Ipratrovent Sterules

In the U.S.

• Atrovent

In Canada

• Alti-Ipratropium
• Alti-Ipratropium With Preservative
• Apo-Ipravent
• Ipratropium Bromide Nebuamp
• Ipratrovent Sterules
• Ratio-Ipratropium
• Ratio-Ipratropium Udv

Available Dosage Forms:

• Solution
• Aerosol Powder
• Aerosol Liquid

Therapeutic Class: Respiratory Agent

Pharmacologic Class: Ipratropium

Ipratropium 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).

Ipratropium belongs 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.

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.

Pediatric

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

Geriatric

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

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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 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.

• Tiotropium

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

Interactions with Food/Tobacco/Alcohol

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 atropine, scopolamine, or hyoscyamine—Should not be used in patients with this condition.

• Difficult urination or
• Enlarged prostate or
• Narrow-angle glaucoma or
• Urinary bladder blockage—Use with caution. May make these conditions worse.

This section provides information on the proper use of a number of products that contain ipratropium. It may not be specific to Ipratrovent Sterules. Please read with care.

This medicine usually comes with patient 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, 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.

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

If you are taking this medicine every day to help control your symptoms, it must be taken at regularly spaced times as ordered by your doctor.

For patients using ipratropium inhalation aerosol:

• If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you how to use it. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.
• There are two formulas of the inhaled aerosol. One contains chlorofluorocarbons and the other contains HFA as the propellant. The taste and inhalation of these may seem different, but the safety and effectiveness of both formulas are similar.
• The ipratropium aerosol canister provides about 200 inhalations, depending on the size of the canister your doctor ordered. You should try to keep a record of the number of inhalations you use so you will know when the canister is almost empty. This canister, unlike some other aerosol canisters, cannot be floated in water to test its fullness.
• When you use the inhaler for the first time, or if you have not used it for a while, the inhaler may not give the right amount of medicine with the first puff. Therefore, before using the inhaler, test or prime it.
• To test or prime the inhaler:
  • Insert the canister firmly into the clean mouthpiece according to the manufacturer's instructions. Check to make sure it is placed properly into the mouthpiece.
  • Take the cap off the mouthpiece and shake the inhaler three or four times.
  • Hold the inhaler away from you at arm's length and press the top of the canister, spraying the medicine two times into the air. The inhaler will now be ready to give the right amount of medicine when you use it.
  • If the inhaler is not used for more than 3 days, prime the inhaler two times to prepare it for use.
• To use the inhaler:
  • Using your thumb and one or two fingers, hold the inhaler upright, with the mouthpiece end down and pointing toward you.
  • Take the cap off the mouthpiece. Check the mouthpiece to make sure it is clear. Then, gently shake the inhaler three or four times.
  • Breathe out slowly to the end of a normal breath.
  • Use the inhalation method recommended by your doctor:
    • Open-mouth method—Place the mouthpiece about 1 or 2 inches (2 finger-widths) in front of your widely opened mouth. Make sure the inhaler is aimed into your mouth so the spray does not hit the roof of your mouth or your tongue.
    • Closed-mouth method—Place the mouthpiece in your mouth between your teeth and over your tongue with your lips closed tightly around it. Make sure your tongue or teeth are not blocking the opening.
  • Start to breathe in slowly and deeply through your mouth. At the same time, press the top of the canister once to get one puff of medicine. Continue to breathe in slowly for 5 to 10 seconds. Count the seconds while breathing in. It is important to press the canister and breathe in slowly at the same time so the medicine gets into your lungs. This step may be difficult at first. If you are using the closed-mouth method and you see a fine mist coming from your mouth or nose, the inhaler is not being used correctly.
  • Hold your breath as long as you can up to 10 seconds. This gives the medicine time to settle into your airways and lungs.
  • Take the mouthpiece away from your mouth and breathe out slowly.
  • If your doctor has told you to inhale more than one puff of medicine at each dose, gently shake the inhaler again, and take the second puff following exactly the same steps you used for the first puff. Press the canister one time for each puff of medicine.
  • When you are finished, wipe off the mouthpiece and replace the cap.
• Your doctor may want you to use a spacer device or holding chamber with the inhaler. A spacer helps get the medicine into the lungs and reduces the amount of medicine that stays in your mouth and throat.
  • To use a spacer device with the inhaler:
    • Attach the spacer to the inhaler according to the manufacturer's directions. There are different types of spacers available, but the method of breathing remains the same with most spacers.
    • Gently shake the inhaler and spacer three or four times.
    • Hold the mouthpiece of the spacer away from your mouth and breathe out slowly to the end of a normal breath.
    • Place the mouthpiece into your mouth between your teeth and over your tongue with your lips closed around it.
    • Press the top of the canister once to release one puff of medicine into the spacer. Within 1 or 2 seconds, start to breathe in slowly and deeply through your mouth for 5 to 10 seconds. Count the seconds while inhaling. Do not breathe in through your nose.
    • Hold your breath as long as you can up to 10 seconds.
    • Take the mouthpiece away from your mouth and breathe out slowly.
    • If your doctor has told you to take more than one puff of medicine at each dose, gently shake the inhaler and spacer again and take the next puff, following exactly the same steps you used for the first puff. Do not put more than one puff of medicine into the spacer at a time.
    • When you are finished, remove the spacer device from the inhaler and replace the cap.
• The mouthpiece has a dose indicator window that shows how much medicine is left. When the dose indicator window displays "40" or changes from green to red color background, this means that you need to refill your prescription or ask your doctor if you need another prescription of this medicine.
• Clean the inhaler, mouthpiece, and spacer at least once a week.
  • To clean the inhaler:
    • Remove the canister from the inhaler and set aside.
    • Wash the mouthpiece, cap, and the spacer with warm, soapy water. Then, rinse well with warm, running water.
    • Shake off the excess water and let the inhaler parts air dry completely before putting the inhaler back together.

For patients using the inhalation solution:

• Use this medicine only in a power-operated nebulizer with an adequate flow rate and equipped with a face mask or mouthpiece. Your doctor will tell you which nebulizer to use. Make sure you understand exactly how to use it. If you have any questions about this, check with your doctor.
• To prepare the medicine for use in the nebulizer:
  • If you are using the single-dose vial of ipratropium:
    • Break away one vial by pulling it firmly from the strip.
    • Twist off the top to open the vial. Use the contents of the vial as soon as possible after opening it.
    • Squeeze the contents of the vial into the cup of the nebulizer. If your doctor has told you to use less than a full vial of solution, use a syringe to withdraw the correct amount of solution from the vial and add it to the nebulizer cup. Be sure to throw away the syringe after one use.
  • If you are using the multiple-dose bottle of ipratropium:
    • Use a syringe to withdraw the correct amount of solution from the bottle and add it to the nebulizer cup. Do not use the same syringe more than once.
• If you have been told to dilute the ipratropium inhalation solution in the nebulizer cup with the sodium chloride solution provided, use a new syringe to add the sodium chloride solution to the cup as directed by your doctor.
• If your doctor told you to use another inhalation solution with the ipratropium inhalation solution, add that solution also to the nebulizer cup.
• To use the nebulizer:
  • Gently shake the nebulizer cup to mix the solutions well.
  • Connect the nebulizer tube to the air or oxygen pump and begin the treatment. Adjust the mask, if you are using one, to prevent mist from getting into your eyes.
  • Use the method of breathing your doctor told you to use to take the treatment. One way is to breathe slowly and deeply through the mask or mouthpiece. Another way is to breathe in and out normally with the mouthpiece in your mouth, taking a deep breath every 1 or 2 minutes. Continue to breathe in the medicine as instructed until no more mist is formed in the nebulizer cup or until you hear a sputtering (spitting or popping) sound.
  • When you have finished, replace the caps on the solutions. Store the bottles of solution in the refrigerator until the next treatment.
  • Clean the nebulizer according to the manufacturer's directions.

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 asthma:
  • For inhalation aerosol dosage form (used with an inhaler):
    • Adults and children 12 years of age and older—1 to 4 puffs four times a day, at regularly spaced times, as needed.
    • Children up to 12 years of age—1 or 2 puffs three or four times a day, at regularly spaced times, as needed.
  • For inhalation solution dosage form (used with a nebulizer):
    • Adults and children 12 years of age and older—500 mcg used in a nebulizer three or four times a day, every 6 to 8 hours, as needed.
    • Children 5 to 12 years of age—125 to 250 mcg used in a nebulizer three or four times a day, every 4 to 6 hours as needed.
    • Children up to 5 years of age—Use and dose must be determined by your doctor.
• For symptoms of chronic obstructive pulmonary disease (COPD):
  • For inhalation aerosol dosage form (used with an inhaler):
    • Adult—At first, 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 and children 12 years of age and older—250 to 500 mcg used in a nebulizer three or four times a day, every 6 to 8 hours.
    • Children up to 12 years of age—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 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.

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.

Check with your doctor at once if your symptoms do not improve within 30 minutes after using a dose of this medicine or if your condition gets worse.

For patients using ipratropium inhalation solution:

• If you are also using cromolyn inhalation solution, do not mix that solution with the ipratropium inhalation solution containing the preservative benzalkonium chloride for use in a nebulizer. To do so will cause the solution to become cloudy. However, if your condition requires you to use cromolyn inhalation solution with ipratropium inhalation solution, it may be mixed with ipratropium inhalation solution that is preservative-free.

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

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.

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.

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.

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.

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:

• Bladder pain
• bloody or cloudy urine
• cough producing mucus
• difficult, burning, or painful urination
• difficulty with breathing
• frequent urge to urinate
• lower back or side pain
• shortness of breath
• tightness in the chest
• wheezing

• Body aches or pain
• chills
• cough
• ear congestion
• fever
• headache
• loss of voice
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Constipation (continuing) or lower abdominal pain or bloating
• fainting
• fast, pounding, or irregular heartbeat or pulse
• severe eye pain
• skin rash or hives
• swelling of the face, lips, or eyelids

• Blindness
• blurred vision
• confusion
• decrease in the frequency of urination
• decrease in the urine volume
• decreased vision
• difficulty in passing urine (dribbling)
• difficulty with swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• hives or welts
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nausea or vomiting
• noisy breathing
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• redness of the white part of the eyes or inside of the eyelids
• sweating
• tearing

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:

• Back pain
• dryness of the mouth
• unpleasant taste

• Acid or sour stomach
• belching
• burning eyes
• diarrhea
• general feeling of discomfort or illness
• heartburn
• indigestion
• joint pain
• loss of appetite
• muscle aches and pains
• nervousness
• pain or tenderness around the eyes and cheekbones
• shivering
• stomach discomfort, upset, or pain
• trembling
• trouble sleeping

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.