Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg are white, oval shaped, biconvex tablets debossed with “ CE ” on one side and “ 223 ” on the other side. Bottles of 60 (NDC 62135-860-60) Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Rx only. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 Rev. 06/2024 L72218; PRINCIPAL DISPLAY PANEL Hyoscyamine Sulfate Extended-Release Tablets 0.375 mg - NDC 62135-860-60 - 60s Bottle Label image description
- HOW SUPPLIED Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg are white, oval shaped, biconvex tablets debossed with “ CE ” on one side and “ 223 ” on the other side. Bottles of 60 (NDC 62135-860-60) Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Rx only. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 Rev. 06/2024 L72218
- PRINCIPAL DISPLAY PANEL Hyoscyamine Sulfate Extended-Release Tablets 0.375 mg - NDC 62135-860-60 - 60s Bottle Label image description
Overview
Hyoscyamine Sulfate Extended-Release Tablets contain 0.375 mg of 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 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 structure: Hyoscyamine Sulfate Extended-Release Tablets also contain as inactive ingredients: microcrystalline cellulose, Hydroxypropyl cellulose, colloidal silicon dioxide, and magnesium stearate. image description
Indications & Usage
Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It 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 is 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 & Administration
Dosage may be adjusted according to the conditions and severity of symptoms. Adults And Pediatric Patients 12 Years Of Age And Older 1 to 2 tablets every 12 hours. Do not crush or chew tablets. Do not exceed 4 tablets in 24 hours.
Warnings & Precautions
WARNINGS In the presence of high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Like other anticholinergic agents, hyoscyamine sulfate may produce drowsiness, dizziness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug. Psychosis has been reported in sensitive individuals given anticholinergic drugs. CNS signs and symptoms include confusion, disorientation, short term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.
Contraindications
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.
Adverse Reactions
All of the following adverse reactions have been reported with hyoscyamine sulfate. Adverse reactions may include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; constipation; bloated feeling; abdominal pain; diarrhea; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion and/or excitement (especially in elderly persons); short-term memory loss; hallucinations; and decreased sweating.
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