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:

Chartwell RX, LLC

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: NDC 62135-830-84, 6 foil pouches, each containing 5 vials, total 30 vials per carton Each vial is made from a low density polyethylene (LDPE) resin. Storage and Handling 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 for: Chartwell RX, LLC. Congers, NY 10920 L71925 Revised: 01/2024

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SOLUTION
CHARTWELL RX, LLC
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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 hours after intra