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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Hyoscyamine Sulfate
Brand Name
Hyoscyamine Sulfate Tab
Generic Name
Hyoscyamine Sulfate
Active Ingredient
HyoscyamineCategory
Non-Standardized Food Allergenic Extract [EPC]
Salt Form
Sulfate
Variants
4
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| .125 mg/1 | TABLET | ORAL | 42192-340 |
| .125 mg/1 | TABLET | ORAL | 63629-5911 |
| .125 mg/1 | TABLET | ORAL | 70518-3847 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Hyoscyamine Sulfate Tab, you must consult a qualified healthcare professional.
| .125 mg/1 | TABLET | ORAL | 42708-183 |
Detailed information about Hyoscyamine Sulfate Tab
Hyoscyamine is a belladonna alkaloid and potent antimuscarinic agent used to treat various gastrointestinal disorders, including irritable bowel syndrome (IBS), and to control secretions. It works by blocking the action of acetylcholine in the body.
Dosage must be individualized based on the severity of symptoms and the patient's tolerance to side effects. According to clinical guidelines, the following are standard ranges:
Pediatric use requires extreme caution due to the risk of anticholinergic toxicity. Dosing is strictly based on body weight.
Hyoscyamine is primarily excreted by the kidneys. In patients with significant renal impairment (decreased GFR), the drug may accumulate, leading to increased side effects. Lower starting doses and extended dosing intervals are generally recommended. Clinical monitoring for signs of toxicity (confusion, urinary retention) is essential.
While the liver plays a role in metabolism, renal excretion is the dominant pathway. However, in patients with severe liver disease, drug clearance may be slightly reduced. Dose adjustments should be made cautiously based on clinical response.
Patients over the age of 65 are significantly more sensitive to the effects of hyoscyamine. The Beers Criteria for Potentially Inappropriate Medication Use in Older Adults lists hyoscyamine as a drug to avoid if possible, due to the high risk of confusion, falls, and urinary retention. If used, the lowest possible dose should be initiated.
If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and return to your regular schedule. Never double the dose to 'catch up,' as this significantly increases the risk of an anticholinergic overdose.
Hyoscyamine overdose can be life-threatening and presents as an 'anticholinergic crisis.' Symptoms include:
In the event of a suspected overdose, contact your local poison control center or seek emergency medical attention immediately. Treatment often involves supportive care and, in severe cases, the administration of physostigmine, a reversible cholinesterase inhibitor.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
Because hyoscyamine blocks acetylcholine throughout the body, side effects are common and predictable based on its mechanism of action. These include:
Hyoscyamine is a potent medication that affects multiple organ systems. It should be used with extreme caution in patients who are sensitive to belladonna alkaloids. Patients should be advised that this medication may cause significant drowsiness or blurred vision, which can impair the ability to perform tasks requiring mental alertness. Furthermore, because hyoscyamine inhibits sweating, patients are at a higher risk for heat exhaustion and heatstroke when exposed to high temperatures or during vigorous exercise.
There are no FDA black box warnings for Hyoscyamine. However, the absence of a black box warning does not imply that the drug is without risk. It is a high-alert medication in certain populations, particularly the elderly and infants.
Certain medications should never be combined with hyoscyamine due to the risk of severe, life-threatening interactions:
Hyoscyamine must NEVER be used in the following conditions:
Hyoscyamine is classified as FDA Pregnancy Category C. This means that animal reproduction studies have shown an adverse effect on the fetus, or there are no adequate and well-controlled studies in humans. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There is no definitive evidence of teratogenicity (birth defects), but because the drug crosses the placenta, it can affect the fetal heart rate. Use during labor can cause tachycardia in the newborn.
Hyoscyamine is excreted in human breast milk. While the amount the infant receives may be small, anticholinergics can cause side effects in the nursing infant, such as dry mouth or irritability. More importantly, hyoscyamine can suppress prolactin secretion, leading to a significant decrease in milk production. Breastfeeding mothers should discuss alternatives with their healthcare provider.
Hyoscyamine is approved for use in children for certain conditions, but the safety margin is narrow. Infants are particularly sensitive to the toxic effects of belladonna alkaloids. In 2010, the FDA issued warnings regarding the use of such products for infant colic due to reports of serious adverse events, including seizures and difficulty breathing. Pediatric dosing must be calculated precisely by a doctor.
Hyoscyamine is a competitive inhibitor of the muscarinic acetylcholine receptors. It specifically targets the M1 (gastric glands, CNS), M2 (heart), and M3 (smooth muscle, exocrine glands) receptors. By competing with acetylcholine for these binding sites, it prevents the activation of the G-protein coupled receptor cascade. In the gut, this prevents the increase in intracellular calcium that normally leads to smooth muscle contraction, thereby acting as an antispasmodic. In the salivary glands, it prevents the activation of secretory pathways, leading to dryness.
The onset of action for oral immediate-release hyoscyamine is approximately 20 to 30 minutes. The duration of effect typically lasts 4 to 6 hours. For extended-release formulations, the effect is sustained over 12 hours. There is a clear dose-response relationship; higher doses lead to more significant heart rate increases and more profound inhibition of secretions. Tolerance to the antispasmodic effects is rare, but patients may become somewhat accustomed to the side effects over time.
| Parameter | Value |
Common questions about Hyoscyamine Sulfate Tab
Hyoscyamine is primarily used to treat gastrointestinal conditions characterized by spasms and hypermotility, such as irritable bowel syndrome (IBS), peptic ulcers, and diverticulitis. It is also effective in managing certain urinary tract problems like bladder spasms and cystitis. Additionally, healthcare providers use it to reduce excessive secretions in the mouth and respiratory tract, particularly before surgery or in palliative care. It works by blocking acetylcholine, a chemical that triggers muscle contractions and fluid secretion. Your doctor may also prescribe it for biliary or renal colic to relieve intense pain caused by muscle spasms.
The most common side effects of hyoscyamine are directly related to its anticholinergic action, which 'dries out' the body's systems. Most patients experience dry mouth, blurred vision, and a decrease in sweating, which can make you more sensitive to heat. Constipation and drowsiness are also very frequent, occurring in more than 10% of users. Some people may notice a slight increase in heart rate or a metallic taste in their mouth. If these symptoms become severe or if you experience an inability to urinate, you should contact your healthcare provider immediately.
No, you should avoid drinking alcohol while taking hyoscyamine. Both alcohol and hyoscyamine can cause drowsiness, dizziness, and impaired mental alertness. When taken together, these effects are significantly intensified, increasing the risk of falls, accidents, and severe sedation. Alcohol can also worsen some of the gastrointestinal symptoms that hyoscyamine is meant to treat. Always consult your doctor before combining any medication with alcohol to ensure your safety.
Hyoscyamine is classified as Pregnancy Category C, meaning its safety has not been fully established in human clinical trials. While it is not known to cause major birth defects, it does cross the placenta and can affect the fetal heart rate. Healthcare providers typically only prescribe hyoscyamine during pregnancy if the benefits to the mother clearly outweigh the potential risks to the developing baby. If you are pregnant or planning to become pregnant, it is essential to discuss alternative treatments for your symptoms with your obstetrician. It should also be used with caution during breastfeeding as it can reduce milk supply.
The onset of action for hyoscyamine depends on the formulation you are using. Immediate-release tablets and elixirs typically begin to work within 20 to 30 minutes of ingestion. Sublingual tablets, which dissolve under the tongue, may have a slightly faster onset of action as they are absorbed directly into the bloodstream. For conditions like IBS, patients often notice a reduction in cramping within an hour of taking the dose. Extended-release versions take longer to reach peak levels but provide a steady effect over a 12-hour period.
If you have been taking hyoscyamine on an 'as-needed' basis, you can generally stop taking it without any issues. However, if you have been taking high doses regularly for a long period, stopping suddenly might cause a 'cholinergic rebound.' This can lead to symptoms like increased sweating, nausea, vomiting, and a sudden return of severe stomach cramps. It is always best to consult your healthcare provider before discontinuing the medication. They may recommend a gradual reduction in your dose to allow your body to adjust.
If you miss a dose of hyoscyamine, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular timing. You should never take two doses at the same time to make up for a missed one, as this increases the risk of serious side effects like rapid heart rate or confusion. If you are using the medication 'as needed' for spasms, simply take the next dose when symptoms occur, provided you follow the daily maximum limit. Setting a reminder on your phone can help you stay on track with scheduled doses.
Weight gain is not a commonly reported side effect of hyoscyamine. Unlike some other medications used for chronic conditions, hyoscyamine does not typically affect metabolism or appetite in a way that leads to fat accumulation. However, some patients may experience bloating or water retention if the medication causes significant constipation. If you notice a rapid or unusual increase in weight while taking this medication, you should discuss it with your doctor to rule out other underlying causes. Maintaining a high-fiber diet and staying hydrated can help manage any bloating associated with the drug.
Hyoscyamine has several significant drug interactions that you must be aware of. It should not be taken with certain forms of potassium supplements or other drugs that have anticholinergic effects, such as some antidepressants or antihistamines. These combinations can lead to severe constipation, urinary retention, or heatstroke. It may also interfere with the absorption of other medications because it slows down the digestive tract. Always provide your doctor and pharmacist with a complete list of all prescriptions, over-the-counter drugs, and herbal supplements you are currently using.
Yes, hyoscyamine sulfate is widely available as a generic medication in several forms, including immediate-release tablets, sublingual tablets, and elixirs. Generic versions are typically much more affordable than brand-name versions like Levsin or Anaspaz. The FDA requires generic medications to have the same active ingredient, strength, and effectiveness as the brand-name versions. You can discuss with your pharmacist whether a generic version is appropriate for your prescription. Most insurance plans cover the generic form of hyoscyamine as a first-line treatment for GI spasms.
Other drugs with the same active ingredient (Hyoscyamine)
> Warning: Stop taking Hyoscyamine and call your doctor immediately if you experience any of these.
Prolonged use of hyoscyamine may lead to chronic constipation or chronic dry mouth. Chronic dry mouth increases the risk of periodontal disease and oral candidiasis (thrush). There is also emerging clinical research (JAMA Internal Medicine, 2015) suggesting that long-term use of potent anticholinergics may be associated with an increased cumulative risk of developing dementia in older adults. Patients should regularly review the necessity of continued therapy with their healthcare provider.
No FDA black box warnings currently exist for hyoscyamine sulfate. However, it carries significant 'Precautions' and 'Warnings' regarding its use in the elderly and those with specific pre-existing conditions like glaucoma or myasthenia gravis.
Report any unusual symptoms to your healthcare provider.
While routine blood work is not typically required for hyoscyamine, healthcare providers may perform the following assessments:
Hyoscyamine frequently causes blurred vision and drowsiness. You should not drive, operate heavy machinery, or participate in hazardous activities until you know how this medication affects you. The risk of impairment is increased if hyoscyamine is combined with alcohol or other sedating medications.
Alcohol should be avoided while taking hyoscyamine. Alcohol can potentiate the sedative effects of the drug, leading to extreme drowsiness, dizziness, and an increased risk of falls or accidents.
While hyoscyamine does not typically cause a 'withdrawal' syndrome in the traditional sense, stopping it abruptly after long-term use may result in a 'cholinergic rebound.' This can manifest as increased sweating, nausea, vomiting, and a return of severe gastrointestinal spasms. If you have been taking hyoscyamine regularly, your doctor may recommend a gradual tapering of the dose.
> Important: Discuss all your medical conditions with your healthcare provider before starting Hyoscyamine.
Hyoscyamine may interfere with certain diagnostic tests:
For each major interaction, the mechanism usually involves either an additive pharmacodynamic effect (two drugs doing the same thing) or a pharmacokinetic change in GI transit time. Management typically involves dose adjustment or choosing an alternative medication.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
Patients who have had a severe allergic reaction to atropine, scopolamine, or other belladonna alkaloids are highly likely to be allergic to hyoscyamine sulfate. Cross-sensitivity is common within this class of medications.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Hyoscyamine.
Elderly patients (65+) are at the highest risk for adverse effects. The central nervous system effects (confusion, delirium) and the peripheral effects (urinary retention, constipation) are significantly more pronounced in this population. Hyoscyamine is listed on the Beers Criteria as a 'potentially inappropriate medication' for the elderly. If it must be used, clinicians are advised to 'start low and go slow.'
Since hyoscyamine is largely eliminated unchanged in the urine, patients with a GFR below 60 mL/min are at risk for drug accumulation. This can lead to prolonged side effects and a higher risk of toxicity. Dose reductions of 25-50% may be necessary depending on the degree of impairment.
While not the primary route of elimination, severe hepatic impairment (Child-Pugh Class C) can alter the metabolism of belladonna alkaloids. Patients with liver cirrhosis should be monitored closely for signs of increased sedation or cognitive impairment.
> Important: Special populations require individualized medical assessment.
| Bioavailability | High (Rapidly absorbed) |
| Protein Binding | ~50% |
| Half-life | 2 - 3.5 hours |
| Tmax | 0.5 - 1 hour (IR) |
| Metabolism | Hepatic (Minor) |
| Excretion | Renal (70-90% unchanged) |
Hyoscyamine is classified as a Belladonna Alkaloid and an Antimuscarinic/Anticholinergic agent. Related medications include Atropine, Scopolamine, and Dicyclomine.