Lidocainedosage

The toxic effects of local anesthetics are additive. When using this product concomitantly with other lidocaine-containing products, consider the total dose of lidocaine and monitor patients for cardiovascular and respiratory vital signs. For surface anesthesia of male adult urethra: 15 mL (300 mg lidocaine HCl) followed by additional 15 mL if needed For surface anesthesia of female adult urethra: 3 mL to 5 mL (60 mg to 100 mg lidocaine HCl) For lubrication for endotracheal intubation: sufficient amount to coat the external surface of endotracheal tube For pediatric patients: Not more than 4.5 mg/kg body weight of lidocaine HCl

2.1 Important

Dosage and Administration Information Administration Precautions The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity when additional local anesthetics are administered with GLYDO (lidocaine HCl jelly) 2%. The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. Although the incidence of adverse effects with GLYDO (lidocaine HCl jelly) 2% is quite low, caution should be exercised, particularly when employing large amounts, since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered. No more than 600 mg of lidocaine HCl should be given in any 12 hour period.

2.2 For Surface

Anesthesia of the Male Adult Urethra Slowly instill approximately 15 mL (300 mg of lidocaine HCl) into the urethra. Apply a penile clamp for several minutes at the corona. An additional dose of not more than 15 mL (300 mg) can be instilled if needed. Prior to sounding or cystoscopy, a penile clamp should be applied for 5 to 10 minutes to obtain adequate anesthesia. A total dose of 30 mL (600 mg) is usually required to fill and dilate the male urethra. Prior to catheterization, 5 mL to 10 mL (100 mg to 200 mg) are recommended for lubrication.

2.3 For Surface

Anesthesia of the Female Adult Urethra Slowly instill approximately 3 mL to 5 mL (60 mg to 100 mg of lidocaine HCl) into the urethra. In order to obtain adequate anesthesia, wait for several minutes prior to performing urological procedures. If desired, some jelly may be deposited on a cotton swab and introduced into the urethra.

2.4 Lubrication for

Endotracheal Intubation Apply a sufficient amount of jelly to coat the external surface of the endotracheal tube shortly before use. Care should be taken to avoid introducing the product into the lumen of the tube. Do not use the jelly to lubricate endotracheal stylettes. (see WARNINGS and ADVERSE REACTIONS concerning rare reports of inner lumen occlusion). It is also recommended that use of endotracheal tubes with dried jelly on the external surface be avoided for lack of lubricating effect.

2.5 Dosing for

Pediatric Patients A maximum dose of GLYDO (lidocaine HCl jelly) 2% for children varies based on age and weight. The maximum dose should not exceed 4.5 mg/kg of body weight. For children over 3 years of age, the maximum dose is determined by the child's age and weight. For example, in a child of 5 years weighing approximately 23 kg, the dose of lidocaine hydrochloride should not exceed approximately 75 mg to 100 mg (3.3 mg/kg to 4.4 mg/kg). The lowest effective dose should be used.