Levbid

hyoscyamine sulfate · Tablet, Extended Release · Oral

Prescription (Rx)

Uses

Levbid ® is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Levbid ® is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of Parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.

Dosage and administration

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.

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 in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.

Warnings

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, Levbid ® 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.

Precautions

General Use with caution in patients with: autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hypertension, and renal disease. Investigate any tachycardia before giving any anticholinergic drugs since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis. Information for Patients Like other anticholinergic agents, Levbid ® 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. Use of Levbid ® 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. Tablets may not completely disintegrate and may be excreted by some patients. Drug Interactions Additive adverse effects resulting from cholinergic blockade may occur when Levbid ® is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines. Antacids may interfere with the absorption of Levbid ® . Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies in animals have been performed to determine the carcinogenic, mutagenic or impairment of fertility potential of Levbid ® ; however, 40 years of marketing experience with hyoscyamine sulfate shows no demonstrable evidence of a problem. Pregnancy Animal reproduction studies have not been conducted with Levbid®. It is also not known whether Levbid ® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Levbid ® should be given to a pregnant woman only if clearly needed. Nursing Mothers Levbid ® is excreted in human milk. Caution should be exercised when Levbid ® is administered to a nursing woman. Geriatric Use Reported clinical experience has not identified differences in safety between patients aged 65 and over and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 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.

Side effects

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.

Drug interactions

Drug Interactions Additive adverse effects resulting from cholinergic blockade may occur when Levbid ® is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines. Antacids may interfere with the absorption of Levbid ® .

Pregnancy

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

Geriatric use

Geriatric Use Reported clinical experience has not identified differences in safety between patients aged 65 and over and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 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.

Overdosage

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. Levbid ® is dialyzable.

Description

Levbid ® extended-release tablets contain 0.375 mg of hyoscyamine sulfate in a formulation designed for oral b.i.d. dosage. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17 H 23 NO 3 )2
• H 2 SO 4
• 2H 2 O and the molecular weight is 712.85. 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 following structure: Each Levbid ® extended-release tablet also contains as inactive ingredients: calcium phosphate dibasic, ethylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and stearic acid. chemical structure

How supplied

Levbid ® (hyoscyamine sulfate 0.375 mg) extended-release tablets are white, capsule-shaped tablets. They are coded AP on one side and 115 on the other. Bottles of 100 NDC 68220-115-10 Store at controlled room temperature 20°-25°C (68°- 77°F); brief excursions permitted to 15°-30°C (59°- 86°F). Please refer to current USP. Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure. KEEP OUT OF REACH OF CHILDREN Also available as: Levsin ® dosage strength package size NDC Sublingual Tablets 0.125 mg 100’s 68220-113-10 Tablets 0.125 mg 100’s 68220-112-10 For more information, call Viatris at 1-877-446-3679 (1-877-4-INFO-RX). LEVBID is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company. © 2025 Viatris Inc. Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. 201090-01 115 Rev. 07/2025 VS:SOV:LVBDER:R1

Patient information

Information for Patients Like other anticholinergic agents, Levbid ® 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. Use of Levbid ® 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. Tablets may not completely disintegrate and may be excreted by some patients.

Label text from the FDA structured product label by Viatris Specialty LLC (revised Jul 15, 2025). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Hyoscyamine Sulfate in 1 product

Levbid NDC products (1)

NDC	Strength & form	Labeler	Type
68220-115	Hyoscyamine Sulfate .375 mg/1 Tablet, Extended Release	Viatris Specialty LLC	UNAPPROVED DRUG OTHER

Frequently asked questions

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Who makes Levbid?

Levbid is listed by 1 labeler in the FDA NDC directory, including Viatris Specialty LLC.