Levsin® tablets (hyoscyamine sulfate tablets USP) contain 0.125 mg hyoscyamine sulfate formulated for oral administration.

Levsin® is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C₁₇H₂₃NO₃)₂•H₂SO₄•2H₂O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, a-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:

Each tablet also contains as inactive ingredients: FD&C blue #1, lactose monohydrate, magnesium stearate, mannitol, starch and stearic acid.

Last updated on RxList: 3/16/2009

Levsin® 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). Also used in the treatment of infant colic (elixir and drops). Levsin® 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 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 four hours or as needed. Do not exceed 12 tablets in 24 hours.

Pediatric patients 2 to under 12 years of age: ½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

Levsin® tablets (hyoscyamine sulfate tablets USP) 0.125 mg are round, blue colored tablets that are imprinted with “AP” on one side and “112” on the other.

Bottles of 100 tablets NDC 68220-112-10
Bottles of 500 tablets NDC 68220-112-50

Store at controlled room temperature 20°- 25°C (68° - 77°F); excursions permitted to15°- 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
Tablets	0.125mg	100	68220-112-10
Tablets	0.125mg	500	68220-112-50
Sub-lingual Tablets	0.125mg	100	68220-113-10
Sub-lingual Tablets	0.125mg	500	68220-113-50
Elixir	0.125mg/5 mL	Pint	0091-4532-16
Drops	0.125mg/mL	15mL	0091-4538-15
Injection	0.5mg/mL	Box of 5-1mL	0091-1536-05
Levbid® extended-	0.375mg	100	68220-115-10
release tablets	0.375mg	500	68220-115-50

Address medical inquiries to: Alaven Pharmaceutical LLC, 2260 Northwest Parkway, Suite A Marietta, GA 30067 Or call toll free 1-888-317-0001. Rev. 02/08.

Last updated on RxList: 3/16/2009

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.

Additive adverse effects resulting from cholinergic blockade may occur when Levsin® 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 Levsin®. Administer Levsin® before meals; antacids after meals.

Last updated on RxList: 3/16/2009

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, Levsin® 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.

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 drug since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis.

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 Levsin®; however, 40 years of marketing experience with hyoscyamine sulfate shows no demonstrable evidence of a problem.

Pregnancy–Pregnancy Category C

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

Nursing Mothers

Levsin® is excreted in human milk. Caution should be exercised when Levsin® 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.

Last updated on RxList: 3/16/2009

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 LD₅₀ for hyoscyamine is 375 mg/kg. Levsin® is dialyzable.

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.

Last updated on RxList: 3/16/2009

Levsin® 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 the smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, and the exocrine glands. At therapeutic doses, it is completely devoid of any action on autonomic ganglia. Levsin® inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. Levsin® also controls excessive pharyngeal, tracheal and bronchial secretions.

Levsin® is absorbed totally and completely by sublingual administration as well as oral administration. Once absorbed, Levsin® disappears rapidly from the blood and is distributed throughout the entire body. The half-life of Levsin® is 2 to 3½ hours. Levsin® is partly hydrolyzed to tropic acid and tropine but the majority of the drug is excreted in the urine unchanged within the first 12 hours. Only traces of this drug are found in breast milk. Levsin® passes the blood brain barrier and the placental barrier.

Last updated on RxList: 3/16/2009

Like other anticholinergic agents, Levsin® 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 Levsin® 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.

Last updated on RxList: 3/16/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

HYOSCYAMINE - ORAL

(hi-oh-SYE-uh-meen)

COMMON BRAND NAME(S): Anaspaz, Cystospaz, Donnamar, Levsin

USES: Hyoscyamine is used to treat a variety of stomach/intestinal problems such as cramps and irritable bowel syndrome. It is also used to treat other conditions such as bladder and bowel control problems, cramping pain caused by kidney stones and gallstones, and Parkinson's disease. In addition, it is used to decrease side effects of certain medications (drugs used to treat myasthenia gravis) and insecticides.

This medication works by decreasing acid production in the stomach, slowing down the natural movements of the gut, and relaxing muscles in many organs (e.g., stomach, intestines, bladder, kidney, gallbladder). Hyoscyamine also lessens the amount of certain body fluids (e.g., saliva, sweat). This medication belongs to a class of drugs known as anticholinergics/antispasmodics.

HOW TO USE: Take this medication by mouth as prescribed, usually 30-60 minutes before meals, or as directed by your doctor.

Dosage is based on your medical condition and response to therapy. Do not increase your dose or take it more often than prescribed without consulting your doctor. Adults and children 12 years and older should not take more than 1.5 milligrams in 24 hours. Children aged 2 to 12 years should not take more than 0.75 milligrams in 24 hours. Ask your doctor or pharmacist for more information.

Antacids lower the absorption of hyoscyamine. If you use antacids, take them after meals and take hyoscyamine before meals; or take antacids at least 1 hour after taking hyoscyamine.

Drink plenty of fluids while taking this medication unless your doctor directs you otherwise.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Dizziness, drowsiness, blurred vision, dry mouth, vision problems, headache, trouble sleeping, constipation, flushing, dry skin, and decreased sweating may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., confusion, unusual excitement), fast/irregular heartbeat, difficulty urinating, decreased sexual ability, loss of coordination, slurred speech, eye pain, vomiting.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking hyoscyamine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow-angle type, untreated open-angle type), enlarged prostate, urinary blockage problems, certain stomach/intestinal problems (e.g., slow gut, blockage, severe ulcerative colitis, infection), heart problems due to severe bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: overactive thyroid, other heart problems (e.g., coronary heart disease, congestive heart failure, fast heartbeat, arrhythmias), high blood pressure, kidney disease, heartburn problems (acid reflux, hiatal hernia), certain nervous system problem (autonomic neuropathy), myasthenia gravis.

Contact lens wearers may need to use wetting eye drops since this medication can cause dry eyes.

This drug may make you dizzy, drowsy, or cause blurred vision; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

This drug may increase the risk for heatstroke because it decreases sweating. Avoid becoming overheated in hot weather, saunas, and during exercise or other strenuous activity.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for confusion and unusual excitement while using this drug.

Children may be more sensitive to the effects of this drug.

Hyoscyamine should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: pramlintide.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting hyoscyamine.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: amantadine, certain anti-arrhythmic drugs (e.g., disopyramide, procainamide, quinidine), anticholinergic drugs (e.g., atropine, glycopyrrolate, scopolamine), antispasmodic drugs (e.g., clidinium, dicyclomine, propantheline), certain anti-Parkinson's drugs (e.g., levodopa, benztropine, trihexyphenidyl), certain azole anti-fungal drugs (ketoconazole, itraconazole), belladonna alkaloids, bisphosphonate drugs (e.g., alendronate, risedronate), corticosteroids (e.g., prednisone), digoxin (slow-dissolving tablets), MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine), phenothiazines (e.g., promethazine), potassium tablets/capsules.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine, meclizine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, haloperidol, amitriptyline, risperidone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include hot/dry skin, fever, unusual excitement, fast/irregular heartbeat, seizures.

NOTES: Do not share this medication with others.

Management of digestive disorders may include lifestyle changes such as stress reduction programs, exercise, stopping smoking, and dietary changes to increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2008 Copyright(c) 2008 First DataBank, Inc.