COMBIVENT RESPIMAT is a combination of ipratropium bromide (an anticholinergic agent) and albuterol sulfate (a beta2-adrenergic agonist) indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

The recommended dose of COMBIVENT RESPIMAT is one inhalation four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed six in 24 hours.

Prior to first use, the COMBIVENT RESPIMAT cartridge is inserted into the COMBIVENT RESPIMAT inhaler and the unit is primed. When using the unit for the first time, patients are to actuate the inhaler toward the ground until an aerosol cloud is visible and then repeat the process three more times. The unit is then considered primed and ready for use. If not used for more than 3 days, patients are to actuate the inhaler once to prepare the inhaler for use. If not used for more than 21 days, patients are to actuate the inhaler until an aerosol cloud is visible and then repeat the process three more times to prepare the inhaler for use [see Patient Counseling Information (17)].

Safety and efficacy of additional doses of COMBIVENT RESPIMAT beyond six inhalations/24 hours have not been studied. Also, safety and efficacy of extra doses of ipratropium or albuterol in addition to the recommended doses of COMBIVENT RESPIMAT have not been studied.

COMBIVENT RESPIMAT consists of a COMBIVENT RESPIMAT inhaler and an aluminum cylinder (COMBIVENT RESPIMAT cartridge) containing a combination of ipratropium bromide (as the monohydrate) and albuterol sulfate. The COMBIVENT RESPIMAT cartridge is only intended for use with the COMBIVENT RESPIMAT inhaler.

Each actuation from the COMBIVENT RESPIMAT inhaler delivers 20 mcg ipratropium bromide (monohydrate) and 100 mcg albuterol (equivalent to 120 mcg albuterol sulfate) from the mouthpiece.

COMBIVENT RESPIMAT is contraindicated in the following conditions [see Warnings and Precautions (5.6)]:

• Hypersensitivity to any of the ingredients in COMBIVENT RESPIMAT
• Hypersensitivity to atropine or any of its derivatives

Use of albuterol, a beta2-adrenergic agonist, may be associated with the following:

• Paradoxical bronchospasm [see Warnings and Precautions (5.1)]
• Cardiovascular effects [see Warnings and Precautions (5.2)]
• Hypersensitivity reactions including anaphylaxis [see Contraindications (4) and Warnings and Precautions (5.6)]
• Hypokalemia [see Warnings and Precautions (5.8)]

Albuterol is a component of COMBIVENT RESPIMAT.

Use of ipratropium bromide, an anticholinergic, may result in the following:

• Ocular effects [see Warnings and Precautions (5.3)]
• Urinary retention [see Warnings and Precautions (5.4)]

Ipratropium bromide is a component of COMBIVENT RESPIMAT.

COMBIVENT RESPIMAT has been used concomitantly with other drugs, including beta-adrenergic bronchodilators, methylxanthines, and oral and inhaled steroids, commonly used in the treatment of chronic obstructive pulmonary disease. There are no formal studies fully evaluating the interaction effects of COMBIVENT RESPIMAT and these drugs with respect to safety and effectiveness.

The effects of overdosage are expected to be related primarily to albuterol sulfate. Acute overdosage with ipratropium bromide by inhalation is unlikely since ipratropium bromide is not well absorbed systemically after inhalation or oral administration. Manifestations of overdosage with albuterol may include anginal pain, hypertension, hypokalemia, tachycardia with rates up to 200 beats per minute, metabolic acidosis, and exaggeration of the pharmacologic effects listed in the Adverse Reactions section [see Adverse Reactions (6)]. As with all beta2-adrenergic agonist aerosol medications, cardiac arrest and even death may be associated with abuse.

Treatment of overdosage consists of discontinuation of COMBIVENT RESPIMAT together with institution of appropriate medical and supportive therapy. Dialysis is not appropriate treatment for overdosage of albuterol as an inhalation aerosol; the judicious use of a cardiovascular beta‑receptor blocker, such as metoprolol tartrate, may be indicated.

COMBIVENT RESPIMAT is a combination of ipratropium bromide (as the monohydrate) and albuterol sulfate.

Ipratropium bromide 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. 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.

The structural formula is:

C20H30BrNO3•H2O    ipratropium bromide    Mol. Wt. 430.4

Albuterol sulfate, chemically known as (1,3-benzenedimethanol, α'-[[(1,1dimethylethyl) amino] methyl]-4-hydroxy, sulfate (2:1)(salt), (±)- is a relatively selective beta2-adrenergic bronchodilator. Albuterol is the official generic name in the United States. The World Health Organization recommended name for the drug is salbutamol. Albuterol sulfate is a white to off-white crystalline powder, freely soluble in water and slightly soluble in alcohol, chloroform, and ether.

The structural formula is:

(C13H21NO3)2•H2SO4    albuterol sulfate    Mol. Wt. 576.7

The drug product, COMBIVENT RESPIMAT, is composed of a sterile, aqueous solution of ipratropium bromide and albuterol sulfate filled into a 4.5 mL plastic container crimped into an aluminum cylinder (COMBIVENT RESPIMAT cartridge) for use with the COMBIVENT RESPIMAT inhaler. Excipients include water for injection, benzalkonium chloride, edetate disodium, and hydrochloric acid. The COMBIVENT RESPIMAT cartridge is only intended for use with the COMBIVENT RESPIMAT inhaler. The COMBIVENT RESPIMAT inhaler is a hand held, pocket sized oral inhalation device that uses mechanical energy to generate a slow moving aerosol cloud of medication from a metered volume of the drug solution. The COMBIVENT RESPIMAT inhaler has an orange-colored cap.

When used with the COMBIVENT RESPIMAT inhaler, each cartridge containing 4 grams of a sterile aqueous solution delivers the labeled number of metered actuations after preparation for use. Each actuation from the COMBIVENT RESPIMAT inhaler delivers 20 mcg ipratropium bromide (monohydrate) and 100 mcg albuterol (equivalent to 120 mcg albuterol sulfate) in 11.4 mcL of solution from the mouthpiece. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds).

Prior to first use, the COMBIVENT RESPIMAT cartridge is inserted into the COMBIVENT RESPIMAT inhaler and the unit is primed. When using the unit for the first time, patients are to actuate the inhaler toward the ground until an aerosol cloud is visible and then repeat the process three more times. The unit is then considered primed and ready for use. If not used for more than 3 days, patients are to actuate the inhaler once to prepare the inhaler for use. If not used for more than 21 days, patients are to actuate the inhaler until an aerosol cloud is visible and then repeat the process three more times to prepare the inhaler for use [see Patient Counseling Information (17)].

The efficacy of COMBIVENT RESPIMAT (20/100 mcg) was evaluated in COPD patients in one randomized, double-blind, double-dummy parallel group trial. This was a 12-week trial in a total of 1460 adult patients (955 males and 505 females) conducted to demonstrate the efficacy and safety of COMBIVENT RESPIMAT (20/100 mcg) in COPD. All patients were required to have a clinical diagnosis of COPD, be at least 40 years of age or older, to have an FEV1 of less than or equal to 65% predicted and an FEV1/FVC ratio of less than or equal to 0.7 at screening, and a smoking history of greater than 10 pack-years prior to entering the trial. Patients with narrow-angle glaucoma, symptomatic prostatic hypertrophy, or bladder neck obstruction were excluded from the trial. The majority of the patients (89%) were Caucasian, had a mean age of 64 years, a mean percent predicted pre-bronchodilator FEV1 of 41% and FEV1/FVC ratio of 0.45. The patients were randomized to one of the following active treatments COMBIVENT RESPIMAT (20/100 mcg) (n=486), CFC-propelled COMBIVENT Inhalation Aerosol (36/206 mcg) (n=491), and ipratropium bromide delivered by the RESPIMAT (20 mcg) (n=483) administered four times a day. Data from 1424 patients were used in the efficacy analyses.

There were three primary efficacy variables: (i) Mean FEV1 over 0 to 6 hours post-dose defined as the AUC of the change from test-day baseline in FEV1 over 0 to 6 hours post-dose divided by 6 hours (FEV1 AUC0-6h); (ii) Mean FEV1 over 0 to 4 hours post-dose defined as the AUC of the change from test-day baseline in FEV1 over 0 to 4 hours post-dose divided by 4 hours (FEV1 AUC0-4h), and (iii) Mean FEV1 over 4 to 6 hours post-dose defined as the AUC of the change from test-day baseline in FEV1 over 4 to 6 hours post-dose divided by 2 hours (FEV1 AUC4-6h). Test-day baseline was the FEV1 recorded prior to inhaling the dose of randomized treatment on test day.

The three primary efficacy comparisons were: (i) Non-inferiority of COMBIVENT RESPIMAT (20/100 mcg) to CFC-propelled COMBIVENT Inhalation Aerosol (36/206 mcg) for the FEV1 AUC0-6h on Test Day 85; (ii) Superiority of COMBIVENT RESPIMAT (20/100 mcg) to ipratropium RESPIMAT (20 mcg) for the FEV1 AUC0-4h on Test Day 85, to demonstrate the contribution of albuterol in the combination product, and (iii) Non-inferiority of COMBIVENT RESPIMAT (20/100 mcg) in comparison to ipratropium RESPIMAT (20 mcg) for FEV1 AUC4-6h on Test Day 85, to demonstrate the contribution of ipratropium in the combination product. Non-inferiority was declared if the lower bound of the 95% confidence interval for the point estimate for the difference of COMBIVENT RESPIMAT minus the comparator was more than -50 mL.

COMBIVENT RESPIMAT (20/100 mcg) was shown to be non-inferior to CFC-propelled COMBIVENT Inhalation Aerosol (36/206 mcg) in terms of mean FEV1 AUC0-6h. The LS mean (mL) (95% CI) of the treatment difference was -3 (-22, 15). The FEV1 AUC0-4h for COMBIVENT RESPIMAT (20/100 mcg), was superior to that of ipratropium bromide [LS mean (mL) (95% CI) of the treatment difference was 47 mL (28, 66)] and the mean FEV1 AUC4-6h for COMBIVENT RESPIMAT (20/100 mcg) was non-inferior to that of ipratropium bromide [LS mean (mL) (95% CI) of the treatment difference was -17 (-39, 5)]. The FEV1 results on Test Days 1, 29, 57, and 85 are shown in Figure 1.

In this trial, COMBIVENT RESPIMAT (20/100 mcg) was shown to be clinically comparable (statistically non-inferior) to CFC-propelled COMBIVENT Inhalation Aerosol (36/206 mcg).

Additionally, in this trial, no differences in these efficacy comparisons were identified in males and females or in patients over 65 years of age versus those under 65 years of age. There were too few African-American subjects to adequately assess differences in effects in that population.

The median time to onset of bronchodilation, defined as an FEV1 increase of 15% or greater from test-day baseline, for the COMBIVENT RESPIMAT (20/100 mcg) group occurred at 13 minutes post-dose on Day 1.

The means are adjusted for treatment baseline and investigator site. A separate ANCOVA was fitted for each time point.
The imputation method for data missing because the patient withdrew from the trial was Last Visit Carried Forward.
The imputation method for data missing at the end of test days depends on why the data were missing.

A second study was conducted in 1118 COPD patients using a higher than approved dose of COMBIVENT RESPIMAT. Patients were randomized to COMBIVENT RESPIMAT (40/200 mcg) (n=345), CFC-propelled COMBIVENT Inhalation Aerosol (36/206 mcg) (n=180), ipratropium delivered by the RESPIMAT (40 mcg) (n=252) or placebo (n= 341). The study was supportive, particularly for safety [see Adverse Reactions (6.1)].

COMBIVENT RESPIMAT Inhalation Spray is supplied in a carton containing one COMBIVENT RESPIMAT cartridge and one COMBIVENT RESPIMAT inhaler.

The COMBIVENT RESPIMAT cartridge is provided as an aluminum cylinder with a tamper protection seal on the cap. The COMBIVENT RESPIMAT cartridge is only intended for use with the COMBIVENT RESPIMAT inhaler.

The COMBIVENT RESPIMAT inhaler is a cylindrical shaped plastic inhalation device with a gray colored body and a clear base. The clear base is removed to insert the cartridge. The inhaler contains a dose indicator. The orange-colored cap and the written information on the label of the gray inhaler body indicate that it is labeled for use with the COMBIVENT RESPIMAT cartridge.

COMBIVENT RESPIMAT Inhalation Spray is available as:
COMBIVENT RESPIMAT Inhalation Spray: 120 metered actuations (NDC 0597-0024-02))

The COMBIVENT RESPIMAT cartridge has a net fill weight of 4 grams and when used with the COMBIVENT RESPIMAT inhaler, is designed to deliver the labeled number of  metered actuations after preparation for use. Each actuation from the COMBIVENT RESPIMAT inhaler delivers 20 mcg ipratropium bromide (monohydrate) and 100 mcg albuterol (equivalent to 120 mcg albuterol sulfate) from the mouthpiece.

When the labeled number of metered actuations has been dispensed from the inhaler, the RESPIMAT locking mechanism will be engaged and no more actuations can be dispensed.

After assembly, the COMBIVENT RESPIMAT inhaler should be discarded at the latest 3 months after first use or when the locking mechanism is engaged, whichever comes first.

Keep out of reach of children. Do not spray into eyes.

Advise the patient to read the FDA-approved patient labeling (Instructions for Use).

Paradoxical Bronchospasm

Inform patients that COMBIVENT RESPIMAT can produce paradoxical bronchospasm that can be life-threatening. If paradoxical bronchospasm occurs, patients should discontinue using COMBIVENT RESPIMAT.

Ocular Effects

Caution patients to avoid spraying the aerosol into their eyes and advise 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.

Since dizziness, accommodation disorder, mydriasis, and blurred vision may occur with use of COMBIVENT RESPIMAT, patients should be cautioned about engaging in activities requiring balance and visual acuity such as driving a car or operating appliances or machinery.

Urinary Retention

Inform patients that COMBIVENT RESPIMAT may cause urinary retention and advise them to consult their physician if they experience difficulty with urination.

Adverse Effects Associated with Beta2-agonists

Inform patients of adverse effects associated with beta2-agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness [see Warnings and Precautions (5.2, 5.5)].

Frequency of Use

The action of COMBIVENT RESPIMAT should last 4 to 5 hours or longer. COMBIVENT RESPIMAT should not be used more frequently than recommended. Safety and efficacy of additional doses of COMBIVENT RESPIMAT beyond six inhalations in 24 hours have not been studied. Patients should be told not to increase the dose or frequency of COMBIVENT RESPIMAT without consulting a physician. Patients should be instructed that if they find that treatment with COMBIVENT RESPIMAT becomes less effective for symptomatic relief, their symptoms become worse, and/or they need to use the product more frequently than usual, medical attention should be sought immediately [see Warnings and Precautions (5.5)].

Hypersensitivity Reactions

Inform patients that hypersensitivity reactions, including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema, may occur after the administration of COMBIVENT RESPIMAT. Advise patients to immediately discontinue COMBIVENT RESPIMAT and consult a physician [see Warnings and Precautions (5.6)].

Concomitant Drug Use

Remind patients that while taking COMBIVENT RESPIMAT, other inhaled drugs should be taken only as directed by a physician [see Drug Interactions (7.1)].

Pregnancy

Patients who are pregnant or nursing should contact their physician about the use of COMBIVENT RESPIMAT [see Use in Specific Populations (8.1, 8.2)].

Preparation for Use and Priming

Instruct patients that priming COMBIVENT RESPIMAT is essential to ensure appropriate content of the medication in each actuation.

When using the unit for the first time, the COMBIVENT RESPIMAT cartridge is inserted into the COMBIVENT RESPIMAT inhaler and the unit is primed. COMBIVENT RESPIMAT patients are to actuate the inhaler toward the ground until an aerosol cloud is visible and then repeat the process three more times. The unit is then considered primed and ready for use. If not used for more than 3 days, patients are to actuate the inhaler once to prepare the inhaler for use. If not used for more than 21 days, patients are to actuate the inhaler until an aerosol cloud is visible and then repeat the process three more times to prepare the inhaler for use.

Distributed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA

Licensed from:
Boehringer Ingelheim International GmbH

RESPIMAT® is a registered trademark of and used under license from Boehringer Ingelheim International GmbH

COMBIVENT® is a registered trademark of and used under license from Boehringer Ingelheim Pharmaceuticals, Inc.

Copyright © 2021 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED

COL10574AL132021
SPL10595A

Instructions for Use
COMBIVENT® RESPIMAT® (COM beh vent - RES peh mat)
(ipratropium bromide and albuterol inhalation spray)

For Oral Inhalation Only
Do not spray COMBIVENT RESPIMAT into your eyes.

Read these Instructions for Use before you start using COMBIVENT RESPIMAT and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or your treatment.

Use COMBIVENT RESPIMAT exactly as prescribed by your doctor. Do not change your dose or how often you use COMBIVENT RESPIMAT without talking with your doctor.

Tell your doctor about all of the medicines you take. COMBIVENT RESPIMAT may affect the way some medicines work and some other medicines may affect the way COMBIVENT RESPIMAT works. Do not use other inhaled medicines with COMBIVENT RESPIMAT without talking to your doctor.

The COMBIVENT RESPIMAT inhaler has a slow moving mist that helps you inhale the medicine.

Do not turn the clear base before inserting the cartridge.

How to store your COMBIVENT RESPIMAT inhaler

• Store COMBIVENT RESPIMAT at room temperature 68°F to 77°F (20°C to 25°C).
• Do not freeze your COMBIVENT RESPIMAT cartridge and inhaler.
• If COMBIVENT RESPIMAT has not been used for more than 3 days, release 1 puff towards the ground.
• If COMBIVENT RESPIMAT has not been used for more than 21 days, repeat steps 4 to 6 under the “Prepare for first use” until a mist is visible. Then repeat steps 4 to 6 three more times.
• Keep your COMBIVENT RESPIMAT cartridge and inhaler out of the reach of children.

How to care for your COMBIVENT RESPIMAT inhaler

Clean the mouthpiece, including the metal part inside the mouthpiece, with a damp cloth or tissue only, at least once a week. Any minor discoloration in the mouthpiece does not affect your COMBIVENT RESPIMAT inhaler.

When to get a new COMBIVENT RESPIMAT inhaler

• Your inhaler contains 120 puffs (120 doses); or if you have a sample, your inhaler contains 60 puffs (60 doses) instead.

• The dose indicator shows approximately how much medicine is left.
• When the dose indicator enters the red area of the scale you need to get a refill; there is approximately medicine for 7 days left (if you have a sample, there is approximately medicine for 3 days left).
• When the dose indicator reaches the end of the red scale, your COMBIVENT RESPIMAT is empty and automatically locks. At this point, the clear base cannot be turned any further.
• Three months after insertion of cartridge, throw away the COMBIVENT RESPIMAT even if it has not been used, or when the inhaler is locked, or when it expires, whichever comes first.

Prepare for first use

1. Remove clear base Keep the cap closed. Press the safety catch while firmly pulling off the clear base with your other hand. Be careful not to touch the piercing element. Write the discard by date on the label (3 months from the date the cartridge is inserted).
2. Insert cartridge Insert the narrow end of the cartridge into the inhaler. Place the inhaler on a firm surface and push down firmly until it clicks into place.
3. Replace clear base Put the clear base back into place until it clicks. Do not remove the clear base or the cartridge after it has been put together.
4. Turn Keep the cap closed. Turn the clear base in the direction of the arrows on the label until it clicks (half a turn).
5. Open Open the cap until it snaps fully open.
6. Press Point the inhaler toward the ground. Press the dose-release button. Close the cap. If you do not see a mist, repeat steps 4 to 6 until a mist is seen. After a mist is seen, repeat steps 4 to 6 three more times. After complete preparation of your inhaler, it will be ready to deliver the number of puffs on the label.

Daily use (T O P)

Turn Keep the cap closed. Turn the clear base in the direction of the arrows on the label until it clicks (half a turn).
Open Open the cap until it snaps fully open.
Press Breathe out slowly and fully. Close your lips around the mouthpiece without covering the air vents. Point the inhaler to the back of your throat. While taking a slow, deep breath through your mouth, Press the dose-release button and continue to breathe in. Hold your breath for 10 seconds or for as long as comfortable. Close the cap until you use your inhaler again.

Answers to Common Questions

It is difficult to insert the cartridge deep enough:

Did you accidentally turn the clear base before inserting the cartridge? Open the cap, press the dose-release button, then insert the cartridge.

Did you insert the cartridge with the wide end first? Insert the cartridge with the narrow end first.

I cannot press the dose-release button:

Did you turn the clear base? If not, turn the clear base in a continuous movement until it clicks (half a turn).

Is the dose indicator on the COMBIVENT RESPIMAT pointing to zero? The COMBIVENT RESPIMAT inhaler is locked after 120 puffs (120 doses). If you have a sample, the COMBIVENT RESPIMAT inhaler is locked after 60 puffs (60 doses). Prepare and use your new COMBIVENT RESPIMAT inhaler.

I cannot turn the clear base:

Did you turn the clear base already? If the clear base has already been turned, follow steps “Open” and “Press” under “Daily use” to get your medicine.

Is the dose indicator on the COMBIVENT RESPIMAT pointing to zero? The COMBIVENT RESPIMAT inhaler is locked after 120 puffs (120 doses). If you have a sample, the COMBIVENT RESPIMAT inhaler is locked after 60 puffs (60 doses). Prepare and use your new COMBIVENT RESPIMAT inhaler.

The dose indicator on the COMBIVENT RESPIMAT reaches zero too soon:

Did you use COMBIVENT RESPIMAT as indicated (1 puff four times daily)? COMBIVENT RESPIMAT will deliver 120 puffs and last 30 days if used at 1 puff four times daily. If you have a sample, COMBIVENT RESPIMAT will deliver 60 puffs and last 15 days if used at 1 puff four times daily.

Did you turn the clear base before you inserted the cartridge? The dose indicator counts each turn of the clear base regardless whether a cartridge has been inserted or not.

Did you spray in the air often to check whether the COMBIVENT RESPIMAT is working? Once you have prepared COMBIVENT RESPIMAT, no test-spraying is required if used daily.

Did you insert the cartridge into a used COMBIVENT RESPIMAT? Always insert a new cartridge into a NEW COMBIVENT RESPIMAT.

My COMBIVENT RESPIMAT sprays automatically:

Was the cap open when you turned the clear base? Close the cap, then turn the clear base.

Did you press the dose-release button when turning the clear base? Close the cap, so the dose-release button is covered, then turn the clear base.

Did you stop when turning the clear base before it clicked? Turn the clear base in a continuous movement until it clicks (half a turn).

My COMBIVENT RESPIMAT doesn’t spray:

Did you insert a cartridge? If not, insert a cartridge.

Did you repeat Turn, Open, Press (TOP) less than three times after inserting the cartridge? Repeat Turn, Open, Press (TOP) three times after inserting the cartridge as shown in steps 4 to 6 under “Prepare for first use”.

Is the dose indicator on the COMBIVENT RESPIMAT pointing to 0 (zero)? You have used up all your medicine and the inhaler is locked.

For more information about COMBIVENT RESPIMAT including current prescribing information or a video demonstration on how to use COMBIVENT RESPIMAT, go to www.combivent.com, scan the code, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

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

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA

Licensed from: Boehringer Ingelheim International GmbH

RESPIMAT® is a registered trademark of and used under license from Boehringer Ingelheim International GmbH

COMBIVENT® is a registered trademark of and used under license from Boehringer Ingelheim Pharmaceuticals, Inc.

Copyright © 2021 Boehringer Ingelheim International GmbH

ALL RIGHTS RESERVED

Revised: December 2021

COL10574AL132021

NDC 0597-0024-02

Combivent® Respimat®
(ipratropium bromide and albuterol
inhalation spray)

20 mcg/100 mcg per actuation*

FOR ORAL INHALATION ONLY

Rx only

4 Grams
120 Metered Doses

Boehringer
Ingelheim