Ipratropium/Albuterol (Salbutamol) Spray - Oral Inhalation

Uses

This product is used to treat and prevent symptoms (wheezing and shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes bronchitis and emphysema). This product contains 2 medications: ipratropium and albuterol (also known as salbutamol). Both drugs work by relaxing the muscles around the airways so that the airways open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using this product and each time you get a refill. Learn how to use this inhaler properly. If you have any questions, ask your doctor or pharmacist.

Follow the instructions for priming the inhaler if you are using it for the first time or if you have not used it for more than 3 days or for more than 21 days. When priming the inhaler, make sure to spray away from the face so that you do not get the medication into your eyes.

Inhale this medication by mouth as directed by your doctor, usually 4 times daily. Your doctor may also direct you to use this medication as needed for wheezing and shortness of breath. Follow your doctor's instructions carefully. However, the manufacturer recommends that you do not use more than 6 inhalations in a 24-hour period. Doing so may increase the risk of serious side effects.

The dosage is based on your medical condition and response to treatment.

Avoid getting this medication into your eyes. It may cause eye pain/irritation, temporary blurred vision, and other vision changes. When using the inhaler, put your lips tightly around the mouthpiece.

Rinse your mouth after using the inhaler to prevent dry mouth and throat irritation.

If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication.

Use this medication regularly to get the most benefit from it. This medication works best if used at evenly spaced intervals. To help you remember, use it at the same times each day. Do not increase your dose, use this medication more often, or stop using it without first consulting your doctor.

Clean the mouthpiece of the inhaler at least once a week as directed.

Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

Tell your doctor if your symptoms do not improve or if they worsen.

Side Effects

See also How to Use section.

Headache, dizziness, cough, nausea, dry mouth, shaking (tremors), nervousness, or constipation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Rarely, this medication may cause severe sudden worsening of breathing problems right after use. If you have sudden worsening of breathing, get medical help right away.

Tell your doctor right away if you have any serious side effects, including:

• difficult/painful urination
• muscle cramps

Get medical help right away if you have any very serious side effects, including:

• chest pain
• fast/pounding/irregular heartbeat
• rapid breathing
• confusion
• eye pain/swelling/redness
• vision changes (such as seeing rainbows around lights at night, blurred vision)

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 or at www.fda.gov/medwatch.

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 this product, tell your doctor or pharmacist if you are allergic to ipratropium or albuterol (salbutamol); or to tiotropium; or to atropine or other belladonna-type drugs; or to levalbuterol; 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:

• high blood pressure
• heart disease (such as chest pain, heart attack, irregular heartbeat)
• personal or family history of glaucoma (angle-closure type)
• difficulty urinating (for example, due to enlarged prostate)
• seizure
• overactive thyroid (hyperthyroidism)
• diabetes

This drug may make you dizzy or blur your vision or cause vision changes. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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

Older adults may be more sensitive to the side effects of this drug, especially problems urinating or constipation.

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.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Albuterol is very similar to levalbuterol. Do not use medications containing levalbuterol while using albuterol.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: chest pain, fast/irregular heartbeat, seizures.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as lung function, blood pressure) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature. Do not freeze. Do not store in the bathroom. The inhaler should be discarded when it becomes locked (which means that all the medication is used up) or 3 months after putting the cartridge in the inhaler, even if there is medication left in the cartridge. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).