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Hyoscyamine

Hyoscyamine

Pronunciation Class: Antimuscarinics/Antispasmodics

VA Class: AU350

CAS Number: 101-31-5

Brands: Anaspaz, Cystospaz, Hyosyne, Levbid, Levsin, Levsinex, NuLev, Symax

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Introduction

Antimuscarinic; a naturally occurring tertiary amine; one of the optical isomers (the l-isomer) constituting atropine (d,l-hyoscyamine).a

Uses for Hyoscyamine

GI Disorders

Adjunct in the treatment of peptic ulcer disease;a however, no conclusive data that it aids in the healing, decreases the rate of recurrence, or prevents complications of peptic ulcers. In patients with gastric ulcer, antimuscarinics may delay gastric emptying and result in antral stasis.a

Adjunct in the treatment of functional GI disorders such as irritable bowel syndrome;100 106 107 108 109 110 112 113 114 115 116 117 118 119 120 121 122 123 124 126 a however, efficacy is limited.a Use only if other measures (e.g., diet, sedation, counseling, amelioration of environmental factors) have been of little or no benefit.a Also has been used in combination with phenobarbital in the treatment of irritable bowel syndrome; however, such combined therapy lacks substantial evidence of efficacy.a

Use with caution, if at all, in the treatment of hypermotility and diarrhea associated with GI disorders such as ulcerative colitis, dysentery, shigellosis, and Clostridium difficile-associated diarrhea and colitis (also known as antibiotic-associated pseudomembranous colitis).a

GU Disorders

Adjunctive therapy in the management of hypermotility disorders of the lower urinary tract.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 a May provide symptomatic relief, but the underlying cause should be determined and specifically treated.a

With the exception of uninhibited or reflex neurogenic bladder, there is generally little evidence to support use of antimuscarinics in the treatment of various GU disorders.a

Infant Colic

Treatment of infant colic;106 109 114 117 120 121 122 123 124 126 however, minimal evidence of efficacy with antimuscarinics.a Infant colic is considered a benign, self-limiting condition that tends to resolve spontaneously and not require medical treatment.a

Surgery

Has been used to inhibit salivation and excessive secretions of the respiratory tract;107 a however, current surgical practice (e.g., using thiopental, halothane, or similar general anesthetics that do not stimulate salivary and tracheobronchial secretions) has reduced the need to control excessive respiratory secretions during surgery.a

Has been used prophylactically to reduce volume and acidity of gastric secretions and to prevent acid-aspiration pneumonitis during surgery; however, antimuscarinics not shown to be effective for this use.107

May be used to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation, thus preventing cholinergic effects during surgery (e.g., cardiac arrhythmias, hypotension, bradycardia) secondary to visceral traction (resulting in vagal stimulation), carotid sinus stimulation, or concomitant drugs (e.g., succinylcholine).107 a

Used to block adverse muscarinic effects of anticholinesterase agents that are used after surgery to terminate curarization.a

Cholinesterase Inhibitor Toxicity

Used parenterally as an antidote in the treatment of cholinesterase inhibitor toxicity.a

Also used orally or sublingually in the treatment of cholinesterase inhibitor toxicity.100 106 109 110 112 113 114 116 117 119 120 121 122 123 124 126

Pesticide Poisoning

Concomitantly with a cholinesterase reactivator (pralidoxime chloride) to reverse muscarinic effects associated with toxic exposure to anticholinesterase compounds (e.g., organophosphate pesticides).a However, other antimuscarinics (principally atropine) are used more commonly.128

Radiographic Uses

Facilitation of endoscopy or hypotonic duodenography by reducing GI motility;107 however, glucagon appears to be more effective and generally is preferred.a

Has been used to increase visualization of the urinary tract in excretion urography.a

Biliary Disorders

Do not rely on antimuscarinics for relief of biliary tract disorders (e.g., combined with opiates for biliary colic) because of weak biliary antispasmodic action.a

Pancreatitis

Has been used to reduce pain and hypersecretion in pancreatitis; however, there is little, if any, evidence that antimuscarinics improve the prognosis of the disease.a

Acute Rhinitis

Has been used as a drying agent in the relief of symptoms of acute rhinitis.a

Parkinsonian Syndrome

Adjunctive therapy in the treatment of parkinsonian syndrome to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis.a

Renal Colic

Has been used in conjunction with morphine or other opiates for the symptomatic relief of renal colic.a

Heart Block

May be useful in some patients in the treatment of partial heart block associated with vagal activity.a

Hyoscyamine Dosage and Administration

Administration

Administer hyoscyamine orally.a

Administer hyoscyamine sulfate orally, sublingually, or by sub-Q, IM, or IV injection.a

Oral Administration

Immediate-release Preparations

Conventional tablets, elixir, oral solution (drops), orally disintegrating tablets, and sublingual tablets generally administered orally 3–6 times daily.100 106 114 116 117 118 119 120 121 122 123 126 One manufacturer (Symax FasTab, Symax SL) recommends administration 30–60 minutes before meals.115 118

Place orally disintegrating tablet on the tongue, allow it to disintegrate, then swallow with or without water.100 118 119

Certain sublingual tablets (Levsin/SL, certain generic preparations) may be chewed.114 116 117

Oral administration of sublingual tablets results in similar pharmacologic effects as sublingual administration, but onset may not be as rapid.114 116 117

Extended-release Preparations

Do not crush or chew extended-release preparations.109 110

Administer Levbid extended-release tablets (or generic preparations) orally every 12 hours; tablets are scored and may be broken to titrate dosage.110 112 113

Administer extended-release capsules (Levsinex Timecaps, generic preparations), Symax SR extended-release tablets, and Symax DuoTab bilayer extended-release tablets orally every 12 hours; swallow capsules or tablets whole; may adjust dosage by reducing dosing interval to 8 hours.108 109 111 124 One manufacturer (Symax DuoTab, Symax SR) recommends administration 30–60 minutes before meals.108 111

Sublingual Administration

Sublingual tablets generally administered 3–6 times daily.114 116 117 One manufacturer (Symax SL) recommends administration 30–60 minutes before meals and at bedtime.115

Parenteral Administration

Administer by sub-Q, IM, or IV injection without prior dilution.107

Dosage

Available as hyoscyamine and hyoscyamine sulfate; dosage of hyoscyamine sulfate expressed in terms of the salt.106 107 108 109 110 111 112 113 114 115 116 118 120 121 122 123 124 126

Titrate dosage carefully according to the condition, severity of symptoms, and the individual patient’s response and tolerance to the drug.100 106 109 110 114 115 116 117 118 119 120 121 122 123 126 Higher than recommended dosage may be required for therapeutic effect.a Use lowest possible effective dosage.a

Pediatric Patients

General Hyoscyamine Sulfate Dosage (for GI/GU/Biliary Disorders, Renal Colic, Acute Rhinitis, Parkinsonian Syndrome, or Cholinesterase Inhibitor Toxicity)

See GU Disorders dosage section for hyoscyamine dosage for GU disorders.

Oral

Recommended dosages of hyoscyamine sulfate vary by age and/or formulation (see Tables 1–4).

Using the dropper provided by the manufacturer, which is calibrated to deliver approximately 32 drops/mL.125

Table 1. Usual Dosages of Hyoscyamine Sulfate (as Oral Solution [Drops]) for Management of GI/GU/Biliary Disorders, Renal Colic, Acute Rhinitis, Parkinsonian Syndrome, or Cholinesterase Inhibitor Toxicity in Pediatric Patients <2 Years of Age120121126
Body Weight

Usual Dosage

Maximum Dosage in a 24-hour Period

3.4 kg (7.5 lb)

4 drops (15.63 mcg) every 4 hours or as needed

24 drops (93.75 mcg)

5 kg (11 lb)

5 drops (19.53 mcg) every 4 hours or as needed

30 drops (117.19 mcg)

7 kg (15 lb)

6 drops (23.44 mcg) every 4 hours or as needed

36 drops (140.63 mcg)

10 kg (22 lb)

8 drops (31.25 mcg) every 4 hours or as needed

48 drops (187.5 mcg)

Table 2. Usual Dosages of Hyoscyamine Sulfate for Management of GI/GU/Biliary Disorders, Renal Colic, Acute Rhinitis, Parkinsonian Syndrome, or Cholinesterase Inhibitor Toxicity in Children 2–11 Years of Age100106108111114115116117118119120121124126
Formulation(s)

Usual Dosage

Maximum Dosage in a 24-hour Period

Conventional tablets, orally disintegrating tablets, or sublingual tablets

62.5–125 mcg every 4 hours or as needed100 106 114 116 117 118 119

Symax SL: 62.5–125 mcg 3 or 4 times daily given 30–60 minutes before meals and at bedtime115

750 mcg100 106 114 116 117 118 119 120 121 126

Elixir

Weight-based dosing (see Table 3)122 123

Oral solution (drops)

31.25–125 mcg every 4 hours or as needed120 121 126

750 mcg120 121 126

Bilayer extended-release tablets, extended-release capsules, extended-release tablets

375 mcg every 12 hours108 111 124

750 mcg108 109 110 111 112 113 124

Table 3. Weight-based Dosing of Hyoscyamine Sulfate (as Elixir) for Management of GI/GU/Biliary Disorders, Renal Colic, Acute Rhinitis, Parkinsonian Syndrome, or Cholinesterase Inhibitor Toxicity in Children 2–11 Years of Age122123125126
Body Weight

Usual Dosage

Maximum Dosage in a 24-hour Period

10 kg (22 lb)

1.25 mL (31.25 mcg) every 4 hours or as needed

7.5 mL (187.5 mcg)

20 kg (44 lb)

2.5 mL (62.5 mcg) every 4 hours or as needed

15 mL (375 mcg)

40 kg (88 lb)

3.75 mL (93.75 mcg) every 4 hours or as needed

22.5 mL (562.5 mcg)

50 kg (110 lb)

5 mL (125 mcg) every 4 hours or as needed

30 mL (750 mcg)

Table 4. Usual Dosages of Hyoscyamine Sulfate for Management of GI/GU/Biliary Disorders, Renal Colic, Acute Rhinitis, Parkinsonian Syndrome, or Cholinesterase Inhibitor Toxicity in Children ≥12 Years of Age100106108109110111112113114115116117118119120121124126
Formulation(s)

Usual Dosage

Maximum Dosage in a 24-hour Period

Conventional tablets, elixir, oral solution (drops), orally disintegrating tablets, sublingual tablets

0.125–0.25 mg every 4 hours or as needed100 106 114 116 117 118 119 120 121 122 123 126

Symax SL tablets: 0.125–0.25 mg 3 or 4 times daily given 30–60 minutes before meals and at bedtime115

1.5 mg100 106 114 116 117 118 119 120 121 122 123 126

Bilayer extended-release tablets, extended-release capsules, extended-release tablets

0.375–0.75 mg every 12 hours.108 109 110 111 112 113 124 Alternatively, may adjust dosage to 0.375 mg every 8 hours as needed108 109 111 124

1.5 mg108 109 110 111 112 113 124

Sublingual

Children 2–11 years of age: 62.5–125 mcg (0.0625–0.125 mg) hyoscyamine sulfate every 4 hours or as needed, not to exceed 750 mcg in a 24-hour period.114 116 117 For Symax SL tablets, 62.5–125 mcg 3 or 4 times daily given 30–60 minutes before meals and at bedtime.115

Children ≥12 years of age: 0.125–0.25 mg hyoscyamine sulfate every 4 hours or as needed, not to exceed 1.5 mg in a 24-hour period.114 116 117 For Symax SL tablets, 0.125–0.25 mg 3 or 4 times daily given 30–60 minutes before meals and at bedtime.115

GU Disorders
Oral

Hyoscyamine: In older pediatric patients, reduce dosage (compared with adult dosage) in proportion to age and weight.a (See Adults under Dosage and Administration.)

Hyoscyamine sulfate: See General Hyoscyamine Sulfate Dosage section.

Sublingual

See General Hyoscyamine Sulfate Dosage section.

Infant Colic
Oral

Children <2 years of age: Dosage of hyoscyamine sulfate based on weight (see Table 5).120 121 126

Using the dropper provided by the manufacturer, which is calibrated to deliver approximately 32 drops/mL.125

Table 5. Usual Dosages of Hyoscyamine Sulfate (as Oral Solution [Drops]) for Management of Infant Colic in Pediatric Patients <2 Years of Age120121126
Body Weight

Usual Dosage

Maximum Dosage in a 24-hour Period

3.4 kg (7.5 lb)

4 drops (15.63 mcg) every 4 hours or as needed

24 drops (93.75 mcg)

5 kg (11 lb)

5 drops (19.53 mcg) every 4 hours or as needed

30 drops (117.19 mcg)

7 kg (15 lb)

6 drops (23.44 mcg) every 4 hours or as needed

36 drops (140.63 mcg)

10 kg (22 lb)

8 drops (31.25 mcg) every 4 hours or as needed

48 drops (187.5 mcg)

Surgery
Preoperatively to Decrease Secretions and Block Cardiac Vagal Reflexes

IV, IM, or Sub-Q Children >2 years of age: 5 mcg/kg (0.005 mg/kg) hyoscyamine sulfate given 30–60 minutes before anesthesia or concurrently with other preanesthetic medications (e.g., opiates, sedatives).107 a

Reversal of Drug-induced Bradycardia

IV Children >2 years of age: 0.125 mg hyoscyamine sulfate; repeat as necessary.107

Muscarinic Blockade during Anticholinesterase Reversal of Curariform Neuromuscular Blockade

IV Children >2 years of age: 0.2 mg hyoscyamine sulfate for each 1 mg of neostigmine methylsulfate or the equivalent dose of physostigmine salicylate or pyridostigmine bromide administered.107

Administer concurrently with (but in a separate syringe) or a few minutes before the anticholinesterase agent.a

If bradycardia is present, administer before the anticholinesterase agent to increase pulse to about 80 bpm.a

Adults

General Hyoscyamine Sulfate Dosage (for GI/GU/Biliary Disorders, Renal Colic, Acute Rhinitis, Parkinsonian Syndrome, or Cholinesterase Inhibitor Toxicity)

See GI Disorders dosage section for parenteral hyoscyamine sulfate dosage for GI disorders and see GU Disorders dosage section for hyoscyamine dosage for GU disorders.

Oral

Recommended dosages of hyoscyamine sulfate vary by formulation (see Table 6).

Table 6. Usual Dosages of Hyoscyamine Sulfate for Management of GI/GU/Biliary Disorders, Renal Colic, Acute Rhinitis, Parkinsonian Syndrome, or Cholinesterase Inhibitor Toxicity in Adults100106108109110111112113114115116117118119120121124126
Formulation(s)

Usual Dosage

Maximum Dosage in a 24-hour Period

Conventional tablets, elixir, oral solution (drops), orally disintegrating tablets, sublingual tablets

0.125–0.25 mg every 4 hours or as needed100 106 114 116 117 118 119 120 121 122 123 126

Symax SL tablets: 0.125–0.25 mg 3 or 4 times daily given 30–60 minutes before meals and at bedtime115

1.5 mg100 106 114 116 117 118 119 120 121 122 123 126

Bilayer extended-release tablets, extended-release capsules, extended-release tablets

0.375–0.75 mg every 12 hours.108 109 110 111 112 113 124 Alternatively, may adjust dosage to 0.375 mg every 8 hours as needed108 109 111 124

1.5 mg108 109 110 111 112 113 124

Sublingual

0.125–0.25 mg hyoscyamine sulfate every 4 hours or as needed, not to exceed 1.5 mg in a 24-hour period.114 116 117

Symax SL tablets: 0.125–0.25 mg hyoscyamine sulfate 3 or 4 times daily given 30–60 minutes before meals and at bedtime.115

GI Disorders
Oral

See General Hyoscyamine Sulfate Dosage section.

Sublingual

See General Hyoscyamine Sulfate Dosage section.

IV, IM, or Sub-Q

0.25–0.5 mg hyoscyamine sulfate every 4 hours, 2–4 times daily; for acute symptoms, a single parenteral dose of 0.25–0.5 mg may be sufficient.a Adjust dosage according to individual patient’s response and tolerance.a

GU Disorders
Oral

Hyoscyamine: 0.15–0.3 mg up to 4 times daily.a

Hyoscyamine sulfate: See General Hyoscyamine Sulfate Dosage section.

Sublingual

See General Hyoscyamine Sulfate Dosage section.

Surgery
Preoperatively to Decrease Secretions and Block Cardiac Vagal Reflexes

IV, IM, or Sub-Q 5 mcg/kg (0.005 mg/kg) hyoscyamine sulfate given 30–60 minutes before anesthesia or concurrently with other preanesthetic medications (e.g., opiates, sedatives).107 a

Reversal of Drug-induced Bradycardia

IV 0.125 mg hyoscyamine sulfate; repeat as necessary.107

Muscarinic Blockade during Anticholinesterase Reversal of Curariform Neuromuscular Blockade

IV 0.2 mg hyoscyamine sulfate for each 1 mg of neostigmine methylsulfate or the equivalent dose of physostigmine salicylate or pyridostigmine bromide administered.107

Administer concurrently with (but in a separate syringe) or a few minutes before the anticholinesterase agent.a

If bradycardia is present, administer before the anticholinesterase agent to increase pulse to about 80 bpm.a

Pesticide Poisoning
Organophosphate Anticholinesterase Pesticides

Initial dose preferably should be administered IV.a

A cholinesterase reactivator (pralidoxime) is administered concomitantly.a

IV or IM, then Oral Initially, 1–2 mg hyoscyamine sulfate IV.a May administer additional 1-mg doses IV or IM every 3–10 minutes until muscarinic signs and symptoms disappear; up to 25 mg may be required during first 24 hours.a Subsequently, administer 0.5–1 mg hyoscyamine sulfate orally at intervals of several hours (maintenance therapy) until signs and symptoms completely subside.a

Radiographic Uses
Endoscopy or Hypotonic Duodenography

IV, IM, or Sub-Q 0.25–0.5 mg hyoscyamine sulfate 5–10 minutes prior to the diagnostic procedure.107

Prescribing Limits

Pediatric Patients

GI/GU/Biliary Disorders, Renal Colic, Acute Rhinitis, Parkinsonian Syndrome, or Cholinesterase Inhibitor Toxicity
Oral or Sublingual

Pediatric patients <2 years of age receiving hyoscyamine sulfate oral solution (drops): In a 24-hour period, maximum 24 drops (93.75 mcg) in infants weighing 3.4 kg, 30 drops (117.19 mcg) in infants weighing 5 kg, 36 drops (140.63 mcg) in infants weighing 7 kg, or 48 drops (187.5 mcg) in infants weighing 10 kg.120 121 126

Children 2–11 years of age: Maximum 750 mcg hyoscyamine sulfate in a 24-hour period.100 106 108 111 114 115 116 117 118 119 120 121 124 126 For weight-based dosing using elixir, in a 24-hour period, maximum 7.5 mL (187.5 mcg) in children weighing 10 kg, 15 mL (375 mcg) in children weighing 20 kg, 22.5 mL (562.5 mcg) in children weighing 40 kg, or 30 mL (750 mcg) in children weighing 50 kg.125

Children ≥12 years of age: Maximum 1.5 mg hyoscyamine sulfate in a 24-hour period.100 106 108 109 110 111 112 113 114 115 116 117 118 119 120 121 124 126

Infant Colic
Oral

Pediatric patients <2 years of age receiving hyoscyamine sulfate oral solution (drops): In a 24-hour period, maximum 24 drops (93.75 mcg) in infants weighing 3.4 kg, 30 drops (117.19 mcg) in infants weighing 5 kg, 36 drops (140.63 mcg) in infants weighing 7 kg, or 48 drops (187.5 mcg) in infants weighing 10 kg.120 121 126

Adults

GI/GU/Biliary Disorders, Renal Colic, Acute Rhinitis, Parkinsonian Syndrome, or Cholinesterase Inhibitor Toxicity
Oral or Sublingual

Maximum 1.5 mg hyoscyamine sulfate in a 24-hour period.100 106 108 109 110 111 112 113 114 115 116 117 118 119 120 121 124 126

Special Populations

Geriatric Patients

Geriatric patients may be more sensitive to drug’s effects at usual adult dosages.108 115

Select dosage with caution, usually starting at low end of dosing range, because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.100 106 109 110 112 113 114 116 117 120 121 122 123 124 (See Geriatric Use under Cautions.)

Cautions for Hyoscyamine

Contraindications

  • Angle-closure glaucoma.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 b

  • Obstructive uropathy (e.g., bladder neck obstruction secondary to prostatic hypertrophy).100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 b
  • Obstructive GI disease (e.g., achalasia, pyloroduodenal stenosis).100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 b
  • Paralytic ileus.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 b
  • Intestinal atony (especially in geriatric or debilitated patients).100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 b
  • Acute hemorrhage when cardiovascular status is unstable.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 b
  • Tachycardia secondary to cardiac insufficiency or thyrotoxicosis.b
  • Severe ulcerative colitis or toxic megacolon complicating ulcerative colitis.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 b
  • Myasthenia gravis100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 (unless used to reduce adverse muscarinic effects of an anticholinesterase agent such as neostigmine).b
  • Myocardial ischemia.108 111 115 118

Warnings/Precautions

Warnings

Thermoregulatory Effects

Exposure to high environmental temperatures may result in heat prostration (fever and heat stroke due to decreased sweating).100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 b Increased risk of hyperthermia in patients who are febrile.b

Diarrhea

May be an early sign of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, use of hyoscyamine would be inappropriate and possibly harmful.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 b

Drowsiness and Blurred Vision

May cause drowsiness, dizziness, or blurred vision.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 b Performance of activities requiring mental alertness and physical coordination may be impaired.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 b

CNS Effects

Psychosis in patients with increased sensitivity to antimuscarinic drugs.100 106 107 109 110 112 113 114 116 117 119 120 121 122 123 124 126 CNS manifestations include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma,107 112 116 119 124 126 euphoria, anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect.100 106 107 109 110 112 113 114 116 117 119 120 121 122 123 124 126

Mental confusion and/or excitement, especially in geriatric patients.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 b

CNS manifestations usually resolve within 12–48 hours after drug is discontinued.100 106 107 109 110 112 113 114 116 117 119 120 121 122 123 124 126

General Precautions

Concomitant Illnesses

Use with caution in patients with autonomic neuropathy, hyperthyroidism, CHD, CHF, cardiac arrhythmias, hypertension, renal disease, or hiatal hernia associated with reflux esophagitis.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 b

Cardiac Tachyarrhythmia

Investigate any tachycardia before administration since antimuscarinics may increase heart rate.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126

GI Precautions

Extreme caution in known or suspected GI infections because of decreased GI motility and retention of causative organism and/or toxins.b

Extreme caution in mild to moderate ulcerative colitis because of suppressed intestinal motility and resultant paralytic ileus and toxic megacolon.b

Caution in gastric ulcer because of delayed gastric emptying and possible antral stasis.b

Caution in esophageal reflux and hiatal hernia because of decreased gastric motility and lower esophageal sphincter pressure leading to gastric retention and reflux aggravation.b

Oropharyngeal or Dental Effects

Long-term use of antimuscarinics may decrease or inhibit salivary flow, thus contributing to development of caries, periodontal disease, oral candidiasis, and discomfort.108 111 115 118

GU Disturbances

Extreme caution in patients with partial obstructive uropathy because of decreased tone and amplitude of contractions of ureters and bladder and resultant urinary retention.b (See Contraindications under Cautions.)

Respiratory Effects

Caution with systemically administered antimuscarinics in debilitated patients with chronic pulmonary disease because a reduction in bronchial secretions may lead to inspissation and formation of bronchial plugs.b

Down’s Syndrome, Spastic Paralysis, and Brain Damage

Increased sensitivity to antimuscarinic effects (e.g., mydriasis, positive chronotropic effect).108 111 115 118 b (See Pediatric Use under Cautions.)

Phenylketonuria

NuLev, Symax FasTab, and generic hyoscyamine sulfate (marketed by Ethex) orally disintegrating tablets contain aspartame (NutraSweet), which is metabolized in the GI tract to provide 1.7, 4.5, and 0.5 mg, respectively, of phenylalanine per 0.125-mg tablet.100 101 102 103 104 105 119 127

Specific Populations

Pregnancy

Category C.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126

Lactation

Distributed into milk.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 Caution if used in nursing women.100 106 107 109 110 112 113 114 116 117 119 120 121 122 123 124 126

Pediatric Use

Manufacturer states that use of Symax DuoTab, Symax FasTab, Symax SL, or Symax SR is not recommended in pediatric patients <2 years of age.108 111 115 118

Infants and children with spastic paralysis or brain damage may have increased sensitivity to antimuscarinic effects (e.g., mydriasis, positive chronotropic effect).108 111 115 118 b Close supervision recommended, and dosage adjustments often required.108 111 115 118

Infants and young children especially susceptible to toxic effects of antimuscarinics.108 111 115 118 Paradoxical reaction (characterized by hyperexcitability) may occur with large doses of antimuscarinics.108 111 115 118

Geriatric Use

Reported clinical experience has not identified differences in safety relative to younger adults.100 106 109 110 113 114 116 117 120 121 122 123 124

Hyoscyamine is substantially eliminated by the kidneys.100 106 109 110 113 114 116 117 120 121 122 123 124 Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.100 106 109 110 112 113 114 116 117 120 121 122 123 124 (See Geriatric Patients under Dosage and Administration.) Monitoring of renal function may be useful.100 106 109 110 113 114 117 120 121 122 123

Geriatric patients especially susceptible to antimuscarinic effects (e.g., constipation, dry mouth, urinary retention [particularly male patients]); if these adverse effects occur, persist, or are severe, consider discontinuance of drug.108 111 115 118 b Possible excitement, agitation, drowsiness, or confusion at usual dosages.108 111 115 118

Antimuscarinics may precipitate undiagnosed glaucoma; use with caution in geriatric patients.108 111 115 118

Continued use of antimuscarinics may severely impair memory, particularly in geriatric patients who already have memory problems.108 111 115 118

Hepatic Impairment

Use with caution in hepatic disease.b

Renal Impairment

Use with caution in renal disease.100 106 107 109 110 112 113 114 116 117 119 120 121 122 123 124 126 b Substantially excreted by the kidneys.100 106 107 108 109 110 111 112 113 114 116 117 118 120 121 122 123 124 126 Possible increased risk of adverse effects.100 106 109 110 113 114 117 120 121 122 123

Common Adverse Effects

Most adverse effects are manifestations of pharmacologic effects at muscarinic-cholinergic receptors and usually are reversible when therapy is discontinued.b

Severity and frequency of adverse effects are dose related and individual intolerance varies greatly; adverse effects occasionally may be obviated by a reduction in dosage but this also may eliminate potential therapeutic effects.b

Adverse effects include dry 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, mental confusion and/or excitement (especially in geriatric patients), short-term memory loss, hallucinations, and decreased sweating.100 106 109 110 113 114 116 117 120 121 122 123 b

Interactions for Hyoscyamine

Drugs with Anticholinergic Effects

Possible additive adverse effects resulting from cholinergic blockade (e.g., xerostomia, blurred vision, constipation).100 106 107 109 110 112 113 114 116 117 119 120 121 122 123 124 126 b Inform patient of this possibility.b

Effects on GI Absorption of Drugs

By inhibiting the motility of the GI tract and prolonging GI transit time, antimuscarinics have the potential to alter GI absorption of various drugs.108 111 115 118 b

Specific Drugs

Drug

Interaction

Comments

Acetaminophen

Possible delay in onset of therapeutic effects (e.g., analgesia, antipyresis) of acetaminophenb

Amantadine

Possible additive adverse effects resulting from cholinergic blockade100 106 107 109 110 112 113 114 116 117 119 120 121 122 123 124 126 b

Inform patient of this possibilityb

Antacids

Decreased GI absorption of hyoscyamine100 106 109 110 112 113 114 116 117 119 120 121 122 123 124 126

Administer oral hyoscyamine at least 1 hour before antacids;b some manufacturers recommend administering hyoscyamine before meals and antacids after meals to prolong effects of postprandial antacid therapy,100 106 112 114 116 117 119 120 121 122 123 124 126 but no substantial difference in gastric pH demonstrated with such combined therapyb

Antiarrhythmic (anticholinergic) agents

Possible additive adverse effects resulting from cholinergic blockadeb

Inform patient of this possibilityb

Anticholinergic drugs

Possible additive adverse effects resulting from cholinergic blockade100 106 107 109 110 112 113 114 116 117 119 120 121 122 123 124 126

Inform patient of this possibilityb

Antidepressants, tricyclic

Possible additive adverse effects resulting from cholinergic blockade100 106 107 109 110 112 113 114 116 117 119 120 121 122 123 124 126 b

Inform patient of this possibilityb

Antihistamines (anticholinergic) (including meclizine)

Possible additive adverse effects resulting from cholinergic blockade100 106 107 109 110 112 113 114 116 117 119 120 121 122 123 124 126 b

Inform patient of this possibilityb

Antiparkinsonian (antimuscarinic) agents

Possible additive adverse effects resulting from cholinergic blockadeb

Inform patient of this possibilityb

Corticosteroids

Possible increased IOPb

Digoxin (slow dissolving)

Possible increased serum digoxin concentrationb

Use digoxin oral solution (elixir) or rapidly dissolving tablets (e.g., Lanoxin)b

Observe closely for signs of digitalis toxicityb

Glutethimide

Possible additive adverse effects resulting from cholinergic blockadeb

Inform patient of this possibilityb

Haloperidol

Possible additive adverse effects resulting from cholinergic blockade100 106 107 109 110 112 113 114 116 117 119 120 121 122 123 124 126

Inform patient of this possibilityb

Ketoconazole

Increased gastric pH decreases ketoconazole absorptionb

Administer hyoscyamine at least 2 hours after ketoconazoleb

Levodopa

Possible increased GI metabolism of levodopa and decreased systemic concentrationsb

Adjust levodopa dosage if hyoscyamine is started or discontinuedb

MAO inhibitors

Possible additive adverse effects resulting from cholinergic blockade100 106 107 109 110 112 113 114 116 117 119 120 121 122 123 124 126

Inform patient of this possibilityb

Meperidine

Possible additive adverse effects resulting from cholinergic blockadeb

Inform patient of this possibilityb

Muscle (anticholinergic) relaxants

Possible additive adverse effects resulting from cholinergic blockadeb

Inform patient of this possibilityb

Phenothiazines

Possible additive adverse effects resulting from cholinergic blockade100 106 107 109 110 112 113 114 116 117 119 120 121 122 123 124 126 b

Inform patient of this possibilityb

Potassium chloride

Slowed GI transit potentiates adverse GI effects of oral potassium chloride (especially wax-matrix tablets)b

Caution if used concomitantly; monitor for possible GI mucosal lesionsb

Hyoscyamine Pharmacokinetics

Absorption

Pharmacokinetics of hyoscyamine (l-hyoscyamine) and atropine (dl-hyoscyamine) generally considered similar.a

Bioavailability

Completely absorbed from the GI tract following oral or sublingual administration.100 106 108 109 110 112 113 114 115 116 117 118 119 120 121 122 123 124 126

Extended-release capsules (Levsinex Timecaps,109 generic preparations124 ) and extended-release tablets (Levbid,110 generic preparations112 113 ) are formulated to release 0.375 mg of the drug at a controlled and predictable rate for a 12-hour period.109 110 112 113 124 Relative bioavailability reportedly is about 81 or 92%, respectively, that of the conventional tablets.112 124 Peak blood concentrations occur in 2.5–5 or about 4 hours following administration of these extended-release capsule or tablet formulations, respectively.109 110 112 113 124

Bilayer extended-release tablets (i.e., Symax DuoTab) are formulated to release 0.125 mg of hyoscyamine sulfate immediately and the remaining 0.25 mg over 8–12 hours.108

Onset

Time to onset and peak pharmacologic action depends on formulation and route of administration (see Table 7).a Oral administration of sublingual tablets results in similar pharmacologic effects as sublingual administration, although onset may not be as rapid.114 116 117

Table 7. Time to Onset and Peak Pharmacologic Action of Hyoscyamine Sulfatea
Formulation (Administration Route)

Time to Onset (minutes)

Time to Peak Effect (minutes)

Conventional tablets (oral)

20–30

30–60

Conventional tablets (sublingual or chewed)

5–20

30–60

Oral solution (i.e., drops) or elixir (oral)

5–20

30–60

Extended-release capsules (oral)

20–30

40–90

Injection (parenteral)

2–3

15–30

Duration

Immediate-release hyoscycamine sulfate preparations: Pharmacologic action generally persists for about 4 hours.a

Hyoscyamine sulfate extended-release capsules: Pharmacologic action persists for about 12 hours.a

Hyoscyamine sulfate injection: Pharmacologic action persists for up to 4 hours.a

Food

Food does not appear to affect absorption.a

Distribution

Extent

Well distributed throughout the body.100 106 107 108 109 110 112 113 114 115 116 117 118 119 120 121 122 123 124 126 a

Crosses the blood-brain barrier.100 106 107 108 109 110 112 113 114 116 117 118 119 120 121 122 123 124 126 a

Small quantities are distributed into milk and are found in placental tissues.100 106 107 108 109 110 112 113 114 115 116 117 118 119 120 121 122 123 124 126 a

Plasma Protein Binding

Approximately 50%.a

Elimination

Metabolism

Partly metabolized in the liver to tropic acid, tropine, and hyoscyamine glucuronide.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126

Elimination Route

Most of a dose is excreted in urine unchanged within 12 hours after administration.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126

Half-life

Immediate-release preparations: About 2–3.5 hours in individuals with normal renal function.100 106 114 116 117 119 120 121 122 123 126

Extended-release capsules: About 5–7 hours.109 124

Extended-release tablets: About 7–9 hours.110 113

Elimination may be biphasic; elimination half-life (determined by urinary excretion) in the terminal phase may be ≥12.5 hours.a

Special Populations

Elimination is prolonged in individuals with renal dysfunction.a

Stability

Storage

Oral

Conventional Tablets and Sublingual Tablets

15–30°C.106 114 115 116 117

Oral Solution (Drops) and Elixir

20–25°C (may be exposed to 15–30°C).120 121 122 123

Orally Disintegrating Tablets

Tight, light resistant containers at 20–25°C (may be exposed to 15–30°C).100 118 119 Protect from moisture.100 119

Extended-release Capsules and Tablets

15–30°C.109 110 111 112 113 124

Parenteral

Injection

15–30°C.107

Actions

  • Competitively inhibits acetylcholine or other cholinergic stimuli at autonomic effectors innervated by postganglionic cholinergic nerves and, to a lesser extent, on smooth muscles that lack cholinergic innervation.100 106 107 108 109 110 112 113 114 116 117 119 120 121 122 123 124 126 b At usual doses, principally antagonizes cholinergic stimuli at muscarinic receptors and has little or no effect on cholinergic stimuli at nicotinic receptors.100 106 107 108 109 110 112 113 114 116 117 119 120 121 122 123 124 126 b

  • Antimuscarinics also have been referred to as anticholinergics (cholinergic blocking agents), but this term is appropriate only when it describes the antagonism of cholinergic stimuli at any cholinergic receptor, whether muscarinic or nicotinic.b
  • Also have been referred to as parasympatholytics because the antagonized functions principally are under the parasympathetic division of the nervous system.b
  • Receptors at various sites are not equally sensitive to inhibition of muscarinic effects.b Relative sensitivity of physiologic functions (proceeding from the most sensitive) is as follows: secretions of the salivary, bronchial, and sweat glands; pupillary dilation, ocular accommodation, and heart rate; contraction of the detrusor muscle of the bladder and smooth muscle of the GI tract; and gastric secretion and motility.b Doses used to decrease gastric secretions are likely to cause dryness of the mouth (xerostomia) and interfere with visual accommodation, and possibly cause difficulty in urinating.b
  • Various antisecretory effects in the GI tract, including reduction of salivation (producing xerostomia) and gastric secretions (only partial reduction in gastric acid secretion).b Prolonged inhibitory effects on the motility of the esophagus, stomach, duodenum, jejunum, ileum, and colon.b
  • Relaxes lower esophageal sphincter with a resultant decrease in lower esophageal sphincter pressure.b
  • Decreases the tone and amplitude of contractions of the ureters and bladder.b May cause urinary retention (e.g., in patients with urinary obstruction).b
  • Can reverse reflex vagal cardiac slowing or asystole such as that induced by inhalation of irritant vapors or by vagal stimulation (e.g., carotid sinus stimulation, pressure on the eyeball).b
  • May cause cutaneous vasodilation, especially at toxic doses (atropine flush).b
  • Reduces secretions from the nose, mouth, pharynx, and bronchi.b Relaxes smooth muscles of the bronchi and bronchioles with a resultant decrease in airway resistance.b
  • Stimulates the medulla and higher cerebral centers and exhibits CNS effects similar to those produced by antimuscarinics used in the treatment of parkinsonian syndrome (e.g., trihexyphenidyl).b
  • Blocks the responses of the sphincter muscle of the iris and the ciliary muscle of the lens to cholinergic stimulation, producing mydriasis and cycloplegia and a resultant decrease in ocular accommodation.b Little effect on IOP except with angle-closure glaucoma where IOP may increase.b
  • Reduces the volume of perspiration by inhibiting sweat-gland secretions.b May suppress sweating sufficiently to increase body temperature.b

Advice to Patients

  • Potential for drug to impair mental alertness or physical coordination; avoid driving or operating machinery or performing hazardous work if such effects occur.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126

  • Risk of heat prostration, fever, or heat stroke secondary to decreased sweating; caution when febrile, exercising, or when exposed to high environmental temperatures.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126
  • Extended-release preparations may not completely disintegrate, and fragments may be excreted in stools.108 109 110 113
  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126
  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126
  • Importance of informing patients of other important precautionary information.100 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 126 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Hyoscyamine
Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

Oral

Tablets

0.15 mg

Cystospaz

Amerifit

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Hyoscyamine Sulfate
Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, extended-release

0.375 mg*

Hyoscyamine Sulfate ER Capsules (with povidone and propylene glycol)

Ethex

Levsinex Timecaps

Schwarz

Elixir

0.125 mg/5 mL

Hyoscyamine Sulfate Elixir (with alcohol 20%)

Cypress, Kremers Urban

Hyosyne Elixir (with alcohol 20%)

Silarx

Levsin (with alcohol 20%)

Schwarz

Solution

0.125 mg/mL*

Hyoscyamine Sulfate Oral Drops (with alcohol 5%)

Cypress, Kremers Urban, Morton Grove, Qualitest

Hyosyne Drops (with alcohol 5%)

Silarx

Levsin Drops (with alcohol 5%)

Schwarz

Tablets

0.125 mg*

Anaspaz (scored)

Ascher

Hyoscyamine Sulfate Tablets

Ethex, Kremers Urban, Qualitest

Levsin (scored)

Schwarz

Tablets, extended release

0.375 mg*

Hyoscyamine Sulfate ER Tablets (scored)

Ethex, Kremers Urban

Levbid (scored)

Schwarz

Symax SR

Capellon

0.375 mg (with extended-release 0.25 mg and immediate-release 0.125 mg)

Symax DuoTab (with povidone)

Capellon

Tablets, orally disintegrating

0.125 mg

Hyoscyamine Sulfate Orally Disintegrating Tablets (with aspartame)

Ethex

NuLev (with aspartame)

Schwarz

Symax FasTab (with aspartame)

Capellon

Oral or Sublingual (Intrabuccal)

Tablets

0.125 mg*

Hyoscyamine Sulfate Sublingual Tablets (scored)

Ethex, Kremers Urban

Levsin/SL (scored)

Schwarz

Symax SL

Capellon

Parenteral

Injection

0.5 mg/mL

Levsin

Schwarz

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Anaspaz 0.125MG Dispersible Tablets (B.F. ASCHER): 100/$35.92 or 300/$79.06

HyoMax-SL 0.125MG Sublingual Tablets (ARISTOS PHARMACEUTICALS): 100/$79.99 or 200/$149.98

HyoMax-SR 0.375MG 12-hr Tablets (ARISTOS PHARMACEUTICALS): 100/$145.99 or 300/$409.98

Hyoscyamine Sulfate 0.125MG Dispersible Tablets (COUNTY LINE PHARMACEUTICALS): 100/$82.99 or 300/$225.99

Hyoscyamine Sulfate 0.125MG Sublingual Tablets (PADDOCK): 30/$26.99 or 90/$58.97

Hyoscyamine Sulfate 0.125MG Tablets (COUNTY LINE PHARMACEUTICALS): 30/$31.99 or 90/$79.99

Hyoscyamine Sulfate CR 0.375MG 12-hr Tablets (PADDOCK): 30/$37.99 or 90/$96.97

Levbid 0.38MG 12-hr Tablets (MEDA PHARMACEUTICALS): 30/$73.49 or 90/$195.28

Levsin 0.125MG/ML Solution (ALAVEN PHARMACEUTICAL): 15/$45.99 or 45/$129.97

Levsin 0.13MG Tablets (MEDA PHARMACEUTICALS): 90/$112.99 or 270/$308.99

Levsin/SL 0.13MG Sublingual Tablets (MEDA PHARMACEUTICALS): 100/$140.99 or 200/$263.97

Symax Duotab 0.375MG Controlled-release Tablets (CAPELLON PHARMACEUTICALS): 30/$73.99 or 60/$139.97

Symax-SL 0.125MG Sublingual Tablets (CAPELLON PHARMACEUTICALS): 30/$98.70 or 60/$154.46

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug’s actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions December 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Schwarz Pharma. NuLev (hyoscyamine sulfate) orally disintegrating tablets. Milwaukee, WI; 2005 Sep.

101. American Medical Association Council on Scientific Affairs. Aspartame: review of safety issues. JAMA. 1985; 254:400-2. [IDIS 202002] [PubMed 2861297]

102. Gossel TA. A review of aspartame: characteristics, safety and uses. US Pharm. 1984; 9:26,28-30.

103. Food and Drug Administration. Aspartame as an inactive ingredient in human drug products; labeling requirements. Proposed rule. [21 CFR Part 201] Fed Regist. 1983; 48:54993-5. (lDIS 178728)

104. Food and Drug Administration. Food additives permitted for direct addition to food for human consumption; aspartame. Final rule. [21 CFR Part 172] Fed Regist. 1983; 48:31376-82. (IDIS 172957)

105. Anon. Aspartame and other sweeteners. Med Lett Drugs Ther. 1982; 24:1-2. [PubMed 7054648]

106. Schwarz Pharma. Levsin (hyoscyamine sulfate) tablets prescribing information. Milwaukee, WI; 2004 Sep.

107. Schwarz Pharma. Levsin (hyoscyamine sulfate) injection prescribing information. Milwaukee, WI; 2003 Sep.

108. Capellon Pharmaceuticals, Ltd. Symax DuoTab (hyoscyamine sulfate) biphasic tablets prescribing information. Fort Worth, TX; 2006 Feb.

109. Schwarz Pharma. Levsinex Timecaps (hyoscyamine sulfate) extended-release capsules prescribing information. Milwaukee, WI; 2004 Sep.

110. Schwarz Pharma. Levbid (hyoscyamine sulfate) extended-release tablets prescribing information. Milwaukee, WI; 2004 Sep.

111. Capellon Pharmaceuticals, Ltd. Symax SR (hyoscyamine sulfate) tablets prescribing information. Fort Worth, TX; 2005 Jan.

112. Ethex Corporation. Hyoscyamine sulfate extended-release tablets prescribing information. St. Louis, MO; 2000 Oct.

113. Kremers Urban. Hyoscyamine sulfate extended-release tablets prescribing information. Mequon, WI; 2004 Aug.

114. Schwarz Pharma. Levbid/SL (hyoscyamine sulfate) tablets prescribing information. Milwaukee, WI; 2004 Sep.

115. Capellon Pharmaceuticals, Ltd. Symax SL (hyoscyamine sulfate) tablets prescribing information. Fort Worth, TX; 2003 May.

116. Ethex Corporation. Hyoscyamine sulfate sublingual tablets prescribing information. St. Louis, MO; 1998 Nov.

117. Kremers Urban. Sublingual hyoscyamine sulfate tablets prescribing information. Mequon, WI; 2004 Aug.

118. Capellon Pharmaceuticals, Ltd. Symax FasTab (hyoscyamine sulfate) tablets prescribing information. Fort Worth, TX; 2003 Nov.

119. Ethex Corporation. Hyoscyamine sulfate orally disintegrating tablets prescribing information. St. Louis, MO; 2005 Jul.

120. Schwarz Pharma. Levsin drops (hyoscyamine sulfate) oral solution prescribing information. Milwaukee, WI; 2005 Mar.

121. Kremers Urban. Hyoscyamine sulfate oral solution prescribing information. Mequon, WI; 2005 Mar.

122. Schwarz Pharma. Levsin (hyoscyamine sulfate) elixir prescribing information. Milwaukee, WI; 2005 Mar.

123. Kremers Urban. Hyoscyamine sulfate elixir prescribing information. Mequon, WI; 2005 Mar.

124. Ethex Corporation. Hyoscyamine sulfate extended-release capsules prescribing information. St. Louis, MO; 1999 Feb.

125. Schwarz Pharma, Milwaukee, WI: Personal communication.

126. Silarx Pharmaceuticals, Inc. Hyosyne (hyoscyamine sulfate) oral drops and Hyosyne (hyoscyamine sulfate) elixir prescribing information. Spring Valley, NY; 1998 Jul.

127. Capellon Pharmaceuticals, Ltd., Ft. Worth, TX: Personal communication.

128. Clark F. Insecticides: organic phosphorus compounds and carbamates. In: Goldfrank LR, Flomenbaum NE, Lewin NA et al, eds. Goldfrank’s toxicologic emergenices. 7th ed. New York: McGraw-Hill; 2002;1346-65.

a. AHFS drug information 2007. McEvoy GK, ed. Hyoscyamine, Hyoscyamine Sulfate. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1276-8.

b. AHFS Drug Information 2007. McEvoy, GK, ed. Antimuscarinics/Antispasmodics General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1259-67.

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hyoscyamine

hyoscyamine

Pronunciation Generic Name: hyoscyamine (hye oh SYE a meen)

Brand Name: Anaspaz, Cystospaz, Ed Spaz, HyoMax, HyoMax DT, HyoMax FT, HyoMax SL, HyoMax SR, Hyospaz, Hyosyne, IB-Stat, Levbid, Levsin, Levsin SL, Levsinex SR, NuLev, Nulev, Symax Duotab, Symax FasTab, Symax SL, Symax SR, …show all 27 brand names

OverviewSide EffectsDosageInteractionsFor ProfessionalsMore…

What is hyoscyamine?

Hyoscyamine produces many effects in the body, including relief from muscle spasms.

Hyoscyamine also reduces the fluid secretions of many organs and glands in the body, such as the stomach, pancreas, lungs, saliva glands, sweat glands, and nasal passages.

Hyoscyamine is used to treat many different stomach and intestinal disorders, including peptic ulcer and irritable bowel syndrome. It is also used to control muscle spasms in the bladder, kidneys, or digestive tract, and to reduce stomach acid. Hyoscyamine is sometimes used to reduce tremors and rigid muscles in people with symptoms of Parkinson’s disease.

Hyoscyamine is also used as a drying agent to control excessive salivation, runny nose, or excessive sweating.

Hyoscyamine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hyoscyamine?

Do not take hyoscyamine if you are allergic to it, or if you have kidney disease, a bladder or intestinal obstruction, severe ulcerative colitis, toxic megacolon, glaucoma, or myasthenia gravis.

Before taking hyoscyamine, tell your doctor if you have heart disease, congestive heart failure, a heart rhythm disorder, high blood pressure, overactive thyroid, or hiatal hernia with gastroesophageal reflux disease.

Video: Rheumatoid Arthritis Learn the signs of RA and how to relieve the pain.

Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.

Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.

What should I discuss with my healthcare provider before taking hyoscyamine?

Do not take hyoscyamine if you are allergic to it, or if you have:

  • kidney disease;

  • an enlarged prostate or problems with urination;
  • intestinal blockage;
  • severe ulcerative colitis, or toxic megacolon;
  • glaucoma; or
  • myasthenia gravis.

To make sure you can safely take hyoscyamine, tell your doctor if you have any of these other conditions:

  • heart disease, congestive heart failure;

  • a heart rhythm disorder;
  • high blood pressure;
  • overactive thyroid; or
  • hiatal hernia with GERD (gastroesophageal reflux disease).

FDA pregnancy category C. It is not known whether hyoscyamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Hyoscyamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take hyoscyamine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your medication may come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Hyoscyamine is usually taken before a meal. Follow your doctor’s instructions.

Do not crush, chew, or open an extended-release tablet or capsule. It is specially made to release medicine slowly in the body. Breaking or crushing the pill would cause too much of the drug to be released at one time. Your doctor may want you to break an extended-release tablet and take only half of it. Follow your doctor’s instructions.

Measure the oral liquid form of hyoscyamine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The sublingual tablet form of this medication must be placed under the tongue, where it will dissolve. Do not swallow the sublingual tablet whole or wash it down with water. You may drink water after the pill has completely dissolved in your mouth.

Before using hyoscyamine oral spray for the first time, you must prime the spray pump. To do this, spray 3 test sprays into the air and away from your face. Prime the spray pump at least 1 test spray any time you have not used the oral spray for longer than 2 days. Spray until a fine mist appears.

After using the oral spray, try not to swallow right away. Do not rinse your mouth or spit for 5 to 10 minutes after using the oral spray.

Store this medication at room temperature away from moisture and heat.

Do not use hyoscyamine oral spray for more than 30 sprays, even if there is medicine still left in the bottle.

See also: Hyoscyamine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, dizziness, dry mouth, trouble swallowing, nausea, vomiting, blurred vision, hot dry skin, and feeling restless or nervous.

What should I avoid while taking hyoscyamine?

Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.

Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.

Hyoscyamine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using hyoscyamine and call your doctor at once if you have any of these serious side effects:

  • diarrhea;

  • confusion, hallucinations;
  • unusual thoughts or behavior;
  • fast, pounding, or uneven heart rate;
  • rash or flushing (warmth, redness, or tingly feeling); or
  • eye pain.

Less serious side effects may include:

  • dizziness, drowsiness, feeling nervous;

  • blurred vision, headache;
  • sleep problems (insomnia);
  • nausea, vomiting, bloating, heartburn, or constipation;
  • changes in taste;
  • problems with urination;
  • decreased sweating;
  • dry mouth; or
  • impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: hyoscyamine side effects (in more detail)

Hyoscyamine Dosing Information

Usual Adult Dose for Irritable Bowel Syndrome:

Immediate-release Tablets: 0.125 to 0.25 mg orally or sublingually every 4 hours or as needed. Do not take more than 12 tablets in 24 hours.

Extended-release Tablets: 0.375 to 0.75 mg orally every 12 hours. Do not exceed 4 tablets in 24 hours.

Timecaps: 0.375 to 0.75 mg orally every 12 hours. Do not exceed 4 capsules in 24 hours

Biphasic tablets: 0.375 to 0.75 mg orally every 12 hours. Dosage may be adjusted to 0.375 mg every 8 hours if needed. Do not exceed 4 tablets in 24 hours.

Elixir: 5 to 10 mL (0.125 to 0.25 mg) every 4 hours or as needed. Do not take more than 12 teaspoonfuls in 24 hours.

Drops: 1 to 2 mL (0.125 to 0.25 mg) every 4 hours as needed. Do not take more than 12 mL in 24 hours.

Usual Adult Dose for Anesthesia:

5 mcg/kg administered 30 to 60 minutes prior to the time of induction of anesthesia or given at the time the preanesthetic narcotic or sedative are administered.

Usual Adult Dose for Endoscopy or Radiology Premedication:

Parenteral:

0.25 to 0.5 mg (0.5 to 1 mL) IV 5 to 10 minutes prior to the diagnostic procedure.

Oral Spray:

Endoscopic retrograde cholangiopancreatography: 2 sprays (0.25 mg) 20 minutes prior to the procedure.

Usual Pediatric Dose for Urinary Incontinence:

Greater than or equal to 2 to less than 12 years:

Immediate-release Tablets: 0.0625 to 0.125 mg sublingually, orally, chew, every 4 hours or as needed. Do not take more than 6 tablets in 24 hours.

Elixir: 1.25 to 5 mL (10 kg to 50 kg child) every 4 hours or as needed. Increase dose by 1.25 mL increments for a 20 kg child, and again for a 40 kg child. Do not take more than 6 teaspoonfuls in 24 hours.

Drops: 0.25 to 1 mL (0.0312 to 0.125 mg) every 4 hours as needed. Do not give more than 6 mL in 24 hours.

Biphasic tablets: 0.375 mg orally every 12 hours. Do not exceed 2 tablets in 24 hours.

Less than 2 years:

Drops: 4 drops for a 3.4 kg child (Do not give more than 24 drops in 24 hours)

5 drops for a 5 kg child (Do not give more than 30 drops in 24 hours),

6 drops for a 7 kg child (Do not give more than 36 drops in 24 hours),

8 drops for a 10 kg child (Do not give more than 48 drops in 24 hours)

Usual Pediatric Dose for Irritable Bowel Syndrome:

Study (n=28)

Greater than 9 years: 0.375 mg orally at bedtime, up to 0.75 mg, for up to 6 months.

Usual Pediatric Dose for Anesthesia:

5 mcg/kg administered 30 to 60 minutes prior to the time of induction of anesthesia or given at the time the preanesthetic narcotic or sedative are administered.

What other drugs will affect hyoscyamine?

Tell your doctor about all other medicines you use, especially:

  • amantadine (Symmetrel);

  • haloperidol (Haldol);
  • an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);
  • phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine); or
  • an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

This list is not complete and other drugs may interact with hyoscyamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Next Page → Side Effects

More hyoscyamine resources

  • Side Effects
  • Recommended Dosage
  • Pregnancy Warnings
  • Drug Images
  • Drug Interactions
  • Support Group
  • 27 Reviews - Add your own review/rating
  • hyoscyamine MedFacts Consumer Leaflet (Wolters Kluwer)
  • Hyoscyamine Monograph (AHFS DI)
  • Anaspaz MedFacts Consumer Leaflet (Wolters Kluwer)
  • Anaspaz Prescribing Information (FDA)
  • HyoMax Prescribing Information (FDA)
  • Hyosyne drops MedFacts Consumer Leaflet (Wolters Kluwer)
  • Hyosyne Prescribing Information (FDA)
  • IB-Stat spray MedFacts Consumer Leaflet (Wolters Kluwer)
  • Levbid extended-release tablets MedFacts Consumer Leaflet (Wolters Kluwer)
  • Levsin Prescribing Information (FDA)
  • NuLev orally disintegrating tablets MedFacts Consumer Leaflet (Wolters Kluwer)
  • Symax Duotab controlled-release tablets MedFacts Consumer Leaflet (Wolters Kluwer)
  • Symax Duotab Prescribing Information (FDA)
  • Symax FasTab Prescribing Information (FDA)
  • Symax SL Prescribing Information (FDA)

Compare hyoscyamine with other medications

  • Anesthesia
  • Crohn’s Disease
  • Endoscopy or Radiology Premedication
  • Irritable Bowel Syndrome
  • Urinary Incontinence

Where can I get more information?

  • Your pharmacist can provide more information about hyoscyamine.

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Hyoscyamine

Hyoscyamine

Pronunciation Generic Name: hyoscyamine (HYE-oh-SYE-a-meen)

Brand Name: Levsin

OverviewSide EffectsInteractionsFor ProfessionalsMore…

Hyoscyamine is used for:

Treating certain stomach or bowel problems (eg, ulcers, spasms or cramping, irritable bowel syndrome, symptoms of colic), certain bladder problems (eg, spastic bladder, cystitis), and excessive secretions caused by inflammation of the pancreas, and for aiding in certain medical procedures or surgery. It may also be used for other conditions as determined by your doctor.

Hyoscyamine is an anticholinergic agent. It works by decreasing the motion of the stomach and intestines and the secretion of stomach fluids, including acid.

Do NOT use hyoscyamine if:

  • you are allergic to any ingredient in hyoscyamine
  • you have severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)
  • you have glaucoma, myasthenia gravis, or heart problems caused by severe bleeding

Contact your doctor or health care provider right away if any of these apply to you.

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Before using hyoscyamine:

Some medical conditions may interact with hyoscyamine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, kidney problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or if you are at risk for glaucoma
  • if you have diarrhea or fever, have been very ill, or are in poor health

Some MEDICINES MAY INTERACT with hyoscyamine. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), other anticholinergics (eg, scopolamine), phenothiazines (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of hyoscyamine’s side effects
  • Narcotic pain medicines (eg, codeine) or potassium chloride because the risk of their side effects may be increased by hyoscyamine
  • Ketoconazole or metoclopramide because their effectiveness may be decreased by hyoscyamine

This may not be a complete list of all interactions that may occur. Ask your health care provider if hyoscyamine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use hyoscyamine:

Use hyoscyamine as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

  • Hyoscyamine is usually given as an injection at your doctor’s office, hospital, or clinic. If you will be using hyoscyamine at home, a health care provider will teach you how to use it. Be sure you understand how to use hyoscyamine. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use hyoscyamine if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of hyoscyamine, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use hyoscyamine.

Important safety information:

  • Hyoscyamine may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use hyoscyamine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using hyoscyamine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
  • Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.
  • Proper dental care is important while you are taking hyoscyamine. Brush and floss your teeth and visit the dentist regularly.
  • Hyoscyamine may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
  • Tell your doctor or dentist that you take hyoscyamine before you receive any medical or dental care, emergency care, or surgery.
  • Use hyoscyamine with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, dry mouth, drowsiness, agitation, confusion, excitability, or memory problems.
  • Caution is advised when using hyoscyamine in CHILDREN; they may be more sensitive to its effects, including excitability.
  • Hyoscyamine should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using hyoscyamine while you are pregnant. Hyoscyamine is found in breast milk. Do not breast-feed while taking hyoscyamine.

Possible side effects of hyoscyamine:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; difficulty breathing; difficulty swallowing; disorientation; dizziness; dry mouth; dry skin; enlarged pupils; excessive thirst; excitability; headache; muscle weakness; nausea; rapid heartbeat with weak pulse; seizures; vomiting.

Proper storage of hyoscyamine: Hyoscyamine is usually handled and stored by a health care provider. If you are using hyoscyamine at home, store hyoscyamine as directed by your pharmacist or health care provider. Keep hyoscyamine out of the reach of children and away from pets.

General information:

  • If you have any questions about hyoscyamine, please talk with your doctor, pharmacist, or other health care provider.
  • Hyoscyamine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take hyoscyamine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about hyoscyamine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to hyoscyamine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using hyoscyamine.

Issue Date: March 6, 2013 Database Edition 13.1.1.003 Copyright © 2013 Wolters Kluwer Health, Inc.

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