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. IPRATROPIUM BROMIDE   INHALATION SOLUTION 0.02%   Read complete instructions carefully before using. Note: Use only as directed by your physician.  More frequent administration or higher  doses are not recommended. Ipratropium  Bromide Inhalation Solution can be mixed in  the nebulizer with albuterol or metaproterenol  if used within one hour but not with  other drugs. Drug stability and safety of  Ipratropium Bromide Inhalation Solution  when mixed with other drugs in the nebulizer  have not been established.   Store between 59°F (15°C) and 86°F (30°C). Protect from l

Product summary:

Ipratropium Bromide Inhalation Solution Unit Dose Vial is supplied as a 0.02% clear, colorless solution containing 2.5 mL. NDC 68788-6897-2, 25 vials in a foil pouch Each vial is made from a low density polyethylene (LDPE) resin. Vials are supplied in a foil pouch. Store between 59°F (15°C) and 86°F (30°C).   Protect from light.   Store unused vials in the foil pouch.   ATTENTION PHARMACIST: Detach “Patient’s Instructions for Use” from Package Insert and dispense with solution. Rx Only  Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Manufactured by: The Ritedose Corporation  Columbia, SC 29203 APRIL 2017 Relabeled By: Preferred Pharmaceuticals Inc.

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%
PRESCRIBING INFORMATION
RX ONLY
RPIN0020
Ipratropium Bromide Inhalation Solution, 0.02%
Prescribing Information
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 gastroin