RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE IMMEDIATELY AVAILABLE WHEN ANY LOCAL ANESTHETIC IS USED. CARCINOGENESIS, MUTAGENESIS: Long-term studies to determine the carcinogenic and mutagenic potential of cocaine are not available. PREGNANCY: TERATOGENIC EFFECTS - PREGNANCY CATEGORY C: Animal reproduction studies have not been conducted with cocaine. It is also not known whether the cocaine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cocaine should be given to a pregnant woman only if needed.

The safety and effectiveness of Cocaine Hydrochloride Topical Solution depends on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Standard textbooks should be consulted for specific techniques and precautions for various anesthetic procedures. The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and physical status. Cocaine Hydrochloride topical solution should be used with caution in patients with severely traumatized mucosa and sepsis in the region of the proposed application. Use with caution in persons with known drug sensitivities.

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