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Hyoscyamine

Pronunciation

Pronunciation

(hye oh SYE a meen)

Index Terms

  • l-Hyoscyamine Sulfate
  • Cystospaz-M
  • ED-SPAZ
  • Hyomax-SL
  • Hyoscyamine Sulfate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Elixir, Oral, as sulfate:

Hyosyne: 0.125 mg/5 mL (473 mL) [contains alcohol, usp; lemon flavor]

Generic: 0.125 mg/5 mL (473 mL)

Solution, Injection, as sulfate:

Levsin: 0.5 mg/mL (1 mL) [contains benzyl alcohol]

Solution, Oral, as sulfate:

Hyosyne: 0.125 mg/mL (15 mL) [lemon flavor]

Generic: 0.125 mg/mL (15 mL)

Tablet, Oral, as sulfate:

Levsin: 0.125 mg

Oscimin: 0.125 mg [peppermint flavor]

Generic: 0.125 mg

Tablet Dispersible, Oral, as sulfate:

Anaspaz: 0.125 mg [scored]

Ed-Spaz: 0.125 mg [scored]

NuLev: 0.125 mg [peppermint flavor]

Oscimin: 0.125 mg [peppermint flavor]

Symax FasTabs: 0.125 mg [DSC] [mint flavor]

Generic: 0.125 mg

Tablet Extended Release, Oral, as sulfate:

Symax Duotab: 0.375 mg [contains brilliant blue fcf (fd&c blue #1)]

Tablet Extended Release 12 Hour, Oral, as sulfate:

Levbid: 0.375 mg

Oscimin SR: 0.375 mg

Symax-SR: 0.375 mg [scored]

Generic: 0.375 mg

Tablet Sublingual, Sublingual, as sulfate:

HyoMax-SL: 0.125 mg [DSC]

Levsin/SL: 0.125 mg

Oscimin: 0.125 mg [peppermint flavor]

Symax-SL: 0.125 mg [mint flavor]

Generic: 0.125 mg

Brand Names: U.S.

  • Anaspaz
  • Ed-Spaz
  • HyoMax-SL [DSC]
  • Hyosyne
  • Levbid
  • Levsin
  • Levsin / SL
  • NuLev
  • Oscimin
  • Oscimin SR
  • Symax Duotab
  • Symax FasTabs [DSC]
  • Symax-SL
  • Symax-SR

Pharmacologic Category

  • Anticholinergic Agent

Pharmacology

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

Absorption

Well absorbed

Metabolism

Hepatic

Excretion

Urine

Onset of Action

2-3 minutes

Duration of Action

Regular release: 4-6 hours; Extended release (Levbid, Symax Duotab): 8-12 hours

Half-Life Elimination

Regular release: 2-3.5 hours; Extended release (Levbid): ~7 hours

Use: Labeled Indications

Anesthesia:

Preoperative antimuscarinic: Preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce volume and acidity of gastric secretions; to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation

Reversal of neuromuscular blockade and associated muscarinic effects: Protects against peripheral muscarinic effects (such as bradycardia and excessive secretions produced by halogenated hydrocarbons and cholinergic agents [such as physostigmine, neostigmine, and pyridostigmine]) given to reverse actions of curariform agents

Antidote for anticholinesterase agent poisoning: Antidote for poisoning by anticholinesterase agents

Biliary and renal colic: Adjunctive therapy with morphine or other opioids for the symptomatic relief of biliary and renal colic

Diagnostic procedures: Reduces GI motility to facilitate diagnostic procedures such as endoscopy or hypotonic duodenography; may also improve radiologic visibility of the kidneys

GI disorders:

Aid in the control of acute episodes of gastric secretion, visceral spasm, hypermotility in spastic colitis, pylorospasm, and associated abdominal cramps; relieve symptoms in functional intestinal disorders (eg, mild dysenteries, diverticulitis) and infant colic (elixir and oral solution)

Adjunctive therapy for treatment in peptic ulcer; irritable bowel syndrome (irritable colon, spastic colon, acute enterocolitis, mucous colitis) and other functional GI disorders; neurogenic bowel disturbances (including splenic flexure syndrome and neurogenic colon)

Pancreatitis: Reduce pain and hypersecretion in pancreatitis

Parkinsonism: In parkinsonism, to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis

Partial heart block: For use in certain cases of partial heart block associated with vagal activity

Rhinitis: “Drying agent” in the relief of symptoms of acute rhinitis

Urinary system disorder: To control hypermotility in spastic bladder and cystitis; adjunctive therapy in the treatment of neurogenic bladder

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; myocardial ischemia. Note: Some extended release products are not recommended in children <12 years of age; refer to manufacturer’s labeling.

Dosing: Adult

Gastrointestinal disorders:

Oral:

Tablet, dispersible:

Anaspaz, ED-SPAZ, NuLev, Symax FasTab: 0.125 to 0.25 mg every 4 hours or as needed; maximum: 1.5 mg daily

Oscimin: 0.125 to 0.25 mg 3 to 4 times daily; may increase to every 4 hours as needed; maximum: 1.5 mg daily

Tablet, extended release:

Levbid: 0.375 to 0.75 mg every 12 hours; maximum: 1.5 mg daily

Oscimin SR, Symax Duotab, Symax SR: 0.375 to 0.75 mg every 12 hours or 0.375 mg every 8 hours; maximum: 1.5 mg daily

Tablet, regular release:

Levsin: 0.125 to 0.25 mg every 4 hours or as needed; maximum: 1.5 mg daily

Oscimin: 0.125 to 0.25 mg 3 to 4 times daily; may increase to every 4 hours as needed; maximum: 1.5 mg daily

Tablet, sublingual (Oscimin, Symax SL): 0.125 to 0.25 mg 3 to 4 times daily; may increase to every 4 hours as needed; maximum: 1.5 mg daily

Drops (Hyosyne [0.125 mg/mL]): 0.125 mg (1 mL) to 0.25 mg (2 mL) every 4 hours or as needed; maximum: 1.5 mg (12 mL) daily

Elixir (Hyosyne [0.125 mg/5 mL]): 0.125 mg (5 mL) to 0.25 mg (10 mL) every 4 hours or as needed; maximum: 1.5 mg (60 mL) daily

IM, IV, SubQ: 0.25 to 0.5 mg; may repeat as needed up to 4 times daily, at 4-hour intervals

Diagnostic procedures: IV: 0.25 to 0.5 mg given 5 to 10 minutes prior to procedure

Preanesthesia: IM, IV, SubQ: 5 mcg/kg given 30 to 60 minutes prior to induction of anesthesia or at the time preoperative opioids or sedatives are administered

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

Reverse neuromuscular blockade: IM, IV, SubQ: 0.2 mg for every 1 mg neostigmine (or the physostigmine/pyridostigmine equivalent)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Gastrointestinal disorders:

Children <2 years: Oral: Drops (Hyosyne [0.125 mg/mL]): Dose as listed, based on age and weight (kg); repeat dose every 4 hours or as needed:

3.4 kg: 4 drops; maximum: 24 drops daily

5 kg: 5 drops; maximum: 30 drops daily

7 kg: 6 drops; maximum: 36 drops daily

10 kg: 8 drops; maximum: 48 drops daily

Children 2 to <12 years: Oral:

Tablets (regular release [Levsin], dispersible [Anaspaz, ED-SPAZ, NuLev, Symax FasTab]): 0.0625 to 0.125 mg every 4 hours or as needed; maximum: 0.75 mg daily

Drops (Hyosyne [0.125 mg/mL]): 0.03125 mg (0.25 mL) to 0.125 mg (1 mL) every 4 hours or as needed; maximum: 0.75 mg (6 mL) daily

Elixir (Hyosyne [0.125 mg/5 mL]): Dose as listed, based on age and weight (kg); repeat dose every 4 hours or as needed:

10 kg: 0.03125 mg (1.25 mL); maximum: 0.75 mg (30 mL) daily

20 kg: 0.0625 mg (2.5 mL); maximum: 0.75 mg (30 mL) daily

40 kg: 0.09375 mg (3.75 mL); maximum: 0.75 mg (30 mL) daily

50 kg: 0.125 mg (5 mL); maximum: 0.75 mg (30 mL) daily

Children ≥12 years and Adolescents: Oral: Regular release tablets, dispersible tablets, sublingual tablets, elixir/drops, extended release tablets: Refer to adult dosing.

Preanesthesia: Children >2 years and Adolescents: IV: Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer’s labeling, use with caution.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling.

Administration

Oral:

Elixir (Hyosyne): Administration prior to meals (~30 to 60 minutes) is recommended (but not required) when used to treat gastrointestinal disorders.

Drops (Hyosyne): Administration prior to meals (~30 to 60 minutes) is recommended (but not required) when used to treat gastrointestinal disorders. Use provided dropper to accurately measure dose.

Tablet, regular release (Levsin, Oscimin): Administration prior to meals (~30 to 60 minutes) is recommended (but not required) when used to treat gastrointestinal disorders.

Tablet, dispersible: Administration prior to meals (~30 to 60 minutes) is recommended (but not required) when used to treat gastrointestinal disorders.

Anaspaz: Tablets may be used sublingually, chewed, or swallowed whole.

Ed-Spaz: Place on top of tongue and allow to dissolve; swallow with saliva.

NuLev, Oscimin, Symax FasTab Chewable Melt: Tablets may be chewed or placed on tongue and allowed to disintegrate.

Tablet, extended release: Administration prior to meals (~30 to 60 minutes) is recommended (but not required) when used to treat gastrointestinal disorders.

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

Oscimin SR, Symax Duotab, Symax SR: Swallow whole.

Tablet, sublingual: Administration prior to meals (~30 to 60 minutes) is recommended (but not required) when used to treat gastrointestinal disorders.

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

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

Oscimin: Administer sublingually.

IM: May be administered without dilution.

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

SubQ: May be administered without dilution.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Drug Interactions

AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Analgesics (Opioid): Anticholinergic Agents may enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy

Antacids: May decrease the serum concentration of Hyoscyamine. Management: Administer immediate release hyoscyamine before meals and antacids after meals when these agents are given in combination. Consider therapy modification

Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Monitor therapy

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Avoid combination

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy

OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy

RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to secretin. Consider therapy modification

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Adverse Reactions

Frequency not defined.

Cardiovascular: Flushing, palpitations, tachycardia

Central nervous system: Amnesia (short-term), ataxia, confusion (more common in elderly), dizziness, drowsiness, excitement (more common in elderly), fatigue, hallucination, headache, insomnia, nervousness, psychosis, speech disturbance

Dermatologic: Hypohidrosis, urticaria

Gastrointestinal: Abdominal pain, ageusia, bloating, constipation, diarrhea, dysgeusia, dysphagia, heartburn, nausea, vomiting, xerostomia

Genitourinary: Decreased lactation, impotence, urinary hesitancy, urinary retention

Hypersensitivity: Hypersensitivity reaction

Neuromuscular & skeletal: Weakness

Ophthalmic: Blurred vision, cycloplegia, increased intraocular pressure, mydriasis

Miscellaneous: Fever

Warnings/Precautions

Concerns related to adverse effect:

• CNS effects: May cause drowsiness and/or blurred vision, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Diarrhea: May be a sign of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; treatment should be discontinued if this occurs.

• Heat prostration: May occur in the presence of increased environmental temperature; use caution in hot weather and/or exercise.

• Oral effects: Prolonged use may lead to development of dental caries, periodontal disease, oral candidiasis, or discomfort due to decreased salivation.

• Psychosis: Has been reported in patients with an extreme sensitivity to anticholinergic effects; usually resolves within 12-48 hours after discontinuation.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with coronary artery disease, tachyarrhythmias, heart failure, or hypertension; evaluate tachycardia prior to administration. Use is contraindicated in patients with unstable cardiovascular status or myocardial ischemia.

• Hiatal hernia: Use with caution in patients with hiatal hernia with reflux esophagitis.

• Hyperthyroidism: Use with caution in patients with hyperthyroidism.

• Neuropathy: Use with caution in patients with autonomic neuropathy.

• Prostatic hyperplasia: Use with caution in patients with prostatic hyperplasia.

• Renal impairment: Use with caution in patients with renal impairment.

Special populations:

• Pediatric: Use with caution in children with spastic paralysis or brain damage; may be more susceptible to anticholinergic effects.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

Pregnancy Risk Factor

C

Pregnancy Considerations

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

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience fatigue, blurred vision, constipation, dry mouth, dry eyes, headache, nausea, vomiting, heartburn, or change in taste. Have patient report immediately to prescriber severe dizziness, passing out, severe diarrhea, confusion, hallucinations, memory impairment, insomnia, altered speech, change in balance, vision changes, severe anxiety, urinary retention, lack of sweat, flushing, tachycardia, arrhythmia, or sexual dysfunction (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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