IMPORTANT SAFETY INFORMATION Diphenhydramine hydrochloride is contraindicated in neonates, premature infants, and as antihistamine therapy in nursing mothers and as a local anesthetic and when a patient is hypersensitive to other antihistamines of similar chemical structure.
Considerable caution should be used in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction.
Local necrosis has been associated with the use of subcutaneous or intradermal use of the drug. It has an atropine-like action and, therefore should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension and in patients with lower respiratory disease including asthma.
It has additive effects with alcohol and other CNS depressants. MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.
The most frequent adverse reactions are: Nervous System: sedation, sleepiness, dizziness, disturbed coordination; GI System: epigastric distress; and Respiratory System: thickening of bronchial secretions
Please see full prescribing information for additional important safety information.
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- U.S. Food and Drug Administration. Current Drug Shortages Index. Available at http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314742.htm and viewed on July 18, 2013.
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