Hyoscyamine Sulfate

INDICATIONS AND USAGE This product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. Along with appropriate analgesics, this product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis. This product is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis and other functional gastrointestinal disorders.

DOSAGE AND ADMINISTRATION Usual dosage: Adults and children over 12 years of age: 1 or 2 tablets every 12 hours. Dosage may be adjusted to 1 tablet every 8 hours if needed. Do not exceed 4 tablets in 24 hours. Tablets should be swallowed whole. Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.

WARNINGS Heat prostration can occur with drug use in the event of high environmental temperature. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, treatment would be inappropriate and possibly harmful. This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous tasks while taking this drug.

CONTRAINDICATIONS Glaucoma, obstructive uropathy, obstructive diseases of the gastrointestinal tract, paralytic ileum, intestinal atony of elderly or debilitated patients, unstable cardiovascular status, severe ulcerative colitis, toxic megacolon, myasthenia gravis, and myocardial ischemia. This product is not recommended for use in children under twelve years of age.

Drug Interactions: Absorption of other oral medications may be decreased during concurrent use with anticholinergics due to decreased gastrointestinal motility and delayed gastric emptying. Drug interactions may occur when anticholinergics are used with the following medications: antacids, antidiarrheals (adsorbent), other anticholinergics, antimyasthenics, cyclopropane, haloperidol, ketoconazole, metoclopramide, opioid (narcotic) analgesics, and potassium chloride.

Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine crosses the placenta. This product should be given to a pregnant woman only if clearly needed.

Nursing Mothers: This product is excreted in human milk. This product should not be administered to a nursing mother.

ADVERSE REACTIONS Not all of the following adverse reactions have been reported with hyoscyamine sulfate. The following adverse reactions have been reported for pharmacologically similar drugs with anticholinergic-antispasmodic action. Adverse reactions may include dryness of the mouth, urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; cycloplegia; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; 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); and decreased sweating. To report SUSPECTED ADVERSE REACTIONS, contact Laser Pharmaceuticals, LLC at 1-844-302-5227 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.