"The US Food and Drug Administration (FDA) has approved an expanded indication for onabotulinum toxin A (Botox, Actavis) for the treatment of adults with upper limb spasticity, according to a company news release.
The expanded i"...
Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
DOSAGE AND ADMINISTRATION
Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine (lidocaine) Injection for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required, only solutions containing epinephrine should be used except in those cases where vasopressor drugs may be contraindicated.
There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Xylocaine (lidocaine) is not approved for this use (see WARNINGS).
These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for the elderly and debilitated patients and patients with cardiac and/or liver disease.
The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (ie, total dose) of local anesthetic used. Thus, an increase in volume and concentration of Xylocaine (lidocaine) Injection will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of Xylocaine (lidocaine) Injection may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine HCl is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.
For intravenous regional anesthesia, only the 50 mL single dose vial containing Xylocaine (lidocaine HCl) 0.5% Injection should be used.
For epidural anesthesia, only the following dosage forms Xylocaine (lidocaine) Injection are recommended:
|1% without epinephrine||10 mL Polyamp DuoFit™|
|1% without epinephrine||30 mL single dose solutions|
|1% with epinephrine||30 mL single dose solutions|
|1.5% without epinephrine||10 mL Polyamp DuoFit™|
|1.5% without epinephrine||20 mL Polyamp DuoFit™|
|1.5% with epinephrine||30 mL ampules, 30 mL single dose solutions|
|2% without epinephrine||10 mL Polyamp DuoFit™|
|2% with epinephrine||20 mL ampules, 20 mL single dose solutions|
Although these solutions are intended specifically for epidural anesthesia, they may also be used for infiltration and peripheral nerve block, provided they are employed as single dose units.
These solutions contain no bacteriostatic agent.
In epidural anesthesia, the dosage varies with the number of dermatomes to be anesthetized (generally 2–3 mL of the indicated concentration per dermatome).
Caudal and Lumbar Epidural Block
As a precaution against the adverse experience sometimes observed following unintentional penetration of the subarachnoid space, a test dose such as 2 to 3 mL of 1.5% lidocaine HCl should be administered at least 5 minutes prior to injecting the total volume required for a lumbar or caudal epidural block. The test dose should be repeated if the patient is moved in a manner that may have displaced the catheter. Epinephrine, if contained in the test dose (10 to 15 mcg have been suggested), may serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Patients on beta blockers may not manifest changes in heart rate, but blood pressure monitoring can detect an evanescent rise in systolic blood pressure. Adequate time should be allowed for onset of anesthesia after administration of each test dose. The rapid injection of a large volume of Xylocaine (lidocaine) Injection through the catheter should be avoided, and, when feasible, fractional doses should be administered.
In the event of the known injection of a large volume of local anesthetic solution into the subarachnoid space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter.
Maximum Recommended Dosages
For normal healthy adults, the individual maximum recommended dose of lidocaine HCl with epinephrine should not exceed 7 mg/kg (3.5 mg/lb) of body weight, and in general it is recommended that the maximum total dose not exceed 500 mg. When used without epinephrine the maximum individual dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight, and in general it is recommended that the maximum total dose does not exceed 300 mg. For continuous epidural or caudal anesthesia, the maximum recommended dosage should not be administered at intervals of less than 90 minutes. When continuous lumbar or caudal epidural anesthesia is used for non-obstetrical procedures, more drug may be administered if required to produce adequate anesthesia.
The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical block in obstetrical patients and non-obstetrical patients is 200 mg total. One half of the total dose is usually administered to each side. Inject slowly, five minutes between sides. (See also discussion of paracervical block in PRECAUTIONS.)
For intravenous regional anesthesia, the dose administered should not exceed 4mg/kg in adults.
It is difficult to recommend a maximum dose of any drug for children, since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's age and weight. For example, in a child of 5 years weighing 50 lbs the dose of lidocaine HCl should not exceed 75–100 mg (1.5 to 2 mg/lb). The use of even more dilute solutions (ie, 0.25 to 0.5%) and total dosages not to exceed 3 mg/kg (1.4 mg/lb) are recommended for induction of intravenous regional anesthesia in children.
In order to guard against systemic toxicity, the lowest effective concentration and lowest effective dose should be used at all times. In some cases it will be necessary to dilute available concentrations with 0.9% sodium chloride injection in order to obtain the required final concentration.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. The Injection is not to be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate.
Table 1: Recommended Dosages
|Procedure||Xylocaine (lidocaine hydrochloride)
Injection (without epinephrine)
|Conc (%)||Vol (mL)||Total Dose (mg)|
|Percutaneous||0.5 or 1||1-60||5-300|
|Peripheral Nerve Blocks, eg|
|Pudendal (each side)||1||10||100|
|Obstetrical analgesia (each side)||1||10||100|
|Sympathetic Nerve Blocks, eg,|
|Cervical (stellate ganglion)||1||5||50|
|Central Neural Blocks Epidural*|
|*Dose determined by number of dermatomes to be anesthetized (2–3 mL/dermatome).|
THE ABOVE SUGGESTED CONCENTRATIONS AND VOLUMES SERVE ONLY AS A GUIDE. OTHER VOLUMES AND CONCENTRATIONS MAY BE USED PROVIDED THE TOTAL MAXIMUM RECOMMENDED DOSE IS NOT EXCEEDED.
Sterilization, Storage and Technical Procedures
Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc) should not be used for skin or mucous membrane disinfection as they have been related to incidents of swelling and edema. When chemical disinfection of multi-dose vials is desired, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. Many commercially available brands of rubbing alcohol, as well as solutions of ethyl alcohol not of USP grade, contain denaturants which are injurious to rubber and therefore are not to be used.
Dosage forms listed as Xylocaine (lidocaine) -MPF indicate single dose solutions that are Methyl Paraben Free (MPF).
|Ampules (mL)||Polyamp DuoFit™(mL)||Single Dose Vials (mL)||Multiple Dose Vials (mL)|
All solutions should be stored at room temperature, approximately 25°C (77°F). Protect from light.
Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173. Revised: February 2010This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/10/2011
Additional Xylocaine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.