ipratropium bromide- Ipratropium Bromide solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

Ipratropium Bromide (UNII: J697UZ2A9J) (Ipratropium cation - UNII:GR88G0I6UL)

Dostupné s:

Cobalt Laboratories, Inc.

INN (Mezinárodní Name):

Ipratropium Bromide

Léková forma:

SOLUTION

Složení:

0.5 mg in 2.5 mL

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.

Přehled produktů:

Ipratropium Bromide Inhalation Solution 0.02% is supplied as a clear, colorless solution in 2.5 mL unit dose vials. 25 unit dose vials per carton, 1 pouch of 25 per carton - NDC 16252-098-22 30 unit dose vials per carton, 1 pouch of 30 per carton - NDC 16252-098-33 60 unit dose vials per carton, 2 pouches of 30 per carton - NDC 16252-098-66 120 unit dose vials per carton, 4 pouches of 30 per carton - NDC 16252-098-11 360 unit dose vials per carton, 12 pouches of 30 per carton - NDC 16252-098-13 Each vial is made from a low density polyethylene (LDPE) resin. Store between 20°C - 25°C (68°F - 77°F) [Excursions between 15°C - 30°C (59°F - 86°F) are acceptable. [See USP Controlled Room Temperature.] Protect from light. Store unused vials in the foil pouch. Attention Pharmacist Detach “Patient’s Instructions for Use” from the package insert and dispense with solution. Manufactured by: Cardinal Health 2200 Lake Shore Drive Woodstock, IL 60098 USA Manufactured for: Cobalt Laboratories, Inc. 24840 S. Tamiami Trail, Suite 1 Bonita Springs, FL 34134

Charakteristika produktu

IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SOLUTION
COBALT LABORATORIES, INC.
----------
Prescribing Information
RX ONLY
DESCRIPTION
The active ingredient in Ipratropium Bromide Inhalation Solution is
ipratropium bromide monohydrate. It
is an anticholinergic bronchodilator chemically described as
8-azoniabicyolo[3.2.1]-octane, 3-(3-
hydroxy-1-oxo-2-phenyl-propoxy)-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 is administered by oral
inhalation with the aid of a nebulizer. It
contains ipratropium bromide 0.02% (anhydrous basis) in a sterile,
isotonic saline solution, pH-adjusted
to 3.4 (3 to 4) with hydrochloric acid.
CLINICAL PHARMACOLOGY
Ipratropium bromide 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) that are caused by interaction of
acetylcholine with the muscarinic
receptor on bronchial smooth muscle.
The bronchodilation following inhalation of ipratropium bromide 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 the gastrointestinal tract. The
half life of elimination is about 1.6 hours after intravenous
administration. Ipratropiurn bromide is
minimally (0 to 9% in vitro) bound to plasma albumi