দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)
Nephron Pharmaceuticals Corporation
IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDE ANHYDROUS 0.5 mg in 2.5 mL
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
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 is a clear, colorless solution containing 2.5 mL, packaged in cartons as listed below: NDC 0487-9801-25, 25 vials per carton / 5 vials per foil pouch NDC 0487-9801-30, 30 vials per carton / 5 vials per foil pouch NDC 0487-9801-60, 60 vials per carton / 5 vials per foil pouch NDC 0487-9801-01, 30 vials per carton / 1 vial per foil pouch Each vial is made from a low density polyethylene (LDPE) resin. Store between 15° C and 30° C (59° F and 86° F). Protect from light. Store in pouch until time of use. Rx Only Manufactured By: Nephron Pharmaceuticals Corporation West Columbia, SC 29172
Abbreviated New Drug Application
IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SOLUTION NEPHRON PHARMACEUTICALS CORPORATION ---------- IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02% 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 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 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 সম্পূর্ণ নথি পড়ুন