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Drug Catalog - Product Detail

HYOSCYAMINE TAB 0.125MG 100CT

NDC Mfr Size Str Form
76439-0308-10 VIRTUS PHARMACEUTICALS OPCO 100 0.125MG TABLET
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Description
DESCRIPTION Hyoscyamine Sulfate Tablets, USP 0.125 mg are white, round, flat beveled edge tablets debossed “10” on one side. Scored on other side. Hyoscyamine Sulfate Tablets contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The molecular formula is (C 17 H 23 NO 3 ) 2 •H 2 SO 4 •2H 2 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 structural formula: Each tablet also contains as inactive ingredients: mannitol, croscarmellose sodium and magnesium stearate. Chemical Structure
How Supplied
HOW SUPPLIED Bottles of 100 NDC 76439-308-10 Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Dosage may be adjusted according to the conditions and severity of symptoms. Hyoscyamine Sulfate Tablets, USP must be taken orally. Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours. Pediatric patients 2 to under 12 years of age: ½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.