PULMICORT FLEXHALER- budesonide aerosol, powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)

Available from:

Rebel Distributors Corp

INN (International Name):

BUDESONIDE

Composition:

BUDESONIDE 90 ug

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older. Important Limitations of Use: The use of PULMICORT FLEXHALER is contraindicated in the following conditions: Teratogenic Effects: Pregnancy Category B Studies of pregnant women, have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. The results from a large population-based prospective cohort epidemiological study reviewing data from three Swedish registries covering approximately 99% of the pregnancies from 1995-1997 (i.e., Swedish Medical Birth Registry; Registry of Congenital Malformations; Child Cardiology Registry) indicate no increased risk for congenital malformations from the use of inhaled budesonide during early pregnancy. Congenital malformations were studied in 2014 infants born to mothers reporting the use of inhaled budesonide for asthma in early pregnancy (usually 10-12 weeks after the last menstrual perio

Product summary:

PULMICORT FLEXHALER is available as a dry powder for inhalation containing budesonide in the following strength: 90 mcg. Each dosage strength contains 60 actuations per device. 90 mcg/dose, 60 dose (NDC 21695-291-01) with a target fill weight of 165 mg (range 140-190). PULMICORT FLEXHALER consists of a number of assembled plastic details, the main parts being the dosing mechanism, the storage unit for drug substance, and the mouthpiece. The inhaler is protected by a white outer tubular cover screwed onto the inhaler. The body of the inhaler is white and the turning grip is brown. The PULMICORT FLEXHALER inhaler cannot be refilled and should be discarded when empty. The number in the middle of the dose indicator window shows how many doses are left in the inhaler. The inhaler is empty when the number zero (“0”) on the red background reaches the middle of the window. If the unit is used beyond the point at which the zero reaches the middle of the window, the correct amount of medication may not be obtained and the unit should be discarded. Store in a dry place at controlled room temperature 20-25°C (68-77°F) [see USP] with the cover tightly in place. Keep out of the reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

PULMICORT FLEXHALER- BUDESONIDE AEROSOL, POWDER
REBEL DISTRIBUTORS CORP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PULMICORT FLEXHALER™ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PULMICORT
FLEXHALER™.
PULMICORT FLEXHALER™ 90 MCG, 180 MCG (BUDESONIDE INHALATION POWDER)
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
PULMICORT FLEXHALER is a corticosteroid indicated for: (1)
• Maintenance treatment of asthma as prophylactic therapy in adult
and pediatric patients six years of age or older. (1.1) (1)
Important Limitations: (1)
• Not indicated for the relief of acute bronchospasm. (1.1) (1)
DOSAGE AND ADMINISTRATION
For oral inhalation only. (2)
Patients 18 Years of Age and Older: For patients 18 years of age and
older, the recommended starting dosage is 360 mcg
twice daily. In some adult patients, a starting dose of 180 mcg twice
daily may be adequate. The maximum dosage should
not exceed 720 mcg twice daily. (2.1) (2)
Patients 6 to 17 Years of Age: The recommended starting dosage is 180
mcg twice daily. In some pediatric patients, a
starting dose of 360 mcg twice daily may be appropriate. The maximum
dosage should not exceed 360 mcg twice daily.
(2.1) (2)
DOSAGE FORMS AND STRENGTHS
FLEXHALER device containing budesonide (90 mcg or 180 mcg) as an
inhalation powder. (3) (3)
CONTRAINDICATIONS
• Primary treatment of status asthmaticus or other acute episodes of
asthma where intensive measures are required. (4)
(4)
• Severe hypersensitivity to milk proteins and any of the
ingredients in PULMICORT FLEXHALER. (4) (4)
WARNINGS AND PRECAUTIONS
• Localized infections: _Candida albicans_ infection of the mouth
and throat may occur. Monitor patients periodically for
signs of adverse effects on the oral cavity. Advise patients to rinse
the mouth following inhalation. (5.1) (5)
• Deterioration of asthma or acute episodes: PULMICORT FLEXHALER
should not be used for relief of acute symptoms.
Patients require immediate re-e