NDC 68220-113 Levsin SL
Hyoscyamine Sulfate Tablet, Orally Disintegrating Oral

Product Information

Levsin SL is a human prescription drug product labeled by Alaven Pharmaceutical Llc. The generic name of Levsin SL is hyoscyamine sulfate. The product's dosage form is tablet, orally disintegrating and is administered via oral form.

Product Code68220-113
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Levsin SL
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Hyoscyamine Sulfate
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormTablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Alaven Pharmaceutical Llc
Labeler Code68220
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
UNAPPROVED DRUG OTHER -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-01-2008
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Levsin SL?


Product Characteristics

Color(s)BLUE (C48333)
ShapeROUND (C48348)
Size(s)8 MM
Imprint(s)AP;113
Score1

Product Packages

NDC 68220-113-10

Package Description: 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

NDC 68220-113-50

Package Description: 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

Product Details

What are Levsin SL Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Hyoscyamine

Hyoscyamine is pronounced as (hye oh sye' a meen)

Why is hyoscyamine medication prescribed?
Hyoscyamine is used to control symptoms associated with disorders of the gastrointestinal (GI) tract. It works by decreasing the motion of the stomach and intestines and ...
[Read More]

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Levsin SL Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Rx only

500364     113     Rev. 02/08


Description



Levsin®/SL tablets (hyoscyamine sulfate tablets USP) contain 0.125 mg hyoscyamine sulfate formulated for sublingual administration. However, the tablets may be chewed or taken orally.

  •  Levsin®/SL 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, ~-(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.


Clinical Pharmacology



Levsin®/SL 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®/SL inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. Levsin®/SL also controls excessive pharyngeal, tracheal and bronchial secretions.

Levsin®/SL is absorbed totally and completely by sublingual administration as well as oral administration. Once absorbed, Levsin®/SL disappears rapidly from the blood and is distributed throughout the entire body. The half-life of Levsin®/SL is 2 to 3½ hours. Levsin®/SL 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®/SL passes the blood brain barrier and the placental barrier. The tablets can be taken orally with the same pharmacological effects occurring; however, the effects may not occur as rapidly as with sublingual administration.


Indications And Usage



Levsin®/SL 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®/SL 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.


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, Levsin®/SL 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 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 drug since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis.


Information For Patients



Information for Patients:

Like other anticholinergic agents, Levsin®/SL 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®/SL 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.


Drug Interactions



Drug Interactions:

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


Carcinogenesis & Mutagenesis & Impairment Of Fertility



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


Pregnancy



Pregnancy-Pregnancy Category C:

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


Nursing Mothers



Nursing Mothers:

Levsin®/SL is excreted in human milk. Caution should be exercised when Levsin®/SL is administered to a nursing woman.


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.


Adverse Reactions



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.


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


Dosage And Administration



Dosage may be adjusted according to the conditions and severity of symptoms. The tablets may be taken sublingually, orally or chewed.

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.


How Supplied:



Levsin®/SL tablets (hyoscyamine sulfate tablets USP) 0.125 mg are round, blue colored tablets that are imprinted with “AP” on one side and “113” on the other.

  •  Bottles of 100 tablets          NDC 68220-113-10
    Bottles of 500 tablets          NDC 68220-113-50
  • Store at controlled room temperature 20°- 25°C (68° - 77°F); 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

    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

    Manufactured for:

    ALAVEN® PHARMACEUTICAL LLC

    Marietta, GA 30067

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


Principal Display Panel – 0.125 Mg



NDC 68220-113-10

Levsin /SL® tablets
(hyoscyamine sulfate tablets USP)
0.125 mg

sublingual / chewable / oral

Rx only

ALAVEN PHARMACEUTICAL LLC

100 tablets

For medical inquiries call 1-888-317-0001

Each tablet contains 0.125 mg hyoscyamine sulfate, USP.

USUAL DOSAGE: See package insert for full prescribing
information.

Dispense in tight, light-resistant containers as defined in
USP/NF with a child-resistant closure.

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.

Mfg. for: Alaven Pharmaceutical LLC
2260 Northwest Parkway
Marietta, GA 30067
www.alavenpharm.com

400646-08 Rev 04/2017


* Please review the disclaimer below.