Proventil HFA (Page 3 of 4)

Adverse Reactions to Proventil HFA

Adverse reaction information concerning PROVENTIL HFA Inhalation Aerosol is derived from a 12-week, double-blind, double-dummy study which compared PROVENTIL HFA Inhalation Aerosol, a CFC 11/12 propelled albuterol inhaler, and an HFA-134a placebo inhaler in 565 asthmatic patients. The following table lists the incidence of all adverse events (whether considered by the investigator drug related or unrelated to drug) from this study which occurred at a rate of 3% or greater in the PROVENTIL HFA Inhalation Aerosol treatment group and more frequently in the PROVENTIL HFA Inhalation Aerosol treatment group than in the placebo group. Overall, the incidence and nature of the adverse reactions reported for PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler were comparable.

Adverse Experience Incidences (% of patients) in a Large 12-week Clinical Trial*
Body System/Adverse Event (Preferred Term) PROVENTILHFAInhalationAerosol(N=193) CFC 11/12PropelledAlbuterolInhaler(N=186) HFA-134aPlaceboInhaler(N=186)
Application Site Disorders Inhalation Site Sensation 6 9 2
Inhalation Taste Sensation 4 3 3
Body as a Whole AllergicReaction/Symptoms 6 4 less than1
Back Pain 4 2 3
Fever 6 2 5
Central and Peripheral Nervous System Tremor 7 8 2
Gastrointestinal System NauseaVomiting 107 92 53
Heart Rate and Rhythm Disorder Tachycardia 7 2 less than 1
Psychiatric Disorders Nervousness 7 9 3
Respiratory System Disorders Respiratory Disorder(unspecified)RhinitisUpper Resp Tract Infection 61621 42220 51418
Urinary System Disorder Urinary Tract Infection 3 4 2

* This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug) which occurred at an incidence rate of at least 3.0% in the PROVENTIL HFA Inhalation Aerosol group and more frequently in the PROVENTIL HFA Inhalation Aerosol group than in the HFA-134a placebo inhaler group.

Adverse events reported by less than 3% of the patients receiving PROVENTIL HFA Inhalation Aerosol, and by a greater proportion of PROVENTIL HFA Inhalation Aerosol patients thatn placebo patients, which have the potential to be related to PROVENTIL HFA Inhalation Aerosol include: dysphonia, increased sweating, dry mouth, chest pain, edema, rigors, ataxia, leg cramps, hyperkinesias, eructation, flatulence, tinnitus, diabetes mellitus, anxiety, depression, somnolence, rash. Palpitation and dizziness have also been observed with PROVENTIL HFA Inhalation Aerosol.

Adverse events reported in a 4-week pediatric clinical trail comparing PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler occurred at a low incidence rate and were similar to those seen in the adult trials.

In small, cumulative dose studies, tremor, nervousness, and headache appeared to be dose related.

Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of inhaled albuterol. In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, insomnia, headache, and drying or irritation of the oropharynx.

OVERDOSE

The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, eg, seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia.

Hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of PROVENTIL HFA Inhalation Aerosol. Treatment consists of discontinuation of PROVENTIL HFA Inhalation Aerosol together with appropriate symptomatic therapy. The judicious use of a cardioselective bete-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 PROVENTIL HFA Inhalation Aerosol.

The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 6800 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximately 3200 times the maximum recommended daily inhalation dose for children on a mg/m2 basis). In mature rats, the subcutaneous median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 3000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximately 1400 times the maximum recommended daily inhalation dose for children on a mg/m2 basis). In young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg (approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximately 64000 times the maximum recommended daily inhalation dose for children on a mg/m2 basis). The inhalation median lethal dose has not been determined in animals.

DOSAGE AND ADMINISTRATION

For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage for adults and children 4 years of age and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient. Each actuation of PROVENTIL HFA Inhalation Aerosol delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece. 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 by releasing four “test sprays” into the air, away from the face.

Exercise Induced Bronchospasm Prevention: The usual dosage for adults and children 4 years of age and older is two inhalations 15 to 30 minutes before exercise.

To maintain proper use of this product, it is important that the mouthpiece be washed and dried thoroughly at least once a week. The inhaler may cease to deliver medication if not properly cleaned and dried thoroughly. See Information for Patients. Keeping the plastic mouthpiece clean is very important to prevent medication build-up and blockage. The inhaler may cease to deliver medication if not properly cleaned and air dried thoroughly. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage.

If a previously effective dose regimen fails to provide the usual response, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, eg, corticosteroids.

HOW SUPPLIED

PROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations (NCD 54868-6051-0).

Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.

SHAKE WELL BEFORE USING.

The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.

WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.

PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.

Developed and Manufactured by

3M Health Care Limited

Loughborough UK

or

3M Drug Delivery Sytems

Northridge, CA 91324

or

Laboratoires 3M

Sante Pithiviers FR

for

Schering Corporation

Kenilworth, NJ 07033 USA

6203 5190 4
Copyright © 1996, 1999, Schering Corporation All rights reserved.Rev. 11/07 29408505T B-29669503

Attention Pharmacist:

Detach Patient’s Instructions for Use from package insert and dispense with the product.

PROVENTIL® HFA

(albuterol sulfate)

Inhalation Aerosol

FOR ORAL INHALATION ONLY

image of Figure 1
(click image for full-size original)
image of Figure 2
(click image for full-size original)

Before using your PROVENTIL HFA (albuterol Sulfate) Inhalation Aerosol, read complete instructions carefully. Children should use PROVENTIL HFA Inhalation Aerosol under adult supervision, as instructed by the patient’s doctor
Please note that image of CFC indicates that this inhalation aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.
image of Figure 1image of Figure 2image of CFC

  1. SHAKE THE INHALER WELL immediately before each use. Then remove the cap from the mouthpiece (see Figure 1). Check mouthpiece for foreign objects prior to use. Make sure the canister is fully inserted into the actuator.
  2. 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.
  3. BREATH OUT FULLY THROUGH THE MOUTH, expelling as much air from your lings as possible. Place the mouthpiece fully into the mouth holding the inhaler in its upright position (see Figure 2) and closing the lips around it.
  4. WHILE BREATHING IN DEEPLY AND SLOWLY THROUGH THE MOUTH, FULLY DEPRESS THE TOP OF THE METAL CANISTER with your index finger (see Figure 2).
  5. HOLD YOUR BREATH AS LONG AS POSSIBLE, up to 10 seconds. Before breathing out, remove the inhaler from your mouth and release your finger from the canister.
  6. If your physician has prescribed additional puffs, wait 1 minute, shake the inhaler again, and repeat steps 2 through 4. Replace the cap after use.
  7. KEEPING THE PLACTIC MOUTHPIECE CLEAN IS EXTREMELY IMPORTANT TO PREVENT MEDICATION BUILD-UP AND BLOCKAGE. THE MOUTHPIECE SHOULD BE WASHED, SHAKEN TO REMOVE EXCESS WATER, AND AIR DRIED THOROUGHLY AT LEAST ONCE A WEEK. INHALER MAY STOP SPRAYING IF NOT PROPERLY CLEANED.


    Routine cleaning instructions:

    Step 1. To clean, remove the canister and mouthpiece cap. Wash the mouthpiece through the top and bottom with warm running water for 30 seconds at lease once a week (see Figure A). Never immerse the metal canister in water.

    image of Figure A
    (click image for full-size original)


    Wash mouthpiece under warm running water.

    image of Figure B
    (click image for full-size original)


    Allow mouthpiece to dry, such as overnight.

    image of Figure C
    (click image for full-size original)


    When blocked, little or no medicine comes out.
    Step 2. To dry, shake off excess water and let the mouthpiece air dry thoroughly, such as overnight (see Figure B). When the mouthpiece is dry, replace the canister and the mouthpiece cap. Blockage from medication build-up is more likely to occur if the mouthpiece is not allowed to air dry thoroughly.
    IF YOUR INHALER HAS BECOME BLOCKED (little or no medication coming out of the mouthpiece, see Figure C), wash the mouthpiece as described in Step 1 and air dry thoroughly as described in Step 2.
    IF YOU NEED TO USE YOUR INHALER BEFORE IT IS COMPLETELY DRY, SHAKE OFF EXCESS WATER, replace the canister, and test spray twice into the air, away from your face, to remove most of the water remaining in the mouthpiece. Then take your dose as prescribed. After such use, rewash and air dry thoroughly as described in Step 1 and 2.

  8. The correct amount of medication in each inhalation cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used. Before you reach the specific number of actuations, you should consult your physician to determine whether a refill is needed. Just as you should not take extra doses without consulting your physician, you also should not stop using PROVENTIL HFA Inhalation Aerosol without consulting your physician.

    You may notice a slightly different taste or spray force than you are used to with PROVENTIL HFA Inhalation Aerosol, compared to other albuterol inhalation aerosol products.

    DOSAGE:

    Use only as directed by your physician.

    WARNINGS:

    The action of PROVENTIL HFA Inhalation Aerosol should last up to 4 to 6 hours. PROVENTIL HFA Inhalation Aerosol should not be used more frequently than recommended. Do not increase the number of puffs or frequency of doses of PROVENTIL HFA Inhalation Aerosol without consulting your physician. If you find that treatment with PROVENTIL HFA Inhalation Aerosol becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, medical attention should be sought immediately. While you are taking PROVENTIL HFA Inhalation Aerosol, other inhaled drugs should be taken only as directed by your physician. If you are pregnant or nursing, contact your physician about the use of PROVENTIL HFA Inhalation Aerosol.

    Common adverse effects of treatment with PROVENTIL HFA Inhalation Aerosol include palpitations, chest pain, rapid heart rate, tremor, or nervousness. Effective and safe use of PROVENTIL HFA Inhalation Aerosol includes an understanding of the way that it should be administered. Use PROVENTIL HFA Inhalation Aerosol only with the yellow actuator supplied with the product. The PROVENTIL HFA Inhalation Aerosol actuator should not be used with other aerosol medications.

    For best results, use at room temperature. Avoid exposing product to extreme heat and cold.

    Shake well before use.

    Contents Under Pressure.

    Do not puncture. Do not store near hear or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Store between 15° and 25°C (59° and 77°F). Avoid spraying in eyes. Keep out of reach of children.

    Further Information: Your PROVENTIL HFA (albuterol sulfate) Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant. Instead, the inhaler contains a hydrofluoroalkane (HFA-134a) as the propellant.

    Developed and Manufactured by

    3M Health Care Limited

    Loughborough UK

    or

    3M Drug Delivery Systems

    Northridge, CA 91324

    or

    Laboratoires 3M

    Sante Pithiviers FR

    for

    Schering Corporation

    Kenilworth, NJ 07033 USA

    Rev. 11/07U.S. Patent No. 5,225,18329669503
    Copyright © 1996, 1999,Schering CorporationAll rights reserved.
image of Figure Aimage of Figure Bimage of Figure C

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