Usual Adult Dose for Asthma

Albuterol 180 mcg-budesonide 160 mcg oral inhalation as needed
(Administered as 2 actuations of this product)

Maximum dose: 6 doses (12 inhalations) a day

Comments:

• This product delivers a combination of albuterol (90 mcg) and budesonide (80 mcg) with a single actuation.
• Prime the product prior to using it for the first time to ensure appropriate product content in each actuation.
• To prime this product, release 4 sprays into the air away from the face, shaking well before each spray.
• When used in geriatric patients with concomitant cardiovascular disease, use with caution.
• Shake well before using.

Renal Dose Adjustments

Caution is recommended when administering high doses of this product to patients with renal impairment.

Liver Dose Adjustments

Dose adjustment may be required. However, no specific guidelines have been suggested.

Precautions

CONTRAINDICATIONS:
Hypersensitivity to the active component or any of the ingredients

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

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For oral inhalation use only.
• Avoid using or storing near heat or an open flame.
• Reprime the inhaler after cleaning or if it is not used for more than seven days, or if it is dropped.
• To re-prime this product, release 2 sprays into the air away from the face, shaking well before each spray.

• Store at 20C to 25C (68F to 77F); excursions are permitted to 15C to 30C (59F to 86F).
• Store in a dry place away from heat and sunlight.

• Exposure to temperatures above 49C (120F) may cause bursting.
• Do not put the canister in a fire or incinerator. Avoid getting spray in your eyes.

• Read the US FDA-approved patient labeling (Medication Guide).
• Watch out for the number of inhalations remaining in the canister using a dose indicator attached to the canister when nearing the end of the usable inhalations.
• Discard this product when the pointer reaches zero or 12 months after removal of the foil pouch, whichever comes first.
• Do not immerse the canister in water to determine the amount remaining in the canister ("float test").
• Shake well before using.
• Seek medical attention immediately if treatment with this product becomes less effective or symptoms worsen.
• Discontinue treatment with this product and contact healthcare provider if paradoxical bronchospasm develops.
• The recommended dose should not be exceeded.
• If hypersensitivity reactions occur, contact the healthcare provider and discontinue use of this product.
• Avoid exposure to chickenpox or measles during treatment with immunosuppressive doses of corticosteroids and, if exposed, consult the physician immediately due to the risk of new or worsening infections.
• Rinse mouth with water, if available, after each inhalation to help reduce the risk of thrush.
• This product may cause systemic corticosteroid effects such as hypercorticism and adrenal suppression.
• This product may also increase the risk of bone mineral density loss.
• Long-term use of this product may increase the risk of increased intraocular pressure, glaucoma, and cataracts; therefore, consider regular eye examinations.