Hyosyne

INDICATIONS AND 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). Also used in the treatment of infant colic (elixir and drops). 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 AND ADMINISTRATION HYOSYNE ORAL DROPS (Hyoscyamine Sulfate Oral Solution) Dosage may be adjusted according to the conditions and severity of symptoms. Measure dosage very carefully. Adults and pediatric patients 12 years of age and older : 1 to 2 mL every four hours or as needed. Do not exceed 12 mL in 24 hours. Pediatric patients 2 to under 12 years of age : 1/4 to 1 mL every four hours or as needed. Do not exceed 6 mL in 24 hours. Pediatric patients under 2 years of age : The following dosage guide is based upon body weight. The doses may be repeated every four hours or as needed. Body Weight Usual Dose Do Not Exceed In 24 Hours 3.4 kg (7.5 lb.) 4 drops 24 drops 5 kg (11 lb.) 5 drops 30 drops 7 kg (15 lb.) 6 drops 36 drops 10 kg (22 lb.) 8 drops 48 drops Package of Hyoscyamine Sulfate Oral Drops is accompanied with a dropper having markings of 3, 4, 5 DROPS, and 0.25 mL. The approximate equivalent amount of hyoscyamine sulfate drops (mL) and its equivalent amount of hyoscyamine sulfate (mg) for each marking are as follows: Approximate Equivalent Amount Marking on Dropper Hyoscyamine Sulfate Oral Drops Solution (mL) Hyoscyamine Sulfate (mg) 3 DROPS 0.08 mL 0.01 mg 4 DROPS 0.11 mL 0.01375 mg 5 DROPS 0.14 mL 0.0175 mg 0.25 mL 0.25 mL 0.03125 mg HYOSYNE ELIXIR (Hyoscyamine Sulfate Elixir) Dosage may be adjusted according to the conditions and severity of symptoms. Measure dosage very carefully. Adults and pediatric patients 12 years of age and older : 1 to 2 teaspoonfuls every four hours or as needed. Do not exceed 12 teaspoonfuls in 24 hours. Pediatric patients 2 to under 12 years of age : Please see the following dosage guide is based on body weight. The doses may be repeated every four hours or as needed. Do not exceed 6 teaspoonfuls in 24 hours. Body Weigh t Usual Dose 10 kg (22 lb.) 1/4 teaspoon (1.25 mL) 20 kg (44 lb.) 1/2 teaspoonful (2.5 mL) 40 kg (88 lb.) 3/4 teaspoonful (3.75 mL) 50 kg (110 lb.) 1 teaspoonful (5 mL)

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.

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, decreased 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.

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.