IPRATROPIUM BROMIDE solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

Ipratropium Bromide (UNII: J697UZ2A9J) (Ipratropium - UNII:GR88G0I6UL)

Tilgængelig fra:

Sandoz Inc.

INN (International Name):

Ipratropium Bromide

Sammensætning:

Ipratropium Bromide 0.5 mg in 2.5 mL

Indgivelsesvej:

RESPIRATORY (INHALATION)

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 blurring of visio

Produkt oversigt:

Ipratropium Bromide Inhalation Solution Unit Dose Vial is supplied as a 0.02% clear, colorless solution containing 2.5 mL. NDC 0781-7157-86, 25 vials in a foil pouch. NDC 0781-7157-64, 30 vials in a foil pouch. NDC 0781-7157-29, 60 vials, two foil pouches of 30 each. 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.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SOLUTION
SANDOZ INC.
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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
administration. I