Atrovent HFA

DRUG DESCRIPTION

The active ingredient in ATROVENT HFA is ipratropium bromide (as the monohydrate). It is an anticholinergic bronchodilator chemically described as 8azoniabicyclo[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:

ATROVENT® HFA (ipratropium bromide HFA)Structural Formula Illustration

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 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, sterile water, dehydrated alcohol, and anhydrous citric acid. This product does not contain chlorofluorocarbons (CFCs) as propellants.

ATROVENT HFA 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.

What are the possible side effects of ipratropium inhalation (Atrovent HFA)?

Stop using ipratropium inhalation and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a fast, pounding heartbeat.

Other less serious side effects are more likely to occur, such as:

  • headache, dizziness;
  • dry mouth, cough, hoarseness;
  • nausea, upset stomach; or
  • blurred vision.

If you switch from Atrovent to...

Read All Potential Side Effects and See Pictures of Atrovent HFA »

What are the precautions when taking ipratropium bromide inhalation aerosol (Atrovent HFA)?

Before using ipratropium, tell your doctor or pharmacist if you are allergic to it; or to atropine or other belladonna-type drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: glaucoma (narrow-angle), difficulty urinating (for example, due to enlarged prostate).

This drug may make you dizzy or cause blurred vision or other vision changes. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell...

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Atrovent HFA Consumer (continued)

SIDE EFFECTS: See also How to Use section.

Dizziness, nausea, stomach upset, or dry mouth may occur. If any of these effects persist or worsen, tell 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.

Infrequently, this medication may cause severe sudden worsening of breathing problems right after use. If you have sudden worsening of breathing, use your quick-relief inhaler and get medical help right away.

Tell your doctor right away if you have any serious side effects, including: vision changes, eye pain, fast/pounding heartbeat, difficult/painful urination.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), 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.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using ipratropium, tell your doctor or pharmacist if you are allergic to it; or to atropine or other belladonna-type drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: glaucoma (narrow-angle), difficulty urinating (for example, due to enlarged prostate).

This drug may make you dizzy or cause blurred vision or other vision changes. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.


Atrovent HFA Patient Information Including Side Effects

Brand Names: Atrovent HFA

Generic Name: ipratropium inhalation (Pronunciation: IP ra TRO pee um)

  • What is ipratropium inhalation (Atrovent HFA)?
  • What are the possible side effects of ipratropium inhalation (Atrovent HFA)?
  • What is the most important information I should know about ipratropium inhalation (Atrovent HFA)?
  • What should I discuss with my healthcare provider before using ipratropium inhalation (Atrovent HFA)?
  • How should I use ipratropium inhalation (Atrovent HFA)?
  • What happens if I miss a dose (Atrovent HFA)?
  • What happens if I overdose (Atrovent HFA)?
  • What should I avoid while using ipratropium inhalation (Atrovent HFA)?
  • What other drugs will affect ipratropium inhalation (Atrovent HFA)?
  • Where can I get more information?

What is ipratropium inhalation (Atrovent HFA)?

Ipratropium inhalation is used to prevent bronchospasm, or narrowing airways in the lungs, in people with bronchitis, emphysema, or COPD (chronic obstructive pulmonary disease).

Ipratropium inhalation may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ipratropium inhalation (Atrovent HFA)?

Stop using ipratropium inhalation and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a fast, pounding heartbeat.

Other less serious side effects are more likely to occur, such as:

  • headache, dizziness;
  • dry mouth, cough, hoarseness;
  • nausea, upset stomach; or
  • blurred vision.

If you switch from Atrovent to Atrovent HFA, you may notice a slightly different taste or feel after inhaling the medication.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ipratropium inhalation (Atrovent HFA)?

Before using this medication, tell your doctor if you have narrow-angle glaucoma, or an enlarged prostate or bladder obstruction. If you have any of these conditions, you may need a dose adjustment or special tests to safely use ipratropium inhalation.

Ipratropium inhalation is used to prevent bronchospasm attacks. This medication will not treat bronchospasm while it is happening. You may still have difficulty breathing and may need to use one of your other medicines to treat the attack. To best control your condition, use ipratropium inhalation regularly, and continue using all your other medicines as directed by your doctor.

Use this medication exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor.

Call your doctor right away if you feel that this medicine is not working as well as usual, or if it makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.

Extreme heat can cause the ipratropium inhalation canister to burst. Do not store your inhaler in your car on hot days. Do not throw an empty canister into open flame.

Keep track of the number of sprays you have used and throw away the inhaler canister after 200 sprays, even if it feels like there is still medicine in it.

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