SYMBICORT- budesonide and formoterol fumarate dihydrate aerosol

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

REMEDYREPACK INC.

Spôsob podávania:

RESPIRATORY (INHALATION)

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

SYMBICORT is indicated for the treatment of asthma in patients 6 years of age and older. SYMBICORT 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: - SYMBICORT is NOT indicated for the relief of acute bronchospasm. SYMBICORT 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. SYMBICORT 160/4.5 is also indicated to reduce exacerbations of COPD. SYMBICORT 160/4.5 is the only strength indicated for the treatment of COPD. Important Limitations of Use: - SYMBICORT is NOT indicated for the relief of acute bronchospasm. The use of SYMBICORT is contraindicated in the following conditions: - Primary treatment of status asthmaticus or other acu

Prehľad produktov:

SYMBICORT is available in two strengths and is supplied in the following package sizes: SYMBICORT Inhalations STRENGTH 160/4.5 DOSE 120 NDC: 70518-2696-00 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 and each 60 inhalation canister has a net fill weight of 6.9 grams (SYMBICORT 80/4.5) or 6 grams (SYMBICORT 160/4.5). 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 SYMBICORT canister should only be used with the SYMBICORT actuator, and the SYMBICORT 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

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

SYMBICORT- BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE AEROSOL
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SYMBICORT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SYMBICORT.
SYMBICORT (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE) INHALATION AEROSOL,
FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
SYMBICORT 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
SYMBICORT 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 SYMBICORT 80/4.5 twice
daily. ( 2.2)
Maintenance treatment in COPD: 2 inhalations of SYMBICORT 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 SYMBICORT. ( 4)
WARNINGS AND PRECAUTIONS
Serious asthma-related events: Long-acting beta2-adrenergic agonists
as monotherapy increase the
risk. (5.1)
Deterioration of disease and acute episodes: Do not initiate in
acutely deteriorating asthma or COPD or
to treat acute symptoms. ( 5.2)
Use with additional long-acting beta
-agonist: Do not use in combination because of risk of overdose. (
5.3)
Localized inf