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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term studies in animals have been performed to determine the carcinogenic,
mutagenic or impairment of fertility potential of Levsin® (hyoscyamine) ; however, 40
years of marketing experience with hyoscyamine sulfate shows no demonstrable
evidence of a problem.
Pregnancy–Pregnancy Category C
Animal reproduction studies have not been conducted with Levsin® (hyoscyamine) . It is
also not known whether Levsin® (hyoscyamine) can cause fetal harm when administered to
a pregnant woman or can affect reproduction capacity. Levsin® (hyoscyamine) should be
given to a pregnant woman only if clearly needed.
Nursing Mothers
Levsin® (hyoscyamine) is excreted in human milk. Caution should be exercised when Levsin® (hyoscyamine)
is administered to a nursing woman.
Geriatric Use
Reported clinical experience has not identified differences in safety between
patients aged 65 and over and younger patients. In general, dose selection for
an elderly patient should be cautious, usually starting at the low end of the
dosing range, reflecting the greater frequency of decreased hepatic, renal,
or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk
of toxic reactions to this drug may be greater in patients with impaired renal
function. Because elderly patients are more likely to have decreased renal function,
care should be taken in dose selection, and it may be useful to monitor renal
function.