IPRATROPIUM BROMIDE- ipratropium bromide solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc

INN (International Name):

IPRATROPIUM BROMIDE

Composition:

IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg in 2.5 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Ipratropium bromide inhalation solution is a clear, colorless solution containing 2.5 mL, packaged in cartons as listed below: 25 vials per carton / 25 vials per foil pouch - 68788-0547-2 Each vial is made from a low density polyethylene (LDPE) resin. Store between 15° C and 30° C (59° F and 86° F). Protect from light. Store in pouch until time of use. Rx Only Manufactured By: Nephron Pharmaceuticals Corporation Orlando, FL 32811

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SOLUTION
PREFERRED PHARMACEUTICALS, INC
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IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02%
FOR INHALATION USE ONLY – NOT FOR INJECTION
DESCRIPTION
The active ingredient in ipratropium bromide inhalation solution is
ipratropium bromide 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 ( _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.
Each mL contains ipratropium bromide 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 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
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 the
gastrointestinal tract. The half-life of elimination is about 1.6
hour