Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
Ipratropium Bromide (UNII: J697UZ2A9J) (Ipratropium cation - UNII:GR88G0I6UL)
Cobalt Laboratories, Inc.
Ipratropium Bromide
SOLUTION
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 0.02% is supplied as a clear, colorless solution in 2.5 mL unit dose vials. 25 unit dose vials per carton, 1 pouch of 25 per carton - NDC 16252-098-22 30 unit dose vials per carton, 1 pouch of 30 per carton - NDC 16252-098-33 60 unit dose vials per carton, 2 pouches of 30 per carton - NDC 16252-098-66 120 unit dose vials per carton, 4 pouches of 30 per carton - NDC 16252-098-11 360 unit dose vials per carton, 12 pouches of 30 per carton - NDC 16252-098-13 Each vial is made from a low density polyethylene (LDPE) resin. Store between 20°C - 25°C (68°F - 77°F) [Excursions between 15°C - 30°C (59°F - 86°F) are acceptable. [See USP Controlled Room Temperature.] Protect from light. Store unused vials in the foil pouch. Attention Pharmacist Detach “Patient’s Instructions for Use” from the package insert and dispense with solution. Manufactured by: Cardinal Health 2200 Lake Shore Drive Woodstock, IL 60098 USA Manufactured for: Cobalt Laboratories, Inc. 24840 S. Tamiami Trail, Suite 1 Bonita Springs, FL 34134
IPRATROPIUM BROMIDE- IPRATROPIUM BROMIDE SOLUTION COBALT LABORATORIES, INC. ---------- Prescribing Information RX ONLY DESCRIPTION The active ingredient in Ipratropium Bromide Inhalation Solution is ipratropium bromide monohydrate. It is an anticholinergic bronchodilator chemically described as 8-azoniabicyolo[3.2.1]-octane, 3-(3- hydroxy-1-oxo-2-phenyl-propoxy)-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. It contains ipratropium bromide 0.02% (anhydrous basis) in a sterile, 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. Ipratropiurn bromide is minimally (0 to 9% in vitro) bound to plasma albumi Прочетете целия документ