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Active pharmaceutical ingredient

Hyoscyamine Sulfate

Hyoscyamine sulfate is an anticholinergic for stomach, bowel and bladder spasms, taken by mouth or under the tongue, that a pharmacy may compound when prescribed.

About this ingredient

Hyoscyamine is a natural plant alkaloid, the levorotatory form of atropine, found in henbane, jimson weed and deadly nightshade. It blocks acetylcholine at muscarinic receptors, which slows movement of the stomach and intestines, reduces stomach acid and dries secretions. Manufactured products include Levsin tablets, Levsin SL orally disintegrating tablets, NuLev chewable tablets, Oscimin, Hyosyne elixir and oral drops, a hyoscyamine sulfate injection, and many generic tablets and orally disintegrating tablets. These products are not FDA-approved: DailyMed files every human hyoscyamine sulfate product listing as "unapproved drug other", and FDA's Drugs@FDA database lists no approved application for hyoscyamine. Their labels list uses such as add-on treatment of peptic ulcer, irritable bowel syndrome, bladder spasm and neurogenic bowel or bladder. A prescriber might order hyoscyamine compounded in a strength or form that is not manufactured. Compounded preparations are not FDA-approved and require a prescription.

Safety and interactions

Hyoscyamine labels carry no boxed warning. Do not use it if you have glaucoma, a urinary blockage such as from an enlarged prostate, a stomach or bowel blockage or paralyzed bowel, severe ulcerative colitis or toxic megacolon, myasthenia gravis, or unstable heart status after major bleeding. It reduces sweating, so heat stroke and fever can occur in hot weather. It can cause drowsiness, dizziness or blurred vision, so avoid driving until you know how it affects you; confusion, hallucinations and other mental changes have been reported, and MedlinePlus says adults 65 and older should not usually take it. Side effects can add up with other anticholinergic medicines, amantadine, haloperidol, phenothiazines, MAO inhibitors, tricyclic antidepressants and some antihistamines; antacids can reduce absorption. The label advises use in pregnancy only if clearly needed and caution in breastfeeding, since it passes into milk. Talk to your prescriber or pharmacist about side effects.

Hyoscyamine is a competitive antimuscarinic that inhibits acetylcholine at postganglionic cholinergic sites and on smooth muscle, cardiac muscle, the sinoatrial and atrioventricular nodes and exocrine glands, without ganglionic action at therapeutic doses (Levsin label). It reduces gastrointestinal propulsive motility, gastric acid secretion and airway secretions. Per the label, it is completely absorbed after oral or sublingual dosing, has a half-life of 2 to 3.5 hours, is partly hydrolyzed to tropic acid and tropine, and is mostly excreted unchanged in urine within 12 hours; it crosses the blood-brain and placental barriers and traces appear in breast milk. Labeled uses on these unapproved products include adjunctive therapy of peptic ulcer and irritable bowel syndrome, visceral spasm, spastic bladder and cystitis, neurogenic bladder and bowel, biliary and renal colic with an opioid, drying in acute rhinitis, parkinsonism rigidity and sialorrhea, and anticholinesterase poisoning. Use with caution in autonomic neuropathy, hyperthyroidism, coronary disease, heart failure, arrhythmias, hypertension, renal disease and hiatal hernia with reflux; investigate tachycardia first. Diarrhea may signal incomplete obstruction in ileostomy or colostomy. LiverTox reports no link to liver injury. Hyoscyamine is not a controlled substance on these labels. Dosing is per prescriber.

Sources

Compounded at Bayview

How we prepare this ingredient

Patient guides for the preparations we make most often. Each one is compounded to order and requires a prescription.

We do not have a patient page for this ingredient yet. That does not mean we cannot make it. Bayview compounds this ingredient to a prescriber's order, and our full compounding formulary lists every preparation we make. Viewing the formulary requires a prescriber account.

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For prescribers

Full formulary with this ingredient

Every preparation in our formulary that contains this ingredient. Strength, base and dose form are set by the prescription.

We compound this ingredient to a prescriber's order. Our full formulary lists every preparation we make with it, including strength, base and dose form. Sign in with a prescriber account to view it.

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Related

Related active ingredients

Other salt forms of this molecule, and ingredients commonly compounded alongside it.

Important information

This page describes an active pharmaceutical ingredient, not a finished drug product. Bayview Pharmacy compounds preparations containing it only on a prescriber's order for an individual patient.

Compounded preparations are not FDA-approved, and the FDA has not evaluated them for safety, effectiveness, or manufacturing quality. Nothing on this page is a claim that any preparation is effective for any condition.

A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice. Discuss your situation with a licensed healthcare provider.

Talk to a compounding pharmacist

Our pharmacists work with prescribers to build preparations around a patient's dose, form and tolerances. Ask us what is possible with this ingredient.