IPRATROPIUM BROMIDE- ipratropium bromide solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Preferred Pharmaceuticals, Inc.

SNN (starptautisko nepatentēto nosaukumu):

Ipratropium Bromide

Kompozīcija:

IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg in 2.5 mL

Ievadīšanas:

RESPIRATORY (INHALATION)

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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°). Protect from light. Store unused

Produktu pārskats:

Ipratropium Bromide Inhalation Solution Unit Dose Vial is supplied as a 0.02% clear, colorless solution containing 2.5 mL. 25 Vials - NDC 68788-9775-2 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.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SOLUTION
PREFERRED PHARMACEUTICALS, INC.
----------
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 intraven