Xylocaine

Xylocaine Manufacturers

• Remedyrepack Inc.
  

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  Xylocaine | Remedyrepack Inc.

  

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  Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine 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 is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

  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 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 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 Injection are recommended:

  1% without epinephrine                         10 mL Plastic Ampule

  1% without epinephrine                         30 mL single dose solutions

  1% with epinephrine   1:200,000           30 mL single dose solutions

  1.5% without epinephrine                      10 mL Plastic Ampule

  1.5% without epinephrine                      20 mL Plastic Ampule

  1.5% with epinephrine  1:200,000          30 mL ampules, 30 mL single dose solutions

  2% without epinephrine                         10 mL Plastic Ampule

  2% with epinephrine   1:200,000           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 to 3 mL of the indicated concentration per dermatome).

   

  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 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.

   

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• Cardinal Health
  

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  Xylocaine | Cardinal Health

  

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  Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine 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 is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

  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 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 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.

  Epidural Anesthesia
  

  For epidural anesthesia, only the following dosage forms Xylocaine Injection are recommended:

  1% without epinephrine                         10 mL Plastic Ampule

  1% without epinephrine                         30 mL single dose solutions

  1% with epinephrine   1:200,000           30 mL single dose solutions

  1.5% without epinephrine                      10 mL Plastic Ampule

  1.5% without epinephrine                      20 mL Plastic Ampule

  1.5% with epinephrine  1:200,000         30 mL ampules, 30 mL single dose solutions

  2% without epinephrine                         10 mL Plastic Ampule

  2% with epinephrine   1:200,000           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 to 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 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.

  Epidural Anesthesia
  

  For epidural anesthesia, only the following dosage forms Xylocaine Injection are recommended:

  1% without epinephrine                         10 mL Plastic Ampule

  1% without epinephrine                         30 mL single dose solutions

  1% with epinephrine   1:200,000           30 mL single dose solutions

  1.5% without epinephrine                      10 mL Plastic Ampule

  1.5% without epinephrine                      20 mL Plastic Ampule

  1.5% with epinephrine  1:200,000         30 mL ampules, 30 mL single dose solutions

  2% without epinephrine                         10 mL Plastic Ampule

  2% with epinephrine   1:200,000           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 to 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 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.

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• Astrazeneca Lp
  

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  Xylocaine | Astrazeneca Lp

  

  ---

  Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine 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.

  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 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 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.

  Epidural Anesthesia

  For epidural anesthesia, only the following dosage forms of Xylocaine Injection are recommended:

  1% without epinephrine

  10 mL Polyamp DuoFit™

  1% without epinephrine

  30 mL single dose solutions

  1% with epinephrine 1:200,000

  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

  1:200,000

  30 ml ampules, 30 mL single dose solutions

  2% without epinephrine

  10 mL Polyamp DuoFit™

  2% with epinephrine

  1:200,000

  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 2-3 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, (10-15 µg 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 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.

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• Astrazeneca Lp
  

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  Xylocaine | Astrazeneca Lp

  

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  Adults Single Direct Intravenous Injection (bolus)

  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 5 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 Xylocaine 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 for lidocaine for prolonged periods.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Do not use if solution is discolored or cloudy.

  Pediatric

  Controlled clinical studies in the pediatric population to establish dosing schedules have not been conducted.

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• App Pharmaceuticals, Llc
  

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  Xylocaine | App Pharmaceuticals, Llc

  

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  When Xylocaine 2% Jelly is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.

  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 Xylocaine 2% Jelly 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.

  For Surface Anesthesia of the Male Adult Urethra
  

  When using Xylocaine 2% Jelly 30 mL tubes, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube.  The cone may be gas sterilized or cold sterilized, as preferred.  Slowly instill approximately 15 mL (300 mg of lidocaine HCl) into the urethra or until the patient has a feeling of tension.  A penile clamp is then applied for several minutes at the corona.  An additional dose of not more than 15 mL (300 mg) can be instilled for adequate anesthesia.

  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, smaller volumes of 5 to 10 mL (100 to 200 mg) are usually adequate for lubrication.
  

  For Surface Anesthesia of the Female Adult Urethra
  

  When using Xylocaine 2% Jelly 30 mL tubes, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube.  The cone may be gas sterilized or cold sterilized, as preferred.  Slowly instill 3 to 5 mL (60 to 100 mg of lidocaine HCl) of the jelly into the urethra.  If desired, some jelly may be deposited on a cotton swab and introduced into the urethra.  In order to obtain adequate anesthesia, several minutes should be allowed prior to performing urological procedures.

  Lubrication for Endotracheal Intubation
  

  Apply a moderate amount of jelly to 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.

  For Surface Anesthesia of the Male Adult Urethra
  

  When using Xylocaine 2% Jelly 30 mL tubes, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube.  The cone may be gas sterilized or cold sterilized, as preferred.  Slowly instill approximately 15 mL (300 mg of lidocaine HCl) into the urethra or until the patient has a feeling of tension.  A penile clamp is then applied for several minutes at the corona.  An additional dose of not more than 15 mL (300 mg) can be instilled for adequate anesthesia.

  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, smaller volumes of 5 to 10 mL (100 to 200 mg) are usually adequate for lubrication.
  

  For Surface Anesthesia of the Female Adult Urethra
  

  When using Xylocaine 2% Jelly 30 mL tubes, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube.  The cone may be gas sterilized or cold sterilized, as preferred.  Slowly instill 3 to 5 mL (60 to 100 mg of lidocaine HCl) of the jelly into the urethra.  If desired, some jelly may be deposited on a cotton swab and introduced into the urethra.  In order to obtain adequate anesthesia, several minutes should be allowed prior to performing urological procedures.

  Lubrication for Endotracheal Intubation
  

  Apply a moderate amount of jelly to 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.

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• Rebel Distributors Corp
  

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  Xylocaine | Rebel Distributors Corp

  

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  Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine 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.

  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 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 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.

  Epidural Anesthesia

  For epidural anesthesia, only the following dosage forms of Xylocaine Injection are recommended:

  1% without epinephrine

  10 mL Polyamp DuoFit™

  1% without epinephrine

  30 mL single dose solutions

  1% with epinephrine 1:200,000

  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

  1:200,000

  30 ml ampules, 30 mL single dose solutions

  2% without epinephrine

  10 mL Polyamp DuoFit™

  2% with epinephrine

  1:200,000

  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 2-3 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, (10-15 µg 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 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.

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• General Injectables & Vaccines, Inc
  

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  Xylocaine | General Injectables & Vaccines, Inc

  

  ---

  Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine Injection for various
  types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrinefree
  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 is not approved for this use (see WARNINGS and DOSAGE AND
  ADMINISTRATION).
  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 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 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.
  Epidural Anesthesia
  For epidural anesthesia, only the following dosage forms Xylocaine 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
  1:200,000
  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
  1:200,000
  2% without epinephrine 10 mL Polyamp DuoFit™
  2% with epinephrine 20 mL ampules, 20 mL single dose solutions
  1:200,000
  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 to 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
  page 7 of 27
  “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 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
  Adults
  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 4 mg/kg in adults.
  Children
  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 to 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
  

  
  Xylocaine (lidocaine hydrochloride) Injection (without epinephrine)
  
  
  
  Conc (%)
  Vol (mL)
  Total Dose (mg)
  Procedure Infiltration
  
  
  
  Percutaneous
  0.5 or 1
  1 to 60
  5 to 300
  Intravenous regional
  0.5
  10 to 60
  50 to 300
  Peripheral Nerve Blocks, eg,
  
  
  
  Brachial
  1.5
  15 to 20
  225 to 300
  Dental
  2
  1 to 5
  20 to 100
  Intercostal
  1
  3
  30
  Paravertebral
  1
  3
  30
  Pudendal (each side)
  1
  10
  100
  Paracervical
  
  
  
  Obstetrical analgesia
  
  
  
  (each side)
  1
  10
  100
  Sympathetic Nerve Blocks, eg,
  
  
  
  Cervical (stellate ganglion)
  1
  5
  50
  Lumbar
  1
  50 to 10
  50 to 100
  Central Neural Blocks
  
  
  
  Epidural*
  
  
  
  Thoracic
  1
  20 to 30
  200 to 300
  Lumbar
  
  
  
  Analgesia
  1
  25 to 30
  250 to 300
  Anesthesia
  1.5
  15 to 20
  225 to 300
  
  2
  10 to 15
  200 to 300
  Caudal
  
  
  
  Obstetrical analgesia
  1
  20 to 30
  200 to 300
  Surgical anesthesia
  1.5
  15 to 20
  225 to 300
  

  
  *Dose determined by number of dermatomes to be anesthetized (2 to 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.

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  ---

  Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine Injection for various
  types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrinefree
  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 is not approved for this use (see WARNINGS and DOSAGE AND
  ADMINISTRATION).
  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 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 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.
  Epidural Anesthesia
  For epidural anesthesia, only the following dosage forms Xylocaine 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
  1:200,000
  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
  1:200,000
  2% without epinephrine 10 mL Polyamp DuoFit™
  2% with epinephrine 20 mL ampules, 20 mL single dose solutions
  1:200,000
  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 to 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 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
  Adults
  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 4 mg/kg in adults.
  Children
  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 to 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)
  Infiltration
  
  
  
  Percutaneous
  0.5 or 1
  1 to 60
  5 to 300
  Intravenous regional
  0.5
  10 to 60
  50 to 300
  Peripheral Nerve Blocks, eg,
  
  
  
  Brachial
  1.5
  15 to 20
  225 to 300
  Dental
  2
  1 to 5
  20 to 100
  Intercostal
  1
  3
  30
  Paravertevral
  1
  3 to 5
  30 to 50
  Pudendal (each side)
  1
  10
  100
  Paracervical
  
   
  
  Obstetrical
  
  
  
  (each side)
  1
  10
  100
  Sympathetic Nerve Blocks, eg,
  
  
  
  Cervical (stellate ganglion)
  1
  5
  50
  Lumbar
  1
  5 to 10
  50 to 100
  Central Neural Blocks
  
  
  
  Epidural*
  
  
  
  Thoracic
  1
  20 to 30
  200 to 300
  Lumbar
  
  
  
  Analgesia
  1
  25 to 30
  250 to 300
  Anesthesia
  1.5
  15 to 20
  225 to 300
  
  2
  10 to 15
  200 to 300
  Caudal
  
  
  
  Obstetrical analgesia
  1
  20 to 30
  200 to 300
  Surgical anesthesia
  1.5
  15 to 20
  225 to 300
  
  
  
  
  
  *Dose determined by number of dermatomes to be anesthetized (2 to 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.

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  Xylocaine | General Injectables & Vaccines, Inc

  

  ---

  Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine 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 is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

  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 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 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.

  Epidural Anesthesia
  

  For epidural anesthesia, only the following dosage forms Xylocaine 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

  1:200,000

  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

  1:200,000

  2% without epinephrine 10 mL Polyamp DuoFit™

  2% with epinephrine 20 mL ampules, 20 mL single dose solutions

  1:200,000

  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 to 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 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
  Adults

  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 4 mg/kg in adults.

  Children

  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 to 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)

  Infiltration

  
  
  
  

  Percutaneous

  0.5 or 1

  1 to 60

  5 to 300

  Intravenous regional

  0.5

  10 to 60

  50 to 300

  Peripheral Nerve Blocks, eg,

  
  
  
  

  Brachial

  1.5

  15 to 20

  225 to 300

  Dental

  2

  1 to 5

  20 to 100

  Intercostal

  1

  3

  30

  Paravertebral

  1

  3 to 5

  30 to 50

  Pudendal (each side)

  1

  10

  100

  Paracervical

  
  
  
  

  Obstetrical analgesia

  
  
  
  

  (each side)

  1

  10

  100

  Sympathetic Nerve Blocks, eg,

  
  
  
  

  Cervical (stellate ganglion)

  1

  5

  50

  Lumbar

  1

  5 to 10

  50 to 100

  Central Neural Blocks

  
  
  
  

  Epidural*

  
  
  
  

  Thoracic

  1

  20 to 30

  200 to 300

  Lumbar

  
  
  
  

  Analgesia

  1

  25 to 30

  250 to 300

  Anesthesia

  1.5

  15 to 20

  225 to 300

  
  

  2

  10 to 15

  200 to 300

  Caudal

  
  
  
  

  Obstetrical analgesia

  1

  20 to 30

  200 to 300

  Surgical anesthesia

  1.5

  15 to 20

  225 to 300

  *Dose determined by number of dermatomes to be anesthetized (2 to 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-MPF indicate single dose solutions that are Methyl Paraben Free (MPF).

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  ---

  Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine Injection for various
  types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrinefree
  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 is not approved for this use (see WARNINGS and DOSAGE AND
  ADMINISTRATION).
  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 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 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.
  Epidural Anesthesia
  For epidural anesthesia, only the following dosage forms Xylocaine 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
  1:200,000
  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
  1:200,000
  2% without epinephrine 10 mL Polyamp DuoFit™
  2% with epinephrine 20 mL ampules, 20 mL single dose solutions
  1:200,000
  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 to 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 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
  Adults
  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 4 mg/kg in adults.
  Children
  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 to 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)
  Infiltration
  
  
  
  Percutaneous
  0.5 or 1
  1 to 60
  5 to 300
  Intravenous regional
  0.5
  10 to 60
  50 to 300
  Peripheral Nerve Blocks, eg,
  
  
  
  Brachial
  1.5
  15 to 20
  225 to 300
  Dental
  2
  1 to 5
  20 to 100
  Intercostal
  1
  3
  30
  Paravertebral
  1
  3 to 5
  30 to 50
  Prudendal (each side)
  1
  10
  100
  Paracervical
  
  
  
  Obstetrical analgesia
  
  
  
  (each side)
  1
  10
  100
  Sympathetic Nerve Blocks, eg,
  
  
  
  Cervical (stellate ganglion)
  1
  5
  50
  Lumbar
  1
  5 to 10
  50 to 100
  Central Neural Blocks
  
  
  
  Epidural*
  
  
  
  Thoracic
  1
  20 to 30
  200 to 300
  Lumbar
  
  
  
  Analgesia
  1
  25 to 30
  250 to 300
  Anesthesia
  1.5
  15 to 20
  225 to 300
  
  2
  10 to 15
  200 to 300
  Caudal
  
  
  
  Obstetrical analgesia
  1
  20 to 30
  200 to 300
  Surgical anesthesia
  1.5
  15 to 20
  225 to 300
  
  *Dose determined by number of dermatomes to be anesthetized (2 to 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.
  

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  Xylocaine | General Injectables & Vaccines, Inc

  

  ---

  Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine Injection for various
  types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrinefree
  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 is not approved for this use (see WARNINGS and DOSAGE AND
  ADMINISTRATION).
  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 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 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.
  Epidural Anesthesia
  For epidural anesthesia, only the following dosage forms Xylocaine 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
  1:200,000
  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
  1:200,000
  2% without epinephrine 10 mL Polyamp DuoFit™
  2% with epinephrine 20 mL ampules, 20 mL single dose solutions
  1:200,000
  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 to 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 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
  Adults
  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 4 mg/kg in adults.
  Children
  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 to 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)
  Infiltration
  
  
  
  Percutaneous
  0.5 or 1
  1 to 60
  5 to 300
  Intravenous regional
  0.5
  10 to 60
  50 to 300
  Peripheral Nerve Blocks, eg,
  
  
  
  Brachial
  1.5
  15 to 20
  225 to 300
  Dental
  2
  1 to 5
  20 to 100
  Intercostal
  1
  3
  30
  Paravertebral
  1
  3 to 5
  30 to 50
  Pudendal (each side)
  1
  10
  100
  Paracervical
  
  
  
  Obstetrical analgesia
  
  
  
  (each side)
  1
  10
  100
  Sympathetic Nerve Blocks, eg,
  
  
  
  Cervical (stellate ganglion)
  1
  5
  50
  Lumbar
  1
  5 to 10
  50 to 100
  Central Neural Blocks
  
  
  
  Epidural*
  
  
  
  Thoracic
  1
  20 to 30
  200 to 300
  Lumbar
  
  
  
  Analgesia
  1
  25 to 30
  250 to 300
  Anesthesia
  1.5
  15 to 20
  225 to 300
  
  2
  10 to 15
  200 to 300
  Caudal
  
  
  
  Obstetrical analgesia
  1
  20 to 30
  200 to 300
  Surgical anesthesia
  1.5
  15 to 20
  225 to 300
  
  
  
  
  *Dose determined by number of dermatomes to be anesthetized (2 to 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-MPF indicate single dose solutions that are Methyl Paraben Free (MPF).
  

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  Xylocaine | General Injectables & Vaccines, Inc

  

  ---

  Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine Injection for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrinefree 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 is not approved for this use (see WARNINGS and DOSAGE AND
  ADMINISTRATION).
  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 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 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.
  Epidural Anesthesia
  For epidural anesthesia, only the following dosage forms Xylocaine 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
  1:200,000
  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
  1:200,000
  2% without epinephrine 10 mL Polyamp DuoFit™
  2% with epinephrine 20 mL ampules, 20 mL single dose solutions
  1:200,000
  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 to 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 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
  Adults
  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 4 mg/kg in adults.
  Children
  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 to 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)
  Infiltration
  
  
  
  Percutaneous
  0.5 or 1
  1 to 60
  5 to 300
  Intravenous regional
  0.5
  10 to 60
  50 to 300
  Peripheral Nerve Blocks, eg,
  
  
  
  Brachial
  1.5
  15 to 20
  225 to 300
  Dental
  2
  1 to 5
  20 to 100
  Intercostal
  1
  3
  30
  Paravertebral
  1
  3 to 5
  30 to 50
  Pudendal
  1
  10
  100
  Paracervical
  
  
  
  Obstetrical analgesia
  
  
  
  (each side)
  1
  10
  100
  Sympathetic Nerve Blocks, eg,
  
  
  
  Cervical (stellate ganglion)
  1
  5
  50
  Lumbar
  1
  5 to 10
  50 to 100
  Central Neural Blocks
  
  
  
  Epidural*
  
  
  
  Thoracic
  1
  20 to 30
  200 to 300
  Lumbar
  
  
  
  Analgesia
  1
  25 to 30
  250 to 300
  Anesthesia
  1.5
  15 to 20
  225 to 300
  
  2
  10 to 15
  200 to 300
  Caudal
  
  
  
  Obstetrical analgesia
  1
  20 to 30
  200 to 300
  Surgical anesthesia
  1.5
  15 to 20
  225 to 300
  *Dose determined by number of dermatomes to be anesthetized (2 to 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-MPF indicate single dose solutions that are Methyl Paraben Free (MPF).
  

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  Xylocaine | General Injectables & Vaccines, Inc

  

  ---

  Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine Injection for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrinefree 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 is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).
  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 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 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.
  Epidural Anesthesia
  For epidural anesthesia, only the following dosage forms Xylocaine 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
  1:200,000
  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
  1:200,000
  2% without epinephrine 10 mL Polyamp DuoFit™
  2% with epinephrine 20 mL ampules, 20 mL single dose solutions
  1:200,000
  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 to 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 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
  Adults
  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 4 mg/kg in adults.
  Children
  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 to 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)
  Infiltration
  
  
  
  Percutaneous
  0.5 or 1
  1 to 60
  5 to 300
  Intravenous regional
  0.5
  10 to 60
  50 to 300
  Peripheral Nerve Blocks, eg,
  
  
  
  Brachial
  1.5
  15 to 20
  225 to 300
  Dental
  2
  1 to 5
  20 to 100
  Intercostal
  1
  3
  30
  Paravertebral
  1
  3 to 5
  30 to 50
  Prudental
  1
  10
  100
  Paracervical
  
  
  
  Obstetrical analgesia
  
  
  
  (each side)
  1
  10
  100
  Sympathetic Nerve Blocks, eg,
  
  
  
  Cervical (stellate ganglion)
  1
  5
  50
  Lumbar
  1
  5 to 10
  50 to 100
  Central Neural Blocks
  
  
  
  Epidural*
  
  
  
  Thoracic
  1
  20 to 30
  200 to 300
  Lumbar
  
  
  
  Analgesia
  1
  25 to 30
  250 to 300
  Anesthesia
  1.5
  15 to 20
  225 to 300
  
  2
  10 to 15
  200 to 300
  Caudal
  
  
  
  Obstetrical analgesia
  1
  20 to 30
  200 to 300
  Surgical anesthesia
  1.5
  15 to 20
  225 to 300
  *Dose determined by number of dermatomes to be anesthetized (2 to 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.
  

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  ---

  Adults

  Single Direct Intravenous Injection (bolus)

  The usual dose is 50 to 100 mg of lidocaine hydrochloride (0.7 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 0.7 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 5 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 Xylocaine 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.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.  Do not use if solution is discolored or cloudy.

  Pediatric

  Controlled clinical studies in the pediatric population to establish dosing schedules have not been conducted.

  Geriatric

  In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

  Adults

  Single Direct Intravenous Injection (bolus)

  The usual dose is 50 to 100 mg of lidocaine hydrochloride (0.7 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 0.7 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 5 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 Xylocaine 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.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.  Do not use if solution is discolored or cloudy.

  Pediatric

  Controlled clinical studies in the pediatric population to establish dosing schedules have not been conducted.

  Geriatric

  In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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• Physicians Total Care, Inc.
  

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  Xylocaine | Physicians Total Care, Inc.

  

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  Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine 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 is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

  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 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 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.

  Epidural Anesthesia
  

  For epidural anesthesia, only the following dosage forms Xylocaine 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

      1:200,000

  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

      1:200,000

  2% without epinephrine                       10 mL Polyamp DuoFit™

  2% with epinephrine                            20 mL ampules, 20 mL single dose solutions

      1:200,000

  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 to 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 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.

  Epidural Anesthesia
  

  For epidural anesthesia, only the following dosage forms Xylocaine 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

      1:200,000

  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

      1:200,000

  2% without epinephrine                       10 mL Polyamp DuoFit™

  2% with epinephrine                            20 mL ampules, 20 mL single dose solutions

      1:200,000

  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 to 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 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.

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• Oak Pharmaceuticals, Inc. (Subsidiary Of Akorn, Inc.)
  

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  Xylocaine | Oak Pharmaceuticals, Inc. (subsidiary Of Akorn, Inc.)

  

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  When Xylocaine 2% Jelly is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.

  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 Xylocaine 2% Jelly 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.

  For Surface Anesthesia of the Male Adult Urethra

  When using Xylocaine 2% Jelly 30 mL tubes, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube. The cone may be gas sterilized or cold sterilized, as preferred. Slowly instill approximately 15 mL (300 mg of lidocaine HCl) into the urethra or until the patient has a feeling of tension. A penile clamp is then applied for several minutes at the corona. An additional dose of not more than 15 mL (300 mg) can be instilled for adequate anesthesia.

  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, smaller volumes of 5 to 10 mL (100 to 200 mg) are usually adequate for lubrication.

  For Surface Anesthesia of the Female Adult Urethra

  When using Xylocaine 2% Jelly 30 mL tubes, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube. The cone may be gas sterilized or cold sterilized, as preferred. Slowly instill 3 to 5 mL (60 to 100 mg of lidocaine HCl) of the jelly into the urethra. If desired, some jelly may be deposited on a cotton swab and introduced into the urethra. In order to obtain adequate anesthesia, several minutes should be allowed prior to performing urological procedures.

  Lubrication for Endotracheal Intubation

  Apply a moderate amount of jelly to 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.

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• Cardinal Health
  

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  Xylocaine | Cardinal Health

  

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  When Xylocaine 2% Jelly is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.

  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 Xylocaine 2% Jelly 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.

  For Surface Anesthesia of the Male Adult Urethra:

  When using Xylocaine 2% Jelly 30 mL tubes, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube. The cone may be gas sterilized or cold sterilized, as preferred. Slowly instill approximately 15 mL (300 mg of lidocaine HCl) into the urethra or until the patient has a feeling of tension. A penile clamp is then applied for several minutes at the corona. An additional dose of not more than 15 mL (300 mg) can be instilled for adequate anesthesia.

  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, smaller volumes of 5-10 mL (100-200 mg) are usually adequate for lubrication.

  For Surface Anesthesia of the Female Adult Urethra:

  When using Xylocaine 2% Jelly 30 mL tubes, sterilize the plastic cone for 5 minutes in boiling water, cool, and attach to the tube. The cone may be gas sterilized or cold sterilized, as preferred. Slowly instill 3−5 mL (60−100 mg of lidocaine HCl) of the jelly into the urethra. If desired, some jelly may be deposited on a cotton swab and introduced into the urethra. In order to obtain adequate anesthesia, several minutes should be allowed prior to performing urological procedures.

  Lubrication for Endotracheal Intubation:

  Apply a moderate amount of jelly to 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.

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• General Injectables & Vaccines, Inc
  

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  Xylocaine | General Injectables & Vaccines, Inc

  

  ---

  Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine Injection for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrinefree 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 is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).
  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 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 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.
  Epidural Anesthesia
  For epidural anesthesia, only the following dosage forms Xylocaine 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
  1:200,000
  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
  1:200,000
  2% without epinephrine 10 mL Polyamp DuoFit™
  2% with epinephrine 20 mL ampules, 20 mL single dose solutions
  1:200,000
  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 to 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 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
  Adults
  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 4 mg/kg in adults.
  Children
  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 to 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) Infiltration Percutaneous 0.5 or 1 1 to 60 5 to 300 Intravenous regional 0.5 10 to 60 50 to 300 Peripheral Nerve Blocks, eg, Brachial 1.5 15 to 20 225 to 300 Dental 2 1 to 5 20 to 100 Intercostal 1 3 30 Paravertebral 1 3 to 5 30 to 50 Pudendal (each side) 1 10 100 Paracervical Obstetrical analgesia (each side) 1 10 100 Sympathetic Nerve Blocks, eg, Cervical (stellate ganglion) 1 5 50 Lumbar 1 5 to 10 50 to 100 Central Neural Blocks Epidural* Thoracic 1 20 to 30 200 to 300 Lumbar Analgesia 1 25 to 30 250 to 300 Anesthesia 1.5 15 to 20 225 to 300 2 10 to 15 200 to 300 Caudal Obstetrical analgesia 1 20 to 30 200 to 300 Surgical anesthesia 1.5 15 to 20 225 to 300

  *Dose determined by number of dermatomes to be anesthetized (2 to 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-MPF indicate single dose solutions that are Methyl Paraben Free (MPF).

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  Xylocaine | Cantrell Drug Company

  

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  FOR SLOW INTRAVENOUS USE. PRESERVATIVE FREE INJECTION SOLUTION.

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• Dentsply Pharmaceutical
  

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  Xylocaine | Dentsply Pharmaceutical

  

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  The dosage of 2% Xylocaine DENTAL solutions (lidocaine HCl and epinephrine) depends on the physical status of the patient, the area of the oral cavity to be anesthetized, the vascularity of the oral tissues, and the technique of anesthesia used. The least volume of solution that results in effective local anesthesia should be administered; time should be allowed between injections to observe the patient for manifestations of an adverse reaction. For specific techniques and procedures of a local anesthesia in the oral cavity, refer to standard textbooks.

  For most routine dental procedures, 2% Xylocaine DENTAL with epinephrine 1:100,000 (lidocaine HCl 2% with a 1:100,000 epinephrine concentration) is preferred. However, when greater depth and a more pronounced hemostasis are required, 2% Xylocaine DENTAL with epinephrine 1:50,000 (lidocaine HCl 2 % with 1:50,000 epinephrine concentration) should be used.

  Dosage requirements should be determined on an individual basis. In oral infiltration and / or mandibular block, initial dosages of 1.0 - 5.0 mL (1/2 to 21⁄2 cartridges) of 2% Xylocaine DENTAL (lidocaine HCl 2% solutions with a 1:50,000 or a 1:100,000 epinephrine concentration) are usually effective.

  In children under 10 years of age, it is rarely necessary to administer more than one-half cartridge (0.9-1.0 mL or 18-20 mg of lidocaine) per procedure to achieve local anesthesia for a procedure involving a single tooth. In maxillary infiltration, this amount will often suffice to the treatment of two or even three teeth. In the mandibular block, however, satisfactory anesthesia achieved with this amount of drug, will allow treatment of the teeth of an entire quadrant. Aspiration is recommended since it reduces the possibility of intravascular injection, thereby keeping the incidence of side effects and anesthetic failures to a minimum. Moreover, injection should always be made slowly.

  Maximum recommended dosages for 2% Xylocaine DENTAL (lidocaine HCl 2% solutions with a 1:50,000 or a 1:100,000 epinephrine concentration).

  Adult

  For normal healthy adults, the amount of lidocaine HCl administered should be kept below 500 mg, and in any case, should not exceed 7 mg/kg (3.2 mg/lb) of body weight.

  Pediatric

  Pediatric patients : It is difficult to recommend a maximum dose of any drug for pediatric patients since this varies as a function of age and weight. For pediatric patients of less than ten years who have a normal lean body mass and normal 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, in pediatric patients of five years weighing 50 Ibs, the dose of lidocaine hydrochloride should not exceed 75-100mg when calculated according to Clark's rule. In any case, the maximum dose of lidocaine hydrochloride should not exceed 7 mg/kg (3.2 mg/lb) of body weight.

  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 and any unused portion of a cartridge of 2% Xylocaine DENTAL should be discarded.

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