Hyoscyamine

Hyoscyamine
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

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Black Box Warning

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

Hyoscyamine is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

ANASPAZ is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome (irritable colon, spastic colon, mucous colitis), acute entercolitis and other functional gastrointestinal disorders. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. ANASPAZ is indicated (along with appropriate analgesics) in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis.

Adults and children 12 years of age and older: 1 or 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours. Children 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

ANASPAZ may be taken orally (swallowed or chewed) or sublingually. The dosage of ANASPAZ should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.

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Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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• Developed by:

• Class of Recommendation:

• Strength of Evidence:

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Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Hyoscyamine in adult patients.

Non–Guideline-Supported Use

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Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hyoscyamine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

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Condition2

There is limited information regarding FDA-Labeled Use of Hyoscyamine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

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Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Hyoscyamine in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

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Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hyoscyamine in pediatric patients.

Contraindications

• Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis); paralytic ileus; intestinal atony of elderly or debilitated patients; unstable cardiovascular status; severe ulcerative colitis; toxic megacolon; myasthenia gravis; myocardial ischemia.

Warnings

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Precautions

• In the presence of high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Like other anticholinergic agents, ANASPAZ may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug.

• Anticholinergic psychosis has been reported in sensitive individuals given anticholinergic drugs. CNS signs and symptoms include confusion, disorientation, short term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, decreased anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. These CNS signs and symptoms usually resolve 12 to 48 hours after drug discontinuation.

• Elderly patients may react with excitement, agitation, drowsiness, and other unfavorable manifestations to even small doses of ANASPAZ.

Adverse Reactions

Clinical Trials Experience

• Not all the following adverse reactions have been associated with ANASPAZ, but have been reported for drugs in the same pharmacological class, with anticholinergic / antispasmodic action. Adverse reactions may include dryness of the mouth, urinary hesitancy, urinary retention, tachycardia, palpitations, blurred vision, mydriasis, cycloplegia, increased intraocular pressure, dry eyes, headache, nervousness, drowsiness, dizziness, weakness, mental confusion and/or excitement (especially in geriatric patients), flushing, insomnia, fever, altered sense of taste, nausea, vomiting, dysphagia, heartburn, constipation, bloated feeling, suppression of lactation, impotence, and decreased sweating. Allergic reactions or drug idiosyncrasies such as anaphylaxis, urticaria and other dermal manifestations may also occur.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Hyoscyamine in the drug label.

Drug Interactions

• Additive adverse effects resulting from cholinergic blockade may occur when ANASPAZ is administered concomitantly with other anti-muscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines.

• Antacids may interfere with the absorption of ANASPAZ; take ANASPAZ before meals and antacids after meals.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category C

• Animal reproduction studies have not been conducted with ANASPAZ. It is also not known whether ANASPAZ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ANASPAZ should be given to a pregnant woman only if clearly needed.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hyoscyamine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Hyoscyamine during labor and delivery.

Nursing Mothers

• ANASPAZ is excreted in human milk. Caution should be exercised when ANASPAZ is administered to a nursing woman.

Pediatric Use

• Safety and effectiveness in pediatric patients below the age of 2 have not been established.

Geriatic Use

• This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

• Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of ANASPAZ and observed closel

Gender

There is no FDA guidance on the use of Hyoscyamine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Hyoscyamine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Hyoscyamine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Hyoscyamine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Hyoscyamine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Hyoscyamine in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Hyoscyamine in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Hyoscyamine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• The signs and symptoms of overdose include headache, nausea, vomiting, dizziness, dry mouth, difficulty in swallowing, dilated pupils, blurred vision, urinary retention, hot dry and flushed skin, tachycardia, hypertension, hypotension, respiratory depression, CNS stimulation, fever, ataxia, excitation, lethargy, stupor, coma, and paralysis (with large overdoses).

• The LD50 for hyoscyamine in rats is 375 mg/kg.

Management

• General measures such as emesis or gastric lavage and administration of activated charcoal should be undertaken immediately. Supportive therapy is given as needed, including artificial respiration if required. Physostigmine may be given by intravenous injection to reverse severe anticholinergic symptoms.

• Hyoscyamine sulfate is dialyzable.

Chronic Overdose

There is limited information regarding Chronic Overdose of Hyoscyamine in the drug label.

Pharmacology

There is limited information regarding Hyoscyamine Pharmacology in the drug label.

Mechanism of Action

• ANASPAZ inhibits specifically the actions of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of smooth muscle, cardiac muscle, the sino-atrial node, the atrioventricular node and exocrine glands. At therapeutic doses, it is completely devoid of any action in the autonomic ganglia. ANASPAZ inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. ANASPAZ also controls excessive pharyngeal, tracheal and bronchial secretions. ANASPAZ is absorbed totally and completely by sublingual administration as well as oral administration. Once absorbed, ANASPAZ disappears rapidly from the blood and is distributed throughout the entire body. The half-life of ANASPAZ is 3.5 hours and the majority of drug is excreted in the urine unchanged within the first 12 hours, with a small amount hydrolyzed to tropic acid and tropine. Only traces of this drug are found in breast milk. ANASPAZ passes the blood-brain and placental barriers.

Structure

• Each ANASPAZ orally disintegrating tablet contains 1-hyoscyamine sulfate 0.125 mg. ANASPAZ may be taken orally (swallowed or chewed) or sublingually. ANASPAZ tablets are compressed, light yellow and scored with the Ascher logo on one side and 225/295 on the other. Inactive ingredients: DC Yellow #10, FDC yellow #6, lactose NF, magnesium stearate NF, mannitol USP, sorbitol NF, pre-gelatinized starch NF, stearic acid NF.

• ANASPAZ is chemically pure 1-hyoscyamine sulfate, one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the chemical formula (C17H23NO3)2•H2SO4•2H2O

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Hyoscyamine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Hyoscyamine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Hyoscyamine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Hyoscyamine in the drug label.

How Supplied

• ANASPAZ (l-hyoscyamine sulfate orally disintegrating tablets) 0.125mg is available as a compressed, light yellow, scored tablet, imprinted with the Ascher logo and 225/295 in bottles of 100 tablets (NDC 0225-0295-15) and 500 tablets (NDC 0225-0295-20).

• Store at room temperature - 59º - 86º F (15º - 30º C) in a dry place.

• Dispense in tight, amber glass or opaque PE plastic containers.

Storage

There is limited information regarding Hyoscyamine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

• ANASPAZ may produce drowsiness, dizziness or blurred vision. Patients should observe caution before operating a motor vehicle or other machinery or performing other tasks requiring mental alertness.

• Use of ANASPAZ may decrease sweating resulting in heat prostration, fever or heat stroke; febrile patients or those who may be exposed to elevated environmental temperatures should use caution.

Precautions with Alcohol

• Alcohol-Hyoscyamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ANASPAZ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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