Combivent Respimat

Combivent Respimat is a prescription medication used to prevent symptoms associated with chronic obstructive pulmonary disease (COPD). Symptoms of COPD include wheezing, difficulty breathing, chest tightness, and coughing.

It is a single product containing 2 medications: ipratropium and albuterol.

Both ipratropium and albuterol belong to a group of drugs called bronchodilators. Ipratropium is also known as an anticholinergic or antimuscarinic agent, and albuterol is also known as a beta-agonist. Both ingredients work by relaxing and opening the air passages to the lungs, which makes breathing easier.

Combivent Respimat is supplied as a metered dose spray to inhale by mouth. It is usually inhaled 4 times a day.

Common side effects of Combivent Respimat include respiratory tract infection, headache, cough, and nervousness.

Combivent Respimat can also cause blurred vision, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how Combivent Respimat affects you.

Combivent Respimat is a prescription medication used to prevent symptoms associated with chronic obstructive pulmonary disease (COPD). Symptoms of COPD include wheezing, difficulty breathing, chest tightness, and coughing.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Before taking Combivent Respimat, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Combivent Respimat or to any of its ingredients
• are allergic to peanuts or soybeans
• are allergic to atropine or related medications
• have or have had urinary difficulties or prostate problems
• have or have had seizures
• have hyperthyroidism
• have high blood pressure
• have an irregular heartbeat
• have diabetes
• have liver problems
• have heart problems
• have kidney problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

• Store Combivent Respimat at at 25°C (77°F).
• Keep this and all medicines out of the reach of children.
• Do not spray into eyes.

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.

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

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.

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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling nervous and excitable.
• Headache.
• Shakiness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Combivent Respimat is 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.

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)].