Hyoscyamine Sulfate Orally Disintegrating Tablet

Pronunciation

Generic Name: hyoscyamine sulfate
Dosage Form: tablet, orally disintegrating

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Hyoscyamine Sulfate Tablets 0.125 mg
Orally Disintegrating

DESCRIPTION:

Each round, white to off-white, mint flavored tablet, can be chewed or placed on tongue for disintegration and contains 0.125 mg of hyoscyamine sulfate USP.

Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids.

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The chemical name is Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate.

Inactive ingredients include anhydrous dibasic calcium phosphate, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sucralose, xylitol.

ACTIONS:

Hyoscyamine has actions similar to those of atropine, but is more potent in both its central and peripheral effects. This product inhibits gastrointestinal propulsive motility and decreases gastric acid secretions. This product controls excessive pharyngeal, tracheal, and bronchial secretion. This product is absorbed by chewing completely as well as by oral or sublingual administration. Once absorbed, this product disappears rapidly from the blood and is distributed throughout the entire body. The majority of hyoscyamine sulfate is excreted in the urine unchanged within the first 12 hours and only traces of hyoscyamine sulfate are found in the breast milk.

INDICATIONS AND USAGE:

This product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. Along with appropriate analgesics, the product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis. This product is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis and other functional gastrointestinal disorders.

CONTRAINDICATIONS:

Glaucoma, obstructive uropathy, obstructive diseases of the gastrointestinal tract, paralytic ileum, intestinal atony of elderly or debilitated patients, unstable cardiovascular status, severe ulcerative colitis, toxic megacolon, myasthenia gravis, and myocardial ischemia.

This product is not recommended for use in children under six years of age.

WARNINGS:

Heat prostration can occur with drug use in the event of high environmental temperature. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, treatment would be inappropriate and possibly harmful. This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous tasks while taking this drug.

PRECAUTIONS:

Use caution in patients with hiatal hernia associated with reflex esophagitis. Use extreme caution and only when needed in patients with autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure and cardiac arrhythmia. Investigate any tachycardia before giving any anticholinergic drugs since they may increase the heart rate.

Prolonged use of anticholinergics may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candidiasis, and discomfort.

Information for Patients:

This medication should be taken 30 minutes to one hour before meals.

This medication should be used with caution during exercise or hot weather; overheating may result in heat stroke.

Hyoscyamine may cause drowsiness, dizziness or blurred vision; patients should observe caution before driving, using machinery or performing other tasks requiring mental alertness.

Drug Interactions:

Absorption of other oral medications may be decreased during concurrent use with anticholinergics due to decreased gastrointestinal motility and delayed gastric emptying.

Drug interactions may occur when anticholinergics are used with the following medications: antacids, antidiarrheals (adsorbent), other anticholinergics, antimyasthenics, cyclopropane, haloperidol, ketoconazole, metoclopramide, opioid (narcotic) analgesics, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, some antihistamines, and potassium chloride.

Pregnancy:

Pregnancy Category C.

Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine crosses the placenta. This product should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

This product is excreted in human milk. This product should not be administered to a nursing mother.

Pediatric Use:

This product is not recommended for use in children under six years of age. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Close supervision is recommended for children with spastic paralysis or brain damage since an increased response to anticholinergics has been reported in these patients and dosage adjustments are often required. When anticholinergics are given to children where the environmental temperature is high, there is a risk of a rapid increase in body temperature because of these medications' suppression of sweat gland activity.

A paradoxical reaction characterized by hyperexcitability may occur in children taking large doses of anticholinergics.

Geriatric Use:

Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion.

Geriatric patients are especially susceptible to the anticholinergic side effects, such as constipation, dryness of mouth, and urinary retention (especially in males). If these side effects occur and continue or are severe, medication should probably be discontinued.

Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of precipitating undiagnosed glaucoma.

Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of anticholinergics since these drugs block the actions of acetylcholine, which is responsible for many functions of the brain, including memory functions.

ADVERSE REACTIONS:

Not all of the following reactions have been reported with hyoscyamine sulfate. The following adverse reactions have been reported for pharmacologically similar drugs with anticholinergic-antispasmodic action. Adverse reactions may include dryness of the mouth, urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; cycloplegia; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; 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); 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. Hyoscyamine is dialyzable.

DOSAGE AND ADMINISTRATION:

Hyoscyamine Sulfate Tablets 0.125 mg are formulated to be chewed or allowed to orally disintegrate. May be taken with or without water.

Adults and pediatric patients 12 years of age or older:

1 to 2 orally disintegrating tablets three to four times a day, thirty minutes to one hour before meals and at bedtime, the dosage being adjusted as needed and tolerated. Do not exceed 12 tablets in 24 hours.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.

Pediatric patients 6 to under 12 years of age:

1/2 to 1 orally disintegrating tablet three to four times a day, thirty minutes to one hour before meals and at bedtime. Dosage should be individualized by physician according to patient's needs and tolerance. Do not exceed 6 tablets in 24 hours.

Note: This product is not recommended for use in children under six years of age.

HOW SUPPLIED:

Hyoscyamine Sulfate Tablets 0.125 mg are round, white to off-white, mint flavored tablets with "PAD" debossed on one side and "H" on the other side. Bottles of 100 orally disintegrating tablets NDC 0574-0247-01.

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

Dispense in a tight, light-resistant container as defined in USP/NF.

Protect from moisture.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid exposure to heat.

Manufactured By
Perrigo®
Minneapolis, MN 55427
(04-12)

PRINCIPAL DISPLAY PANEL - 0.125 mg Bottle Label

Rx Only

Perrigo®

NDC 0574-0247-01

Hyoscyamine Sulfate
Tablets ODT
0.125 mg
Orally Disintegrating

100 Tablets

HYOSCYAMINE SULFATE 
hyoscyamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0574-0247
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.125 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
CROSPOVIDONE  
MAGNESIUM STEARATE  
MANNITOL  
CELLULOSE, MICROCRYSTALLINE  
SUCRALOSE  
XYLITOL  
Product Characteristics
Color WHITE (White to Off-White) Score no score
Shape ROUND Size 13mm
Flavor MINT Imprint Code PAD;H
Contains         
Packaging
# Item Code Package Description
1 NDC:0574-0247-01 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/06/2012
Labeler - Paddock Laboratories, LLC (967694121)
Establishment
Name Address ID/FEI Operations
Paddock Laboratories, LLC 967694121 LABEL(0574-0247), MANUFACTURE(0574-0247)
Revised: 08/2012
 
Paddock Laboratories, LLC



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