IPRATROPIUM BROMIDE solution
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
04-02-2023
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Active ingredient:
IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)
Available from:
A-S Medication Solutions
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. Ipratropium Bromide Inhalation Solution 0.02% Read complete instructions carefully before using. - Twist open the top of one unit dose vial and squeeze the contents into the nebulizer reservoir. (Figure 1). - Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2). - Connect the nebulizer to the compressor. - 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, care should be taken to avoid leakage around the mask as temporary blu
Product summary:
Product: 50090-0668 NDC: 50090-0668-0 25 mL in a POUCH / 1 in a CARTON
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SOLUTION
A-S MEDICATION SOLUTIONS
----------
IPRATROPIUM BROMIDE INHALATION SOLUTION 0.02%
PRESCRIBING INFORMATION
RX ONLY
DESCRIPTION
The active ingredient, ipratropium bromide monohydrate, USP, 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 Monohydrate C
H
BrNO
•H
O Mol.Wt. 430.4
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, 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 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 adm
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