VENTOLIN Dailymed

10 Overdosage

The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms uled under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, sleeplessness. Hypokalemia and metabolic acidosis may also occur.

As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of VENTOLIN HFA. Treatment consists of discontinuation of VENTOLIN HFA together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of VENTOLIN HFA.

The oral median lethal dose of albuterol sulfate in mice is greater than 2,000 mg/kg (approximately 6,800 times the maximum recommended daily inhalation dose for adults on a mg/m basis and approximately 3,200 times the maximum recommended daily inhalation dose for children on a mg/m basis). In mature rats, the subcutaneous median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 3,000 times the maximum recommended daily inhalation dose for adults on a mg/m basis and approximately 1,400 times the maximum recommended daily inhalation dose for children on a mg/m basis). In young rats, the subcutaneous median lethal dose is approximately 2,000 mg/kg (approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m basis and approximately 6,400 times the maximum recommended daily inhalation dose for children on a mg/m basis). The inhalation median lethal dose has not been determined in animals. ^{2 2 2 2 2 2}

11 Description

The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta -adrenergic bronchodilator. Albuterol sulfate has the chemical name α -[( -butylamino)methyl]-4-hydroxy- -xylene-α, α′-diol sulfate (2:1)(salt) and the following chemical structure: ₂ ¹ tert m

Albuterol sulfate is a white crystalline powder with a molecular weight of 576.7, and the empirical formula is (C H NO ) •H SO . It is soluble in water and slightly soluble in ethanol. _{13 21 3 2 2 4}

The World Health Organization recommended name for albuterol base is salbutamol.

VENTOLIN HFA is a pressurized metered-dose aerosol unit fitted with a counter. VENTOLIN HFA is intended for oral inhalation only. Each unit contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no other excipients.

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

After priming, each actuation of the inhaler delivers 120 mcg of albuterol sulfate, USP in 75 mg of suspension from the valve and 108 mcg of albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece).

Each 18-g canister provides 200 inhalations. Each 8-g canister provides 60 inhalations.

This product does not contain chlorofluorocarbons (CFCs) as the propellant.

12 Clinical Pharmacology

12.1 Mechanism of Action

In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta -adrenergic receptors compared with isoproterenol. While it is recognized that beta -adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta -receptors in the human heart existing in a concentration between 10% and 50% of cardiac beta-adrenergic receptors. The precise function of these receptors has not been established . _{2 2 2} [see Warnings and Precautions (5.4)]

Activation of beta -adrenergic receptors on airway smooth muscle leads to the activation of adenylcyclase and to an increase in the intracellular concentration of cyclic-3′,5′-adenosine monophosphate (cyclic AMP). This increase of cyclic AMP leads to the activation of protein kinase A, which inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in relaxation. Albuterol relaxes the smooth muscles of all airways, from the trachea to the terminal bronchioles. Albuterol acts as a functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor challenges. Increased cyclic AMP concentrations are also associated with the inhibition of release of mediators from mast cells in the airway. ₂

Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes . [see Warnings and Precautions (5.4)]

12.2 Pharmacokinetics

The systemic levels of albuterol are low after inhalation of recommended doses. A study conducted in 12 healthy male and female subjects using a higher dose (1,080 mcg of albuterol base) showed that mean peak plasma concentrations of approximately 3 ng/mL occurred after dosing when albuterol was delivered using propellant HFA-134a. The mean time to peak concentrations (T ) was delayed after administration of VENTOLIN HFA (T  = 0.42 hours) as compared to CFC-propelled albuterol inhaler (T  = 0.17 hours). Apparent terminal plasma half-life of albuterol is approximately 4.6 hours. No further pharmacokinetic studies for VENTOLIN HFA were conducted in neonates, children, or elderly subjects. _{max max max}

13 Nonclinical Toxicology

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year study in Sprague-Dawley rats, albuterol sulfate caused a dose-related increase in the incidence of benign leiomyomas of the mesovarium at and above dietary doses of 2.0 mg/kg (approximately 14 times the maximum recommended daily inhalation dose for adults on a mg/m basis and approximately 6 times the maximum recommended daily inhalation dose for children on a mg/m basis). In another study this effect was blocked by the coadministration of propranolol, a non-selective beta-adrenergic antagonist. In an 18-month study in CD-1 mice, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 500 mg/kg (approximately 1,700 times the maximum recommended daily inhalation dose for adults on a mg/m basis and approximately 800 times the maximum recommended daily inhalation dose for children on a mg/m basis). In a 22-month study in Golden hamsters, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 50 mg/kg (approximately 225 times the maximum recommended daily inhalation dose for adults on a mg/m basis and approximately 110 times the maximum recommended daily inhalation dose for children on a mg/m basis). ^{2 2 2 2 2 2}

Albuterol sulfate was not mutagenic in the Ames test or a mutation test in yeast. Albuterol sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH1 strain mouse micronucleus assay.

Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses of albuterol sulfate up to 50 mg/kg (approximately 340 times the maximum recommended daily inhalation dose for adults on a mg/m basis). ²

13.2 Animal Toxicology and/or Pharmacology

Intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations amounting to approximately 5.0% of the plasma concentrations. In structures outside the blood-brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those in the whole brain. Preclinical:

Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently. The clinical relevance of these findings is unknown.

Propellant HFA-134a is devoid of pharmacological activity except at very high doses in animals (380 to 1,300 times the maximum human exposure based on comparisons of AUC values), primarily producing ataxia, tremors, dyspnea, or salivation. These are similar to effects produced by the structurally related CFCs, which have been used extensively in metered-dose inhalers.

In animals and humans, propellant HFA-134a was found to be rapidly absorbed and rapidly eliminated, with an elimination half-life of 3 to 27 minutes in animals and 5 to 7 minutes in humans. Time to maximum plasma concentration (T ) and mean residence time are both extremely short, leading to a transient appearance of HFA-134a in the blood with no evidence of accumulation. _max

A study in CD-1 mice given albuterol sulfate subcutaneously showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg (less than the maximum recommended daily inhalation dose for adults on a mg/m basis) and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg (approximately 8 times the maximum recommended daily inhalation dose for adults on a mg/m basis). The drug did not induce cleft palate formation at a dose of 0.025 mg/kg (less than the maximum recommended daily inhalation dose for adults on a mg/m basis). Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with 2.5 mg/kg of isoproterenol (positive control). Reproductive Toxicology Studies: ^{2 2 2}

A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 fetuses (37%) when albuterol sulfate was administered orally at a 50 mg/kg dose (approximately 680 times the maximum recommended daily inhalation dose for adults on a mg/m basis). ²

In an inhalation reproduction study in New Zealand white rabbits, albuterol sulfate/HFA-134a formulation exhibited enlargement of the frontal portion of the fetal fontanelles at and above inhalation doses of 0.0193 mg/kg (less than the maximum recommended daily inhalation dose for adults on a mg/m basis). ²

A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus.

14 Clinical Studies

14.1 Bronchospasm Associated With Asthma

The efficacy of VENTOLIN HFA was evaluated in two 12-week, randomized, double-blind, placebo controlled trials in patients 12 years of age and older with mild to moderate asthma. These trials included a total of 610 patients (323 males, 287 females). In each trial, patients received 2 inhalations of VENTOLIN HFA, CFC 11/12-propelled albuterol, or HFA-134a placebo 4 times daily for 12 weeks’ duration. Patients taking the HFA-134a placebo inhaler also took VENTOLIN HFA for asthma symptom relief on an as-needed basis. Some patients who participated in these clinical trials were using concomitant inhaled steroid therapy. Efficacy was assessed by serial forced expiratory volume in 1 second (FEV ). In each of these trials, 2 inhalations of VENTOLIN HFA produced significantly greater improvement in FEV over the pretreatment value than placebo. Results from the 2 clinical trials are described below. Adult and Adolescent Patients 12 Years of Age and Older: _{1 1}

In a 12-week, randomized, double-blind study, VENTOLIN HFA (101 patients) was compared to CFC 11/12-propelled albuterol (99 patients) and an HFA-134a placebo inhaler (97 patients) in adolescent and adult patients 12 to 76 years of age with mild to moderate asthma. Serial FEV measurements [shown below as percent change from test-day baseline at Day 1 (n = 297) and at Week 12 (n = 249)] demonstrated that 2 inhalations of VENTOLIN HFA produced significantly greater improvement in FEV over the pretreatment value than placebo. _{1 1}

FEV as Percent Change From Predose in a Large, 12-Week Clinical Trial ₁

Day 1

Week 12

In the responder population (≥15% increase in FEV within 30 minutes postdose) treated with VENTOLIN HFA, the mean time to onset of a 15% increase in FEV over the pretreatment value was 5.4 minutes, and the mean time to peak effect was 56 minutes. The mean duration of effect as measured by a 15% increase in FEV over the pretreatment value was approximately 4 hours. In some patients, duration of effect was as long as 6 hours. _{1 1 1}

The second 12-week randomized, double-blind study was conducted to evaluate the efficacy and safety of switching patients from CFC 11/12-propelled albuterol to VENTOLIN HFA. During the 3-week run-in phase of the study, all patients received CFC 11/12-propelled albuterol. During the double-blind treatment phase, VENTOLIN HFA (91 patients) was compared to CFC 11/12-propelled albuterol (100 patients) and an HFA-134a placebo inhaler (95 patients) in adolescent and adult patients with mild to moderate asthma. Serial FEV measurements demonstrated that 2 inhalations of VENTOLIN HFA produced significantly greater improvement in pulmonary function than placebo. The switching from CFC 11/12-propelled albuterol inhaler to VENTOLIN HFA did not reveal any clinically significant changes in the efficacy profile. ₁

In the 2 adult studies, the efficacy results from VENTOLIN HFA were significantly greater than placebo and were clinically comparable to those achieved with CFC 11/12-propelled albuterol, although small numerical differences in mean FEV response and other measures were observed. Physicians should recognize that individual responses to beta-adrenergic agonists administered via different propellants may vary and that equivalent responses in individual patients should not be assumed. ₁

The efficacy of VENTOLIN HFA was evaluated in one 2-week, randomized, double-blind, placebo-controlled trial in 135 pediatric patients 4 to 11 years of age with mild to moderate asthma. In this trial, patients received VENTOLIN HFA, CFC 11/12-propelled albuterol, or HFA-134a placebo. Serial pulmonary function measurements demonstrated that 2 inhalations of VENTOLIN HFA produced significantly greater improvement in pulmonary function than placebo and that there were no significant differences between the groups treated with VENTOLIN HFA and CFC 11/12-propelled albuterol. In the responder population treated with VENTOLIN HFA, the mean time to onset of a 15% increase in peak expiratory flow rate (PEFR) over the pretreatment value was 7.8 minutes, and the mean time to peak effect was approximately 90 minutes. The mean duration of effect as measured by a 15% increase in PEFR over the pretreatment value was greater than 3 hours. In some patients, duration of effect was as long as 6 hours. Pediatric Patients 4 Years of Age:

14.2 Exercise-Induced Bronchospasm

One controlled clinical study in adult patients with asthma (N = 24) demonstrated that 2 inhalations of VENTOLIN HFA taken approximately 30 minutes prior to exercise significantly prevented exercise-induced bronchospasm (as measured by maximum percentage fall in FEV following exercise) compared to an HFA-134a placebo inhaler. In addition, VENTOLIN HFA was shown to be clinically comparable to a CFC 11/12-propelled albuterol inhaler for this indication. ₁

• PHARMACIST—DETACH HERE AND GIVE LEAFLET TO PATIENT  

Patient Information

VENTOLIN HFA ^® (vent′ o-lin)

(albuterol sulfate)

Inhalation Aerosol

Read this Patient Information before you start using VENTOLIN HFA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is VENTOLIN HFA?

VENTOLIN HFA is a prescription medicine used in people 4 years of age and older to:

• treat or prevent bronchospasm in people who have reversible obstructive airway disease •
• prevent exercise-induced bronchospasm •

It is not known if VENTOLIN HFA is safe and effective in children under 4 years of age.

Who should not use VENTOLIN HFA?

are allergic to albuterol sulfate or any of the ingredients in VENTOLIN HFA. See the end of this Patient Information leaflet for a complete ul of ingredients in VENTOLIN HFA. Do not use VENTOLIN HFA if you

What should I tell my healthcare provider before I use VENTOLIN HFA?

Before you use VENTOLIN HFA, tell your healthcare provider 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 VENTOLIN HFA will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant. •
• are breastfeeding or plan to breastfeed. It is not known if VENTOLIN HFA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you are using VENTOLIN HFA. •

including prescription and nonprescription medicines, vitamins, and herbal supplements. Tell your healthcare provider about all the medicines you take,

VENTOLIN HFA and other medicines may affect each other and cause side effects. VENTOLIN HFA may affect the way other medicines work, and other medicines may affect the way VENTOLIN HFA works.

Especially tell your healthcare provider if you take:

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

Ask your healthcare provider or pharmacist for a ul of these medicines if you are not sure.

Know the medicines you take. Keep a ul of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use VENTOLIN HFA?

• For detailed instructions, see “ ” at the end of this Patient Information. • Instructions for Use
• Use VENTOLIN HFA exactly as your healthcare provider tells you to use it. •
• increase your dose or take extra doses of VENTOLIN HFA without first talking to your healthcare provider. • Do not
• If your child needs to use VENTOLIN HFA, watch your child closely to make sure your child uses the inhaler correctly. Your healthcare provider will show you how your child should use VENTOLIN HFA. •
• Each dose of VENTOLIN HFA should last up to 4 hours to 6 hours. •
• Get medical help right away if VENTOLIN HFA 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 VENTOLIN HFA, use other inhaled medicines and asthma medicines only as directed by your healthcare provider. •
• Call your healthcare provider if your asthma symptoms like wheezing and trouble breathing become worse over a few hours or days. Your healthcare provider may need to give you another medicine to treat your symptoms. •

What are the possible side effects of VENTOLIN HFA?

VENTOLIN HFA may cause serious side effects, including:

• If this happens, stop using VENTOLIN HFA and call your healthcare provider or get emergency help right away. Paradoxical bronchospasm is more likely to happen with your first use of a new canister of medicine. • worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm).
• • heart problems, including faster heart rate and higher blood pressure
• • possible death in people with asthma who use too much VENTOLIN HFA
• Call your healthcare provider right away if you have any of the following symptoms of an allergic reaction: • allergic reactions.
  • 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 VENTOLIN HFA, including increases in blood sugar

Common side effects of VENTOLIN HFA include:

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

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

These are not all the possible side effects of VENTOLIN HFA. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store VENTOLIN HFA?

• Store VENTOLIN HFA at room temperature between 59°F and 77°F (15°C and 25°C) with the mouthpiece down. •
• Avoid exposure to extreme heat and cold. •
• Shake the VENTOLIN HFA canister well before use. •
• puncture the VENTOLIN HFA canister. • Do not
• store the VENTOLIN HFA canister near heat or a flame. Temperatures above 120°F may cause the canister to burst. • Do not
• throw the VENTOLIN HFA canister into a fire or an incinerator. • Do not
• Avoid spraying VENTOLIN HFA in your eyes. •

Keep VENTOLIN HFA and all medicines out of the reach of children.

General information about the safe and effective use of VENTOLIN HFA

Medicines are sometimes prescribed for purposes other than those uled in a Patient Information leaflet. Do not use VENTOLIN HFA for a condition for which it was not prescribed. Do not give VENTOLIN HFA to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about VENTOLIN HFA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about VENTOLIN HFA that is written for healthcare professionals.

For more information, go to www.ventolin.com or call 1-888-825-5249.

What are the ingredients in VENTOLIN HFA?

Active ingredient: albuterol sulfate

Inactive ingredient: propellant HFA-134a

Instructions for Use

VENTOLIN HFA ^® (vent′ o-lin)

(albuterol sulfate)

Inhalation Aerosol

Read this Instructions for Use before you start using VENTOLIN HFA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

The parts of your VENTOLIN HFA inhaler:

There are 2 main parts of your VENTOLIN HFA inhaler:

• the blue plastic actuator that sprays the medicine into your mouth. See Figure A. •
• the metal canister that holds the medicine. See Figure A. •

Figure A

The actuator has a protective cap that covers the mouthpiece. The strap on the cap will stay attached to the actuator.

use this actuator with a canister of medicine from any other inhaler. Do not

use this canister of medicine with an actuator from any other inhaler. Do not

The canister has a counter that shows you how many sprays of medicine you have left. The number shows through a window in the back of the actuator. The counter starts at either 204 or 64, depending on which size inhaler you have. See Figure B.

Figure B

Priming your VENTOLIN HFA inhaler:

Your VENTOLIN HFA inhaler must be primed before you use it for the first time, when it has not been used for more than 14 days in a row, or if it has been dropped. Do not prime your VENTOLIN HFA every day.

• Remove your VENTOLIN HFA inhaler from its packaging. •
• Throw away the pouch and the drying packet that comes inside the pouch. •
• Remove the protective cap from the mouthpiece. •
• Shake the inhaler well, and spray it into the air away from your face. See Figure C. •

Figure C

• Shake and spray the inhaler like this 3 more times to finish priming it. After you prime the actuator for the first time, the dose counter in the window on the back of the actuator should show the number 200 or 60, depending on which size inhaler you have. See Figure D. •

Figure D

Each time you use your VENTOLIN HFA inhaler:

• Make sure the canister fits firmly in the plastic actuator. •
• Look into the mouthpiece to make sure there are no foreign objects there, especially if the strap is no longer attached to the actuator or the cap has not been used to cover the mouthpiece. •

Reading the dose counter on your VENTOLIN HFA actuator:

• The dose counter will count down by 1 number each time you spray the inhaler. •
• The dose counter stops counting when it reaches It will continue to show . • 000. 000
• The dose counter cannot be reset, and it is permanently attached to the metal canister. try to change the numbers for the dose counter or take the counter off the metal canister. • Never
• remove the canister from the plastic actuator except during cleaning to prevent accidently spraying a dose of VENTOLIN HFA into the air. • Do not

Using your VENTOLIN HFA inhaler:

Step 1. before each spray. Take the cap off the mouthpiece of the actuator. Shake the inhaler well

Step 2. Hold the inhaler with the mouthpiece down. See Figure E.

Figure E

Step 3. Breathe out through your mouth and push as much air from your lungs as you can. Put the mouthpiece in your mouth and close your lips around it. See Figure F.

Figure F

Step 4. Push the top of the canister all the way down while you breathe in deeply and slowly through your mouth. See Figure F.

Step 5. Right after the spray comes out, take your finger off the canister. After you have breathed in all the way, take the inhaler out of your mouth and close your mouth.

Step 6. , up to 10 seconds, then breathe normally. Hold your breath as long as you can

, wait 1 minute and shake the inhaler again. Repeat Steps 2 through Step 6. If your healthcare provider has told you to use more sprays

Step 7. Put the cap back on the mouthpiece after every time you use the inhaler. Make sure the cap snaps firmly into place.

Cleaning your VENTOLIN HFA actuator:

It is very important to keep the plastic actuator clean so the medicine will not build-up and block the spray. See Figure G.

Figure G

• The inhaler may stop spraying if it is not cleaned correctly. • Do not try to clean the metal canister or let it get wet.
• at least once a week as follows: • Wash the actuator

Step 8. Take the canister out of the actuator, and take the cap off the mouthpiece. The strap on the cap will stay attached to the actuator.

Step 9. Hold the actuator under the faucet and run warm water through it for about 30 seconds. See Figure H.

Figure H

Step 10. Turn the actuator upside down and run warm water through the mouthpiece for about 30 seconds. See Figure I.

Figure I

Step 11. Shake off as much water from the actuator as you can. Look into the mouthpiece to make sure any medicine build-up has been completely washed away. If there is any build-up, repeat Steps 9 and 10.

Step 12. Let the actuator air-dry completely, such as overnight. See Figure J.

Figure J

Step 13. When the actuator is dry, put the canister in the actuator and make sure it fits firmly. Shake the inhaler well and spray it once into the air away from your face. (The counter will count down by 1 number.) Put the cap back on the mouthpiece.

If you need to use your inhaler before the actuator is completely dry:

• Shake as much water off the actuator as you can. •
• Put the canister in the actuator and make sure it fits firmly. •
• Shake the inhaler well and spray it once into the air away from your face. •
• Take your VENTOLIN HFA dose as prescribed. •
• Follow cleaning Steps 8 through 13 above. •

Replacing your VENTOLIN HFA inhaler:

• , you need to refill your prescription or ask your doctor for another prescription for VENTOLIN HFA. • When the dose counter on the actuator shows the number 020
• as soon as the dose counter shows , after the expiration date on the VENTOLIN HFA packaging, or 12 months after you open the foil pouch, whichever comes first. You should not keep using the inhaler after the dose counter shows even though the canister may not be completely empty. You cannot be sure you will receive the right amount of medicine. • Throw the VENTOLIN HFA inhaler away 000 000

VENTOLIN is a registered trademark of GlaxoSmithKline.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2012, GlaxoSmithKline. All rights reserved.

October 2012

VNT:8PIL