Formoterol and glycopyrrolate

Formoterol is a bronchodilator. Glycopyrrolate is an anticholinergic. These medications work by relaxing muscles in the airways to improve breathing.

Formoterol and glycopyrrolate is a combination medicine used to prevent airflow obstruction or bronchospasm in people with COPD (chronic obstructive pulmonary disease).

This medicine is not for use in treating asthma.

Formoterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Talk with your doctor about your individual risk.

Formoterol and glycopyrrolate may also be used for purposes not listed in this medication guide.

If this medicine gets in your eyes, rinse them with water and call your doctor if you have ongoing eye redness even after rinsing.

Do not use a second form of formoterol (such as Foradil, Dulera, Perforomist, Symbicort) or use a similar other long-acting inhaled bronchodilator such as salmeterol (Advair, Serevent) or arformoterol (Brovana) unless your doctor has told you to.

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

2 inhalations orally twice a day, in the morning and in the evening
Maximum dose: 2 inhalations twice daily

Comments:
-Two inhalations of formoterol 4.8 mcg-glycopyrrolate 9 mcg equal one dose.

Uses: Long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

Applies to formoterol / glycopyrrolate: inhalation aerosol powder

Along with its needed effects, formoterol / glycopyrrolate 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 while taking formoterol / glycopyrrolate:

• Bladder pain
• bloody or cloudy urine
• chest pain
• cough
• difficult, burning, or painful urination
• frequent urge to urinate
• lower back or side pain

• Blindness
• blurred vision
• decrease in the frequency of urination
• decrease in urine volume
• decreased vision
• difficulty with breathing
• dizziness
• eye pain
• fainting
• headache
• hives or welts, itching, or skin rash
• irregular heartbeat
• nausea or vomiting
• nervousness
• noisy breathing
• pounding in the ears
• recurrent large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• redness of the skin
• slow or fast heartbeat
• tearing
• tightness in the chest

Some side effects of formoterol / glycopyrrolate 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:

• Difficulty with moving
• dry mouth
• fear
• fever
• muscle pain or stiffness
• muscle spasm
• pain in the arms or legs
• pain in the joints
• pain or tenderness around the eyes and cheekbones
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

Applies to formoterol / glycopyrrolate: inhalation aerosol

Respiratory

Common (1% to 10%): Cough (4%); In less than 2%: Chest pain, influenza, acute sinusitis[Ref]

Cardiovascular

Frequency not reported: Formoterol fumarate: Palpitations, cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia, extrasystoles)[Ref]

Gastrointestinal

Common (1% to 10%): In less than 2%: Tooth abscess, oropharyngeal pain, vomiting, dry mouth
Frequency not reported: Formoterol fumarate: Nausea[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection (2.6%)
Frequency not reported: Worsening of urinary retention[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions (formoterol fumarate)[Ref]

Metabolic

Frequency not reported: Formoterol fumarate: Hyperglycemia[Ref]

Musculoskeletal

Common (1% to 10%): In less than 2%: Arthralgia, muscle spasm, pain in the extremity[Ref]

Nervous system

Common (1% to 10%): In less than 2%: Headache, dizziness
Frequency not reported: Formoterol fumarate: Tremor[Ref]

Ocular

Frequency not reported: Worsening of narrow-angle glaucoma[Ref]

Other

Common (1% to 10%): In less than 2%: Fall, fatigue, contusion[Ref]

Psychiatric

Common (1% to 10%): Anxiety (less than 2%)
Frequency not reported: Paradoxical bronchospasm; Formoterol fumarate: Restlessness, sleep disturbances, agitation[Ref]

Some side effects of formoterol / glycopyrrolate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Administration advice:
-For oral inhalation only.
-Priming the inhalation device before using for the first time to ensure appropriate drug content in each actuation. The manufacturer product information should be consulted for additional instructions for its use.
-Shake well before using.

Missed dose:
-If a dose is missed, take the next dose at the usual time.
-Do not use more often or more puffs than prescribed.

Storage requirements:
-Store at controlled room temperature 20C to 25C (68F to 77F)
-The canister should be at room temperature before use

Limitations of use:
-This drug is not indicated for the relief of acute bronchospasm or for the treatment of asthma.

Patient advice:
-Patients should read the medication guide and instructions for the use of this drug.
-A rescue inhaler should be provided to patients to treat acute symptoms. Patients should be instructed on how to use the rescue inhaler.
-Seek medical attention immediately if symptoms get worse, or if more inhalations than usual of their rescue inhaler are needed.
-Therapy should not be stopped without physician/provider guidance since symptoms may recur after discontinuation.
-Discontinue previous regular use of short acting beta2-agonist and use them only for the symptomatic relief of acute symptoms.