Hyoscyamine SL 0.125 mg (hyoscyamine sulfate tablets, USP)

HYOSCYAMINE SL - hyoscyamine sulfate tablet, orally disintegrating 
Breckenridge Pharmaceutical, Inc.

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Hyoscyamine SL
0.125 mg
(hyoscyamine sulfate tablets, USP)

Rx Only

DESCRIPTION

Hyoscyamine SL tablets are formulated for sublingual administration. However, the tablets may be chewed or taken orally.

Each tablet contains
Hyoscyamine Sulfate, USP.............................................................. 0.125 mg

Inactive Ingredients: Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Starch and Stearic Acid.

Allergen: Contains Milk

CLINICAL PHARMACOLOGY

Hyoscyamine 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, α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure:

Chemical Structure

Hyoscyamine Sulfate 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 the autonomic ganglia. Hyoscyamine Sulfate inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. Hyoscyamine Sulfate also controls excessive pharyngeal, tracheal, and bronchial secretions.

Hyoscyamine Sulfate is absorbed totally and completely by sublingual administration as well as oral administration. Once absorbed, Hyoscyamine Sulfate disappears rapidly from the blood and is distributed throughout the entire body. The half-life of Hyoscyamine Sulfate is 2 to 3 1/2 hours. Hyoscyamine Sulfate 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. Hyoscyamine Sulfate 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

Hyoscyamine Sulfate 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). Hyoscyamine Sulfate 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, Hyoscyamine Sulfate 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.

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

Like other anticholinergic agents, Hyoscyamine Sulfate 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 Hyoscyamine Sulfate 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

Additive adverse effects resulting from cholinergic blockade may occur when Hyoscyamine Sulfate SL is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors (or for 14 days after stopping MAOI therapy), tricyclic antidepressants or some antihistamines.

Antacids may interfere with the absorption of Hyoscyamine Sulfate SL. Administer Hyoscyamine Sulfate SL before meals; antacids after meals.

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 Hyoscyamine Sulfate SL.

Pregnancy Category C

Animal reproduction studies have not been conducted with Hyoscyamine Sulfate SL. It is also not known whether Hyoscyamine Sulfate SL can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should not be given to a pregnant woman (see CLINICAL PHARMACOLOGY).

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.

Nursing Mothers

Hyoscyamine Sulfate SL is excreted in human milk. Because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

This product is not indicated for use in the pediatric population.

Geriatric Use

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 Sulfate is 375 mg/kg. Hyoscyamine Sulfate 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 children 12 years of age and older

1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

This product is not indicated for use in the pediatric population (see PRECAUTIONS, Pediatric Use.)

HOW SUPPLIED

Hyoscyamine SL 0.125 mg Tablets (hyoscyamine sulfate, USP) are available as a round, white, bisected tablet. They are debossed B 656 in bottles of 100 tablets NDC 51991-656-01.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Store at 25°C(77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.

Protect from light and moisture.

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

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Manufactured by:
Contract Pharmacal Corp.
Hauppauge, NY 11788 USA

Distributed by:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

Rx Only

Iss. 09/09

PRINCIPAL DISPLAY PANEL - 0.125 mg Tablet Bottle

Breckenridge
Pharmaceutical, Inc.

NDC 51991-656-01

Hyoscyamine SL
0.125 mg

(hyoscyamine sulfate tablets, USP)

DO NOT USE IF IMPRINTED SAFETY SEAL
UNDER CAP IS BROKEN OR MISSING

Rx Only

100 Tablets

Chemical Structure

HYOSCYAMINE SL 
hyoscyamine sulfate   tablet, orally disintegrating
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)51991-656
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hyoscyamine Sulfate (Hyoscyamine) Hyoscyamine Sulfate0.125 mg
Inactive Ingredients
Ingredient NameStrength
Cellulose, Microcrystalline 
Magnesium Stearate 
Lactose 
Mannitol 
Stearic Acid 
Starch, Corn 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code B;656
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
151991-656-01100 TABLET In 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved other10/19/2009

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corporation057795122MANUFACTURE
Revised: 10/2009Breckenridge Pharmaceutical, Inc.