HYOSCYAMINE SULFATE  - hyoscyamine sulfate tablet, multilayer 
Kylemore Pharmaceuticals, LLC

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Hyoscyamine Sulfate 0.125 mg IR/Hyoscyamine Sulfate 0.250 mg SR

DESCRIPTION



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CLINICAL PHARMACOLOGY






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, this 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


WARNINGS


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. Tablets should be swallowed whole. 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 anti-cholinergics, antimyasthenics, cyclopropane, haloperidol, ketoconazole, metoclopramide, opioid (narcotic) analgesics 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 two years of age. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Close supervision is recommended for infants and 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 adverse 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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

OVERDOSAGE



DOSAGE AND ADMINISTRATION

Adults and children 12 years of age and older:
Children 2 to under 12 years of age:

Note:

HOW SUPPLIED

Yellow and white, bilayered, capsule-shaped tablets debossed “251” on one side. Bottles of 90 tablets, NDC 49769-251-90.

Dispense in tight, light-resistant containers as defined in the USP/NF.

Store at controlled room temperature, 20°- 25°C (68°-77°F), see USP Controlled Room Temperature.

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.

Manufactured for
Kylemore Pharmaceuticals
Suwanee, GA 30024
Rev. 12/09 251-10

PACKAGING:

Hyoscyamine Sulfate 0.125 mg IR/Hyoscyamine Sulfate 0.250 mg SR label:

label


HYOSCYAMINE SULFATE 
hyoscyamine sulfate   tablet, multilayer
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49769-251
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE .375 mg
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color yellow (yellow-white, bilayered) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code 251
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 49769-251-90 90 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/05/2010 08/13/2010

Labeler - Kylemore Pharmaceuticals, LLC (831892471)
Revised: 01/2010 Kylemore Pharmaceuticals, LLC