HYOSCYAMINE SULFATE

Hyoscyamine Sulfate Oral Drops (Hyoscyamine Sulfate Oral Solution, USP) contains 0.125 mg hyoscyamine sulfate per mL with 5% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Elixir, USP (Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Tablets, USP contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Sublingual Tablets contain 0.125 mg hyoscyamine sulfate for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine Sulfate Orally Disintegrating Tablets contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. 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 Oral Drops also contain as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. Hyoscyamine Sulfate Elixir also contains as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose. Hyoscyamine Sulfate Tablets also contain as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Hyoscyamine Sulfate Sublingual Tablets also contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. Hyoscyamine Sulfate Orally Disintegrating Tablets also contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. "Structure"

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.

Hyoscyamine Sulfate Oral Drops (Hyoscyamine Sulfate Oral Solution, USP) 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 Use 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 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 Weight 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) Hyoscyamine Sulfate Tablets, 0.125 mg Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg Dosage may be adjusted according to the conditions and severity of symptoms. The sublingual tablets may be taken sublingually, orally or chewed. 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: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

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.

The following adverse reactions have been reported with hyoscyamine sulfate and 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; 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.