Formoterol Fumarate + Glycopyrrolate + Budesonide

This inhaler is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). This Inhaler is not indicated for the relief of acute bronchospasm or for the treatment of asthma.

This Inhaler is a pressurized metered-dose inhaler that delivers a combination of micronized Budesonide, an inhaled corticosteroid (ICS), micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate, an inhaled long-acting beta2-adrenergic agonist (a LABA), for oral inhalation. ICS medicines such as budesonide help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems. Anticholinergic medicines, such as glycopyrrolate, and LABA medicines, such as formoterol fumarate help the muscles around the airways in the lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

The recommended dosage of is two inhalations twice daily, once in the morning and again in the evening, by oral inhalation. Do not take more than two inhalations twice daily. After inhalation, rinse mouth with water without swallowing.

• Strong cytochrome P450 3A4 inhibitors (e.g. ritonavir): Use with caution. May cause systemic corticosteroid effects.
• Other adrenergic drugs may potentiate effect: Use with caution.
• Diuretics, xanthine derivatives or steroids may potentiate hypokalemia or ECG changes. Use with caution.
• Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of formoterol fumarate on cardiovascular system.
• Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm.
• Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of this spray with other anticholinergic-containing drugs.

This is contraindicated in patients who have demonstrated hypersensitivity to budesonide, glycopyrrolate, formoterol, or any of the excipients.

Serious asthma-related events-hospitalizations, intubations, death, Candida albicans infection, increased risk of pneumonia, immunosuppression and risk of infections, hypercorticism and adrenal suppression, paradoxical bronchospasm, hypersensitivity reactions including anaphylaxis, cardiovascular effects, reduction in bone mineral density, worsening of narrow-angle glaucoma and cataracts, worsening of urinary retention

There are no adequate and well-controlled studies with this inhaler or with two of its individual components, Glycopyrrolate or Formoterol Fumarate, in pregnant women to inform a drug-associated risk. There are no available data on the effects of this inhaler on the breastfed child or on milk production. Budesonide, like other ICS, is present in human milk. There are no available data on the presence of Glycopyrrolate or Formoterol Fumarate in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this inhaler and any potential adverse effects on the breastfed child from this inhaler or from the underlying maternal condition.

The safety and efficacy of this inhaler in patients with asthma have not been established. this inhaler is not indicated for the treatment of asthma. This inhaler has not been studied in patients with acutely deteriorating COPD. The use of this inhaler in this setting is not appropriate. This inhaler should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. This inhaler has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled short-acting beta2-agonist. When beginning treatment with this inhaler, patients who have been taking inhaled, short-acting beta2-agonists on a regular basis (e.g., four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms. When prescribing this inhaler, the healthcare provider should also prescribe an inhaled, short acting beta 2-agonist and instruct the patient on how it should be used. Increasing inhaled beta 2-agonist use is a signal of deteriorating disease for which prompt medical attention is indicated.

The daily dosage of this inhaler should not be increased beyond the recommended dose. As with other inhaled drugs containing beta2-adrenergic agents, this inhaler should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

No cases of overdose have been reported with this inhaler; therefore, the risks associated with overdosage for the individual components described below apply to this inhaler. Treatment of overdosage consists of discontinuation of this inhaler together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. Cardiac monitoring is recommended in case of overdosage.

Budesonide: If used at excessive doses for prolonged periods, systemic corticosteroid effects, such as hypercorticism may occur.

Glycopyrrolate: High doses of Glycopyrrolate, a component of this inhaler, may lead to anticholinergic signs and symptoms such as nausea, vomiting, dizziness, lightheadedness, blurred vision, increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), obstipation, or difficulties in voiding.

Formoterol Fumarate: An overdose of Formoterol Fumarate would likely lead to an exaggeration of effects that are typical for beta2-agonists: seizures, angina, hypertension, hypotension, tachycardia, atrial and ventricular tachyarrhythmias, nervousness, headache, tremor, palpitations, muscle cramps, nausea, dizziness, sleep disturbances, metabolic acidosis, hyperglycemia, hypokalemia. As with all sympathomimetic medications, cardiac arrest, and even death may be associated with overdosage of Formoterol Fumarate.

Combined bronchodilators

Hepatic impairment: Budesonide and formoterol fumarate systemic exposure may increase in patients with severe hepatic impairment. Monitor patients for signs of increased drug exposure.

Renal impairment: In patients with severe renal impairment, use should be considered only if the potential benefit of the treatment outweighs the risk.

Pediatric Use: This is not indicated for use in children. The safety and effectiveness of this spray have not been established in pediatric patients.

Geriatric Use: Based on available data, no adjustment of the dosage of This in geriatric patients is necessary, but greater sensitivity in some older individuals cannot be ruled out.

Do not store above 30° C. Keep in a dry place. Protect from light and keep out of the reach of children. Keep away from eyes. Discard within three months after removing from the foil pouch.