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|Oxeze Inhalation-Local

FORMOTEROL (Inhalation-Local)

Some commonly used brand names are:

In the U.S.—

• Foradil

In Canada—

• Oxeze

Category

• Bronchodilator, adrenergic (inhalation)

Description

Formoterol(for-MOE-tur-all) belongs to the family of medicines known as [beta ]₂ -agonists. It is used to help prevent the symptoms of asthma. When used regularly every day, inhaled formoterol decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Inhaled formoterol works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.

This medicine may be taken with other asthma medicines known as corticosteroids.

Formoterol is also used for patients with COPD (Chronic Obstructive Pulmonary Disease). These are diseases such as chronic bronchitis and emphysema.

This medicine is available only with your doctor"s prescription, in the following dosage form:

• Inhalation
• Capsule for inhalation (U.S. and Canada)

Before Using This Medicine

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 formoterol, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to formoterol or inhaled lactose. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Formoterol has not been studied in pregnant women. However, animal studies have shown an increase in the number of birth defects and other negative effects on the fetus.

Breast-feeding—It is not known if inhaled formoterol is distributed in human breast milk. However, it is distributed in rat milk. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine been done only in patients 5 years of age and older, and there is no specific information comparing use of formoterol in children less than 5 years of age with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other 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 formoterol, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Antidepressants, tricyclic (amitriptyline [e.g. Elavil], amoxapine [e.g. Asendin], clomipramine [e.g. Anafranil], desipramine [e.g. Norpramin], doxepin [e.g. Adapin, Sinequan, or Zonalon], imipramine [e.g., Tofranil], nortriptyline [e.g. Aventyl or Pamelor], protriptyline [e.g. Vivactil]) or
• Disopyramide (e.g. Norpace) or
• Monoamine oxidase inhibitors (furazolidine [e.g., Furoxone], isocarboxazid [e.g. Marplan], phenelzine [e.g. Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g. Parnate]) or
• Phenothiazines (chlorpromazine [e.g. Thorazine], haloperidol [e.g. Haldol], methdilazine [e.g. Tacaryl], prochlorperazine [e.g. Compazine], promethazine [e.g. Phenergan], trimeprazine [e.g. Temaril]) or
• Procainamide (e.g. Procan SR, Procanbid, or Pronestyl) or
• Quinidine (e.g. Quinaglute) or

• Beta-receptor blocking agents (acebutolol [e.g. Sectral], atenolol [e.g. Tenormin], betoxolol [e.g. Frisium], bisoprolol [e.g. Zebeta], carteolol [e.g. Cartrol or Ocupress], carvedilol [e.g. Coreg], esmolol [e.g. Brevibloc], labetalol [e.g. Normodyne or Trandate], metoprolol [e.g. Lopressor or Toprol XL], nadolol [e.g. Corgard], oxprenolol [e.g. Trasicor], penbutolol [e.g. Levatol], pindolol [e.g. Visken], propranolol [e.g. Inderal], sotalol [e.g. Betapace], or timolol [e.g. Blocadren or Timoptic]

Other medical problems—The presence of other medical problems may affect the use of formoterol. Make sure you tell your doctor if you have any other medical problems, especially:

• Acutely deteriorating asthma

• Blocked heart or
• High blood pressure or
• Irregular heartbeat or
• Structural problems with the heart or
• Weak heart, unable to circulate blood effectively—Risk of increased side effects

• Diabetes—Risk of increased side effects

• Overactive thyroid
• Seizures or
• Strong response to this kind of medicine—Risk of increased side effects

Proper Use of This Medicine

Dosing—Inhaled formoterol is used to prevent asthma attacks. It is not used to relieve an attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your health care professional.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

Do not stop using this medicine or other asthma medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

Inhaled formoterol is used with a special inhaler and usually comes with patient directions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your health care professional to show you what to do. Also, ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly.

Do not wash and reuse your inhaler. Use a new inhaler with each refill of your medicine.

Do not use a spacer with this medicine.

Do not exhale into your inhaler.

Do not use the inhaler for this medicine with any other medicine.

Dry your hands before handling this medicine.

The dose of formoterol 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 formoterol. If your dose is different, do not change it unless your doctor tells you to do so.

The number of inhaled doses that you take depends on the strength of the medicine.

• For inhalation:
  • Adults and children 5 years of age and older— 12 mcg by oral inhalation every 12 hours
  • Children younger than 6 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—To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any blood or heart problems that may be caused by this medicine.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Do not use this medicine to treat wheezing that is getting worse. Call your doctor right away if wheezing worsens while using formoterol.

You may also be taking an anti-inflammatory medicine along with this medicine.Do not stop taking the anti-inflammatory medicine even if your asthma seems better, unless you are told to do so by your doctor

Although this medicine decreases the number of asthma episodes, these medicines may increase the chances of a severe asthma episode when they do occur. Be sure to read about these risks in the Medication Guide and talk to your doctor or pharmacist about any questions or concerns that you have.

Side Effects of This Medicine

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.

Developed: 03/05/2001
Revised: 12/02/2005

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