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What is the most important information I should know about Formoterol and glycopyrrolate?
All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication. Formoterol and glycopyrrolate is not indicated for the treatment of asthma.
Formoterol and glycopyrrolate is contraindicated in patients with hypersensitivity to Glycopyrrolate (Formoterol and glycopyrrolate), Formoterol (Formoterol and Glycopyrrolate (Formoterol and glycopyrrolate)) fumarate, or to any component of the product.
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What are the possible side effects of Formoterol and glycopyrrolate?
LABAs, such as Formoterol (Formoterol and Glycopyrrolate (Formoterol and glycopyrrolate)) fumarate, one of the active ingredients in Formoterol and glycopyrrolate, increase the risk of asthma-related death. Formoterol and glycopyrrolate is not indicated for the treatment of asthma.
The following adverse reactions are described in greater detail elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The clinical program for Formoterol and glycopyrrolate included 4,911 subjects with COPD in two 24-week lung function trials, one long-term safety extension study of 28 weeks, and 10 other trials of shorter duration. A total of 1,302 subjects have received at least 1 dose of Formoterol and glycopyrrolate. The safety data described below are based on the two 24-week trials and the one 28-week long-term safety extension trial. Adverse reactions observed in the other trials were similar to those observed in these confirmatory trials.
24-Week TrialsThe incidence of adverse reactions with Formoterol and glycopyrrolate in Table 1 is based on reports in two 24-week, placebo-controlled trials (Trials 1 and 2; n=2,100 and n=1,610, respectively). Of the 3,710 subjects, 56% were male and 91% were Caucasian. They had a mean age of 63 years and an average smoking history of 51 pack-years, with 54% identified as current smokers. At screening, the mean post-bronchodilator percent predicted forced expiratory volume in 1 second (FEV) was 51% (range: 19% to 82%) and the mean percent reversibility was 20% (range: -32% to 135%).
Subjects received one of the following treatments: Formoterol and glycopyrrolate, Glycopyrrolate (Formoterol and glycopyrrolate) 18 mcg, Formoterol (Formoterol and Glycopyrrolate (Formoterol and glycopyrrolate)) fumarate 9.6 mcg, or placebo twice daily or active control.
Table 1: Adverse Reactions with Formoterol and glycopyrrolate ≥ 2% Incidence and More Common than with Placebo in Subjects with Chronic Obstructive Pulmonary Disease
| Adverse Reaction | Formoterol and glycopyrrolate (n=1036) % | Glycopyrrolate (Formoterol and glycopyrrolate) 18 mcg BID (n=890) % | Formoterol (Formoterol and Glycopyrrolate (Formoterol and glycopyrrolate)) Fumarate 9.6 mcg BID (n=890) % | Placebo (n=443) % |
| Respiratory, thoracic, and mediastinal disorders | ||||
| Cough | 4.0 | 3.0 | 2.7 | 2.7 |
| Infections and infestation | ||||
| Urinary tract infection | 2.6 | 1.8 | 1.5 | 2.3 |
Other adverse reactions defined as events with an incidence of > 1% but less than 2% with Formoterol and glycopyrrolate but more common than with placebo included the following: arthralgia, chest pain, tooth abscess, muscle spasms, headache, oropharyngeal pain, vomiting, pain in extremity, dizziness, anxiety, dry mouth, fall, influenza, fatigue, acute sinusitis, and contusion.
Long-Term Safety Extension TrialIn a 28-week long-term safety extension trial, 893 subjects who successfully completed Trial 1 or Trial 2 were treated for up to an additional 28 weeks for a total treatment period of up to 52 weeks with Formoterol and glycopyrrolate, Glycopyrrolate (Formoterol and glycopyrrolate) 18 mcg, Formoterol (Formoterol and Glycopyrrolate (Formoterol and glycopyrrolate)) fumarate 9.6 mcg administered twice daily or active control. Because the subjects continued from Trial 1 or Trial 2 into the safety extension trial, the demographic and baseline characteristics of the long-term safety extension trial were similar to those of the placebo-controlled efficacy trials described above. The adverse reactions reported in the long-term safety trial were consistent with those observed in the 24-week placebo-controlled trials.
Additional Adverse ReactionsOther adverse reactions that have been associated with the component Formoterol (Formoterol and Glycopyrrolate (Formoterol and glycopyrrolate)) fumarate include: hypersensitivity reactions, hyperglycemia, sleep disturbance, agitation, restlessness, tremor, nausea, tachycardia, palpitations, cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia, and extrasystoles).
Formoterol and glycopyrrolate is a combination of Glycopyrrolate (Formoterol and glycopyrrolate) and Formoterol (Formoterol and Glycopyrrolate (Formoterol and glycopyrrolate)) fumarate indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Important Limitation of Use: Formoterol and glycopyrrolate is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
Formoterol and glycopyrrolate in an inhalation aerosol containing a combination of Formoterol (Formoterol and Glycopyrrolate (Formoterol and glycopyrrolate)) and Glycopyrrolate (Formoterol and glycopyrrolate). Formoterol (Formoterol and Glycopyrrolate (Formoterol and glycopyrrolate)) is a bronchodilator. Glycopyrrolate (Formoterol and glycopyrrolate) is an anticholinergic. These medications work by relaxing muscles in the airways to improve breathing.
Formoterol and glycopyrrolate is used to prevent airflow obstruction or bronchospasm in people with COPD (chronic obstructive pulmonary disease).
Formoterol and glycopyrrolate is not for use in treating asthma.
Formoterol (Formoterol and Glycopyrrolate (Formoterol and glycopyrrolate)) 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.
Use Formoterol and glycopyrrolate exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Formoterol and glycopyrrolate is not a rescue medicine. It will not work fast enough to treat a bronchospasm attack. Use only a fast acting inhalation medicine for an attack.
The usual dose of Formoterol and glycopyrrolate is 2 inhalations 2 times per day, once in the morning and once in the evening. Follow your doctor's instructions.
Shake the medicine well just before you inhale your dose.
Formoterol and glycopyrrolate comes with patient instructions for safe and effective use, and directions for priming and cleaning the inhaler device. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Clean the mouthpiece of your inhaler device at least 1 time every week to keep it from getting clogged. Remove the medicine canister before cleaning the device. Ask your pharmacist if you have questions about cleaning the device.
Use Formoterol and glycopyrrolate regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Seek medical attention if you think your COPD medications are not working as well, or if you feel like you need to use them more often.
You should not stop using Formoterol and glycopyrrolate suddenly. Stopping suddenly may make your condition worse.
Store Formoterol and glycopyrrolate at room temperature away from moisture and heat. Always keep the cover on the inhaler device when not in use.
Keep the Bevespi canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.
Throw the inhaler device away 3 months after you have taken it out of the sealed pouch, or when the dose indicator on the canister shows a "0" (zero puffs left), whichever comes first. Each canister contains 120 puffs.
Do not float the medicine canister in water to see if there is medicine left in it. Get your prescription refilled before the dose indicator reaches 0. Always use the new inhaler device provided with your refill.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled IndicationsChronic obstructive pulmonary disease: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
Formoterol and glycopyrrolate (Glycopyrrolate (Formoterol and glycopyrrolate)/Formoterol (Formoterol and Glycopyrrolate (Formoterol and glycopyrrolate)) fumarate 9 mcg/4.8 mcg) should be administered as two inhalations taken twice daily in the morning and in the evening by the orally inhaled route only. Do not take more than two inhalations twice daily.
Formoterol and glycopyrrolate contains 120 inhalations per canister. The canister has an attached dose indicator, which indicates how many inhalations remain. The dose indicator display will move after every tenth actuation. When nearing the end of the usable inhalations, the color behind the number in the dose indicator display window changes to red. Formoterol and glycopyrrolate should be discarded when the dose indicator display window shows zero.
Priming Formoterol and glycopyrrolate is essential to ensure appropriate drug content in each actuation. Prime Formoterol and glycopyrrolate before using for the first time. To prime Formoterol and glycopyrrolate, release 4 sprays into the air away from the face, shaking well before each spray. Formoterol and glycopyrrolate must be re-primed when the inhaler has not been used for more than 7 days. To re-prime Formoterol and glycopyrrolate, release 2 sprays into the air away from the face, shaking well before each spray.
How suppliedDosage Forms And StrengthsInhalation Aerosol: Formoterol and glycopyrrolate is a pressurized metered dose inhaler that delivers 9 mcg of Glycopyrrolate (Formoterol and glycopyrrolate) and 4.8 mcg of Formoterol (Formoterol and Glycopyrrolate (Formoterol and glycopyrrolate)) fumarate per inhalation. Two inhalations equal one dose. Formoterol and glycopyrrolate contains 120 inhalations per canister. The canister has an attached dose indicator and is supplied with a white plastic actuator with an orange dust cap.
Storage And HandlingFormoterol and glycopyrrolate Inhalation Aerosol is supplied as a pressurized aluminum canister with an attached dose indicator, a white plastic actuator and mouthpiece, and an orange dust cap. Each 120 inhalation canister has a net fill weight of 10.7 grams. Each canister is packaged in a foil pouch with desiccant sachet and is placed into a carton. Each carton contains one canister and a Medication Guide (NDC 0310-4600-12).
The Formoterol and glycopyrrolate canister should only be used with the Formoterol and glycopyrrolate actuator, and the Formoterol and glycopyrrolate actuator should not be used with any other inhalation drug product.
The correct amount of medication in each inhalation cannot be assured after the label number of inhalations from the canister have been used, when the dose indicator display window shows zero, even though the canister may not feel completely empty. Formoterol and glycopyrrolate should be discarded when the dose indicator display window shows zero or 3 months after removal from the foil pouch, whichever comes first. Never immerse the canister into water to determine the amount remaining in the canister (“float test”).
Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
For best results, the canister should be at room temperature before use. Shake well before using. Keep out of reach of children.
Contents Under PressureDo not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator. Avoid spraying in eyes.
Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. By: Aventis Pharma LTD, Holmes Chapel CW48BE, United Kingdom. Apr: April 2016
See also:
What other drugs will affect Formoterol and glycopyrrolate?
No formal drug interaction studies have been performed with Formoterol and glycopyrrolate.
Adrenergic DrugsIf additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of Formoterol (Formoterol and Glycopyrrolate (Formoterol and glycopyrrolate)), a component of Formoterol and glycopyrrolate, may be potentiated.
Xanthine Derivatives, Steroids, Or DiureticsConcomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of beta2 adrenergic agonists such as Formoterol (Formoterol and Glycopyrrolate (Formoterol and glycopyrrolate)), a component of Formoterol and glycopyrrolate.
Non-Potassium Sparing DiureticsThe ECG changes and/or hypokalemia that may result from the administration of non-potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta2-agonists, especially when the recommended dose of the beta2-agonist is exceeded. Approximately 17% of subjects were taking non-potassium sparing diuretics during the two 24-week placebo-controlled trials in subjects with COPD. The incidence of adverse events in subjects taking non-potassium-sparing diuretics was similar between Formoterol and glycopyrrolate and placebo treatment groups. In addition, there was no evidence of a treatment effect on serum potassium with Formoterol and glycopyrrolate compared to placebo in subjects taking non-potassium sparing diuretics during the two 24-week trials. However, caution is advised in the coadministration of Formoterol and glycopyrrolate with non-potassium-sparing diuretics.
Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, QTc Prolonging DrugsFormoterol and glycopyrrolate, as with other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval may be associated with an increased risk of ventricular arrhythmias.
Beta-BlockersBeta-adrenergic receptor antagonists (beta-blockers) and Formoterol and glycopyrrolate may interfere with the effect of each other when administered concurrently. Beta-blockers not only block the therapeutic effects of beta2-agonists, but may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
AnticholinergicsThere is a potential for an additive interaction with concomitantly used anticholinergic medications. Therefore, avoid coadministration of Formoterol and glycopyrrolate with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.
