Note: Oral dosage forms (drops and elixirs) are different (ie, 0.125 mg/mL [drops] and 0.125 mg/5 mL [solution]); precaution should be taken to verify and avoid confusion between the different concentrations; dose should be clearly presented with corresponding product formulation.
Gastrointestinal and urinary systemic spasms (including infant colic, biliary and renal colic):
Infants and Children <2 years: Oral: Drops (eg, Hyosyne [0.125 mg/mL]): Do not exceed 6 doses in 24 hours
3.4 to <5 kg: 0.01375 mg (0.11 mL or 4 drops) every 4 hours or as needed; maximum daily dose: 0.0825 mg (0.66 mL or 24 drops)/day
5 to <7 kg: 0.0175 mg (0.14 mL or 5 drops) every 4 hours or as needed; maximum daily dose: 0.105 mg (0.84 mL or 30 drops)/day
7 to <10 kg: 0.02 mg (0.16 mL or 6 drops) every 4 hours or as needed; maximum daily dose: 0.12 mg (0.96 mL or 36 drops)/day
≥10 kg: 0.0275 mg (0.22 mL or 8 drops) every 4 hours or as needed; maximum daily dose: 0.165 mg (1.32 mL or 48 drops)/day
Children 2 to <12 years: Oral:
Drops (eg, Hyosyne [0.125 mg/mL]): 0.03125 mg (0.25 mL) to 0.125 mg (1 mL) every 4 hours or as needed; maximum daily dose: 0.75 mg (6 mL)/day; do not exceed 6 doses in 24 hours
Elixir (eg, Hyosyne [0.125 mg/5 mL]): Do not exceed 6 doses in 24 hours:
10 to <20 kg: 0.03125 mg (1.25 mL) every 4 hours or as needed; maximum daily dose: 0.1875 mg (7.5 mL)/day
20 to <40 kg: 0.0625 mg (2.5 mL) every 4 hours or as needed; maximum daily dose: 0.375 mg (15 mL)/day
40 to <50 kg: 0.09375 mg (3.75 mL) every 4 hours or as needed; maximum daily dose: 0.5625 mg (22.5 mL)/day
≥50 kg: 0.125 mg (5 mL) every 4 hours or as needed; maximum daily dose: 0.75 mg (30 mL)/day
Tablets, immediate release: regular tablet [Levsin], sublingual [Levsin/SL], dispersible [Anaspaz, ED-SPAZ, NuLev]): 0.0625 to 0.125 mg every 4 hours or as needed; maximum daily dose: 0.75 mg/day
Children ≥12 years and Adolescents: Oral:
Immediate release:
Drops (Hyosyne [0.125 mg/mL]): 0.125 mg (1 mL) to 0.25 mg (2 mL) every 4 hours or as needed; maximum daily dose: 1.5 mg (12 mL)/day
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 daily dose: 1.5 mg (60 mL)/day
Tablet, dispersible:
Anaspaz, ED-SPAZ, NuLev: 0.125 to 0.25 mg every 4 hours or as needed; maximum daily dose: 1.5 mg/day
Oscimin: 0.125 to 0.25 mg 3 to 4 times daily; may increase to every 4 hours as needed; maximum daily dose: 1.5 mg/day
Tablet:
Levsin: 0.125 to 0.25 mg every 4 hours or as needed; maximum daily dose: 1.5 mg/day
Oscimin: 0.125 to 0.25 mg 3 to 4 times daily; may increase to every 4 hours as needed; maximum daily dose: 1.5 mg/day
Tablet, sublingual
Levsin/SL: 0.125 to 0.25 mg every 4 hours or as needed; maximum daily dose: 1.5 mg/day
Oscimin, Symax SL: 0.125 to 0.25 mg 3 to 4 times daily; may increase to every 4 hours as needed; maximum daily dose: 1.5 mg/day
Extended release: Tablet:
Levbid: 0.375 to 0.75 mg every 12 hours; maximum daily dose: 1.5 mg/day
Oscimin SR, Symax Duotab, Symax SR: 0.375 to 0.75 mg every 12 hours or 0.375 mg every 8 hours; maximum daily dose: 1.5 mg/day
Preanesthesia: Children >2 years and Adolescents: IM, IV, SubQ: 5 mcg/kg administered 30 to 60 minutes prior to induction of anesthesia or at the time preoperative opioids or sedatives are administered
Reduce drug-induced bradycardia during surgery: Children >2 years and Adolescents: IV: 0.125 mg; repeat as needed
Reversal of neuromuscular blockage: Children >2 years and Adolescents: IV, IM, SubQ: 0.2 mg for every 1 mg neostigmine (or physostigmine/pyridostigmine equivalent)
Dialyzable. There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Hyoscyamine: Drug information")
GI disorders:
Note: American College of Gastroenterology guidelines recommend against use of antispasmodics such as hyoscyamine for the treatment of global symptoms of irritable bowel syndrome (IBS) (ACG [Lacy 2021]); however, some experts consider as-needed use beneficial for relief of abdominal pain associated with IBS (Wald 2021).
Oral:
Immediate release: 0.125 to 0.25 mg every 4 to 8 hours or as needed; maximum: 1.5 mg/day.
Extended release: 0.375 to 0.75 mg every 12 hours or 0.375 mg every 8 hours; maximum: 1.5 mg/day.
IM, IV, SUBQ: 0.25 to 0.5 mg; may repeat as needed up to 4 times daily, at 4-hour intervals.
There are no dosage adjustments provided in the manufacturer’s labeling, use with caution.
There are no dosage adjustments provided in the manufacturer’s labeling.
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 [preservative free]:
Levsin: 0.5 mg/mL (1 mL)
Generic: 0.5 mg/mL (1 mL)
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 Disintegrating, Oral, as sulfate:
Anaspaz: 0.125 mg [scored; contains corn starch, fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]
Ed-Spaz: 0.125 mg [scored]
NuLev: 0.125 mg [peppermint flavor]
Oscimin: 0.125 mg [DSC] [peppermint 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 [DSC]
Symax-SR: 0.375 mg [scored]
Generic: 0.375 mg
Tablet Sublingual, Sublingual, as sulfate:
Levsin/SL: 0.125 mg
Oscimin: 0.125 mg [peppermint flavor]
Symax-SL: 0.125 mg [mint flavor]
Generic: 0.125 mg
May be product dependent
Oral: Administration before meals (~30 to 60 minutes) is recommended but not required when used to treat gastrointestinal disorders. Additional product specific details:
Drops (Hyosyne): Use provided dropper to accurately measure dose
Tablet, dispersible:
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: Tablets may be chewed or placed on tongue and allowed to disintegrate
Tablet, extended release:
Levbid: Do not crush or chew
Oscimin SR, Symax Duotab, Symax SR: Swallow whole
Tablet, sublingual:
Levsin/SL: Tablets may be used sublingually, chewed, or swallowed whole
Symax SL: Tablets may be used sublingually or swallowed whole
Oscimin: Administer sublingually
Parenteral: May be administered undiluted IM, IV, and SubQ. There is no administration rate information provided in the manufacturer's labeling; some centers have administered over at least 1 minute.
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 GI 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: 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 GI disorders.
Levbid: Do not crush or chew.
Oscimin SR, Symax Duotab, Symax SR: Swallow whole.
Bariatric surgery: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Do not cut, crush, or chew. Switch to IR tablet, sublingual tablet, or oral solution.
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.
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).
Oral:
Gastrointestinal: Treatment of infant colic; 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); adjunctive therapy for treatment of peptic ulcer, irritable bowel syndrome, other functional GI disorders, and neurogenic bowel disturbances; adjunctive therapy for symptomatic relief of biliary colic
Urinary: Aid in the control of hypermotility in spastic bladder and cystitis; adjunctive therapy in treatment of neurogenic bladder; adjunctive therapy for symptomatic relief of renal colic
Other: Treatment of acute rhinitis as a "drying agent"; antidote for poisoning by anticholinesterase agents; management of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis
Note: Approved ages and uses for products may vary; consult labeling for specific information.
Drops (eg, Hyosyne): FDA approved in pediatric patients weighing ≥3.4 kg and adults
Elixir (eg, Hyosyne): FDA approved in ages ≥2 years and adults
Extended release tablets (eg, Levbid, Oscimin SR, Symax SR): FDA approved in ages ≥12 years and adults
Extended release biphasic tablets (eg, Symax Duotab): FDA approved in ages ≥12 years and adults
Orally disintegrating tablet (eg, Anaspaz, ED-Spaz, NuLev): FDA approved in ages ≥2 years and adults
Orally disintegrating tablet (eg, Oscimin): FDA approved in ages ≥12 years and adults
Oral tablet (eg, Levsin): FDA approved in ages ≥2 years and adults
Sublingual tablet (eg, Levsin SL): FDA approved in ages ≥2 years and adults
Sublingual tablet (eg, Oscimin, Symax SL): FDA approved in ages ≥12 years and adults
Injection: Adjunct to anesthesia, reduction of drug-induced bradycardia during surgery, and reversal of neuromuscular blockade (FDA approved in ages >2 years and adults); treatment of GI urinary tract disorders caused by spasm, biliary, and renal colic, antidote for poisoning by anticholinesterase agents, reduction of GI motility to facilitate diagnostic procedures and to improve radiologic visibility of the kidneys, and reduction of pain and hypersecretion of pancreatitis (FDA approved in adults)
Anaspaz may be confused with Anaprox, Antispas
Levbid may be confused with Enbrel, Lithobid, Lopid, Lorabid
Levsin/SL may be confused with Levaquin
Beers Criteria: Hyoscyamine is identified in the Beers Criteria as a potentially inappropriate medication to be avoided in patients 65 years and older (independent of diagnosis or condition) due to its highly anticholinergic properties and uncertain effectiveness as an antispasmodic (Beers Criteria [AGS 2019]).
Pharmacy Quality Alliance (PQA): Hyoscyamine is identified as a high-risk medication in patients 65 years and older on the PQA’s Use of High-Risk Medications in the Elderly (HRM) performance measure, a safety measure used by the Centers for Medicare and Medicaid Services (CMS) for Medicare plans (PQA 2017).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. 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
Hypersensitivity to belladonna alkaloids or any component of the formulation; glaucoma; obstructive uropathy (eg, bladder neck obstruction due to prostatic hypertrophy); myasthenia gravis; obstructive GI tract disease (eg, achalasia, pyloroduodenal stenosis), 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.
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.
Large doses of anticholinergics may cause a paradoxical reaction in children characterized by hyperexcitability. Oral dosage forms (drops and elixirs) are different (ie, 0.125 mg/mL [drops] and 0.125 mg/5 mL [solution]); precaution should be taken to verify and avoid confusion between the different concentrations; dose should be clearly presented with corresponding product formulation. Hyosyne oral drops contain 5% v/v alcohol. Hyosyne oral elixir contains 20% v/v alcohol.
None known.
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
Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. 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. Risk C: Monitor therapy
Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Risk C: Monitor therapy
Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination
CloZAPine: Anticholinergic Agents may enhance the constipating effect of CloZAPine. Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for signs and symptoms of gastrointestinal hypomotility and consider prophylactic laxative treatment. Risk D: Consider therapy modification
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 C: Monitor therapy
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination
Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. 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
Ketoconazole (Systemic): Hyoscyamine may decrease the serum concentration of Ketoconazole (Systemic). Management: Take hyoscyamine at least 2 hours after ingestion of ketoconazole. Monitor for decreased therapeutic effects of ketoconazole if used together with hyoscyamine. Risk D: Consider therapy modification
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
Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy
Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor therapy
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: 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. Risk X: Avoid combination
Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Risk X: Avoid combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk X: Avoid combination
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy
Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of 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
Animal reproduction studies have not been conducted. Hyoscyamine crosses the placenta.
Pulse, anticholinergic effects, urine output, GI symptoms
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
Onset of action: 2 to 3 minutes
Duration: Regular release: 4 to 6 hours; Extended release (Levbid, Symax Duotab): 8 to 12 hours
Absorption: Well absorbed
Metabolism: Hepatic
Half-life elimination: Regular release: 2 to 3.5 hours; Extended release (Levbid): ~7 hours
Excretion: Urine
Elixir (Hyoscyamine Sulfate Oral)
0.125 mg/5 mL (per mL): $0.22 - $0.23
Solution (Hyoscyamine Sulfate Injection)
0.5 mg/mL (per mL): $71.20
Solution (Hyoscyamine Sulfate Oral)
0.125 mg/mL (per mL): $2.65
Solution (Levsin Injection)
0.5 mg/mL (per mL): $71.54
Sublingual (Hyoscyamine Sulfate Sublingual)
0.125 mg (per each): $0.56 - $0.85
Sublingual (Levsin/SL Sublingual)
0.125 mg (per each): $2.87
Tablet, 12-hour (Hyoscyamine Sulfate ER Oral)
0.375 mg (per each): $0.99 - $1.65
Tablet, 12-hour (Levbid Oral)
0.375 mg (per each): $4.90
Tablet, orally-disintegrating (Anaspaz Oral)
0.125 mg (per each): $0.30
Tablet, orally-disintegrating (Hyoscyamine Sulfate Oral)
0.125 mg (per each): $0.57 - $1.23
Tablet, orally-disintegrating (NuLev Oral)
0.125 mg (per each): $2.26
Tablets (Hyoscyamine Sulfate Oral)
0.125 mg (per each): $0.56 - $1.02
Tablets (Levsin Oral)
0.125 mg (per each): $2.87
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