ATROVENTHFA- ipratropium bromide aerosol, metered

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM BROMIDE - UNII:J697UZ2A9J)

Tilgjengelig fra:

Physicians Total Care, Inc.

INN (International Name):

IPRATROPIUM BROMIDE

Sammensetning:

IPRATROPIUM BROMIDE 17 ug

Administreringsrute:

RESPIRATORY (INHALATION)

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

ATROVENT HFA Inhalation Aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. ATROVENT HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to ipratropium bromide or other ATROVENT HFA Inhalation Aerosol components. ATROVENT HFA Inhalation Aerosol is also contraindicated in patients who are hypersensitive to atropine or its derivatives. Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol Read complete instructions carefully before using. Important Points to Remember About Using ATROVENT HFA Inhalation Aerosol    Although ATROVENT HFA Inhalation Aerosol may taste and feel different    when breathed in compared to your Atrovent® (ipratropium    bromide) Inhalation Aerosol CFC inhaler, they contain the same    medicine.    You do not have to shake the ATROVENT HFA Inhalation Aerosol canister    before using it.    ATROVENT HFA Inhala

Produkt oppsummering:

ATROVENT HFA Inhalation Aerosol is supplied in a 12.9 g pressurized stainless steel canister as a metered-dose inhaler with a white mouthpiece that has a clear, colorless sleeve and a green protective cap (NDC 54868-5511-0 ). The ATROVENT HFA Inhalation Aerosol canister is to be used only with the accompanying ATROVENT HFA Inhalation Aerosol mouthpiece. This mouthpiece should not be used with other aerosol medications. Similarly, the canister should not be used with other mouthpieces. Each actuation of ATROVENT HFA Inhalation Aerosol delivers 21 mcg of ipratropium bromide from the valve and 17 mcg from the mouthpiece. Each 12.9 gram canister provides sufficient medication for 200 actuations. The canister should be discarded after the labeled number of actuations has been used. The amount of medication in each actuation cannot be assured after this point, even though the canister is not completely empty. Store at 25°C (77°F); excursions permitted to 15 °-30 °C (59 °-86 °F) [see USP Controlled Room Temperature]. For optimal results, the canister should be at room temperature before use. Address medical inquiries to: http://us.boehringer-ingelheim.com, [phone] or [phone] TTY. Patients should be reminded to read and follow the accompanying “Patient's Instructions for Use ”, which should be dispensed with the product. Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw the inhaler into a fire or incinerator. Warning: Keep out of children's reach. Avoid spraying in eyes. Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA Licensed from: Boehringer Ingelheim International GmbH Copyright 2010 Boehringer Ingelheim International GmbH ALL RIGHTS RESERVED Rev: July 2010 IT1902GG1710 10003001/06 Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, OK      74146

Autorisasjon status:

New Drug Application

Preparatomtale

ATROVENTHFA - IPRATROPIUM BROMIDE AEROSOL, METERED
PHYSICIANS TOTAL CARE, INC.
----------
ATROVENT HFA
(IPRATROPIUM BROMIDE HFA)
INHALATION AEROSOL
_ATTENTION PHARMACIST: DETACH "PATIENT'S INSTRUCTIONS FOR USE" FROM
PACKAGE INSERT AND_
_DISPENSE WITH THE PRODUCT._
FOR ORAL INHALATION ONLY
PRESCRIBING INFORMATION
DESCRIPTION
The active ingredient in ATROVENT HFA Inhalation Aerosol is
ipratropium bromide (as the
monohydrate). It is an anticholinergic bronchodilator chemically
described as 8-
azoniabicyclo[3.2.1]octane,
3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-
,bromide monohydrate, (3-endo, 8-syn)-: a synthetic quaternary
ammonium compound, chemically related
to atropine. The structural formula for ipratropium bromide is:
C
H BrNO •H O ipratropium bromide Mol. Wt. 430.4
Ipratropium bromide is a white to off-white crystalline substance,
freely soluble in water and methanol,
sparingly soluble in ethanol, and insoluble in lipophilic solvents
such as ether, chloroform, and
fluorocarbons.
ATROVENT HFA Inhalation Aerosol is a pressurized metered-dose aerosol
unit for oral inhalation
that contains a solution of ipratropium bromide. The 200 inhalation
unit has a net weight of 12.9 grams.
After priming, each actuation of the inhaler delivers 21 mcg of
ipratropium bromide from the valve in
56 mg of solution and delivers 17 mcg of ipratropium bromide from the
mouthpiece. The actual amount
of drug delivered to the lung may depend on patient factors, such as
the coordination between the
actuation of the device and inspiration through the delivery system.
The excipients are HFA-134a
(1,1,1,2-tetrafluoroethane) as propellant, sterile water, dehydrated
alcohol, and anhydrous citric acid.
This product does not contain chlorofluorocarbons (CFCs) as
propellants.
Atrovent
HFA (ipratropium bromide HFA) Inhalation Aerosol should be primed
before using for the
first time by releasing 2 test sprays into the air away from the face.
In cases where the inhaler has not
been used for more than 3 days, prime the inhaler