IPRATROPIUM BROMIDE solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)

Dostupné s:

Physicians Total Care, Inc.

Podání:

RESPIRATORY (INHALATION)

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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. Read complete instructions carefully before using. - Remove vial pouch from the foil pouch. - 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 vi

Přehled produktů:

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: NDC 54868-4082-1 25 vials per carton/5 vials per foil pouch NDC 54868-4082-0 60 vials per carton/5 vials per foil pouch Each vial is made from a low density polyethylene (LDPE) resin. Store between 15° and 30°C (59° and 86°F). Protect from light. Store in pouch until time of use. ATTENTION PHARMACIST: Detach "Patient's Instructions for Use" from Package Insert and dispense with solution. Rx only. DEY® , Napa, CA 94558 03-343-22 JAN 06

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

IPRATROPIUM BROMIDE - IPRATROPIUM BROMIDE SOLUTION
PHYSICIANS TOTAL CARE, INC.
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PRESCRIBING INFORMATION
FOR INHALATION USE ONLY–NOT FOR INJECTION.
DESCRIPTION
The active ingredient in Ipratropium Bromide Inhalation Solution is
ipratropium bromide monohydrate. 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 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.
Each mL contains ipratropium bromide 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 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 in