<p>There is insufficient information available to establish the safety of azelastine in human pregnancy. At high oral doses azelastine has shown to induce adverse effects (foetal death, growth retardation and skeletal malformation) in experimental animals. Local ocular application will result in minimal systemic exposure (picogram range). However, caution should be exercised when using Azelastine hydrochloride Eye drops, solution during pregnancy. Azelastine is excreted into the milk in low quantities. For that reason Azelastine hydrochloride Eye drops, solution is not recommended during lactation.</p>