Formex

Formex is a bronchodilator. It works by relaxing muscles in the airways to improve breathing. Formex inhalation is used to prevent bronchoconstriction in people with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. The use of Formex is pending revision due to safety concerns in regards to an increased risk of severe exacerbation of asthma symptoms, leading to hospitalization as well as death in some patients using long acting beta agonists for the treatment of asthma.

A bronchodilator used for the long term, symptomatic treatment of reversible bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (Chronic obstructive pulmonary disease;)

Formex is used to treat symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (wheezing or difficulty with breathing).

Formex belongs to the family of medicines known as bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. It is taken by inhalation (an inhaler) to help decrease coughing, wheezing, shortness of breath, and troubled breathing by increasing the flow of air into the lungs.

When used regularly everyday, inhaled Formex decreases the number and severity of COPD. However, it will not relieve symptoms of a COPD attack that has already started.

Formex is available only with your doctor's prescription.

• Formex may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Formex with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Formex will not stop sudden symptoms of COPD once they have already started. Be sure to carry a short-acting bronchodilator inhaler (eg, albuterol) with you at all times to treat any breathing problems that may occur between doses of Formex (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop sudden symptoms, check with your doctor or pharmacist.
• If you have been regularly using a short-acting bronchodilator inhaler, talk with your doctor about how to use it with Formex. Short-acting bronchodilators are normally used with Formex to treat breathing problems that may occur between doses.
• The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use Formex in high doses. Do NOT use more than recommended dose or use more often than prescribed.
• Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it often, or if your breathing problems get worse.
• Contact your doctor or seek medical care right away if you have breathing problems that worsen quickly, or if you use your short-acting bronchodilator and do not get relief.
• Talk with your doctor or pharmacist about all of your breathing medicines and how to use them. Do not start, stop, or change the dose of any breathing medicine unless your doctor tells you to.
• The medicine may sometimes cause severe breathing problems right after you use a dose. If this happens, use your short-acting bronchodilator. Contact your doctor or seek other medical care at once.
• Formex may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• Lab tests, including lung function and blood potassium levels, may be performed while you use Formex. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Formex should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Formex while you are pregnant. It is not known if Formex is found in breast milk. If you are or will be breast-feeding while you use Formex, check with your doctor. Discuss any possible risks to your baby.

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.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Caution is recommended when using in patients with liver dysfunction due to increased systemic exposure.

Precautions

US BOXED WARNING:

-The risk of asthma-related deaths is increased in patients using long-acting beta2-adrenergic agonists (LABA). This effect was observed in a clinical trial using a different LABA and is considered to be a class effect.

-The safety and efficacy of Formex has not been determined in patients with asthma.

-All LABA are contraindicated in patients with asthma who are not using a long-term asthma control medication.

Recommendation:

-Avoid use of LABA in patients not using a long-term asthma control medication.

Safety and efficacy have not been established in patients younger than 18 years.

Dialysis

Data not available

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

Use Formex as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Formex comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Formex refilled.
• Be sure to use Formex exactly as prescribed by your doctor. Space doses about 12 hours apart unless your doctor tells you otherwise. Do not use more than 2 vials in 1 day.
• Formex should only be inhaled using a nebulizer. Do not inject or swallow it.
• A health care provider will teach you how to use the nebulizer. Be sure you know what type of nebulizer to use with Formex and how to use it. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Store Formex in the original foil pouch in a dry place. Do not remove from the foil pouch or the vial until right before use.
• Do not use Formex if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Do not mix Formex with other medicines in your nebulizer machine.
• To use Formex, twist open the top of the vial and pour the entire contents into the nebulizer reservoir.
• Connect the nebulizer reservoir to the mouthpiece or face mask. Connect the nebulizer to the compressor.
• Sit in a comfortable, upright position. Place the mouthpiece in your mouth (or put on the face mask) and turn on the nebulizer.
• Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 10 minutes).
• Clean the nebulizer according to the instructions. Failure to properly clean the nebulizer could lead to bacteria entering the medicine. This may lead to an infection. To avoid bacteria entering the medicine, use the entire contents right after opening the vial for the first time.
• Continue to use Formex even if you feel well. Do not miss any doses.
• If you miss a dose of Formex, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Formex.

See also:
What are the possible side effects of Formex?

Applies to Formex: inhalation solution

In addition to its needed effects, some unwanted effects may be caused by Formex. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Formex:

More common:

• Back pain
• chest pain
• diarrhea
• pain

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• chills
• cough
• difficult or labored breathing
• fever
• general feeling of discomfort or illness
• headache
• joint pain
• leg cramps
• loss of appetite
• muscle aches and pains
• nausea
• pain or tenderness around the eyes and cheekbones
• rapid weight gain
• rash
• shivering
• shortness of breath
• sore throat
• stuffy or runny nose
• sweating
• tightness of the chest
• tingling of the hands or feet
• trouble with sleeping
• troubled breathing
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting
• wheezing

If any of the following symptoms of overdose occur while taking Formex, get emergency help immediately:

Symptoms of overdose:

• Arm, back, or jaw pain
• blurred vision
• chest discomfort
• chest tightness or heaviness
• confusion
• convulsions
• decreased urine
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• dry mouth
• fast, pounding, or irregular heartbeat or pulse
• increased thirst
• mood changes
• muscle pain or cramps
• muscle tremors
• nervousness
• no blood pressure or pulse
• numbness or tingling in the hands, feet, or lips
• pounding in the ears
• rapid, deep breathing
• restlessness
• slow heartbeat
• stomach cramps
• stopping of the heart
• tremor
• unconsciousness