Lidocaine Hydrochloride And Dextrose

Lidocaine Hydrochloride And Dextrose Manufacturers

• Baxter Healthcare Corporation
  

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  Lidocaine Hydrochloride And Dextrose | Baxter Healthcare Corporation

  

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  Therapy of ventricular arrhythmias is often initiated with a single IV bolus of 50 to 100 mg of lidocaine hydrochloride injection. Following acute treatment by bolus in patients in whom arrhythmias tend to recur and who are incapable of receiving oral antiarrhythmic agents, intravenous infusion of Lidocaine Hydrochloride and 5% Dextrose Injection, USP is administered continuously at the rate of 1 to 4 mg/min (20 to 50 mcg/kg/min in the average 70 kg adult). The 0.4% solution (4 mg/mL) can be given at a rate of 15 to 60 mL/hr (0.25 to 1 mL/min). The 0.8% solution (8 mg/mL) can be given at a rate of 7.5 to 30 mL/hr (0.12 to 0.5 mL/min). Precise dose is determined by patient response.

  “Pharmacokinetic data indicate reduced elimination of lidocaine after prolonged infusion (24 hours) with resultant prolongation of the half-life to approximately three times that seen following a single administration. Failure to adjust the rate of infusion in keeping with this altered ability to eliminate lidocaine may result in toxic accumulation of the drug in the patient’s serum.” 1

  Intravenous infusions of lidocaine hydrochloride must be administered under constant ECG monitoring to avoid potential overdosage and toxicity. Intravenous infusion should be terminated 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 beyond 24 hours. As soon as possible and when indicated, patients should be changed to an oral antiarrhythmic agent for maintenance therapy.

  Caution: When administering lidocaine hydrochloride by continuous infusion, it is advisable to closely monitor the infusion rate. Administer Lidocaine Hydrochloride and 5% Dextrose Injection, USP only with a calibrated infusion device.

  Pediatric: Although controlled clinical studies to establish pediatric dosing schedules have not been conducted, the American Heart Association’s Standards and Guidelines recommends a bolus dose of 1 mg/kg followed by an infusion rate of 30 µg/kg/min.2

  Lidocaine hydrochloride should not be added to blood transfusion assemblies.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions, where possible.

  All injections in VIAFLEX Plus plastic containers are intended for intravenous administration using sterile equipment.

  Because dosages of this drug are titrated to response, no additives should be made to Lidocaine Hydrochloride and 5% Dextrose Injection, USP.

  1 LeLorier, et al., Pharmacokinetics of lidocaine after prolonged intravenous infusions in uncomplicated myocardial infarction, Ann Int. Med. 87:700-702. 2 American Heart Association, Standards and Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiac Care (ECC), JAMA Vol. 244. No. 5: 453-509.

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• B. Braun Medical Inc.
  

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  Lidocaine Hydrochloride And Dextrose | B. Braun Medical Inc.

  

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  Therapy of ventricular arrhythmias is often initiated with a single IV bolus of 1 mg/kg of Lidocaine Hydrochloride Injection USP. Following acute treatment by bolus in patients in whom arrhythmias tend to recur and who are incapable of receiving oral antiarrhythmic agents, intravenous infusion of Lidocaine Hydrochloride and 5% Dextrose Injection USP is administered continuously.

  Rate of Administration Adults (20 to 50 mcg/kg/min):    Average 70 kg adult   mg/min mL/hr mL/min 0.4% Lidocaine Hydrochloride and
  5% Dextrose Injection USP
  (4 mg lidocaine hydrochloride/mL)  1–4  15–60  0.25–1.0 0.8% Lidocaine Hydrochloride and
  5% Dextrose Injection USP
  (8 mg lidocaine hydrochloride/mL)  1–4  7.5–30  0.12–0.5

  Pediatric Patients (30 mcg/kg/min).1

  Pharmacokinetic data indicate reduced elimination of lidocaine after prolonged infusion (24 hours) with resultant prolongation of the half-life to approximately three times that seen following a single administration. Failure to adjust the rate of infusion in keeping with this altered ability to eliminate lidocaine may result in toxic accumulation of the drug in the patient's serum.2

  Intravenous infusions of lidocaine hydrochloride must be administered under constant ECG monitoring to avoid potential overdosage and toxicity. Intravenous infusion should be terminated 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 beyond 24 hours. As soon as possible and when indicated, patients should be changed to an oral antiarrhythmic agent for maintenance therapy.

  Caution: Concentrated solutions of lidocaine hydrochloride (greater than 0.2%) should be administered by carefully calibrated infusion devices.

  1 Standards and Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiac Care (ECC). American Heart Association, JAMA 244 (5):453–509, 1980. 2 LeLorier J, Grenon D, Latour Y, et al.: Pharmacokinetics of lidocaine after prolonged intravenous infusions in uncomplicated myocardial infarction. Ann Int Med 87:700–702, 1977. Pediatric Use

  Therapy should be initiated with a single IV bolus of 1 mg/kg of Lidocaine Hydrochloride Injection USP. A maintenance intravenous infusion of Lidocaine Hydrochloride and 5% Dextrose Injection USP administered at a recommended infusion rate of 30 mcg/kg/min may be given.1

  Geriatric Use

  Patients with reduced hepatic function or diminished hepatic blood flow (as in heart failure and after cardiac surgery), or those over 70 years of age should receive half the usual loading dose and also should be given lower maintenance levels of intravenous lidocaine. Patients over 65 years may benefit from dosing based upon body weight (see CLINICAL PHARMACOLOGY and PRECAUTIONS, Geriatric Use).

  Lidocaine hydrochloride should not be added to blood transfusion assemblies.

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

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• Hospira, Inc.
  

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  Lidocaine Hydrochloride And Dextrose | Hospira, Inc.

  

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  A 0.4% or 0.8% solution of Lidocaine Hydrochloride and 5% Dextrose Injection, USP is not suitable for bolus administration and is to be used only for infusion following appropriate bolus administration.

  IN THE ADULT PATIENT, DOSAGE SHOULD BE LIMITED TO NO MORE THAN 200 TO 300 MG OF LIDOCAINE ADMINISTERED DURING A ONE-HOUR PERIOD.

  Patients with reduced hepatic function or diminished hepatic blood flow (as in heart failure and after cardiac surgery), or those over 70 years of age, should receive half the usual loading dose and also should be given lower maintenance levels of intravenous lidocaine. Patients over 65 years may benefit from dosing based upon body weight.

  For continuous intravenous infusion, in patients whose arrhythmia tends to recur following a temporary response to a single or once repeated direct injection and who are incapable of receiving oral antiarrhythmic therapy, lidocaine hydrochloride may be infused continuously in a concentration of 0.4% (4 mg/mL) or 0.8% (8 mg/mL) at a rate of 1 to 4 mg (0.25 to 1 mL of 0.4% or 0.125 to 0.5 mL of 0.8%) per minute (20 to 50 micrograms/kg/minute) in the average 70 kg adult. I.V. infusion of the drug must be administered under constant ECG monitoring to avoid potential overdosage and toxicity. I.V. infusion should be terminated as soon as the patient’s basic cardiac rhythm appears to be stable or at the earliest signs of toxicity. As soon as possible, and when indicated, patients should be changed to an oral antiarrhythmic agent for maintenance therapy.

  Prolonged (24 hour) infusion of the drug also appears to result in a longer half-life and reduced rate of clearance (even in patients without cardiac or hepatic failure) that may result in toxic accumulation of lidocaine in the plasma. After the first 24 hours, the rate of infusion of lidocaine should be reduced by about one-half to compensate for the drop in the rate of elimination of the drug.

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

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

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• Hospira, Inc.
  

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  Lidocaine Hydrochloride And Dextrose | Hospira, Inc.

  

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  Spinal anesthesia with 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP may be induced in the right or left lateral recumbent or the sitting position. Since this is a hyperbaric solution, the anesthetic will tend to move in the direction in which the table is tilted. After the desired level of anesthesia is obtained and the anesthetic has become fixed, usually in 5 to 10 minutes with lidocaine, the patient may be positioned according to the requirement of the surgeon or obstetrician.

  In clinical trials, the safety of hyperbaric lidocaine for single injection spinal anesthesia was demonstrated using 22 or 25 gauge spinal needles. In these studies, free flow of CSF was visible before injection of lidocaine.

  Neurologic deficits have been reported with the use of small bore needles and microcatheters for spinal anesthesia. It has been postulated, based on in vitro models, that these deficits were caused by pooling and non-uniform distribution of concentrated local anesthetic within the subarachnoid space.1 Animal studies suggest mixing of 5% lidocaine hydrochloride with an equal volume of CSF or preservative-free 0.9% saline solution may reduce the risk of nerve injury due to pooling of concentrated local anesthetic.2 (See PRECAUTIONS).

  Intrathecal distribution of anesthetic may be facilitated by using a spinal needle of sufficient gauge to insure adequate withdrawal of CSF through the needle prior to and after anesthetic administration. If the technique is properly placed in the subarachnoid space, a separate injection is seldom necessary.

  An incomplete or patchy block not responsive to patient repositioning may indicate misplacement or inadequate distribution of drug. To avoid excessive drug pooling, additional doses of lidocaine should not be administered with the same needle placement.

  INJECTIONS SHOULD BE MADE SLOWLY. Consult standard textbooks for specific techniques for spinal anesthetic procedures.

  There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures.  5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

  Recommended dosages

  Normal healthy adults: The following recommended dosages are for normal healthy adults and serve only as a guide to the amount of anesthetic required for most routine procedures. In all cases, the smallest dose that will produce the desired result should be given.

  If the technique is properly performed, and the needle is properly placed in the subarachnoid space, it should not be necessary to administer more than one ampul (100 mg).

  Obstetrical low spinal or “saddle block” anesthesia:

  The dosage recommended for normal vaginal delivery is approximately 1 mL (50 mg). For Caesarean section and those deliveries requiring intrauterine manipulations, 1.5 mL (75 mg) is usually adequate.

  Surgical anesthesia:

  The dosage recommended for abdominal anesthesia is 1.5 to 2 mL (75 to 100 mg).

  Pediatric Patients:

  The dosage recommendations in healthy adolescents, 16 years of age and older, is the same as for normal healthy adults. There is insufficient data in pediatric patients below the age of 16 years to make dosage recommendations (see PRECAUTIONS).

  Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored and/or contain particulate matter should not be used.

  Unused portions of solutions should be discarded following initial use.

  5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP may be autoclaved once at 15 pounds pressure, 121°C (250°F) for 15 minutes. Since this preparation contains dextrose, carmelization may occur under prolonged heating and, in some instances, prolonged storage. Therefore this preparation should not be autoclaved more than once, according to the above instructions, and should not be permitted to remain in the autoclave any longer than necessary. Do not administer any solution which is discolored or contains particulate matter.

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