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Benadryl Warnings, Precautions, Pregnancy, Nursing, Abuse - Diphenhydramine
WARNINGS
Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction.
Usage in Children: In infants and children, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death.
As in adults, antihistamines may diminish mental alertness in children. In the young child, particularly, they may produce excitation.
Use in the Elderly (approximately 60 years or older): Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.
PRECAUTIONS
General
Diphenhydramine hydrochloride has an atropine-like action and therefore should be used with caution in patients with a history of lower respiratory disease, including asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension.
Information for the Patient
Patients taking diphenhydramine hydrochloride should be advised that this drug may cause drowsiness and has an additive effect with alcohol.
Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term studies in animals to determine mutagenic and carcinogenic potential have not been performed.
Pregnancy
Pregnancy Category B
Reproduction studies have been performed in rats and rabbits at doses up to 5 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to diphenhydramine hydrochloride. 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.
Injection
Use with caution in patients with lower respiratory disease including asthma.
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