Professional Documents
Culture Documents
Pronunciation
Brand Names: US
Anaspaz; Colidrops [DSC]; Ed-Spaz; HyoMax-SL; Hyosyne; Levbid; Levsin; Levsin/SL; NuLev; Oscimin; Oscimin
Levsin
Buwecon (TW); Duboisine (FR); Egacene (NL); Egazil Duretter (DK, FI, NO, SE); Eyosin (PH); Levsin
Pharmacologic Category
Anticholinergic Agent
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)
* See Dosage and Administration in AHFS Essentials for additional information.
Dosing: Geriatric
Dosing: Pediatric
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.
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
* See Uses in AHFS Essentials for additional information.
Administration: IM
Administration: IV
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.
Administration: Subcutaneous
Storage/Stability
Store at 20C to 25C (68F to 77F); excursions are permitted between 15C and 30C (59F and 86F).
Storage/Stability
Store at 20C to 25C (68F to 77F); excursions are permitted between 15C and 30C (59F and 86F).
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 manufacturers labeling.
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 manufacturers labeling.
* See Cautions in AHFS Essentials for additional information.
Geriatric Considerations
Avoid long-term use; the potential for toxic reactions is higher than the potential benefit, elderly are
particularly prone to CNS side effects of anticholinergics (eg, confusion, delirium, hallucinations). Side effects often occur before clinical
response is obtained.
Pregnancy Considerations
Crosses the placenta, effects to the fetus not known; use during pregnancy only if clearly needed.
Breast-Feeding Considerations
Excreted in breast milk in trace amounts. May also suppress lactation. Breast-feeding is not
recommended.
Adverse Reactions
Metabolism/Transport Effects
Drug Interactions
None known.
Open Interactions
AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Risk C: Monitor therapy
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the
therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: 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. Risk C: 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. Risk D: Consider therapy modification
Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Exceptions: Levocabastine (Nasal). Risk C:
Monitor therapy
Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products.
Exceptions: Cannabidiol. Risk C: Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic).
Risk C: Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse
effects may be increased. Risk X: Avoid combination
Glycopyrrolate: Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate. Risk X: Avoid combination
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X:
Avoid combination
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy
OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Risk C: Monitor therapy
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. Risk X: Avoid
combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk D: Consider
therapy modification
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy
RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Risk C: 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. Risk D: Consider therapy modification
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like
Diuretics. Risk C: Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy
Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Assess potential for interactions with any drugs that may add to
anticholinergic effects. IV/IM: Have patient void before administration. Monitor for excessive dryness of eyes, nose, mouth, or throat.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Pricing: US
Elixir (Hyoscyamine Sulfate Oral)
0.125 mg/5 mL (473 mL): $104.99
Solution (Hyoscyamine Sulfate Oral)
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
Pharmacodynamics/Kinetics
Onset of action: 2-3 minutes
Duration: Regular release: 4-6 hours; Extended release (Levbid, Symax Duotab): 8-12 hours
Absorption: Well absorbed
Metabolism: Hepatic
Half-life elimination: Regular release: 2-3.5 hours; Extended release (Levbid): ~7 hours
Excretion: Urine
Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes
upon discontinuation).
Effects on Bleeding
Related Information
Beers Criteria Potentially Inappropriate Medications for Geriatrics
Oral Medications That Should Not Be Crushed or Altered
Index Terms
References
Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]
American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 updated Beers Criteria for
potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2015;63(11):2227-2246. doi:10.1111/jgs.13702[PubMed
26446832]
Anaspaz [package insert]. Lenexa, KS: B. F. Ascher amp Company Inc; June 2010.
Boyson SJ, Bethanechol for Anticholinergic Side Effects, Ann Neurol, 1988, 23(4):422-3. [PubMed 3382184]
Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcoholUnited States. MMWR Morb Mortal Wkly Rep.
1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm[PubMed 6810084]
Ed-Spaz [package insert]. Ripley, MS: Edwards Pharmaceutical Inc; May 2010.
Hyosine oral drops and elixir [package insert]. Spring Valley, NY: Silarx Pharmaceuticals Inc; April 2007.
"Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs.
Pediatrics. 1997;99(2):268-278.[PubMed 9024461]
Levbid [package insert]. Marietta, GA: Alaven; January 2008.
Levsin [package insert]. Marietta, GA: Alaven; February 2008
Levsin/SL [package insert]. Marietta, GA: Alaven; February 2008.
NuLev [package insert]. Marietta, GA: Alaven; April 2009.
Oscimin orally disintegrating tablets (hyoscyamine sulfate) [prescribing information]. Canton, MS: Larken Laboratories Inc; June 2014.
Oscimin sublingual tablets (hyoscyamine sulfate) [prescribing information]. Canton, MS: Larken Laboratories Inc; May 2014.
Oscimin tablets (hyoscyamine sulfate) [prescribing information]. Canton, MS: Larken Laboratories Inc; June 2014.
Oscimin-SR (hyoscyamine sulfate) [prescribing information]. Canton, MS: Larken Laboratories Inc; July 2014.
Shutt LE and Bowes JB, Atropine and Hyoscine, Anaesthesia, 1979, 34(5):476-90.[PubMed 382907]
Symax FasTab [package insert]. Fort Worth, TX: Capellon Pharmaceuticals; April 2006.
Symax Duotab (hyoscyamine sulfate) [prescribing information]. Fort Worth, TX: Capellon Pharmaceuticals; June 2014.
Symax-SR [package insert]. Fort Worth, TX: Sovereign Pharmaceuticals; June 2008.
Symax-SL (hyoscyamine sulfate) [prescribing information]. Fort Worth, TX: Capellon Pharmaceuticals; June 2014.