Pronunciation:

ip-ra-TROE-pee-um BROE-mide, al-BUE-ter-ol SUL-fate

Brand Names:

• Combivent
• Combivent Respimat
• Duoneb
• Ratio-Ipra Sal Udv

Dosage Forms:

• Solution
• Spray

Classifications:

Therapeutic—

Bronchodilator

Pharmacologic—

Ipratropium

Uses of This Medicine:

Ipratropium and albuterol combination is used to help control the symptoms of lung diseases, such as asthma, chronic bronchitis, and emphysema. It is also used to treat air flow blockage and prevent the worsening of chronic obstructive pulmonary disease (COPD) in patients who need another medicine.

Ipratropium and albuterol belong to the family of medicines known as bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ipratropium and albuterol combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Combivent® Respimat® spray in the elderly.

No information is available on the relationship of age to the effects of Combivent® in geriatric patients.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Potassium Citrate

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Amantadine
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Atenolol
• Atomoxetine
• Bemetizide
• Bendroflumethiazide
• Benzthiazide
• Betaxolol
• Bisoprolol
• Bumetanide
• Buprenorphine
• Carteolol
• Carvedilol
• Celiprolol
• Chlorothiazide
• Chlorthalidone
• Clomipramine
• Clopamide
• Clozapine
• Codeine
• Cyclopenthiazide
• Cyclothiazide
• Desipramine
• Diazoxide
• Dibenzepin
• Digoxin
• Doxepin
• Esmolol
• Ethacrynic Acid
• Etozolin
• Furosemide
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Hydrochlorothiazide
• Hydroflumethiazide
• Imipramine
• Indapamide
• Iobenguane I 123
• Isocarboxazid
• Labetalol
• Levalbuterol
• Levobunolol
• Linezolid
• Lofepramine
• Melitracen
• Methacholine
• Methyclothiazide
• Methylene Blue
• Metipranolol
• Metolazone
• Metoprolol
• Nadolol
• Nebivolol
• Nortriptyline
• Opipramol
• Oxprenolol
• Oxycodone
• Ozanimod
• Penbutolol
• Phenelzine
• Pindolol
• Piretanide
• Polythiazide
• Procarbazine
• Propranolol
• Protriptyline
• Quetiapine
• Quinethazone
• Rasagiline
• Revefenacin
• Safinamide
• Scopolamine
• Secretin Human
• Selegiline
• Sotalol
• Tapentadol
• Tianeptine
• Timolol
• Tiotropium
• Torsemide
• Tranylcypromine
• Trichlormethiazide
• Trimipramine
• Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Betel Nut

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to soya lecithin, soybean, or peanuts, history of—Combivent® brand should not be used in patients with this condition.

• Blood circulation problems or
• Heart or blood vessel disease or
• Heart rhythm problems (eg, arrhythmia) or
• Hypertension (high blood pressure)—Use with caution. May increase risk for serious side effects.

• Diabetes or
• Difficult urination or
• Enlarged prostate or
• Hyperthyroidism (an overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Narrow-angle glaucoma or
• Seizures or
• Urinary bladder blockage—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

This medicine usually comes with patient directions or instructions. Read them carefully before using the medicine. If you do not understand the directions or you are not sure how to use the inhaler or nebulizer, ask your doctor to show you how to use it.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may cause your lung condition to become worse.

When you use the inhalation solution, make sure you use a jet nebulizer that is connected to an air compressor with a good air flow. Use a face mask or mouthpiece to inhale the medicine.

Keep the spray away from your eyes. This medicine may cause eye pain or discomfort, irritation, blurred vision, or start seeing halos or odd colors when you look at things. If it does come into contact with your eyes, check with your doctor right away.

To use the Combivent® inhaler:

• Insert the metal canister firmly and fully into the clear end of the Combivent® Inhalation Aerosol mouthpiece. This mouthpiece should not be used with other inhaled medicines.
• Remove the cap and look at the mouthpiece to make sure it is clean.
• Shake the inhaler for at least 10 seconds and test spray it in the air 3 times before using it for the first time or if the inhaler has not been used for 24 hours.
• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.
• Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down once on the top of the canister.
• Hold your breath for about 10 seconds, then breathe out slowly.
• If you are supposed to use more than one puff, wait 1 to 2 minutes before inhaling the second puff. Repeat these steps for the second puff, starting with shaking the inhaler.
• When you have finished all of your doses, rinse your mouth with water.
• Clean the inhaler mouthpiece every day with hot water. Dry it thoroughly before use.

To use the Combivent® Respimat® spray:

• Insert the cartridge into the Combivent® Respimat® inhaler.
• Before using the inhaler, prime it by spraying the medicine towards the ground (away from your face), until an aerosol cloud is visible. Repeat 3 more times. The inhaler is now ready for use.
• If the inhaler is not used for more than 3 days, prime the inhaler once to prepare it for use. If it not used for more than 21 days, prime the inhaler 3 times.
• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible.
• Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down once the release button of the inhaler.
• Hold your breath for about 10 seconds, then breathe out slowly.
• After using the inhaler, clean the mouthpiece with a damp cloth or tissue at least once a week.
• This inhaler has a dose indicator window that shows how much medicine is left. When the pointer enters the red area of the scale, it is time that you need to refill your prescription.
• Throw away the inhaler 3 months from its first use or when the inhaler is locked (after 60 or 120 puffs).

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For symptoms of chronic obstructive pulmonary disease (COPD):
  • For inhalation aerosol dosage form (used with an inhaler):
    • Adults—2 puffs four times a day and as needed. Do not use more than 12 puffs in any 24-hour period.
    • Children—Use and dose must be determined by your doctor.
  • For inhalation solution dosage form (used with a nebulizer):
    • Adults—Use one 3 milliliter (mL) vial in the nebulizer four times a day. You may use 2 additional treatments per day if needed.
    • Children—Use and dose must be determined by your doctor.
  • For inhalation spray dosage form (used with an inhaler):
    • Adults—One puff four times a day. You may take additional doses per day if needed. Do not use more than 6 puffs in any 24-hour period.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

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

Storage—

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

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to help reduce any unwanted effects.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using this medicine and check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

Check with your doctor at once if difficulty with breathing continues after using a dose of this medicine or if your condition gets worse.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Tell your doctor right away if you feel chest pain, notice any changes in your blood pressure (such as feeling lightheaded or changes in vision), or notice your heart beating faster or slower.

Take all of your COPD medicines as your doctor ordered. If you use any type of corticosteroid medicine to control your breathing, keep using it as ordered by your doctor. This includes corticosteroid medicines that are taken by mouth or inhaled (such as prednisone, Azmacort®, or Flovent®). If any of your COPD medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.

This medicine may cause dizziness, blurred vision, or trouble in seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to see well.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

chills

cough

cough producing mucus

difficulty with breathing

ear congestion

fever

headache

loss of voice

runny nose

sneezing

sore throat

stuffy nose

tightness in the chest

unusual tiredness or weakness

Less common

Bladder pain

bloody or cloudy urine

blurred vision

burning while urinating burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain

congestion

diarrhea

difficult, burning, or painful urination

dizziness

fainting

fast, slow, irregular, pounding, or racing heartbeat or pulse

frequent urge to urinate

general feeling of discomfort or illness

hoarseness

increased sputum

joint pain

loss of appetite

lower back or side pain

muscle aches and pains

nausea

nervousness

noisy breathing

pain

pain or tenderness around the eyes and cheekbones

pounding in the ears

shakiness in the legs, arms, hands, or feet

shivering

sweating

swelling

tender, swollen glands in the neck

trembling or shaking of the hands or feet

trouble sleeping

trouble swallowing

voice changes

vomiting

Rare

Skin rash or hives

swelling of the face, lips, eyelids, mouth, or throat

Incidence not known

Chest discomfort

decrease in the frequency of urination

decrease in urine volume

difficulty in passing urine (dribbling)

itching skin

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

pain or discomfort in the arms, jaw, back, or neck

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

welts

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Acid or sour stomach

bad, unusual, or unpleasant (after) taste

belching

change in taste

diarrhea

difficulty with moving

dry mouth

heartburn

indigestion

muscle pain or stiffness

stomach discomfort, upset, or pain

voice changes

Incidence not known

Bigger, dilated, or enlarged pupils (black part of the eye)

blindness

change in near or distance vision

decreased vision

difficulty in focusing eyes

dry throat

eye pain

increased sensitivity of the eyes to light

itching, redness, tearing, or other sign of eye irritation not present before use of this medicine or becoming worse during use

lack or loss of strength

noisy breathing

redness of the white part of the eyes or inside of the eyelids

swelling of the eye

swelling or inflammation of the mouth

tearing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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