Astero Gel Dosage

Each pump of the Astero® bottle (30mL Airless Metered Dose bottle) (NDC:35781-2500-3)(90mL Airless Metered Dose bottle) (NDC:35781-2500-9) will deliver 0.25 mL of Astero® (10 mg Lidocaine Hydrochloride USP), enough to cover a 2-inch by 2-inch area of skin. A single application should not exceed 4 pumps of the M-DOSE bottle, equal to 1 gram of Astero®, (40 mg of Lidocaine Hydrochloride USP).
No more than 12 pumps of the M-DOSE bottle, approximately 3 grams of Astero® (120 mg Lidocaine Hydrochloride USP,) should be administered in any one day. Although the incidence of adverse effects with Astero® 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.
2.1 Dosage for children: The recommended dose of Astero® varies as a function of age and weight. For children less than ten years who have a normal lean body mass and a normal lean body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark’s rule). For example, a child of five years weighing 50 lbs., the dose of lidocaine should not exceed 75-100 mg (approximately 1.9 to 2.5 grams of Astero®) when calculated according to Clark’s rule. In general, the maximum amount of lidocaine administered should not exceed 4.5 mg/kg (2.0 mg/lb) of body weight of the child. Do not use on children under 2 unless directed by a physician.
2.2 Administration: Apply as directed. Do not exceed 12 pumps in a twenty-four-hour (24-hour) period. One pump covers an area of 2 x2 inches.