Hyoscyamine Sulfate Extended-Release (Page 2 of 2)

ADVERSE REACTIONS

The following adverse reactions have been reported for hyoscyamine sulfate and 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; fatigue; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; 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 LD for hyoscyamine is 375 mg/kg. Hyoscyamine sulfate is dialyzable. ₅₀

DOSAGE AND ADMINISTRATION

Dosage may be adjusted according to the conditions and severity of symptoms.

1 to 2 tablets every 12 hours. Do not crush or chew tablets. Do not exceed 4 tablets in 24 hours. Adults and pediatric patients 12 years of age and older:

HOW SUPPLIED

NDC:68151-5182-0 in a PACKAGE of 1 TABLETS

Hyoscyamine Sulfate E.R.

Label Image

HYOSCYAMINE SULFATE EXTENDED-RELEASE hyoscyamine sulfate extended-release tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-5182(NDC:43199-014) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.375 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE HYDROXYPROPYL CELLULOSE (TYPE H) MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE

Product Characteristics Color WHITE Score no score Shape CAPSULE Size 14mm Flavor Imprint Code CL;14 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68151-5182-0 1 TABLET (1 TABLET) in 1 PACKAGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/03/2010

Labeler — Carilion Materials Management (079239644)

Registrant — Carilion Materials Management (079239644)

Establishment
Name	Address	ID/FEI	Operations
Carilion Materials Management		079239644	REPACK (68151-5182)

Revised: 02/2010 Carilion Materials Management