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Pronunciation:

(hye oh SYE a meen)

U.S. Brand Names:

Anaspaz®; Cystospaz®; Cystospaz-M® [DSC]; Hyosine; Levbid®; Levsin®; Levsinex®; Levsin/SL®; NuLev™; Spacol [DSC]; Spacol T/S [DSC]; Symax SL; Symax SR

Synonyms:

Hyoscyamine Sulfate; l-Hyoscyamine Sulfate

Generic Available:

Yes

Canadian Brand Names:

Cystospaz®; Levsin®

Use:

Oral: Adjunctive therapy for peptic ulcers, irritable bowel, neurogenic bladder/bowel; treatment of infant colic, GI tract disorders caused by spasm; to reduce rigidity, tremors, sialorrhea, and hyperhidrosis associated with parkinsonism; as a drying agent in acute rhinitis

Injection: Preoperative antimuscarinic to reduce secretions and block cardiac vagal inhibitory reflexes; to improve radiologic visibility of the kidneys; symptomatic relief of biliary and renal colic; reduce GI motility to facilitate diagnostic procedures (ie, endoscopy, hypotonic duodenography); reduce pain and hypersecretion in pancreatitis, certain cases of partial heart block associated with vagal activity; reversal of neuromuscular blockade

Pregnancy Risk Factor:

Pregnancy Implications:

Crosses the placenta, effects to the fetus not known; use during pregnancy only if clearly needed.

Lactation:

Enters breast milk/not recommended

Contraindications:

Hypersensitivity to belladonna alkaloids or any component of the formulation; glaucoma; obstructive uropathy; myasthenia gravis; obstructive GI tract disease, paralytic ileus, intestinal atony of elderly or debilitated patients, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis; unstable cardiovascular status in acute hemorrhage, myocardial ischemia

Warnings/Precautions:

Heat prostration may occur in hot weather. Diarrhea may be a sign of incomplete intestinal obstruction, treatment should be discontinued if this occurs. May produce side effects as seen with other anticholinergic medications including drowsiness, dizziness, blurred vision, or psychosis. Children and the elderly may be more susceptible to these effects. Use with caution in children with spastic paralysis. Use with caution in patients with autonomic neuropathy, coronary heart disease, CHF, cardiac arrhythmias, prostatic hyperplasia, hyperthyroidism, hypertension, chronic lung disease, renal disease, and hiatal hernia associated with reflux esophagitis. Use with caution in the elderly, may precipitate undiagnosed glaucoma and/or severely impair memory function (especially in those patients with previous memory problems).

NuLev™: Contains phenylalanine

Adverse Reactions:

Frequency not defined.

Cardiovascular: Palpitations, tachycardia

Central nervous system: Ataxia, dizziness, drowsiness, headache, insomnia, mental confusion/excitement, nervousness, speech disorder

Dermatologic: Urticaria

Endocrine & metabolic: Lactation suppression

Gastrointestinal: Bloating, constipation, dry mouth, loss of taste, nausea, vomiting

Genitourinary: Impotence, urinary hesitancy, urinary retention

Neuromuscular & skeletal: Weakness

Ocular: Blurred vision, cycloplegia, increased ocular tension, mydriasis

Miscellaneous: Allergic reactions, sweating decreased

Overdosage/Toxicology:

Symptoms of overdose include dilated, unreactive pupils; blurred vision; hot, dry flushed skin; CNS stimulation; dryness of mucous membranes; difficulty swallowing; foul breath; diminished or absent bowel sounds; urinary retention; tachycardia; hyperthermia; hypertension; and increased respiratory rate. For anticholinergic overdose with severe life-threatening symptoms, physostigmine 0.5-2 mg SubQ or I.V. slowly, may be given to reverse these effects; may repeat as necessary to reverse the effects, up to total of 5 mg. Hyoscyamine sulfate is dialyzable.

Drug Interactions:

Amantadine: Additive adverse effects may occur due to cholinergic blockade.

Antacids: Antacids may decrease absorption of hyoscyamine; administer hyoscyamine before meals and give antacids after meals.

Antihistamines: Additive adverse effects may occur with some antihistamines due to cholinergic blockade.

Antimuscarinics: Additive adverse effects may occur due to cholinergic blockade.

Haloperidol: Additive adverse effects may occur due to cholinergic blockade.

MAO inhibitors: Additive adverse effects may occur due to cholinergic blockade.

Phenothiazines: Additive adverse effects may occur due to cholinergic blockade.

Tricyclic antidepressants: Additive adverse effects may occur due to cholinergic blockade.

Stability:

Store at controlled room temperature. Protect NuLev™ from moisture.

Mechanism of Action:

Blocks the action of acetylcholine at parasympathetic sites in smooth muscle, secretory glands and the CNS; increases cardiac output, dries secretions, antagonizes histamine and serotonin

Pharmacodynamics/Kinetics:

Onset of action: 2-3 minutes

Duration: 4-6 hours

Absorption: Well absorbed

Distribution: Crosses placenta; small amounts enter breast milk

Protein binding: 50%

Metabolism: Hepatic

Half-life elimination: 3-5 hours

Excretion: Urine

Dosage:

Oral: Children: Gastrointestinal disorders: Dose as listed, based on age and weight (kg) using 0.125 mg/mL drops; repeat dose every 4 hours as needed:

Children <2 years:

3.4 kg: 4 drops; maximum: 24 drops/24 hours

5 kg: 5 drops; maximum: 30 drops/24 hours

7 kg: 6 drops; maximum: 36 drops/24 hours

10 kg: 8 drops; maximum: 48 drops/24 hours

Oral, S.L.:

Children 2-12 years: Gastrointestinal disorders: Dose as listed, based on age and weight (kg); repeat dose every 4 hours as needed:

10 kg: 0.031-0.033 mg; maximum: 0.75 mg/24 hours

20 kg: 0.0625 mg; maximum: 0.75 mg/24 hours

40 kg: 0.0938 mg; maximum: 0.75 mg/24 hours

50 kg: 0.125 mg; maximum: 0.75 mg/24 hours

Children >12 years and Adults: Gastrointestinal disorders: 0.125-0.25 mg every 4 hours or as needed (before meals or food); maximum: 1.5 mg/24 hours

Cystospaz®: 0.15-0.3 mg up to 4 times/day

Oral (timed release): Children >12 years and Adults: Gastrointestinal disorders: 0.375-0.75 mg every 12 hours; maximum: 1.5 mg/24 hours

I.M., I.V., SubQ: Children >12 years and Adults: Gastrointestinal disorders: 0.25-0.5 mg; may repeat as needed up to 4 times/day, at 4-hour intervals

I.V.: Children >2 year and Adults: I.V.: Preanesthesia: 5 mcg/kg given 30-60 minutes prior to induction of anesthesia or at the time preoperative narcotics or sedatives are administered

I.V.: Adults: Diagnostic procedures: 0.25-0.5 mg given 5-10 minutes prior to procedure

To reduce drug-induced bradycardia during surgery: 0.125 mg; repeat as needed

To reverse neuromuscular blockade: 0.2 mg for every 1 mg neostigmine (or the physostigmine/pyridostigmine equivalent)

Administration:

Oral: Tablets should be administered before meals or food.

Levbid®: Tablets are scored and may be broken in half for dose titration; do not crush or chew.

Levsin/SL®: Tablets may be used sublingually, chewed, or swallowed whole.

NuLev™: Tablet is placed on tongue and allowed to disintegrate before swallowing; may take with or without water.

Symax SL: Tablets may be used sublingually or swallowed whole.

I.M.: May be administered without dilution.

Inject over at least 1 minute. May be administered without dilution.

Dietary Considerations:

Should be taken before meals or food; NuLev™ contains phenylalanine

Patient Education:

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. Take as directed before meals; do not increase dose and do not discontinue without consulting prescriber. Void immediately before taking medication. Do not crush or chew (swallow whole) extended release form. Levbid® and Levsinex® may not completely disintegrate and may be excreted. You may experience dizziness or blurred vision (use caution when driving or engaging in tasks that require alertness until response to drug is known); dry mouth (sucking on lozenges may help); photosensitivity (wear dark glasses in bright sunlight); decreased ability to sweat (use caution in hot weather or hot rooms or when engaging in strenuous activity); or impotence (temporary). Report excessive and persistent anticholinergic effects (blurred vision, headache, flushing, tachycardia, nervousness, constipation, dizziness, insomnia, mental confusion or excitement, dry mouth, altered taste perception, dysphagia, palpitations, bradycardia, urinary hesitancy or retention, impotence, decreased sweating). Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Breast-feeding is not recommended.

Sublingual tablets: Place tablet under tongue and allow to dissolve.

Orally-disintegrating tablet (Nu-Lev™): Place tablet on tongue and allow to disintegrate before swallowing. Take with or without food.

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause drowsiness; may rarely cause restlessness, amnesia, or delirium

Mental Health: Effects on Psychiatric Treatment:

Concurrent use with psychotropics may produce additive sedation and dry mouth

Dosage Forms:

[DSC] = Discontinued product

Capsule, timed release, as sulfate (Cystospaz-M® [DSC], Levsinex®): 0.375 mg

Elixir, as sulfate: 0.125 mg/5 mL (480 mL)

Hyosine: 0.125 mg/5 mL (480 mL) [contains alcohol 20% and sodium benzoate; orange flavor]

Levsin®: 0.125 mg/5 mL (480 mL) [contains alcohol 20%; orange flavor]

Injection, solution, as sulfate (Levsin®): 0.5 mg/mL (1 mL)

Liquid, as sulfate (Spacol [DSC]): 0.125 mg/5 mL (120 mL) [sugar free, alcohol free, simethicone based, bubble gum flavor]

Solution, oral drops, as sulfate: 0.125 mg/mL (15 mL)

Hyosine: 0.125 mg/mL (15 mL) [contains alcohol 5% and sodium benzoate; orange flavor]

Levsin®: 0.125 mg/mL (15 mL) [contains alcohol 5%; orange flavor]

Tablet (Cystospaz®): 0.15 mg

Tablet, as sulfate (Anaspaz®, Levsin®, Spacol [DSC]): 0.125 mg

Tablet, extended release, as sulfate (Levbid®, Symax SR, Spacol T/S [DSC]): 0.375 mg

Tablet, orally-disintegrating, as sulfate (NuLev™): 0.125 mg [contains phenylalanine 1.7 mg/tablet, mint flavor]

Tablet, sublingual, as sulfate: 0.125 mg

Levsin/SL®: 0.125 mg [peppermint flavor]

Symax SL: 0.125 mg

International Brand Names:

Cystospaz® (CA); Egacene® (NL); Egazil Duretter® (DK, FI, NO, SE); Levsin® (CA, HK); Neo-Allospasmin® (BG, JO, KW, LB, MA, MY, SY); Sulfate de Duboisine® (FR)

References

Boyson SJ, "Bethanechol for Anticholinergic Side Effects,"Ann Neurol, 1988, 23(4):422-3.

Rumack BH, "Anticholinergic Poisoning: Treatment With Physostigmine,"Pediatrics, 1973, 52(3):449-51.

Shutt LE and Bowes JB, "Atropine and Hyoscine,"Anaesthesia, 1979, 34(5):476-90.

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