Country: United States
Language: English
Source: NLM (National Library of Medicine)
HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X)
Carilion Materials Management
HYOSCYAMINE SULFATE
HYOSCYAMINE SULFATE 0.375 mg
ORAL
PRESCRIPTION DRUG
Hyoscyamine Sulfate Extended-Release Tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, 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 Extended-Release 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 red
NDC:68151-5182-0 in a PACKAGE of 1 TABLETS
unapproved drug other
HYOSCYAMINE SULFATE EXTENDED-RELEASE- HYOSCYAMINE SULFATE EXTENDED- RELEASE TABLET CARILION MATERIALS MANAGEMENT _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 EXTENDED-RELEASE TABLETS, 0.375 MG PI-9328 REV 02/09 RX ONLY DESCRIPTION Hyoscyamine Sulfate Extended-Release Tablets contain 0.375 mg hyoscyamine sulfate in a formulation designed for oral b.i.d. dosage. 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, α-(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: Colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate and microcrystalline cellulose. 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 the 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 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 3 1/2 hours. Hyoscyamine sulfate Read the complete document