Combivent

DRUG DESCRIPTION

COMBIVENT (ipratropium bromide and albuterol sulfate) Inhalation Aerosol 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-methyl8-(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:

Ipratropium bromide Structural Formula Illustration

C20H30BrNO3•H2O ipratropium bromide Mol. Wt. 430.4

Albuterol sulfate, chemically known as (1,3-benzenedimethanol, ?'-[[(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

Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol contains a microcrystalline suspension of ipratropium bromide and albuterol sulfate in a pressurized metered-dose aerosol unit for oral inhalation administration. The 200 inhalation unit has a net weight of 14.7 grams. Each actuation meters 21 mcg of ipratropium bromide and 120 mcg of albuterol sulfate from the valve and delivers 18 mcg of ipratropium bromide and 103 mcg of albuterol sulfate (equivalent to 90 mcg albuterol base) from the mouthpiece. The excipients are dichlorodifluoromethane, dichlorotetrafluoroethane, and trichloromonofluoromethane as propellants and soya lecithin.

What are the precautions when taking ipratropium bromide and albuterol sulfate (Combivent)?

Before using this product, tell your doctor or pharmacist if you are allergic to ipratropium or albuterol (salbutamol); or to atropine or other belladonna-type drugs; or if you have any other allergies. This product may contain inactive ingredients (such as soy lecithin from soybeans), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. 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), glaucoma (narrow-angle), difficulty urinating (for example, due to enlarged prostate), seizure, overactive thyroid (hyperthyroidism),...

Read All Potential Precautions of Combivent »


Combivent Consumer (continued)

SIDE EFFECTS: See also How to Use section.

Headache, dizziness, nausea, dry mouth, shaking (tremors), or nervousness 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, get medical help right away.

Tell your doctor right away if you have any serious side effects, including: eye pain, vision changes (such as blurred vision, seeing halos), difficult/painful urination, muscle cramps.

Get medical help right away if you have any serious side effects, including: chest pain, fast/pounding/irregular heartbeat.

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 this product, tell your doctor or pharmacist if you are allergic to ipratropium or albuterol (salbutamol); or to atropine or other belladonna-type drugs; or if you have any other allergies. This product may contain inactive ingredients (such as soy lecithin from soybeans), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. 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), glaucoma (narrow-angle), difficulty urinating (for example, due to enlarged prostate), seizure, overactive thyroid (hyperthyroidism), diabetes.

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.



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