The active ingredient in ATROVENT HFA Inhalation Aerosol is ipratropium bromide (as the monohydrate). It is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1]octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8- (1-methylethyl)-,bromide monohydrate, (3-endo, 8-syn)-: a synthetic quaternary ammonium compound, chemically related to atropine. The structural formula for ipratropium bromide is:

C₂₀H₃₀BrNO₃ • H₂O     ipratropium bromide Mol. Wt. 430.4

Ipratropium bromide is a white to off-white crystalline substance, freely soluble in water and methanol, sparingly soluble in ethanol, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons.

ATROVENT HFA Inhalation Aerosol is a pressurized metered-dose aerosol unit for oral inhalation that contains a solution of ipratropium bromide. The 200 inhalation unit has a net weight of 12.9 grams. After priming, each actuation of the inhaler delivers 21 mcg of ipratropium bromide from the valve in 56 mg of solution and delivers 17 mcg of ipratropium bromide from the mouthpiece. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the device and inspiration through the delivery system. The excipients are HFA-134a (1,1,1,2-tetrafluoroethane) as propellant, purified water, dehydrated alcohol, and anhydrous citric acid. This product does not contain chlorofluorocarbons (CFCs) as propellants.

Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol should be primed before using for the first time by releasing 2 test sprays into the air away from the face. In cases where the inhaler has not been used for more than 3 days, prime the inhaler again by releasing 2 test sprays into the air away from the face.

Last updated on RxList: 12/4/2008

ATROVENT HFA Inhalation Aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

Patients should be instructed on the proper use of their inhaler (see PATIENT'S INSTRUCTIONS FOR USE).

Patients should be advised that although Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol may have a slightly different taste and inhalation sensation than that of an inhaler containing Atrovent® (ipratropium bromide) Inhalation Aerosol CFC, they are comparable in terms of the safety and efficacy.

ATROVENT HFA Inhalation Aerosol is a solution aerosol that does not require shaking. However, as with any other metered dose inhaler, some coordination is required between actuating the canister and inhaling the medication.

Patients should “prime” or actuate ATROVENT HFA Inhalation Aerosol before using for the first time by releasing 2 test sprays into the air away from the face. In cases where the inhaler has not been used for more than 3 days, prime the inhaler again by releasing 2 test sprays into the air away from the face. Patients should avoid spraying ATROVENT HFA Inhalation Aerosol into their eyes.

The usual starting dose of ATROVENT HFA Inhalation Aerosol is two inhalations four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed 12 in 24 hours. Each actuation of ATROVENT HFA Inhalation Aerosol delivers 17 mcg of ipratropium bromide from the mouthpiece.

ATROVENT HFA Inhalation Aerosol is supplied in a 12.9 g pressurized stainless steel canister as a metered-dose inhaler with a white mouthpiece that has a clear, colorless sleeve and a green protective cap (NDC 0597-0087-17).

The ATROVENT HFA Inhalation Aerosol canister is to be used only with the accompanying ATROVENT HFA Inhalation Aerosol mouthpiece. This mouthpiece should not be used with other aerosol medications. Similarly, the canister should not be used with other mouthpieces. Each actuation of ATROVENT HFA Inhalation Aerosol delivers 21 mcg of ipratropium bromide from the valve and 17 mcg from the mouthpiece. Each 12.9 gram canister provides sufficient medication for 200 actuations. The canister should be discarded after the labeled number of actuations has been used. The amount of medication in each actuation cannot be assured after this point, even though the canister is not completely empty.

Store at 25°C (77°F);excursions permitted to 15 ° -30° C (59° -86° F) [see USP Controlled Room Temperature]. For optimal results, the canister should be at room temperature before use.

Address medical inquiries to: http://us.boehringer-ingelheim.com, (800) 542-6257 or (800) 459-9906 TTY.

Patients should be reminded to read and follow the accompanying “Patient's Instructions for Use”, which should be dispensed with the product.

Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw the inhaler into a fire or incinerator.

Warning: Keep out of children's reach. Avoid spraying in eyes.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Rev: April 2008. FDA rev date: 10/14/2008

Last updated on RxList: 12/4/2008

The adverse reaction information concerning ATROVENT HFA Inhalation Aerosol is derived from two 12-week, double-blind, parallel group studies and one open-label, parallel group study that compared ATROVENT HFA Inhalation Aerosol, ATROVENT Inhalation Aerosol CFC, and placebo (in one study only) in 1,010 COPD patients. The following table lists the incidence of adverse events that occurred at a rate of greater than or equal to 3% in any ipratropium bromide group. Overall, the incidence and nature of the adverse events reported for ATROVENT HFA Inhalation Aerosol, ATROVENT Inhalation Aerosol CFC, and placebo were comparable.

TABLE 1: Adverse Experiences Reported in ≥ 3% of Patients in any Ipratropium Bromide Group

	Placebo-controlled 12 week Study 244.1405 and Active-controlled 12 week Study 244.1408			Active-controlled 1-year Study 244.2453
	Atrovent HFA (N=243) %	Atrovent CFC (N=183) %	Placebo (N=128) %	Atrovent HFA (N=305) %	Atrovent CFC (N=151) %
Total With Any Adverse Event	63	68	72	91	87
BODY AS A WHOLE - GENERAL DISORDERS
Back pain	2	3	2	7	3
Headache	6	9	8	7	5
Influenza-like symptoms	4	2	2	8	5
CENTRAL & PERIPHERAL NERVOUS SYSTEMDISORDERS
Dizziness	3	3	2	3	1
GASTROINTESTINAL SYSTEM DISORDERS
Dyspepsia	1	3	1	5	3
Mouth dry	4	2	2	2	3
Nausea	4	1	2	4	4
RESPIRATORY SYSTEM DISORDERS
Bronchitis	10	11	6	23	19
COPD exacerbation	8	14	13	23	23
Coughing	3	4	6	5	5
Dyspnea	8	8	4	7	4
Rhinitis	4	2	4	6	2
Sinusitis	1	4	3	11	14
Upper respiratory tract infection	9	10	16	34	34
URINARY SYSTEM DISORDERS
Urinary tract infection	2	3	1	10	8

In the one open label controlled study in 456 COPD patients, the overall incidence of adverse events was also similar between Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol and Atrovent® (ipratropium bromide) Inhalation Aerosol CFC formulations.

Overall, in the above mentioned studies, 9.3% of the patients taking 42 mcg ATROVENT HFA Inhalation Aerosol and 8.7% of the patients taking 42 mcg ATROVENT Inhalation Aerosol CFC reported at least one adverse event that was considered by the investigator to be related to the study drug. The most common drug-related adverse events were dry mouth (1.6% of ATROVENT HFA Inhalation Aerosol and 0.9% of ATROVENT Inhalation Aerosol CFC patients), and taste perversion (bitter taste) (0.9% of ATROVENT HFA Inhalation Aerosol and 0.3% of ATROVENT Inhalation Aerosol CFC patients).

As an anticholinergic drug, cases of precipitation or worsening of narrow-angle glaucoma, mydriasis, acute eye pain, hypotension, palpitations, urinary retention, tachycardia, constipation, bronchospasm, including paradoxical bronchospasm have been reported.

Allergic-type reactions such as skin rash, pruritus, angioedema of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reactions have been reported (see CONTRAINDICATIONS).

Post-Marketing Experience

In a 5-year placebo-controlled trial, hospitalizations for supraventricular tachycardia and/or atrial fibrillation occurred with an incidence rate of 0.5% in COPD patients receiving ATROVENT Inhalation Aerosol CFC.

Allergic-type reactions such as skin rash, angioedema of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reactions have been reported, with positive rechallenge in some cases.

Additionally, urinary retention, mydriasis, gastrointestinal distress (diarrhea, nausea, vomiting), and bronchospasm, including paradoxical bronchospasm, have been reported during the post-marketing period with use of ATROVENT Inhalation Aerosol CFC.

ATROVENT HFA Inhalation Aerosol has been used concomitantly with other drugs, including sympathomimetic bronchodilators, methylxanthines, oral and inhaled steroids, that may be used in the treatment of chronic obstructive pulmonary disease. With the exception of albuterol, there are no formal studies fully evaluating the interaction effects of ATROVENT and these drugs with respect to effectiveness.

Anticholinergic agents: Although ipratropium bromide is minimally absorbed into the systemic circulation, there is some potential for an additive interaction with concomitantly used anticholinergic medications. Caution is therefore advised in the co-administration of ATROVENT HFA Inhalation Aerosol with other anticholinergic-containing drugs.

Last updated on RxList: 12/4/2008

ATROVENT HFA Inhalation Aerosol is a bronchodilator for the maintenance treatment of bronchospasm associated with COPD and is not indicated for the initial treatment of acute episodes of bronchospasm where rescue therapy is required for rapid response.

Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.

Inhaled medicines, including ATROVENT HFA Inhalation Aerosol, may cause paradoxical bronchospasm. If this occurs, treatment with ATROVENT HFA Inhalation Aerosol should be stopped and other treatments considered.

General

ATROVENT HFA Inhalation Aerosol should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction.

Information for Patients

Appropriate and safe use of ATROVENT HFA Inhalation Aerosol includes providing the patient with the information listed below and an understanding of the way it should be administered (see PATIENT'S INSTRUCTIONS FOR USE).

Patients should be advised that ATROVENT HFA Inhalation Aerosol is a bronchodilator for the maintenance treatment of bronchospasm associated with COPD and is not indicated for the initial treatment of acute episodes of bronchospasm where rescue therapy is required for rapid response.

Patients should be cautioned to avoid spraying the aerosol into their eyes and be advised that this may result in precipitation or worsening of narrow-angle glaucoma, mydriasis, increased intraocular pressure, acute eye pain or discomfort, temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion. Patients should also be advised that should any combination of these symptoms develop, they should consult their physician immediately.

The action of Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol should last 2-4 hours. Patients should be advised not to increase the dose or frequency of ATROVENT HFA Inhalation Aerosol without patients consulting their physician. Patients should also be advised to seek immediate medical attention if treatment with ATROVENT HFA Inhalation Aerosol becomes less effective for symptomatic relief, their symptoms become worse, and/or patients need to use the product more frequently than usual.

Patients should be advised on the use of ATROVENT HFA Inhalation Aerosol in relation to other inhaled drugs.

Patients should be reminded that ATROVENT HFA Inhalation Aerosol should be used consistently as prescribed throughout the course of therapy.

Patients should be advised that although the taste and inhalation sensation of ATROVENT HFA Inhalation Aerosol may be slightly different from that of the CFC (chlorofluorocarbon) formulation of ATROVENT Inhalation Aerosol, they are comparable in terms of safety and efficacy.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic activity at doses up to 6 mg/kg (approximately 240 and 120 times the maximum recommended daily inhalation dose in adults on a mg/m² basis). Results of various mutagenicity studies (Ames test, mouse dominant lethal test, mouse micronucleus test and chromosome aberration of bone marrow in Chinese hamsters) were negative.

Fertility of male or female rats at oral doses up to 50 mg/kg (approximately 2000 times the maximum recommended daily inhalation dose in adults on a mg/m² basis) was unaffected by ipratropium bromide administration. At an oral dose of 500 mg/kg (approximately 20,000 times the maximum recommended daily inhalation dose in adults on a mg/m² basis), ipratropium bromide produced a decrease in the conception rate.

Pregnancy

Teratogenic Effects: Pregnancy Category B.

Oral reproduction studies were performed at doses of 10 mg/kg/day in mice, 1,000 mg/kg in rats and 125 mg/kg/day in rabbits. These doses correspond in each species, respectively, to approximately 200, 40000, and 10000 times the maximum recommended daily inhalation dose in adults on a mg/m² basis. Inhalation reproduction studies were conducted in rats and rabbits at doses of 1.5 and 1.8 mg/kg (approximately 60 and 140 times the maximum recommended daily inhalation dose in adults on a mg/m² basis). These studies demonstrated no evidence of teratogenic effects as a result of ipratropium bromide. At oral doses 90 mg/kg and above in rats (approximately 3600 times the maximum recommended daily inhalation dose in adults on a mg/m² basis) embryotoxicity was observed as increased resorption. This effect is not considered relevant to human use due to the large doses at which it was observed and the difference in route of administration. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether the active component, ipratropium bromide, is excreted in human milk. Although lipid-insoluble quaternary cations pass into breast milk, it is unlikely that ipratropium bromide would reach the infant to an important extent, especially when taken by aerosol. However, because many drugs are excreted in human milk, caution should be exercised when ATROVENT HFA Inhalation Aerosol is administered to a nursing mother.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

Geriatric Use

In the pivotal 12-week study, both ATROVENT HFA Inhalation Aerosol and Atrovent® (ipratropium bromide) Inhalation Aerosol CFC formulations were equally effective in patients over 65 years of age and under 65 years of age.

Of the total number of subjects in clinical studies of ATROVENT HFA Inhalation Aerosol, 57% were ≥ 65 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

Last updated on RxList: 12/4/2008

Acute overdose by inhalation is unlikely since ipratropium bromide is not well absorbed systemically after inhalation or oral administration. Oral median lethal doses of ipratropium bromide were greater than 1001 mg/kg in mice (approximately 20,000 times the maximum recommended daily inhalation dose in adults on a mg/m² basis); 1,663 mg/kg in rats (approximately 66,000 times the maximum recommended daily inhalation dose in adults on a mg/m² basis); and 400 mg/kg in dogs (approximately 53,000 times the maximum recommended daily inhalation dose in adults on a mg/m² basis).

ATROVENT HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to ipratropium bromide or other ATROVENT HFA Inhalation Aerosol components. ATROVENT HFA Inhalation Aerosol is also contraindicated in patients who are hypersensitive to atropine or its derivatives.

Last updated on RxList: 12/4/2008

Mechanism of Action

Ipratropium bromide is an anticholinergic (parasympatholytic) agent which, based on animal studies, appears to inhibit vagally-mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released at the neuromuscular junctions in the lung. Anticholinergics prevent the increases in intracellular concentration of cyclic guanosine monophosphate (cyclic GMP) which are caused by interaction of acetylcholine with the muscarinic receptors on bronchial smooth muscle.

Pharmacodynamic Properties

Controlled clinical studies have demonstrated that Atrovent® (ipratropium bromide) Inhalation Aerosol CFC does not alter either mucociliary clearance or the volume or viscosity of respiratory secretions.

Pharmacokinetics

Most of an administered dose is swallowed as shown by fecal excretion studies. Ipratropium bromide is a quaternary amine. It is not readily absorbed into the systemic circulation either from the surface of the lung or from the gastrointestinal tract as confirmed by blood level and renal excretion studies.

Autoradiographic studies in rats have shown that ipratropium bromide does not penetrate the blood-brain barrier. The half-life of elimination is about 2 hours after inhalation or intravenous administration. Ipratropium bromide is minimally bound (0 to 9% in vitro) to plasma albumin and α₁-acid glycoprotein. It is partially metabolized to inactive ester hydrolysis products. Following intravenous administration, approximately one-half of the dose is excreted unchanged in the urine.

A pharmacokinetic study with 29 chronic obstructive pulmonary disease (COPD) patients (48-79 years of age) demonstrated that mean peak plasma ipratropium concentrations of 59±20 pg/mL were obtained following a single administration of 4 inhalations of ATROVENT HFA Inhalation Aerosol (84 mcg). Plasma ipratropium concentrations rapidly declined to 24±15 pg/mL by six hours. When these patients were administered 4 inhalations QID (16 inhalations/day=336 mcg) for one week, the mean peak plasma ipratropium concentration increased to 82±39 pg/mL with a trough (6 hour) concentration of 28±12 pg/mL at steady state.

Special Populations

Geriatric Patients

In the pharmacokinetic study with 29 COPD patients, a subset of 14 patients were > 65 years of age. Mean peak plasma ipratropium concentrations of 56±24 pg/mL were obtained following a single administration of 4 inhalations (21 mcg/puff) of Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol (84 mcg). When these 14 patients were administered 4 inhalations QID (16 inhalations/day) for one week, the mean peak plasma ipratropium concentration only increased to 84±50 pg/mL indicating that the pharmacokinetic behavior of ipratropium bromide in the geriatric population is consistent with younger patients.

Renally Impaired Patients

The pharmacokinetics of ATROVENT HFA Inhalation Aerosol have not been studied in patients with renal insufficiency.

Hepatically Impaired Patients

The pharmacokinetics of ATROVENT HFA Inhalation Aerosol have not been studied in patients with hepatic insufficiency.

Clinical Studies

Conclusions regarding the efficacy of ATROVENT HFA Inhalation Aerosol were derived from two randomized, double-blind, controlled clinical studies. These studies enrolled males and females ages 40 years and older, with a history of COPD, a smoking history of > 10 pack- years, an FEV₁ < 65% and an FEV₁/FVC < 70%.

One of the studies was a 12-week randomized, double-blind active and placebo controlled study in which 505 of the 507 randomized COPD patients were evaluated for the safety and efficacy of 42 mcg (n=124) and 84 mcg (n=126) ATROVENT HFA Inhalation Aerosol in comparison to 42 mcg (n=127) Atrovent® (ipratropium bromide) Inhalation Aerosol CFC and their respective placebos (HFA n=62, CFC n=66). Data for both placebo HFA and placebo CFC were combined in the evaluation.

Serial FEV₁ (shown in Figure 1, below, as means adjusted for center and baseline effects on test day 1 and test day 85 (primary endpoint)) demonstrated that 1 dose (2 inhalations/21 mcg each) of ATROVENT HFA Inhalation Aerosol produced significantly greater improvement in pulmonary function than placebo. During the six hours immediately post-dose on day 1, the average hourly improvement in adjusted mean FEV₁ was 0.148 liters for ATROVENT HFA Inhalation Aerosol (42 mcg) and 0.013 liters for placebo. The mean peak improvement in FEV₁, relative to baseline, was 0.295 liters, compared to 0.138 liters for placebo. During the six hours immediately post-dose on day 85, the average hourly improvement in adjusted mean FEV₁ was 0.141 liters for ATROVENT HFA Inhalation Aerosol (42 mcg) and 0.014 liters for placebo. The mean peak improvement in FEV₁, relative to baseline, was 0.295 liters, compared to 0.140 liters for placebo.

ATROVENT HFA Inhalation Aerosol (42 mcg) was shown to be clinically comparable to ATROVENT Inhalation Aerosol CFC (42 mcg).

Figure 1 - Day 1 and Day 85 (Primary Endpoint) Results

In this study, both Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol and Atrovent® (ipratropium bromide) Inhalation Aerosol CFC formulations were equally effective in patients over 65 years of age and under 65 years of age.

The median time to improvement in pulmonary function (FEV₁ increase of 15% or more) was within approximately 15 minutes, reached a peak in 1-2 hours, and persisted for 2 to 4 hours in the majority of the patients. Improvements in Forced Vital Capacity (FVC) were also demonstrated.

The other study was a 12-week, randomized, double-blind, active-controlled clinical study in 174 adults with COPD, in which ATROVENT HFA Inhalation Aerosol 42 mcg (n=118) was compared to ATROVENT Inhalation Aerosol CFC 42 mcg (n=56). Safety and efficacy of HFA and CFC formulations were shown to be comparable.

The bronchodilatory efficacy and comparability of Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol vs. Atrovent® (ipratropium bromide) Inhalation Aerosol CFC were also studied in a one-year open-label safety and efficacy study in 456 COPD patients. The safety and efficacy of HFA and CFC formulations were shown to be comparable.

Last updated on RxList: 12/5/2008

Atrovent® HFA
(ipratropium bromide HFA) Inhalation Aerosol

Read complete instructions carefully before using.

Important Points to Remember About Using ATROVENT HFA Inhalation Aerosol

Although ATROVENT HFA Inhalation Aerosol may taste and feel different when breathed in compared to your Atrovent® (ipratropium bromide) Inhalation Aerosol CFC inhaler, they contain the same medicine.

You do not have to shake the ATROVENT HFA Inhalation Aerosol canister before using it.

ATROVENT HFA Inhalation Aerosol should be "primed" two times before taking the first dose from a new inhaler or when the inhaler has not been used for more than three days.To prime, push the canister against the mouthpiece (see Figure 1), allowing the medicine to spray into the air. Avoid spraying the medicine into your eyes while priming ATROVENT HFA Inhalation Aerosol.

Ask your doctor how to use other inhaled medicines with ATROVENT HFA Inhalation Aerosol.

Use ATROVENT HFA Inhalation Aerosol exactly as prescribed by your doctor. Do not change your dose or how often you use ATROVENT HFA Inhalation Aerosol without talking with your doctor. Talk to your doctor if you have questions about your medical condition or your treatment.

Instructions

1. Insert the metal canister into the clear end of the mouthpiece (see Figure 1). Make sure the canister is fully and firmly inserted into the mouthpiece. The ATROVENT HFA Inhalation Aerosol canister is for use only with the ATROVENT HFA Inhalation Aerosol mouthpiece. Do not use the ATROVENT HFA Inhalation Aerosol canister with other mouthpieces. This mouthpiece should not be used with other inhaled medicines.

2. Remove the green protective dust cap. If the cap is not on the mouthpiece, make sure there is nothing in the mouthpiece before use. For best results, the canister should be at room temperature before use.

3. Breathe out (exhale) deeply through your mouth. Hold the canister upright as shown in Figure 2, between your thumb and first 2 fingers. Put the mouthpiece in your mouth and close your lips. Keep your eyes closed so that no medicine will be sprayed into your eyes. Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol can cause blurry vision, narrow-angle glaucoma or worsening of this condition or eye pain if the medicine is sprayed into your eyes.

4. Breathe in (inhale) slowly through your mouth and at the same time firmly press once on the canister against the mouthpiece as shown in Figure 3. Keep breathing in deeply.

5. Hold your breath for ten seconds and then remove the mouthpiece from your mouth and breathe out slowly, as in Figure 4. Wait at least 15 seconds and repeat steps 3 to 5 again.

6. Replace the green protective dust cap after use.

7. Keep the mouthpiece clean. It is very important to keep the mouthpiece clean. At least once a week, wash the mouthpiece, shake it to remove excess water and let it air dry all the way (see the instructions below).

Mouthpiece Cleaning Instructions:

Step A. Remove and set aside the canister and dust cap from the mouthpiece (see Figure 1).

Step B. Wash the mouthpiece through the top and bottom with warm running water for at least 30 seconds (see Figure 5). Do not use anything other than water to wash the mouthpiece.

Step C. Dry the mouthpiece by shaking off the excess water and allow it to air-dry all the way.

Step D. When the mouthpiece is dry, replace the canister. Make sure the canister is fully and firmly inserted into the mouthpiece.

Step E. Replace the green protective dust cap.

If the mouthpiece becomes blocked, and little or no medicine comes out of the mouthpiece, wash the mouthpiece as described in Steps A to E under the “Mouthpiece Cleaning Instructions”.

8. Keep track of the number of sprays used. Discard the canister after 200 sprays. Even though the canister is not empty, you cannot be sure of the amount of medicine in each spray after 200 sprays.

This product does not contain any chlorofluorocarbon (CFC) propellants.

The contents of Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol are under pressure. Do not puncture the canister. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw the container into a fire or incinerator.

Keep ATROVENT HFA Inhalation Aerosol and all medicines out of the reach of children.

Avoid spraying into eyes.

Address medical inquiries to: http://us.boehringer-ingelheim.com, (800) 542-6257 or (800) 459-9906 TTY.

Store at 25°C (77°F);excursions permitted to 15 ° -30°C (59° -86°F). For best results, store the canister at room temperature before use.

Last updated on RxList: 12/5/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

IPRATROPIUM BREATH ACTIVATED INHALER - INHALATION

(IP-ra-TROE-pee-um)

COMMON BRAND NAME(S): Atrovent

USES: Ipratropium is used to treat lung diseases such as chronic bronchitis and emphysema. It relaxes the muscles around your airways so that they open up and you breathe more easily. This medication is a type of bronchodilator.

In general, use your quick-relief inhaler (e.g., albuterol) for acute attacks of shortness of breath unless otherwise directed by your doctor. Ipratropium does not work as fast as your quick-relief inhaler, but if so prescribed by your doctor you may use it to relieve an acute attack.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used in combination with other drugs to treat asthma in select patients.

HOW TO USE: Read the Patient Information Leaflet that comes with this product. Learn how to use this medication properly. Consult your doctor or pharmacist if you have any questions.

Shake the canister well before using. If using the ipratropium HFA inhaler, you do not need to shake the canister. It is recommended that you use a spacer device with this medication. Ask your doctor or pharmacist for more information.

You should do some test sprays before using a canister for the first time or if it hasn't been used for more than a day.

Inhale this medication by mouth usually 4 times a day, or as directed by your doctor. Close your eyes and place your lips tightly around the mouthpiece to avoid spraying any of this medication into your eyes. This will minimize the risk of temporary blurred vision, other vision changes, and eye irritation.

If two inhalations/puffs are prescribed, wait at least one minute between them. If you are using other inhalers at the same time, wait several minutes between each medication.

Rinse your mouth after using this inhaler to prevent dry mouth and throat irritation.

If you are directed to take this medication regularly, it works best if used consistently at evenly spaced intervals. Remember to use it at the same times each day. Do not increase your dose, use it more frequently, or stop using this medication without first consulting your doctor. Dosage is based on your medical condition and response to therapy.

Keep track of the number of inhalations you use, and throw away the canister after you have used the labeled number of inhalations on the package.

Be sure you understand which of your inhalers you should use on a regular daily basis and which you should use for acute attacks. Consult your doctor about what you should do in case of worsening shortness of breath or cough, increased sputum, or worsening peak flow meter readings (whether you can self-medicate and when you must seek immediate medical attention).

Inform your doctor if your symptoms do not improve or worsen.

SIDE EFFECTS: See also How to Use.

Dry mouth, dry throat, a bad taste in your mouth, or cough may occur as your body adjusts to this drug. Nervousness, dizziness, headache, nausea, constipation, or stomach upset may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/pounding/irregular heartbeat, vision changes, eye pain, increased wheezing/trouble breathing, trouble urinating.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using ipratropium, tell your doctor or pharmacist if you are allergic to it; or to peanuts, soybean, soya lecithin, atropine, other belladonna-type drugs; or if you have any other allergies. (For patients using the ipratropium HFA inhaler, the peanut/soybean/soya lecithin allergy warning does not apply.)

Before using this medication, tell your doctor or pharmacist your medical history, especially of: narrow angle glaucoma, trouble urinating, enlarged prostate.

Although unlikely, this medication may cause dizziness. It may also cause temporary blurred vision or other vision changes if accidentally sprayed into your eyes. If these effects occur, use caution engaging in activities requiring alertness and clear vision such as driving or using machinery. Limit alcoholic beverages.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: certain antihistamines (e.g., diphenhydramine, meclizine), anti-spasmodic drugs (e.g., dicyclomine, hyoscyamine), drugs used to treat Parkinson's disease (e.g., benztropine, trihexyphenidyl), muscle relaxants (e.g., cyclobenzaprine), certain psychiatric medicines (phenothiazines such as chlorpromazine), pramlintide, tricyclic antidepressants (e.g., amitriptyline, imipramine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. Use the remaining doses for the day at evenly spaced intervals. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Do not puncture or expose this medication to high heat or open flame. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.