Ventolin Nebules P.F.

Name: Ventolin Nebules P.F.

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Commonly used brand name(s)

In the U.S.

Accuneb
ProAir HFA
Proair Respiclick
Proventil
Proventil HFA
ReliOn Ventolin HFA
Ventolin
Ventolin HFA

In Canada

Alti-Salbutamol Inhalation Aerosol
Apo-Salvent
Salbutamol
Salbutamol Nebuamp
Salbutamol Respirator Solution
Ventolin Inhaler
Ventolin Nebules P.F.
Ventolin Respirator
Ventolin Rotacaps

Available Dosage Forms:

Aerosol Powder
Solution
Capsule
Powder
Suspension

Therapeutic Class: Bronchodilator

Pharmacologic Class: Sympathomimetic

Uses For Ventolin Nebules P.F.

Albuterol is used to treat or prevent bronchospasm in patients with asthma, bronchitis, emphysema, and other lung diseases. This medicine is also used to prevent wheezing caused by exercise (exercise-induced bronchospasm).

Albuterol 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 Ventolin Nebules P.F.

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 inhalation aerosol (eg, Proair® HFA) in children 4 years of age and older, albuterol inhalation powder (eg, Proair® Respiclick®) in children 4 years of age and older, and albuterol inhalation solution (eg, Accuneb®) in children 2 years of age and older. However, safety and efficacy have not been established for the albuterol inhalation aerosol and albuterol inhalation powder in children younger than 4 years of age, and albuterol inhalation solution in children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of albuterol inhalation aerosol (eg, Proair® HFA) and albuterol inhalation powder (eg, Proair® Respiclick®) in geriatric patients. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution and an adjustment in the dose for patients receiving albuterol inhalation aerosol and albuterol inhalation powder.

No information is available on the relationship of age to the effects of albuterol inhalation solution (eg, Accuneb®) in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Proper Use of albuterol

This section provides information on the proper use of a number of products that contain albuterol. It may not be specific to Ventolin Nebules P.F.. Please read with care.

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 asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.

The albuterol inhalation solution (eg, Accuneb®) 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 in the nebulizer:

Use one container of solution or mix the exact amount of solution using the dropper provided for each dose.
Place the inhalation solution in the medicine reservoir or nebulizer cup on the machine.
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.

The albuterol inhalation aerosol (eg, Proair® HFA) and albuterol inhalation powder (eg, Proair® Respiclick®) is used with a special inhaler that comes with patient instructions. Read the directions carefully before using this medicine. If you or your child do not understand the directions or are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check you or your child on a regular basis to make sure you are using it properly.

To use the inhalation aerosol:

The inhaler should be at room temperature before you use it.
Insert the metal canister firmly and fully into the clear end of the Proair® HFA mouthpiece. This mouthpiece should not be used with other inhaled medicines.
Remove the cap and look at the mouthpiece to make sure it is clean.
Shake the inhaler well and test spray it in the air 3 times before using it for the first time or if the inhaler has not been used for more than 2 weeks.
To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.
Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down once on the top of the canister.
Hold your breath for about 10 seconds, then breathe out slowly.
If you are supposed to use more than one puff, wait 1 minute before inhaling the second puff. Repeat these steps for the second puff, starting with shaking the inhaler.
When you have finished all of your doses, rinse your mouth with water and spit the water out.
Clean the inhaler mouthpiece at least once a week with warm running water for 30 seconds, and dry it completely.
If you need to use the inhaler before it is completely dry, shake off the excess water, replace the canister, and spray it 2 times in the air away from the face. Use your regular dose.
After using the inhaler, wash the mouthpiece again and dry it completely.
If the mouthpiece becomes blocked, washing it will help.

To use the inhalation powder:

Take the inhaler from the foil pouch before you use it for the first time.
The inhaler provides about 200 inhalations. The dose counter will change to red when there are "20" doses left. Call your doctor or pharmacist for a refill of prescription or medicine.
Make sure the cap is closed before using this medicine. Do not open the cap unless you are going to use it.
Hold the inhaler upright as you open the cap fully until you hear a "click". Your inhaler is now ready to use.
To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it.
Breathe in through your mouth as deeply as you can until you have taken a full deep breath.
Do not block the vent above the mouthpiece with your lips or fingers.
Hold your breath for about 10 seconds or as long as you comfortably can.
Remove the inhaler from your mouth and check the dose counter to make sure you received the medicine.
Close the cap firmly over the mouthpiece after using the inhaler. Always close the cap after each use.
If you are supposed to use more than one puff, repeat these steps for the second puff, starting with opening the cap fully.
Keep the inhaler clean and dry at all times. Do not wash or put any part of the inhaler in water.
If you need to clean the mouthpiece, wipe it gently with a dry cloth or tissue.

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 aerosol dosage form (inhaler):
- For treatment or prevention of bronchospasm:
  - Adults and children 4 years of age and older—Two puffs every 4 to 6 hours as needed.
  - Children younger than 4 years of age—Use and dose must be determined by your child's doctor.
- For prevention of exercise-induced bronchospasm:
  - Adults and children 4 years of age and older—Two puffs taken 15 to 30 minutes before exercise.
  - Children younger than 4 years of age—Use and dose must be determined by your child's doctor.
For inhalation powder dosage form (inhaler):
- For treatment or prevention of bronchospasm:
  - Adults and children 4 years of age and older—Two puffs every 4 to 6 hours as needed.
  - Children younger than 4 years of age—Use and dose must be determined by your child's doctor.
- For prevention of exercise-induced bronchospasm:
  - Adults and children 4 years of age and older—Two puffs taken 15 to 30 minutes before exercise.
  - Children younger than 4 years of age—Use and dose must be determined by your child's doctor.
For inhalation solution dosage form (used with a nebulizer):
- For prevention of bronchospasm:
  - Adults and children older than 12 years of age—2.5 milligrams (mg) in the nebulizer 3 or 4 times per day as needed.
  - Children 2 to 12 years of age—0.63 to 1.25 mg in the nebulizer 3 or 4 times per day as needed.
  - Children younger than 2 years of age—Use and dose must be determined by your child's doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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

Keep 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.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away Proair® Respiclick® 13 months after opening the foil pouch, when the dose counter reaches "0", or after the expiration date, whichever comes first.

Precautions While Using Ventolin Nebules P.F.

It is very important that your doctor check the progress of you or your child 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 inhaled medicines that are similar, such as isoproterenol (Isuprel®), levalbuterol (Xopenex™), 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 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.

Albuterol may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis 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, trouble 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, 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.

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.

Ventolin Nebules P.F. Side Effects

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, irregular, pounding, or racing heartbeat or pulse
shakiness in the legs, arms, hands, or feet
trembling or shaking of the hands or feet

Less common

Abdominal or stomach pain
bladder pain
bloody or cloudy urine
chest discomfort
chest pain
cough or hoarseness
cough producing mucus
diarrhea
difficult or labored breathing
difficulty with swallowing
dizziness
feeling of warmth
fever or chills
frequent urge to urinate
hives, itching, or skin rash
loss of appetite
lower back or side pain
nausea
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
redness of the face, neck, arms, and occasionally, upper chest
runny nose
sore throat
swollen, painful, or tender lymph glands in the neck, armpit, or groin
tightness in the chest
unusual tiredness or weakness
weakness

Rare

Hives or welts
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
noisy breathing
redness of the skin
swelling of the mouth or throat
trouble breathing

Incidence not known

Agitation
arm, back, or jaw pain
chest tightness or heaviness
confusion
convulsions
decreased urine
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
dry mouth
extra heartbeats
fainting
flushed, dry skin
fruit-like breath odor
hallucinations
headache
increased hunger
increased thirst
increased urination
irritability
lightheadedness
muscle pain or cramps
nervousness
nightmares
numbness or tingling in the hands, feet, or lips
pounding in the ears
rapid, deep breathing
restlessness
shakiness
slow or fast heartbeat
stomach cramps
sweating
unexplained weight loss
unusual feeling of excitement
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: