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Drugs reference index «Perforomist»

Perforomist


Perforomist

Generic Name: formoterol (Inhalation route)

for-MOE-ter-ol

Inhalation, oralCapsule
  • POWDER
    • Long-acting beta(2)-adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, formoterol fumarate should only be used as additional therapy for patients not adequately controlled on other asthma-controller medications (e.g., low-to-medium dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies, including formoterol fumarate. Data from a large placebo-controlled US study that compared the safety of another long-acting beta(2)-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta(2)-adrenergic agonist), the active ingredient in formoterol fumarate .

Long-acting beta(2)-adrenergic agonists may increase the risk of asthma-related deaths. Therefore, when treating patients with asthma, formoterol fumarate should only be used for patients not adequately controlled on other asthma-controller medications or whose disease severity clearly warrants initiation of treatment with two maintenance therapies .

Inhalation, oralSolution
  • SOLUTION
    • Long-acting beta(2)-adrenergic agonists may increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta(2)-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta(2)-adrenergic agonist), the active ingredient in formoterol fumarate inhalation solution .

Long-acting beta(2)-adrenergic agonists may increase the risk of asthma-related death. A placebo-controlled study with another long-acting beta(2)-adrenergic agonist (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. The finding of an increase in the risk of asthma-related deaths with salmeterol may apply to formoterol .

Commonly used brand name(s):

In the U.S.

  • Foradil Aerolizer
  • Perforomist

Available Dosage Forms:

  • Aerosol Powder
  • Solution
  • Capsule

Therapeutic Class: Bronchodilator

Pharmacologic Class: Sympathomimetic

Uses For Perforomist

Formoterol 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 may be used to prevent wheezing caused by exercise (exercise-induced bronchospasm) .

Formoterol is also used for patients with COPD (Chronic Obstructive Pulmonary Disease). This disease includes chronic bronchitis and emphysema .

This medicine is available only with your doctor's prescription .

Before Using Perforomist

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of formoterol inhalation powder in children who are 5 years of age and older. Safety and efficacy have not been established for children less than 5 years of age .

Appropriate studies have not been performed on the relationship of age to the effects of formoterol inhalation solution in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of formoterol in the elderly. However, elderly patients are more likely to have age-related heart or blood vessel disease, which may require caution in patients receiving formoterol .

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Alprenolol
  • Arotinolol
  • Atenolol
  • Befunolol
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bopindolol
  • Brofaromine
  • Bucindolol
  • Bupranolol
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Clorgyline
  • Dilevalol
  • Esmolol
  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Labetalol
  • Landiolol
  • Lazabemide
  • Levobetaxolol
  • Levobunolol
  • Linezolid
  • Mepindolol
  • Metipranolol
  • Metoprolol
  • Moclobemide
  • Nadolol
  • Nebivolol
  • Nialamide
  • Nipradilol
  • Oxprenolol
  • Pargyline
  • Penbutolol
  • Phenelzine
  • Pindolol
  • Procarbazine
  • Propranolol
  • Rasagiline
  • Selegiline
  • Sotalol
  • Talinolol
  • Tertatolol
  • Timolol
  • Toloxatone
  • Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

  • Acutely deteriorating asthma or
  • Acutely deteriorating COPD—This medicine should not be used with these conditions .
  • Diabetes or
  • Heart problems or
  • High blood pressure or
  • Hypokalemia (low potassium in the blood) or
  • Irregular heartbeat or
  • Ketoacidosis or
  • Overactive thyroid or
  • Seizures—May cause side effects to become worse.
  • Lactose intolerance—Use with caution. The capsule form of this medicine contains lactose .

Proper Use of formoterol

This section provides information on the proper use of a number of products that contain formoterol. It may not be specific to Perforomist. Please read with care.

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

In order for this medicine to help prevent asthma or COPD 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 or COPD medicines that your doctor has prescribed for you unless you have discussed this with your doctor .

Formoterol inhalation solution should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one .

You will use the formoterol inhalation solution with an inhaler device called a nebulizer. The nebulizer turns the medicine into a fine mist that you breathe in through your mouth and to your lungs. Do not mix any other medicines with the solution. Your doctor will show you how to use your nebulizer .

Formoterol inhalation powder 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 doctor to show you what to do. Also, ask your doctor to check how you use the inhaler to make sure you are using it properly .

How to use the formoterol inhalation powder:

  • Dry your hands before handling this medicine.
  • Open the foil pouch containing a blister card of capsules. Do not remove a capsule until you are ready for a dose.
  • Place the capsule only in the capsule-chamber in the base of the inhaler. Do not swallow the capsule and do not place a capsule directly into the mouthpiece.
  • Hold the mouthpiece of the inhaler upright and press both buttons at the same time. Press the buttons only once. You should hear a click as the capsule is being pierced.
  • Breathe out fully. Do not exhale into the mouthpiece.
  • Tilt your head slightly backwards. Keep the inhaler level, with the blue buttons to the left and right. Place the mouthpiece in your mouth then close your lips around the mouthpiece.
  • Breathe in quickly and deeply.
  • Remove the inhaler from your mouth. Hold your breath as long as you can and then exhale.
  • Open the inhaler after using it, and remove and discard the empty capsule. Do not leave the used capsule inside the chamber.
  • Close the mouthpiece and then replace the cover.
  • Do not wash the inhaler. Keep it dry.
  • Do not use a spacer with this medicine.
  • You may reuse your inhaler. But use a new inhaler with each refill of your medicine.
  • Do not use the inhaler for this medicine with any other medicine .

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 inhalation powder:
    • For preventing an asthma attack:
      • Adults and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation every 12 hours.
      • Children younger than 5 years of age—Use and dose must be determined by your doctor .
    • For preventing exercise-induced bronchospasm:
      • Adults and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation at least 15 minutes before exercise, as needed. Doses should be at least 12 hours apart.
      • Children younger than 5 years of age—Use and dose must be determined by your doctor .
    • For maintenance treatment of COPD:
      • Adults and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation every 12 hours.
      • Children younger than 5 years of age—Use and dose must be determined by your doctor .
    • For inhalation solution:
      • For maintenance treatment of COPD:
        • Adults—20 micrograms (mcg) (1 vial) two times a day (morning and evening) by oral nebulization.
        • Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.

Precautions While Using Perforomist

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.

This medicine should only be used as an additional treatment for patients who cannot be treated with other asthma medicines (such as inhaled corticosteroids) or for asthma patients that require two medicines, including formoterol. Ask your doctor if you have any questions .

Talk to your doctor or get medical care right away if :

  • Your symptoms do not improve after using this medicine for 1 week or if they become worse.
  • Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often (e.g., you use 1 whole canister of your short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of your short-acting inhaler for 2 or more days in a row).
  • You have a significant decrease in your peak flow when measured as directed by 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, this medicine 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 .

Perforomist Side Effects

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.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Body aches or pain
  • chills
  • cold or flu-like symptoms
  • cough or hoarseness
  • difficulty with breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Less common
  • Chest pain or discomfort
  • cough-producing mucous
  • dry throat
  • labored breathing
  • pain or tenderness around eyes and cheekbones
  • shortness of breath
  • stuffy nose
  • tender, swollen glands in neck
  • tightness in chest
  • trauma
  • trouble swallowing
  • voice changes
  • wheezing
Rare
  • Convulsions
  • decreased urine
  • dry mouth
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • increased thirst
  • loss of appetite
  • noisy breathing
  • palpitations
Incidence not determined
  • Blurred vision
  • confusion
  • difficulty swallowing
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • hives
  • itching
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash
  • sweating
Symptoms of overdose

Get emergency help immediately if any of the following symptoms of overdose occur:

  • Arm, back, or jaw pain
  • chest tightness or heaviness
  • fatigue
  • general feeling or discomfort or illness
  • increased hunger or thirst
  • increased urination
  • mood changes
  • muscle pain
  • muscle spasm or jerking of all extremities
  • nausea
  • no blood pressure or pulse
  • numbness or tingling in hands, feet, or lips
  • palpitations or pounding in the ears
  • pounding or racing heartbeat or pulse
  • sleeplessness
  • slow heartbeat
  • stopping of heart
  • sudden loss of consciousness
  • unconsciousness
  • vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Agitation
  • back pain
  • fear or nervousness
  • increased mucous in throat and lungs
  • leg cramps
  • muscle cramps
  • redness of skin
  • restlessness
  • shakiness in legs, arms, hands, or feet
  • trembling or shaking of hands or feet
  • trouble sleeping
  • unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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  • Perforomist Prescribing Information (FDA)
  • Perforomist Consumer Overview
  • Perforomist Solution MedFacts Consumer Leaflet (Wolters Kluwer)
  • Foradil Aerolizer MedFacts Consumer Leaflet (Wolters Kluwer)
  • Foradil Aerolizer Detailed Consumer Information (PDR)

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