Product Elements:
Hyoscyamine sulfate hyoscyamine sulfate alcohol anhydrous citric acid fd&c red no. 40 fd&c yellow no. 6 lemon glycerin water sodium benzoate sodium citrate sorbitol sucrose hyoscyamine sulfate hyoscyamine hyoscyamine sulfate hyoscyamine sulfate alcohol anhydrous citric acid fd&c red no. 40 fd&c yellow no. 6 lemon glycerin water sodium benzoate sodium citrate sorbitol sucrose hyoscyamine sulfate hyoscyamine hyoscyamine sulfate hyoscyamine sulfate microcrystalline cellulose crospovidone, unspecified silicon dioxide magnesium stearate hyoscyamine sulfate hyoscyamine to off white ce;116
Indications and Usage:
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 âdrying agentâ in the relief of
Read more... 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.
Warnings:
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 an
Read more...d symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.
Dosage and Administration:
Dosage and administration 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 fol
Read more...lows: 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 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 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.
Contraindications:
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:
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.
Overdosage:
Overdosage the signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and cns stimulation. measures to be taken are immediate lavage of the stomach and injection of physostigmine 0.5 to 2 mg intravenously and repeated as necessary up to a total of 5 mg. fever may be treated symptomatically (tepid water sponge baths, hypothermic blanket). excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 ml of a 2% solution) by rectal infusion. in the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns. in rats, the ld 50 for hyoscyamine is 375 mg/kg. hyoscyamine sulfate is dialyzable.
Description:
Description 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 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. "structure"
Clinical Pharmacology:
Clinical pharmacology hyoscyamine sulfate inhibits specifically the actions of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. these peripheral cholinergic receptors are present in the autonomic effector cells of the smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, and the exocrine glands. at therapeutic doses, it is completely devoid of any action on autonomic ganglia. hyoscyamine sulfate inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. hyoscyamine sulfate also controls excessive pharyngeal, tracheal and bronchial secretions. hyoscyamine sulfate is absorbed totally and completely by oral administration. once absorbed, hyoscyamine sulfate disappears rapidly from the blood and is distributed throughout the entire body. the half-life of hyoscyamine sulfate is 2 to 3 1/2 hours. hyoscyamine sulfate is partly hydro
Read more...lyzed to tropic acid and tropine but the majority of the drug is excreted in the urine unchanged within the first 12 hours. only traces of this drug are found in breast milk. hyoscyamine sulfate passes the blood brain barrier and the placental barrier.
How Supplied:
How supplied hyoscyamine sulfate oral drops (hyoscyamine sulfate oral solution, usp) (hyoscyamine sulfate 0.125 mg per ml) is orange colored, lemon flavored, and contains 5% ethyl alcohol. it is supplied in a 20 ml bottle (ndc 62135-513-52). hyoscyamine sulfate elixir, usp (hyoscyamine sulfate 0.125 mg per 5 ml) is orange colored, lemon flavored, and contains 20% ethyl alcohol. it is supplied in a pint (473 ml) bottle (ndc 62135-511-47). hyoscyamine sulfate tablets, usp , 0.125 mg are white to off white, round tablets debossed with âceâ on one side and â116â on the other. bottles of 120 ndc 62135-512-12 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. 11/2022 l70981
Package Label Principal Display Panel:
Package label.principal display panel hyoscyamine sulfate elixir, usp (0.125 mg/ 5 ml) - ndc 62135-511-47- 473ml label hyoscyamine sulfate oral solution, usp (0.125 mg/ 1 ml) - ndc 62135-513-52- 20ml label hyoscyamine sulfate tablets, usp - 0.125 mg- ndc 62135-512-12- 120s-bottle-label "image description" image description image description