A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Levsin Warnings, Precautions, Pregnancy, Nursing, Abuse - Hyoscyamine
Levsin Warnings, Precautions, Pregnancy, Nursing, Abuse - Hyoscyamine
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, LEVSIN 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.
Information for Patients
See PATIENT INFORMATION section.
Drug Interactions
See DRUG INTERACTIONS section.
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; 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. It is also not known
whether LEVSIN can cause fetal
harm when administered to a pregnant
woman or can affect
reproduction capacity. LEVSIN should be given to a pregnant
woman only if clearly
needed.
Nursing Mothers
LEVSIN is excreted in human
milk. Caution should be exercised when LEVSIN is administered to
a nursing woman.
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