Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X)
Wallace Pharmaceuticals Inc.
HYOSCYAMINE SULFATE
HYOSCYAMINE SULFATE 0.125 mg
ORAL
PRESCRIPTION DRUG
Hyoscyamine sulfate tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Hyoscyamine sulfate tablets are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents. Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis); paralytic ileus, intestinal atony of elderly or debilitated patients; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.
Hyoscyamine Sulfate Tablets, USP 0.125 mg are round, blue colored tablets that are imprinted with “AP” on one side and “112” on the other. Bottles of 100 tablets NDC 51525-0112-1 Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Please refer to current USP. Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure. KEEP OUT OF REACH OF CHILDREN Also available as: Dosage Strength Package Size NDC Hyoscyamine Sulfate Sublingual Tablets 0.125 mg 100 51525-0113-1 Hyoscyamine Sulfate Extended-Release Tablets 0.375 mg 100 51525-0115-1 Distributed by: Wallace Pharmaceuticals Inc. Somerset, New Jersey 08873-4120 ©2018 Mylan Pharmaceuticals Inc. WALLACE and are trademarks of Wallace Pharmaceuticals Inc., a Mylan Company IN-1121-03 Rev. 3/2018 Printed in USA 70011272
unapproved drug other
HYOSCYAMINE- HYOSCYAMINE SULFATE TABLET WALLACE PHARMACEUTICALS INC. _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- HYOSCYAMINE SULFATE TABLETS, USP RX ONLY DESCRIPTION Hyoscyamine sulfate tablets, USP contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C H NO ) •H SO •2H O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, -(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure: Each tablet also contains as inactive ingredients: FD&C blue #1, lactose monohydrate, magnesium stearate, mannitol, starch and stearic acid. CLINICAL PHARMACOLOGY Hyoscyamine sulfate inhibits specifically the actions of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of the smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, and the exocrine glands. At therapeutic doses, it is completely devoid of any action on autonomic ganglia. Hyoscyamine sulfate inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. Hyoscyamine sulfate also controls excessive pharyngeal, tracheal and bronchial secretions. Hyoscyamine sulfate is absorbed totally and completely by sublingual administration as well as oral administration. Once absorbed, hyoscyamine sulfate disappears rapidly from the blood and is distributed throughout the entire body. The half-life of hyoscyamine sulfate is 2 to 3½ hours. Hyoscyamine sulfate is partly hydrolyzed to tropic acid and tropine but the majority of the drug is excreted in Lees het volledige document