Hyoscyamine Sulfate 0.125 MG Oral Tablet
Generic Name: HYOSCYAMINE SULFATE
Brand Name: Hyoscyamine Sulfate
- Substance Name(s):
- HYOSCYAMINE SULFATE
WARNINGS
SECTION 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 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.
OVERDOSAGE
SECTION 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 of 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 sulfate is dialyzable.
DESCRIPTION
SECTION Hyoscyamine Sulfate Tablets, USP 0.125 mg are white, round, flat beveled edge tablets debossed “10” on one side.
Scored on other side.
Hyoscyamine Sulfate Tablets contain 0.125 mg hyoscyamine sulfate formulated for oral administration.
Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids.
The molecular 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 structural formula: Each tablet also contains as inactive ingredients: mannitol, croscarmellose sodium and magnesium stearate.
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HOW SUPPLIED
SECTION Bottles of 100 NDC 76439-0308-10 Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F).
[See USP Controlled Room Temperature].
Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure.
INDICATIONS AND USAGE
SECTION Hyoscyamine sulfate is indicated whenever antispasmodic or anticholinergic therapy is desired.
The high degree of purity allows effective action at very low dosage, with a minimal incidence of unwanted side effects.
DOSAGE AND ADMINISTRATION
SECTION Dosage may be adjusted according to the conditions and severity of symptoms.
Hyoscyamine Sulfate Tablets, USP must be taken orally.
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.