COMBIVENT RESPIMAT- ipratropium bromide and albuterol spray, metered

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL), ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)

Disponible desde:

Boehringer Ingelheim Pharmaceuticals Inc.

Designación común internacional (DCI):

IPRATROPIUM BROMIDE

Composición:

IPRATROPIUM BROMIDE ANHYDROUS 20 ug

Vía de administración:

RESPIRATORY (INHALATION)

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

COMBIVENT RESPIMAT is a combination of ipratropium bromide (an anticholinergic agent) and albuterol sulfate (a beta2 -adrenergic agonist) indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator. COMBIVENT RESPIMAT is contraindicated in the following conditions [see Warnings and Precautions (5.6) ]: - Hypersensitivity to any of the ingredients in COMBIVENT RESPIMAT - Hypersensitivity to atropine or any of its derivatives Risk Summary There are no randomized clinical studies of COMBIVENT RESPIMAT, or its individual components, ipratropium bromide and albuterol sulfate, in pregnant women. Ipratropium is negligibly absorbed systemically following oral inhalation; therefore, maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology (12.3)] . Published literature, including cohort studies, case control studies and case series, over s

Resumen del producto:

COMBIVENT RESPIMAT Inhalation Spray is supplied in a carton containing one COMBIVENT RESPIMAT cartridge and one COMBIVENT RESPIMAT inhaler. The COMBIVENT RESPIMAT cartridge is provided as an aluminum cylinder with a tamper protection seal on the cap. The COMBIVENT RESPIMAT cartridge is only intended for use with the COMBIVENT RESPIMAT inhaler. The COMBIVENT RESPIMAT inhaler is a cylindrical shaped plastic inhalation device with a gray colored body and a clear base. The clear base is removed to insert the cartridge. The inhaler contains a dose indicator. The orange-colored cap and the written information on the label of the gray inhaler body indicate that it is labeled for use with the COMBIVENT RESPIMAT cartridge. COMBIVENT RESPIMAT Inhalation Spray is available as: COMBIVENT RESPIMAT Inhalation Spray: 120 metered actuations (NDC 0597-0024-02)) The COMBIVENT RESPIMAT cartridge has a net fill weight of 4 grams and when used with the COMBIVENT RESPIMAT inhaler, is designed to deliver the labeled number of  metered actuations after preparation for use. Each actuation from the COMBIVENT RESPIMAT inhaler delivers 20 mcg ipratropium bromide (monohydrate) and 100 mcg albuterol (equivalent to 120 mcg albuterol sulfate) from the mouthpiece. When the labeled number of metered actuations has been dispensed from the inhaler, the RESPIMAT locking mechanism will be engaged and no more actuations can be dispensed. After assembly, the COMBIVENT RESPIMAT inhaler should be discarded at the latest 3 months after first use or when the locking mechanism is engaged, whichever comes first. Keep out of reach of children. Do not spray into eyes. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Avoid freezing.

Estado de Autorización:

New Drug Application

Ficha técnica

COMBIVENT RESPIMAT- IPRATROPIUM BROMIDE AND ALBUTEROL SPRAY, METERED
BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COMBIVENT RESPIMAT
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR COMBIVENT
RESPIMAT.
COMBIVENT RESPIMAT (IPRATROPIUM BROMIDE AND ALBUTEROL INHALATION
SPRAY), FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
COMBIVENT RESPIMAT Inhalation Spray is a combination of ipratropium
bromide (an anticholinergic agent)
and albuterol sulfate (a beta ‑adrenergic agonist) indicated for:
Patients with chronic obstructive pulmonary disease (COPD) on a
regular aerosol bronchodilator who
continue to have evidence of bronchospasm and who require a second
bronchodilator (1)
DOSAGE AND ADMINISTRATION
For oral inhalation only
One inhalation four times a day, not to exceed six inhalations in 24
hours (2)
DOSAGE FORMS AND STRENGTHS
Inhalation spray: 20 mcg ipratropium bromide (monohydrate) and 100 mcg
albuterol (equivalent to 120
mcg albuterol sulfate) per actuation with the COMBIVENT RESPIMAT
inhaler (3)
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients in COMBIVENT RESPIMAT (4)
Hypersensitivity to atropine or any of its derivatives (4)
WARNINGS AND PRECAUTIONS
Paradoxical bronchospasm: Discontinue COMBIVENT RESPIMAT immediately
and treat with alternative
therapy if paradoxical bronchospasm occurs (5.1)
Patients with cardiovascular system disorders: Use with caution
because of beta-adrenergic stimulation
(5.2)
Ocular effects: Advise patients to avoid spraying into eyes and to
contact a physician if blurred vision,
halos, or other visual disturbances occur. Monitor patients with
narrow-angle glaucoma. (5.3)
Urinary retention: Use with caution in patients with prostatic
hyperplasia or bladder-neck obstruction
(5.4)
Hypersensitivity reactions including anaphylaxis: Discontinue
COMBIVENT RESPIMAT and institute
alternative therapy if immediate hypersensitivity reacti