Arformoterol Inhalation

Name: Arformoterol Inhalation

Before Using arformoterol

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 arformoterol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to arformoterol 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 have not been performed on the relationship of age to the effects of arformoterol inhalation in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of arformoterol inhalation in the elderly. However, elderly patients are more likely to be sensitive to some side effects of arformoterol than younger adults.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal 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

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 arformoterol. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma or
  • Diabetes or
  • Electrolyte imbalance (e.g., low potassium in the blood) or
  • Heart or blood vessel disease or
  • Heart rhythm problems (e.g., arrhythmia) or
  • Hypertension (high blood pressure) or
  • Ketoacidosis (acids in the blood) or
  • Liver disease or
  • Overactive thyroid or
  • Seizures—Use with caution. May make these conditions worse.
  • COPD attack, severe—Should not be used if you are having a severe COPD attack, or if symptoms of COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack.

How should I use arformoterol inhalation?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not use arformoterol inhalation to treat a sudden bronchospasm attack. It will not work fast enough. Use only a fast-acting inhalation medication.

If you were switched from a short-acting bronchodilator to arformoterol inhalation, stop using the other bronchodilator and use it only for a sudden bronchospasm attack. Short-acting bronchodilators include albuterol (Proventil, Ventolin, Combivent), bitolterol (Tornalate), levalbuterol (Xopenex), metaproterenol (Alupent, Metaprel), or pirbuterol (Maxair).

Arformoterol solution for inhalation is for use only with a standard jet nebulizer machine connected to an air compressor. Do not mix arformoterol with other medicines in the nebulizer. Do not take this medicine by mouth or swallow it.

To use the solution with a nebulizer:

  • Open the foil pouch and squeeze all of the medicine out into the chamber of the nebulizer. Attach the mouthpiece or face mask to the drug chamber. Then, attach the drug chamber to the compressor.

  • Sit upright in a comfortable position. Place the mouthpiece into your mouth or put the face mask on, covering your nose and mouth. Turn on the compressor.

  • Breathe in slowly and evenly until you have inhaled all of the medicine (usually 5 to 10 minutes). The treatment is complete when no more mist is formed by the nebulizer and the drug chamber is empty.

  • Clean the nebulizer after each use. Follow the cleaning directions that came with your nebulizer.

Seek medical attention if you think your medications are not working as well.

COPD is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Keep this medicine in the foil pouch until you are ready to use it. Once a pouch is opened, you must use the medicine right away. Throw the empty pouch away where children and pets cannot get to it.

Store the foil pouches in the refrigerator but do not allow them to freeze.

You may store the foil pouches at room temperature but you must use them within 6 weeks. Store the single-use vials at room temperature and protect them from heat and light. Do not use any medicine if it does not look clear and colorless in the vial.

Arformoterol inhalation dosing information

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

15 mcg inhaled by nebulization twice daily (morning and evening).

Maximum Daily Dose: 30 mcg

Comments:
-Not for use to treat acute deteriorations of COPD.

Use: Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Side Effects

Nervousness, dizziness, shaking (tremor), headache, nausea, dry mouth, or trouble sleeping 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.

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

Tell your doctor right away if you have any serious side effects, including: fast/pounding/irregular heartbeat, muscle cramps/weakness, increased thirst/urination.

Get medical help right away if you have any very serious side effects, including: chest pain, rapid breathing, confusion, severe dizziness, fainting.

Rarely, this medication has caused severe (possibly fatal), sudden worsening of breathing problems (paradoxical bronchospasm). If you have trouble breathing or sudden wheezing, use your quick-relief inhaler and get medical help right away.

A very serious allergic reaction to this drug 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.

List Arformoterol Solution For Nebulization side effects by likelihood and severity.

Precautions

Before using arformoterol, tell your doctor or pharmacist if you are allergic to it; or to formoterol; 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: diabetes, heart problems (such as irregular heartbeat, angina, previous heart attack), high blood pressure, liver problems, seizures, overactive thyroid (hyperthyroidism), swelling of an artery (aneurysm), a certain tumor of the adrenal gland (pheochromocytoma).

Arformoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using arformoterol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using arformoterol safely.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness 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).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

See also Uses section.

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.

Other Comments

Storage requirements:
-Refrigerate in protective foil pouch; protect from light and excessive heat.
-After opening foil pouch, return all unopened unit-dose vials to the pouch and place in refrigerator.
-Unopened foil pouches may be stored at room temperature for up to 6 weeks.
-If stored at room temperature, discard unused portion after 6 weeks or the expiration date, whichever is sooner.
-Use opened unit-dose vials immediately

Arformoterol Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. US FDA pregnancy category: C

Animal studies have shown teratogenicity at higher than clinically used doses. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Arformoterol Breastfeeding Warnings

Studies conducted in rats have shown excretion in breast milk resulting in increased death rate of pups.

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

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