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
Clemastin Warnings, Precautions, Pregnancy, Nursing, Abuse - Clemastine
Clemastin Warnings, Precautions, Pregnancy, Nursing, Abuse - Clemastine
WARNINGS
Antihistamines should be used with considerable caution in patients
with: narrow angle glaucoma,
stenosing peptic ulcer,
pyloroduodenal obstruction, symptomatic prostatic
hypertrophy, and
bladder neck
obstruction.
Use with CNS Depressants:
Clemastine has additive
effects with alcohol and other CNS
depressants (hypnotics, sedatives, tranquilizers, etc.).
Use in Activities Requiring Mental Alertness: Patients should
be warned about engaging in activities requiring mental
alertness such as driving a car or operating appliances, machinery,
etc.
Use in the Elderly (approximately 60 years or older): Antihistamines
are more likely to cause
dizziness, sedation,
and hypotension
in elderly patients.
PRECAUTIONS
General
Clemastine fumarate should be used with caution in patients with:
history of bronchial
asthma, increased intraocular
pressure, hyperthyroidism,
cardiovascular disease, and hypertension.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis and Mutagenesis: In
a 2-year oral study in
the rat at a dose
of 84 mg/kg (about 500 times the adult
human dose) and an 85-week
oral study in the mouse
at 206 mg/kg (about 1300 times the adult human
dose), clemastine fumarate showed no
evidence of carcinogenesis.
No mutagenic studies have been conducted with clemastine fumarate.
Impairment of Fertility: Oral doses of clemastine fumarate
in the rat produced a decrease
in mating ability
of the male at 312 times
the adult human
dose. This effect was
not found at 156 times the adult human dose.
Pregnancy
Teratogenic Effects. Pregnancy Category B: Oral reproduction
studies performed with clemastine fumarate in rats and rabbits at
doses up to 312 and 188 times the adult
human doses respectively,
have revealed no evidence
of teratogenic effects.
There are no adequate and
well-controlled studies of clemastine fumarate in pregnant
women. Because animal
reproduction studies are not always predictive of human
response, this drug should
be used in pregnancy
only if clearly needed.
Nursing Mothers
Although quantitative
determinations of antihistaminic
drugs in breast milk have not been reported, qualitative
tests have documented the excretion of diphenhydramine, pyrilamine,
and tripelennamine in human
milk.
Because of the potential
for adverse reactions in nursing
infants from antihistamines, a decision should be made whether to
discontinue nursing or to discontinue the drug.
Pediatric Use
The safety and efficacy
of Clemastine Fumarate Syrup has been confirmed in the pediatric
population (age 6
years through 12). Safety and dose
tolerance studies have confirmed pediatric
patients 6 through 11 years tolerated dosage ranges of 0.75 to 2.25
mg clemastine. In
pediatric patients
particularly, antihistamines in overdosage may produce hallucinations,
convulsions and death. Symptoms of antihistamine
toxicity in pediatric
patients may include fixed dilated pupils, flushed face, dry mouth,
fever, excitation, hallucinations,
ataxia, incoordination,
athetosis, tonic- clonic
convulsions, and postictal depression (see OVERDOSAGE).
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