PULMICORT FLEXHALER- budesonide aerosol, powder

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

AstraZeneca Pharmaceuticals LP

INN (nemzetközi neve):

BUDESONIDE

Összetétel:

BUDESONIDE 180 ug

Az alkalmazás módja:

RESPIRATORY (INHALATION)

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older. Limitations of Use: The use of PULMICORT FLEXHALER is contraindicated in the following conditions: Risk Summary There are no adequate well-controlled studies of PULMICORT FLEXHALER in pregnant women. However, there are published studies on the use of budesonide, the active ingredient in PULMICORT FLEXHALER, in pregnant women. In animal reproduction studies, budesonide, administered by the subcutaneous route, caused structural abnormalities, was embryocidal, and reduced fetal weights in rats and rabbits at less than the maximum recommended human daily inhalation dose (MRHDID), but these effects were not seen in rats that received inhaled doses approximately 2 times the MRHDID (see Data ). Studies of pregnant women have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. Experience with oral corticosteroids suggests that rod

Termék összefoglaló:

PULMICORT FLEXHALER is available as a dry powder for inhalation containing budesonide in the following 2 strengths: 90 mcg and 180 mcg. Each dosage strength contains 60 or 120 actuations per device. 180 mcg/dose (NDC 0186-0916-12) with a target fill weight of 225 mg (range 200-250), and 90 mcg/dose, 60 dose (NDC 0186-0917-06) 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.

Engedélyezési státusz:

New Drug Application

Termékjellemzők

PULMICORT FLEXHALER- BUDESONIDE AEROSOL, POWDER
ASTRAZENECA PHARMACEUTICALS LP
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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™ (BUDESONIDE) INHALATION POWDER
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
PULMICORT FLEXHALER is a corticosteroid indicated for:
•
Limitations of Use:
Not indicated for the relief of acute bronchospasm (1)
DOSAGE AND ADMINISTRATION
For oral inhalation only.
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•
DOSAGE FORMS AND STRENGTHS
FLEXHALER device containing budesonide (90 mcg or 180 mcg) as an
inhalation powder (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
•
Maintenance treatment of asthma as prophylactic therapy in adult and
pediatric patients six years of
age or older (1)
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)
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)
Primary treatment of status asthmaticus or other acute episodes of
asthma where intensive
measures are required (4)
Severe hypersensitivity to milk proteins and any of the ingredients in
PULMICORT FLEXHALER (4)
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)
Deterioration of Asthma or Acute Episodes: PULMICORT FLEXHALER should
not be used for relief of
acute symptoms. Patients require immediate re-evaluation during
rapidly deteriorat