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:

Aurobindo Pharma Limited

INN (International Name):

IPRATROPIUM BROMIDE

Composition:

IPRATROPIUM BROMIDE 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. 1. Remove vial from the foil pouch. 2. Twist open the top of one unit dose vial and squeeze the contents into the nebulizer reservoir (Figure 1). 3. Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2). 4. Connect the nebulizer to the compressor. 5. 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

Product summary:

Ipratropium Bromide Inhalation Solution is a clear, colorless solution supplied in a unit-dose vial containing 2.5 mL. Supplied in cartons as listed below: 0.02% (0.5 mg/2.5 mL)          NDC 65862-905-25                    25 vials per carton / 25 vials per foil pouch          NDC 65862-905-30                    30 vials per carton / 30 vials per foil pouch          NDC 65862-905-60                    60 vials per carton / 30 vials per foil pouch          NDC 65862-905-03                    30 vials per carton / 1 vial per foil pouch Each vial is made from a low density polyethylene (LDPE) resin. Vials are supplied in a foil pouch. Store between 15° and 30°C (59° and 86°F). Protect from light. S tore in pouch until time of use.   ATTENTION PHARMACIST: Detach “Patient’s Instructions for Use” from Package Insert and dispense with solution.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SOLUTION
AUROBINDO PHARMA LIMITED
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IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02%
FOR INHALATION USE ONLY – NOT FOR INJECTION.
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
The active ingredient in Ipratropium Bromide Inhalation Solution is
ipratropium bromide
monohydrate, USP. 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 USP is a white to off-white crystalline powder,
soluble in water,
freely soluble in methanol and slightly soluble in ethanol. It is a
quaternary ammonium
compound and thus exists in an ionized state in aqueous solutions. It
is insoluble in
isopropyl alcohol, chloroform, methylene chloride and benzene.
Ipratropium Bromide Inhalation Solution is administered by oral
inhalation with the aid of
a nebulizer. Each mL 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 Inhalation Solution 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) which 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 syst