Lidocaine and tetracaine (topical application route)

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lidocaine and tetracaine combination in children 3 years of age and older. Safety and efficacy have not been established in children younger than 3 years of age.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lidocaine and tetracaine combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dronedarone
• Saquinavir
• Vernakalant

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Amiodarone
• Amprenavir
• Arbutamine
• Bupivacaine Liposome
• Bupropion
• Cobicistat
• Darunavir
• Dasabuvir
• Delavirdine
• Disopyramide
• Donepezil
• Encainide
• Etravirine
• Flecainide
• Fosamprenavir
• Fosphenytoin
• Hyaluronidase
• Lopinavir
• Metoprolol
• Mexiletine
• Moricizine
• Nadolol
• Phenytoin
• Procainamide
• Propafenone
• Quinidine
• Sotalol
• Succinylcholine
• Telaprevir
• Tocainide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cimetidine

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Glucose-6-phosphate dehydrogenase deficiency (G6PD) or
• Heart problems or
• Lung or breathing problems or
• Methemoglobinemia (blood disorder), hereditary or idiopathic (unknown cause)—Use with caution. May increase risk of having methemoglobinemia.

• Infection at or near the place of application or
• Large sores, broken skin, or severe injury at the area of application—Use with caution. The chance of side effects may be increased.

• Liver disease, severe or
• Pseudocholinesterase deficiency (enzyme problem)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

More common

• Flushing or redness of the skin
• swelling
• unusually warm skin

Less common

• Blistering, burning, crusting, dryness, or flaking of the skin
• change in the color of treated skin
• itching, scaling, severe redness, soreness, or swelling of the skin
• rash

Rare

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• cough
• fainting or loss of consciousness
• fast or irregular breathing
• fever
• hives or welts
• hoarseness
• lower back or side pain
• painful or difficult urination
• swelling of the eyes or eyelids
• tightness in the chest
• trouble with breathing

Incidence not known

• Blurred vision
• chest pain or discomfort
• cold, clammy, or pale skin
• confusion
• difficulty with breathing
• difficulty with swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, slow, or irregular heartbeat
• feelings of coldness, heat, or numbness
• irregular, fast or slow, or shallow breathing
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• no breathing
• noisy breathing
• pale or blue lips, fingernails, or skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• shakiness in the legs, arms, hands, or feet
• slow heart rate
• sweating
• trembling or shaking of the hands or feet
• twitching
• unusual tiredness or weakness

Symptoms of overdose

• Change in consciousness
• fast, pounding, or irregular heartbeat or pulse
• no blood pressure or pulse
• stopping of the heart

Rare

• Headache
• nausea
• sleepiness or unusual drowsiness
• vomiting

Incidence not known

• Continuing ringing or buzzing or other unexplained noise in the ears
• depression
• double vision
• drowsiness
• false or unusual sense of well-being
• fear
• hearing loss
• nervousness