Label: ED-SPAZ- hyoscyamine sulfate tablet, orally disintegrating 

  • Label RSS
  • NDC Code(s): 0485-0082-01
  • Packager: EDWARDS PHARMACEUTICALS, INC.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 05/10

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  • SPL UNCLASSIFIED SECTION

    Rx Only

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  • DESCRIPTION

    Hyoscyamine sulfate orally disintegrating tablets contain 0.125 mg hyoscyamine sulfate formulated for oral administration.

    Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The molecular formula is (C17H23NO3)2•H2SO4•2H2O 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 structural formula:

    Chemical Structure

    Each tablet also contains as inactive ingredients: mannitol, croscarmellose sodium and magnesium stearate.

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  • 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 sublingual administration as well as 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 3½ hours. Hyoscyamine sulfate is partly hydrolyzed 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.

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  • 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.

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  • 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.

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  • 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, euphoria, 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.

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  • PRECAUTIONS

    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 drug since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis.

    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.

    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 before meals; antacids after meals.

    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.

    Pregnancy

    Category C

    Animal reproduction studies have not been conducted with hyoscyamine sulfate. It is also not known whether hyoscyamine sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine sulfate should be given to a pregnant woman only if clearly needed.

    Nursing Mothers

    Hyoscyamine sulfate is excreted in human milk. Caution should be exercised when hyoscyamine sulfate is administered to a nursing woman.

    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.

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  • 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.

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  • 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 of 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.

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  • DOSAGE AND ADMINISTRATION

    Dosage may be adjusted according to the conditions and severity of symptoms. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg must be placed on top of the tongue when it will dissolve in seconds, then swallow with saliva. Administering with liquid is not necessary.

    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

    ½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

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  • HOW SUPPLIED

    ED-SPAZ Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg are white, round, flat beveled edge tablets debossed "634" on one side and a score line on other side.

    Bottles of 100 NDC 0485-0082-01

    Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Please refer to current USP.

    Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

    Manufactured by:
    Belcher Pharmaceuticals, Inc.
    6911 Bryan Dairy Road
    Largo, FL 33777

    Manufactured for:
    Edwards Pharmaceutical, Inc.
    111 W. Mulberry St.
    Ripley, MS 38663

    May 2010
    L18I
    R-0510

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  • PRINCIPAL DISPLAY PANEL - 0.125 mg Tablet Bottle Label

    NDC 0485-0082-01

    ED-SPAZ
    Hyoscyamine Sulfate Orally
    Disintegrating
    Tablets

    0.125 mg

    100 Tablets

    Rx only

    PRINCIPAL DISPLAY PANEL - 0.125 mg Tablet Bottle Label
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  • INGREDIENTS AND APPEARANCE
    ED-SPAZ 
    hyoscyamine sulfate tablet, orally disintegrating
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0485-0082
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.125 mg
    Inactive Ingredients
    Ingredient Name Strength
    mannitol  
    croscarmellose sodium  
    magnesium stearate  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND (FLAT, BEVELED EDGE) Size 6mm
    Flavor Imprint Code 634
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0485-0082-01 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 05/12/2010
    Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)
    Establishment
    Name Address ID/FEI Business Operations
    BELCHER PHARMACEUTIALS, INC. 829721302 MANUFACTURE, PACK, LABEL, ANALYSIS
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