Xylocaine

Lidocaine has not been adequately studied in pregnant women. Studies in animals have not shown evidence of harm to the fetus.

It is not known whether lidocaine is excreted in breast milk.

Injectable Solution: 0.5%, 1%, 1.5%, 2%, 4%, and 5%; 200, 400 and 800 mg/100 mL

All solutions should be stored at room temperature, 25 C (77 F) and protected from light.

Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection.

See INDICATIONS for specific uses.

Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8.

Lidocaine HCl (C14H22N2O•HCl) has the following structural formula:

Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol and has the molecular wt. 183.21. Epinephrine (C9H13NO3) has the following structural formula:

Dosage forms listed as Xylocaine (lidocaine) -MPF indicate single dose solutions that are Methyl Paraben Free (MPF).

Xylocaine (lidocaine) MPF is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Xylocaine (lidocaine) in multiple dose vials: Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to approximately 6.5 (5.0–7.0) with sodium hydroxide and/or hydrochloric acid.

Xylocaine (lidocaine) MPF with Epinephrine is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer. Xylocaine (lidocaine) with Epinephrine in multiple dose vials: Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to approximately 4.5 (3.3–5.5) with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen.

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution (See ADVERSE REACTIONS, WARNINGS and PRECAUTIONS).

Management Of Local Anesthetic Emergencies

The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should be administered.

The first step in the management of convulsions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask.

Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of clrculatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation (e.g., ephedrine).

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted. Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated.

Dialysis is of negligible value in the treatment of acute overdosage with lidocaine.

The intravenous LD50 of lidocaine HCl in female mice is 26 (21-31) mg/kg and the subcutaneous LD50 is 264 (203-304) mg /kg.

Lidocaine can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after using this medication

Avoid eating or chewing within 1 hour after lidocaine injection is used to numb your mouth or throat. You may have trouble swallowing which could lead to choking. You may also accidentally bite the inside of your mouth if you are still numb an hour after treatment with lidocaine injection.

Systemic

Adverse experiences following the administration of lidocaine HCl are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption or inadvertent intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported:

Central Nervous System

CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.

Drowsiness following the administration of lidocaine HCl is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.

Cardiovascular System

Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.

Allergic

Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to local anesthetic agents or to the methylparaben used as a preservative in the multiple dose vials. Allergic reactions as result of sensitivity to lidocaine HCl are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

Neurologic

The incidences of adverse reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration and the physical status of the patient. In a prospective review of 10,440 patients who received lidocaine HCl for spinal anesthesia, the incidences of adverse reactions were reported to be about 3 percent each for positional headaches, hypotension and backache; 2 percent for shivering; and less than 1 percent each for peripheral nerve symptoms, nausea, respiratory inadequacy and double vision. Many of these observations may be related to local anesthetic techniques, with or without a contribution from the local anesthetic.

In the practice of caudal or lumbar epidural block, occasional unintentional penetration of the subarachnoid space by the catheter may occur. Subsequent adverse effects may depend partially on the amount of drug administered subdurally. These may include spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel control, and loss of perineal sensation and sexual function. Persistent motor, sensory and/or autonomic (sphincter control) deficit of some lower spinal segments with slow recovery (several months) or incomplete recovery have been reported in rare instances when caudal or lumbar epidural block has been attempted. Backache and headache have also been noted following use of these anesthetic procedures.

There have been reported cases of permanent injury to extraocular muscles requiring surgical repair following retrobulbar administration.

Read the entire FDA prescribing information for Xylocaine (Lidocaine)

Topical:

Xylocaine is a prescription medication used to prevent pain before procedures or to relieve pain due to certain conditions.  Xylocaine jelly and solution can be used to prevent and control pain during procedures, such as intubation and eye surgery, and relieve pain due to conditions such as inflammation of the urethra and sore throat. 

Injectable:

Injectable Xylocaine is used as an anesthetic during surgical procedures or to treat arrhythmias. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Xylocaine. See the “Xylocaine Precautions” section.

Topical:

Common side effects of topical Xylocaine include:

• irritation at site of application
• including burning
• blisters
• bruising
• redness
• swelling at the site of application

The oral solution may also cause vomiting, seizures, ringing in the ears, and irregular heartbeat. 

Injectable:

Common side effects of injectable Xylocaine include:

• confusion
• nervousness
• numbness
• blurred vision
• irregular heartbeat
• vomiting
• seizures
• ringing in the ears
• headache
• shivering
• dizziness
• drowsiness

This is not a complete list of Xylocaine side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Xylocaine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Xylocaine or to any of its ingredients
• are allergic to other local anesthetics, including bupivacaine (Marcaine), etidocaine (Duranest), mepivacaine (Carbocaine, Prolocaine), or prilocaine (Citanest)
• have Stokes-Adams syndrome or Wolff-Parkinson-White syndrome
• have sinoatrial, atrioventricular, or intraventricular block
• have or have had liver disease
• are having surgery, including dental surgery
• are pregnant or breastfeeding

Systemic
Adverse experiences following the administration of lidocaine HCl are similar in nature to those observed with other amide local
anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive
dosage, rapid absorption or inadvertent intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished
tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most
commonly reported:
Central Nervous System
CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension,
euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness,
twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very
brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and
respiratory arrest.
Drowsiness following the administration of lidocaine HCl is usually an early sign of a high blood level of the drug and may occur as a
consequence of rapid absorption.
Cardiovascular System
Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse,
which may lead to cardiac arrest.
Allergic
Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur
as a result of sensitivity either to local anesthetic agents or to the methylparaben used as a preservative in the multiple dose vials.
Allergic reactions as result of sensitivity to lidocaine HCl are extremely rare and, if they occur, should be managed by conventional
means. The detection of sensitivity by skin testing is of doubtful value.
Neurologic
The incidences of adverse reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic
administered and are also dependent upon the particular drug used, the route of administration and the physical status of the patient.
In a prospective review of 10,440 patients who received lidocaine HCl for spinal anesthesia, the incidences of adverse reactions
were reported to be about 3 percent each for positional headaches, hypotension and backache; 2 percent for shivering; and less than 1
percent each for peripheral nerve symptoms, nausea, respiratory inadequacy and double vision. Many of these observations may be
related to local anesthetic techniques, with or without a contribution from the local anesthetic.
In the practice of caudal or lumbar epidural block, occasional unintentional penetration of the subarachnoid space by the catheter
may occur. Subsequent adverse effects may depend partially on the amount of drug administered subdurally. These may include
spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel
control, and loss of perineal sensation and sexual function. Persistent motor, sensory and/or autonomic (sphincter control) deficit of
some lower spinal segments with slow recovery (several months) or incomplete recovery have been reported in rare instances when
caudal or lumbar epidural block has been attempted. Backache and headache have also been noted following use of these anesthetic
procedures.
There have been reported cases of permanent injury to extraocular muscles requiring surgical repair following retrobulbar
administration.