pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Cholinergic Muscarinic Antagonists; Histamine Receptor Antagonists; Serotonin Antagonists.

Cholinergic MuscarinicHistamine ReceptorSerotonin

Indications

Sourced from openFDA
  • Hyoscyamine sulfate extended-release tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps.

Contraindications

Sourced from openFDA
  • 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 in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.contraindicated

Dosage & administration

Sourced from openFDA

Dosage may be adjusted according to the conditions and severity of symptoms. Adults And Pediatric Patients 12 Years Of Age And Older 1 to 2 tablets every 12 hours. Do not crush or chew tablets. Do not exceed 4 tablets in 24 hours.

Warnings & precautions

Sourced from openFDA

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, hyoscyamine sulfate may produce drowsiness, dizziness, 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. Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine sulfate. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, euphoria, anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.

Adverse reactions

Sourced from openFDA

All of the following adverse reactions have been reported with hyoscyamine sulfate. Adverse reactions may include dryness of the 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; some degree of mental confusion and/or excitement (especially in elderly persons); short-term memory loss; hallucinations; and decreased sweating.

Use in specific populations

Sourced from openFDA

Pregnancy – Pregnancy Category C Animal reproduction studies have not been conducted with hyoscyamine sulfate. It is also not known whether hyoscyamine sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine sulfate should be given to a pregnant woman only if clearly needed.

Overdosage

Sourced from openFDA

The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Measures to be taken are immediate lavage of the stomach and injection of physostigmine 0.5 to 2 mg intravenously and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (tepid water sponge baths, hypothermic blanket). Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns. In rats, the LD 50 for hyoscyamine is 375 mg/kg. Hyoscyamine sulfate is dialyzable.

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
10,048 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea8968.9%
  2. 2Diarrhoea7757.7%
  3. 3Pain7417.4%
  4. 4Fatigue6946.9%
  5. 5Drug Ineffective6056.0%
  6. 6Headache5795.8%
  7. 7Dizziness5785.8%
  8. 8Vomiting5275.2%
  9. 9Abdominal Pain5265.2%
  10. 10Dyspnoea4864.8%
  11. 11Anxiety4524.5%
  12. 12Off Label Use4354.3%
  13. 13Fall4294.3%
  14. 14Asthenia3833.8%
  15. 15Weight Decreased3823.8%

Literature

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Recent PubMed references pinned to Hyoscyamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 500 ClinicalTrials.gov registrations naming Hyoscyamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Hyoscyamine work?
Mechanism-of-action classes: Cholinergic Muscarinic Antagonists; Histamine Receptor Antagonists; Serotonin Antagonists.
What is Hyoscyamine used for?
According to FDA labeling, Hyoscyamine carries indications including: Hyoscyamine sulfate extended-release tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Hyoscyamine?
Hyoscyamine is classified as Belladonna alkaloids, tertiary amines, Cholinergic Muscarinic Antagonists, Histamine Receptor Antagonists, Serotonin Antagonists, Cardiovascular Activity Alteration, Decreased Respiratory Secretions.
What are the brand names for Hyoscyamine?
Hyoscyamine is marketed under brand names including Anaspaz, Digenyx, Digex, Donnatal, Ed Spaz, Hyophen, Levbid, Levsin.
What are the contraindications for Hyoscyamine?
Hyoscyamine labeling lists contraindications including: 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 in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.. Always consult the full prescribing information and a clinician.
Note. Data for hyoscyamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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