LidoRx

Lidocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Lidocaine topical (for use on the skin) is used to reduce pain or discomfort caused by skin irritations such as sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches, or burns. Lidocaine topical is also used to treat rectal discomfort caused by hemorrhoids.

Lidocaine topical may also be used for purposes not listed in this medication guide.

An overdose of numbing medicine can cause fatal side effects if too much of the medicine is absorbed through your skin.

Do not use large amounts of lidocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice.

Keep both used and unused lidocaine skin patches out of the reach of children or pets. The amount of lidocaine in the skin patches could be harmful to a child or pet who accidentally sucks on or swallows the patch.

You should not use lidocaine topical if you are allergic to any type of numbing medicine.

Fatal overdoses have occurred when numbing medicines were used without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). However, overdose has also occurred in women treated with a numbing medicine before having a mammography.

Be aware that many cosmetic procedures are performed without a medical doctor present.

To make sure lidocaine topical is safe for you, tell your doctor if you have:

• liver disease; or
• if you take a heart rhythm medicine.

Lidocaine topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether lidocaine topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not allow this medicine to come into contact with your eyes. If it does, rinse with water.

Avoid touching the sticky side of a lidocaine skin patch while applying it.

Avoid accidentally injuring treated skin areas while they are numb. Avoid coming into contact with very hot or very cold surfaces.

It is not likely that other drugs you take orally or inject will have an effect on topically applied lidocaine. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Lidocaine Ointment 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx.

It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.

EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS, PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT.

THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS.

Lidocaine Ointment 5% should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption.

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. (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 administration. 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 circulatory 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.

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

The oral LD 50 of lidocaine HCl in non-fasted female rats is 459 (346-773) mg/kg (as the salt) and 214 (159-324) mg/kg (as the salt) in fasted female rats.

When Lidocaine Ointment 5% is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.

Adult

A single application should not exceed 5 g of Lidocaine Ointment 5%, containing 250 mg of lidocaine base (equivalent chemically to approximately 300 mg of lidocaine hydrochloride). This is roughly equivalent to squeezing a six (6) inch length of ointment from the tube. In a 70 kg adult this dose equals 3.6 mg/kg (1.6 mg/lb) lidocaine base. No more than one-half tube or one-third of a jar, approximately 17-20 g of ointment or 850-1000 mg lidocaine base should be administered in any one day.

Although the incidence of adverse effects with Lidocaine Ointment 5% 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.

When Lidocaine Ointment 5% is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.

Adult

A single application should not exceed 5 g of Lidocaine Ointment 5%, containing 250 mg of lidocaine base (equivalent chemically to approximately 300 mg of lidocaine hydrochloride). This is roughly equivalent to squeezing a six (6) inch length of ointment from the tube. In a 70 kg adult this dose equals 3.6 mg/kg (1.6 mg/lb) lidocaine base. No more than one-half tube or one-third of a jar, approximately 17-20 g of ointment or 850-1000 mg lidocaine base should be administered in any one day.

Although the incidence of adverse effects with Lidocaine Ointment 5% 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.

Lidocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Lidocaine topical (for use on the skin) is used to reduce pain or discomfort caused by skin irritations such as sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches, or burns. Lidocaine topical is also used to treat rectal discomfort caused by hemorrhoids.

Lidocaine topical may also be used for purposes not listed in this medication guide.

You should not use lidocaine topical if you are allergic to any type of numbing medicine.

Fatal overdoses have occurred when numbing medicines were used without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). However, overdose has also occurred in women treated with a numbing medicine before having a mammography.

Be aware that many cosmetic procedures are performed without a medical doctor present.

To make sure lidocaine topical is safe for you, tell your doctor if you have:

• liver disease; or

• if you take a heart rhythm medicine.

Lidocaine topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether lidocaine topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Use this medicine exactly as directed on the label, or as it has been prescribed by your doctor. Do not apply this medicine in larger amounts than recommended.

Improper use of lidocaine topical may result in death.

Lidocaine topical comes in many different forms (gel, spray, cream, lotion, ointment, liquid, skin patch).

Do not take by mouth. Lidocaine topical is for use only on the skin. If this medicine gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Your body may absorb too much of this medicine if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Do not apply this medicine to swollen skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Do not cover treated skin unless your doctor has told you to.

Lidocaine topical may be applied with your finger tips or a cotton swab.

If your medicine comes with patient instructions for safe and effective use, follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Store at room temperature away from moisture and heat.

Keep both used and unused lidocaine topical skin patches out of the reach of children or pets. The amount of lidocaine in the skin patches could be harmful to a child or pet who accidentally sucks on or swallows the patch. Seek emergency medical attention if this happens.