasm

For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children is 2 inhalations repeated every 4 to 6 hours; in some patients, 1 inhalation every 4 hours may be sufficient. More frequent administration or a greater number of inhalations is not recommended.

Exercise-Induced Bronchospasm

For prevention of exercise-induced bronchospasm, the usual dosage for adults and children aged 4 years and older is 2 inhalations 15 to 30 minutes before exercise.

Administration Information

Ventolin HFA should be administered by the orally inhaled route only.

Priming: Priming Ventolin HFA is essential to ensure appropriate albuterol content in each actuation. Prime Ventolin HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime Ventolin HFA, release 4 sprays into the air away from the face, shaking well before each spray.

Cleaning: To ensure proper dosing and to prevent actuator orifice blockage, wash the actuator with warm water and let it air-dry completely at least once a week.

Inhalation Aerosol. Blue plastic inhaler with a blue strapcap containing a pressurized metered-dose aerosol canister containing 60 or 200 metered inhalations and fitted with a counter. Each actuation delivers 108 mcg of albuterol sulfate (90 mcg of albuterol base) from the mouthpiece.

Ventolin HFA is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see Warnings and Precautions (5.6), Description (11)].