Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Maintenance

2 oral inhalations twice a day (morning and evening)
Maximum dose: 2 inhalations twice a day

Comments:

• Limitations of Use: This drug is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
• Each inhalation contains budesonide 160 mcg, formoterol fumarate 4.8 mcg, and glycopyrrolate 9 mcg.

Renal Dose Adjustments

Severe renal dysfunction (CrCl up to 30 mL/min/1.73 m2): Data not available

Comments:

• Formal pharmacokinetic (PK) studies have not been performed in patients with renal dysfunction.
• This drug should only be used in patients with severe renal dysfunction if the expected benefit outweighs the potential risk.

Liver Dose Adjustments

Severe liver dysfunction: Close monitoring recommended.

Comments:

• Formal PK studies have not been performed in patients with liver dysfunction.
• Budesonide and formoterol fumarate are primarily cleared by hepatic metabolism, so liver dysfunction may lead to accumulation of these drugs in plasma.

Precautions

CONTRAINDICATIONS:
Demonstrated hypersensitivity to an active component or to any of the ingredients

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

Consult WARNINGS section for additional precautions.

Dialysis

ESRD requiring dialysis: Data not available

Comments:

• Formal PK studies have not been performed in patients with renal dysfunction.
• This drug should only be used in patients with ESRD requiring dialysis if the expected benefit outweighs the potential risk.

Other Comments

Administration advice:

• Shake well before each spray.
• Prime inhaler before first use by releasing 4 sprays into the air away from face; if not used for more than 7 days, if dropped, or after weekly cleaning, prime inhaler again by releasing 2 sprays into the air away from face.
• After inhalation, rinse mouth with water without swallowing.
• Only use the canister of this drug with the provided actuator; do not use this actuator with any other inhalation drug product.
• Do not use near heat or open flames; avoid spraying in eyes.
• Discard when the dose indicator display window shows zero OR 3 months (120-inhalation canister) or 3 weeks (28-inhalation canister) after removal from foil pouch, whichever comes first; never immerse canister into water to determine amount remaining in canister ("float test").

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Keep in dry place away from heat and sunlight.
• Do not store near heat or open flames; bursting may occur if exposed to temperatures above 49C (120F).

• No dosage adjustment is needed for elderly patients.
• Contents are under pressure; the canister should not be punctured and should never be thrown into fire or incinerator.

• Endocrine: For inadequate adrenal response (postoperatively or during periods of stress)
• General: For systemic corticosteroid effects
• Genitourinary: For signs/symptoms of prostatic hyperplasia or bladder-neck obstruction
• Infections/Infestations: For pneumonia
• Musculoskeletal: Bone mineral density (before starting therapy and periodically thereafter)
• Ocular: For signs/symptoms of acute narrow-angle glaucoma

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).