lidocaine hydrochloride injection, USP ANSYR, ABBOJECT Dosage and Administration

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DOSAGE AND ADMINISTRATION

Adults:

Single Direct Intravenous Injection (bolus): ONLY THE 5 mL, 50 MG or 100 MG DOSAGE SIZES should be used for direct intravenous injection. The usual dose is 50 to 100 mg of lidocaine hydrochloride (0.70 to 1.4 mg/kg; 0.32 to 0.63 mg/lb) administered intravenously under ECG monitoring. This dose may be administered at the rate of approximately 25 to 50 mg/min (0.35 to 0.70 mg/kg/min; 0.16 to 0.32 mg/lb/min). Sufficient time should be allowed to enable a slow circulation to carry the drug to the site of action. If the initial injection of 50 to 100 mg does not produce a desired response, a second dose may be injected after five minutes. NO MORE THAN 200 TO 300 MG OF LIDOCAINE HYDROCHLORIDE SHOULD BE ADMINISTERED DURING A ONE HOUR PERIOD.

Continuous Intravenous Infusion: Following bolus administration, intravenous infusions of lidocaine hydrochloride may be initiated at the rate of 1 to 4 mg/min of lidocaine hydrochloride (0.014 to 0.057 mg/kg/min; 0.006 to 0.026 mg/lb/min). The rate of intravenous infusions should be reassessed as soon as the patient's basic cardiac rhythm appears to be stable or at the earliest signs of toxicity. It should rarely be necessary to continue intravenous infusions of lidocaine for prolonged periods.

When administering lidocaine hydrochloride (or any potent medication) by continuous intravenous infusion, it is advisable to use a precision volume control I.V. set.

Pediatric: Controlled clinical studies in the pediatric population to establish dosing schedules have not been conducted. The American Heart Association's Standards and Guidelines recommends a bolus dose of 1 mg/kg, and an infusion rate of between 20-50 mcg/kg/min for prolonged therapy. When drug clearance is reduced, as in patients with shock, congestive heart failure or cardiac arrest, the infusion rate should not exceed 20 mcg/kg/min.

NOTE: Regarding Prolonged Infusions: There are data that indicate the half-life may be 3 hours or longer following infusions of greater than 24 hours in duration. Do not use if solution is discolored or cloudy.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.

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Dosage and Administration

DOSAGE AND ADMINISTRATION

Adults:

Single Direct Intravenous Injection (bolus): ONLY THE 5 mL, 50 MG or 100 MG DOSAGE SIZES should be used for direct intravenous injection. The usual dose is 50 to 100 mg of lidocaine hydrochloride (0.70 to 1.4 mg/kg; 0.32 to 0.63 mg/lb) administered intravenously under ECG monitoring. This dose may be administered at the rate of approximately 25 to 50 mg/min (0.35 to 0.70 mg/kg/min; 0.16 to 0.32 mg/lb/min). Sufficient time should be allowed to enable a slow circulation to carry the drug to the site of action. If the initial injection of 50 to 100 mg does not produce a desired response, a second dose may be injected after five minutes. NO MORE THAN 200 TO 300 MG OF LIDOCAINE HYDROCHLORIDE SHOULD BE ADMINISTERED DURING A ONE HOUR PERIOD.

Continuous Intravenous Infusion: Following bolus administration, intravenous infusions of lidocaine hydrochloride may be initiated at the rate of 1 to 4 mg/min of lidocaine hydrochloride (0.014 to 0.057 mg/kg/min; 0.006 to 0.026 mg/lb/min). The rate of intravenous infusions should be reassessed as soon as the patient's basic cardiac rhythm appears to be stable or at the earliest signs of toxicity. It should rarely be necessary to continue intravenous infusions of lidocaine for prolonged periods.

When administering lidocaine hydrochloride (or any potent medication) by continuous intravenous infusion, it is advisable to use a precision volume control I.V. set.

Pediatric: Controlled clinical studies in the pediatric population to establish dosing schedules have not been conducted. The American Heart Association's Standards and Guidelines recommends a bolus dose of 1 mg/kg, and an infusion rate of between 20-50 mcg/kg/min for prolonged therapy. When drug clearance is reduced, as in patients with shock, congestive heart failure or cardiac arrest, the infusion rate should not exceed 20 mcg/kg/min.

NOTE: Regarding Prolonged Infusions: There are data that indicate the half-life may be 3 hours or longer following infusions of greater than 24 hours in duration. Do not use if solution is discolored or cloudy.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.

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