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®/SL; 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®/SL (hyoscyamine sulfate tablets) . It
is also not known whether Levsin®/SL (hyoscyamine sulfate tablets) can cause fetal harm when administered
to a pregnant woman or can affect reproduction capacity. Levsin®/SL (hyoscyamine sulfate tablets) should
be given to a pregnant woman only if clearly needed.
Levsin®/SL (hyoscyamine sulfate tablets) is excreted in human milk. Caution should be exercised when
Levsin®/SL (hyoscyamine sulfate tablets) is administered to a nursing woman.
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