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Hyoscyamine (Hyoscyamine Sulfate) - Warnings and Precautions

 
 



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 Tablets 0.125 mg 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. CNS signs and symptoms include confusion, disorientation, short term memory loss, hallucinations, dysarthria, ataxia, coma,
euphoria, decreased 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.

No long-term studies in animals have been performed to determine the carcinogenic, mutagenic or impairment of fertility potential of Hyoscyamine Sulfate SL Tablets 0.125 mg.

PREGNANCY--PREGNANCY CATEGORY C

Pregnancy--Pregnancy Category C:
Animal reproduction studies have not been conducted with Hyoscyamine Sulfate SL Tablets 0.125 mg. It is also not known whether Hyoscyamine Sulfate SL Tablets 0.125 mg can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyoscyamine
Sulfate SL Tablets 0.125 mg should be given to a pregnant woman only if clearly needed.

Nursing Mothers:
Hyoscyamine Sulfate is excreted in human milk. Caution should be exercised when Hyoscyamine Sulfate SL Tablets 0.125 mg is administered to a nursing woman.

Page last updated: 2009-09-01

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