Hyoscyamine Sulfate is a human prescription drug labeled by 'Alvogen Inc.'. National Drug Code (NDC) number for Hyoscyamine Sulfate is 47781-012. This drug is available in dosage form of Tablet, Orally Disintegrating. The names of the active, medicinal ingredients in Hyoscyamine Sulfate drug includes Hyoscyamine Sulfate - .125 mg/1 . The currest status of Hyoscyamine Sulfate drug is Active.

Hyoscyamine sulfate hyoscyamine sulfate hyoscyamine sulfate hyoscyamine silicon dioxide crospovidone (120 .mu.m) magnesium stearate mannitol sorbitol cl;12 structure label

Drug interactions: additive adverse effects resulting from cholinergic blockade may occur when hyoscyamine sulfate is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (mao) inhibitors, tricyclic antidepressants or some antihistamines. antacids may interfere with the absorption of hyoscyamine sulfate. administer hyoscyamine sulfate orally disintegrating tablets before meals; antacids after meals.

Indications and usage hyoscyamine sulfate orally disintegrating tablets are effective as adjunctive therapy in the treatment of peptic ulcer. they can also be used to control gastric secretions, 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 orally disintegrating tablets are indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of Read more...

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 including hyoscyamine sulfate. cns signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, anxiety, decreased anxiety, fatigue, insomnia, agitation and mannerisms and in Read more...

General: use with caution in patients with: autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hypertension and renal disease. investigate any tachycardia before giving any anticholinergic drugs since they may increase the heart rate. use with caution in patients with hiatal hernia associated with reflux esophagitis.

Dosage and administration dosage may be adjusted according to the conditions and severity of symptoms. place a hyoscyamine sulfate orally disintegrating tablet on tongue, allowing the tablet to rapidly disintegrate and be swallowed. may be taken with or without water. 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 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 the following adverse reactions have been reported for 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; cycloplegia; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; 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.

Drug interactions: additive adverse effects resulting from cholinergic blockade may occur when hyoscyamine sulfate is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (mao) inhibitors, tricyclic antidepressants or some antihistamines. antacids may interfere with the absorption of hyoscyamine sulfate. administer hyoscyamine sulfate orally disintegrating tablets before meals; antacids after meals.

Geriatric use: reported clinical experience has not identified differences in safety between patients aged 65 and over and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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 ld50 for hyoscyamine is 375 mg/kg. hyoscyamine sulfate is dialyzable.

Description 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: each tablet also contains as inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, sorbitol and flavor.

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 the 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 hy Read more...

Carcinogenesis, mutagenesis, impairment of fertility: no long-term studies in animals have been performed to determine the carcinogenic, mutagenic or impairment of fertility potential of hyoscyamine sulfate; however, 40 years of marketing experience with hyoscyamine sulfate shows no demonstrable evidence of a problem.

How supplied hyoscyamine sulfate orally disintegrating tablets 0.125 mg are white, round, flat-faced, beveled edge, mint flavored tablets debossed with “cl” on one side and “12” on the other. bottles of 100 ndc 47781-012-01 store at controlled room temperature 20° to 25°c (68° to 77°f); excursion permitted to 15° to 30°c (59° to 86°f). please refer to current usp. dispense in tight, light-resistant containers as defined in usp/nf with a child-resistant closure. keep out of reach of children to report suspected adverse reactions, contact alvogen, inc. at 1-866-770-3024 or fda at 1-800-fda-1088 or www.fda.gov/medwatch for voluntary reporting of suspected adverse reactions.

Information for patients: 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. use of hyoscyamine sulfate may decrease sweating resulting in heat prostration, fever or heat stroke; febrile patients or those who may be exposed to elevated environmental temperatures should use caution.

Principal display panel ndc 47781- 012 -01 hyoscyamine sulfate orally disintegrating tablets 0.125 mg rx only 100 tablets