IPRATROPIUM BROMIDE solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)

Dostupné s:

Sun Pharmaceutical Industries, Inc.

Podání:

RESPIRATORY (INHALATION)

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. Ipratropium bromide is contraindicated in known or suspected cases of hypersensitivity to ipratropium bromide, or to atropine and its derivatives. Ipratropium Bromide (IH-pruh-TROE-pee-uhm BROE-mide)  Inhalation Solution, USP 0.02% Read complete instructions carefully before using. 1. Remove vial from the foil pouch. 2. Twist open the top of one unit dose vial and squeeze the contents into the nebulizer reservoir (Figure 1). 3. Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2). 4. Connect the nebulizer to the compressor. 5. Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) or put on the face mask and turn on the compressor. If a face mask is used, ca

Přehled produktů:

Ipratropium Bromide Inhalation Solution, USP is a clear, colorless solution supplied in a unit-dose vial containing 2.5 mL. Supplied in cartons as listed below: NDC 47335-706-49    carton of 25 vials (5 vials per foil pouch) NDC 47335-706-52    carton of 30 vials (5 vials per foil pouch) NDC 47335-706-54    carton of 60 vials (5 vials per foil pouch) Each vial is made from a low density polyethylene (LDPE) resin. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in pouch until time of use. Dispense with Patient's Instructions For Use available at: https://www.sunpharma.com/usa/products

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

IPRATROPIUM BROMIDE - IPRATROPIUM BROMIDE SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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IPRATROPIUM BROMIDE INHALATION SOLUTION, USP 0.02%
RX ONLY
PRESCRIBING INFORMATION
FOR INHALATION USE ONLY–NOT FOR INJECTION.
DESCRIPTION
The active ingredient in Ipratropium Bromide Inhalation Solution, USP
is ipratropium
bromide monohydrate, USP. 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 (endo, syn)-,(±)-; a synthetic
quaternary
ammonium compound, chemically related to atropine.
Ipratropium bromide is a white crystalline substance, freely soluble
in water and lower
alcohols. It is a quaternary ammonium compound and thus exists in an
ionized state in
aqueous solutions. It is relatively insoluble in non-polar media.
Ipratropium Bromide Inhalation Solution, USP is administered by oral
inhalation with the
aid of a nebulizer. Each mL contains ipratropium bromide, USP 0.02%
(anhydrous basis)
in a sterile, preservative-free, isotonic saline solution, pH adjusted
to 3.4 (3 to 4) with
hydrochloric acid.
CLINICAL PHARMACOLOGY
Ipratropium Bromide Inhalation Solution is an anticholinergic
(parasympatholytic) agent
that, based on animal studies, appears to inhibit vagally-mediated
reflexes by
antagonizing the action of acetylcholine, the transmitter agent
released from the vagus
nerve.
Anticholinergics prevent the increases in intracellular concentration
of cyclic guanosine
monophosphate (cyclic GMP) which are caused by interaction of
acetylcholine with the
muscarinic receptor on bronchial smooth muscle.
The bronchodilation following inhalation of Ipratropium Bromide
Inhalation Solution is
primarily a local, site-specific effect, not a systemic one. Much of
an administered dose is
swallowed but not absorbed as shown by fecal excretion studies.
Following nebulization
of a 2 mg dose, a mean 7% of the dose was absorbed into the systemic
circulation
either from the surface of the lung or from