United States - English - NLM (National Library of Medicine)

alcon laboratories, inc. - tetracaine hydrochloride (unii: 5nf5d4opci) (tetracaine - unii:0619f35cgv) - tetracaine hydrochloride 5 mg in 1 ml - tetracaine hydrochloride ophthalmic solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. none. risk summary there are no adequate and well-controlled studies with tetracaine hydrochloride ophthalmic solution 0.5% in pregnant women.  animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature. risk summary there are no data to assess whether tetracaine hydrochloride ophthalmic solution 0.5% is excreted in human milk or to assess its effects on milk production/excretion.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tetracaine hydrochloride ophthalmic solution 0.5% and any potential adverse effects on the breastfed child from tetracaine hydrochloride ophthalmic solution 0.5% or from the underlying maternal condition. no human data on the effect of tetracaine hydrochloride ophthalmic solution 0.5% on fertility are available. safety in the pediatric population has been demonstrated in clinical trials.  efficacy of tetracaine hydrochloride ophthalmic solution for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population. no overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution have been observed between elderly and younger patients.