BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE aerosol

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X), FORMOTEROL FUMARATE (UNII: W34SHF8J2K) (FORMOTEROL - UNII:5ZZ84GCW8B)

Inapatikana kutoka:

REMEDYREPACK INC.

Njia ya uendeshaji:

RESPIRATORY (INHALATION)

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is indicated for the treatment of asthma in patients 6 years of age and older. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (LABA). Important Limitations of Use: - BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is NOT indicated for the relief of acute bronchospasm. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 is also indicated to reduce exacerbations of COPD. BUDESONIDE AND FORMOTEROL

Bidhaa muhtasari:

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is available in BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160mcg/4.5mcg 120 Inhalations NDC: 70518-3107-00 PACKAGING: 1 in 1 CARTON, 1 in 1 POUCH, 120 in 1 CANISTER TYPE 2 Each strength is supplied as a pressurized aluminum canister with an attached counting device, a red plastic actuator body with a white mouthpiece, and attached gray dust cap. Each 120 inhalation canister has a net fill weight of 10.2 grams. Each canister is packaged in a foil overwrap pouch with desiccant sachet and placed into a carton. Each carton contains one canister and a Patient Information leaflet. The BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL canister should only be used with the BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL actuator, and the BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL actuator should not be used with any other inhalation drug product. The correct amount of medication in each inhalation cannot be ensured after the labeled number of inhalations from the canister have been used, even though the inhaler may not feel completely empty and may continue to operate. The inhaler should be discarded when the labeled number of inhalations have been used or within 3 months after removal from the foil pouch. Never immerse the canister into water to determine the amount remaining in the canister (“float test”). Store at controlled room temperature 20°C to 25°C (68°F to 77°F) [see USP]. Store the inhaler with the mouthpiece down. For best results, the canister should be at room temperature before use. Shake well for 5 seconds before using. Keep out of the reach of children. Avoid spraying in eyes. CONTENTS UNDER PRESSURE. Do not puncture or incinerate. Do not store near heat or open flame. Exposure to temperatures over 120ºF may cause bursting. Never throw container into fire or incinerator. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Idhini hali ya:

New Drug Application Authorized Generic

Tabia za bidhaa

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE- BUDESONIDE AND
FORMOTEROL FUMARATE DIHYDRATE AEROSOL
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUDESONIDE AND
FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR BUDESONIDE AND FORMOTEROL FUMARATE
DIHYDRATE
INHALATION AEROSOL.
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL, FOR
ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is a
combination product
containing a corticosteroid and a long-acting beta
-adrenergic agonist indicated for:
Treatment of asthma in patients 6 years of age and older. ( 1.1)
Maintenance treatment of airflow obstruction and reducing
exacerbations in patients with chronic
obstructive pulmonary disease (COPD) including chronic bronchitis
and/or emphysema. ( 1.2)
Important limitations:
Not indicated for the relief of acute bronchospasm. ( 1.1, 1.2)
DOSAGE AND ADMINISTRATION
For oral inhalation only.
Treatment of asthma in patients 12 years and older: 2 inhalations of
BUDESONIDE AND FORMOTEROL
FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 or 160/4.5 twice daily.
Starting dosage is based on
asthma severity. ( 2.2)
Treatment of asthma in patients aged 6 to less than 12 years: 2
inhalations of BUDESONIDE AND
FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 80/4.5 twice daily. (
2.2)
Maintenance treatment in COPD: 2 inhalations of BUDESONIDE AND
FORMOTEROL FUMARATE
DIHYDRATE INHALATION AEROSOL 160/4.5 twice daily. ( 2.3)
DOSAGE FORMS AND STRENGTHS
Metered-dose inhaler containing a combination of budesonide (80 or 160
mcg) and formoterol (4.5 mcg)
as an inhalation aerosol. (3)
CONTRAINDICATIONS
Primary treatment of status asthmaticus or acute episodes of asthma or
COPD requiring intensive
measures. ( 4)
Hypersensitivity to any of the ingredients in BUDESONIDE AND
FORMOTEROL FUMARATE DIHYDRATE
INHALATION AEROS