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
Tenex Warnings, Precautions, Pregnancy, Nursing, Abuse - Guanfacine
Tenex Warnings, Precautions, Pregnancy, Nursing, Abuse - Guanfacine
WARNINGS
No information provided.
PRECAUTIONS
General
Like other antihypertensive
agents, guanfacine should be used with caution in patients with
severe coronary insufficiency, recent myocardial
infarction, cerebrovascular disease
or chronic renal
or hepatic failure.
Sedation
Guanfacine, like other orally active central
a2-adrenergic agonists, causes
sedation or drowsiness,
especially when beginning therapy. These symptoms are dose-related
(see ADVERSE REACTIONS).
When guanfacine is used with other centrally active depressants
(such as phenothiazines, barbiturates, or benzodiazepines), the
potential for additive
sedative effects should
be considered.
Rebound
Abrupt cessation of therapy with orally active central
a2-adrenergic agonists may
be associated with increases (from depressed
on-therapy levels) in plasma
and urinary catecholamines, symptoms of nervousness
and anxiety” and, less commonly, increases in blood
pressure to levels
significantly greater than those prior to therapy.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenic
effect was observed in
studies of 78 weeks in mice at doses more than 150 times the maximum
recommended human dose
and 102 weeks in rats at doses more than 100 times the maximum
recommended human dose.
In a variety of test models,
guanfacine was not mutagenic. No adverse effects were observed in
fertility studies in male
and female rats.
Pregnancy Category B
Administration of guanfacine to rats at 70 times the maximum
recommended human dose
and to rabbits at 20 times the maximum
recommended human dose
resulted in no evidence
of harm to the fetus. Higher doses (100 and 200 times the maximum
recommended human dose
in rabbits and rats respectively) were associated with reduced fetal
survival and maternal
toxicity. Rat experiments have shown that guanfacine crosses the
placenta. There are, however, no adequate and well-controlled studies
in pregnant women.
Because animal reproduction
studies are not always predictive of human
response, this drug should
be used during pregnancy only if clearly needed.
Labor and Delivery
Guanfacine is not recommended in the treatment
of acute hypertension
associated with toxemia
of pregnancy. There is no information available on the effects of
guanfacine on the course of labor
and delivery.
Nursing Mothers
It is not known whether guanfacine is excreted in human
milk. Because many drugs are excreted in human
milk, caution should be exercised when guanfacine hydrochloride
is administered to a nursing
woman. Experiments with rats have shown that guanfacine is excreted
in the milk.
Pediatric Use
Safety and effectiveness
in pediatric patients
under 12 years of age have not been demonstrated. Therefore, the
use of guanfacine in this age group is not recommended.
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