Lidocaine and prilocaine Topical

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For lidocaine and prilocaine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to lidocaine and prilocaine 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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lidocaine and prilocaine topical cream in children. However, because of lidocaine and prilocaine's toxicity, it should be used with caution, after other medicines have been considered or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lidocaine and prilocaine topical cream in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving lidocaine and prilocaine topical cream.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

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 lidocaine and prilocaine, 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 lidocaine and prilocaine 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.

• Acecainide
• Amiodarone
• Bretylium
• Dofetilide
• Ibutilide
• Sotalol

Interactions with Food/Tobacco/Alcohol

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.

Other Medical Problems

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

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency, history of or
• Heart disease or
• Heart rhythm problems or
• Infection at or near the place of application or
• Large sores, broken skin, or severe injury at the area of application—May cause side effects to become worse.

• Methemoglobinemia (blood disorder), history of—Should not use in patients with this condition.

• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Lidocaine and prilocaine are local anesthetics (numbing medicines). They work by blocking nerve signals in your body.

Lidocaine and prilocaine topical (for the skin) is a combination medicine used to numb the skin or surfaces of the penis or vagina. This medicine is used to prepare you for minor surgery or medical procedures on these areas.

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

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe burning, stinging, or irritation where the medicine was applied;

• swelling or redness;

• sudden dizziness or drowsiness after medicine is applied;

• confusion, blurred vision, ringing in your ears;

• bruising or purple appearance of the skin; or

• unusual sensations of temperature.

Common side effects may include:

• mild burning where the medicine is applied;

• itching, rash; or

• changes in skin color where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Anesthesia:

Venipuncture and intravenous cannulation: 2.5 g (one-half of 5 g tube) over 20 to 25 cm2 of skin surface for at least 1 hour.

Painful dermatologic procedure on a large skin area such as split thickness skin graft harvesting: 2 g per 10 cm2 of skin surface for at least 2 hours.

Genital skin (male): adjunct prior to local anesthetic infiltration, 1 g per 10 cm2 of skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after the removal of the cream. Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream.

Genital mucous membranes (female): 5 to 10 g for 5 to 10 minutes. Occlusion is not necessary for absorption. The procedure or the local anesthetic infiltration should be performed immediately after the removal of the cream.

Applied directly into periodontal pockets to provide localized anesthesia: Apply lidocaine-prilocaine liquid on the gingival margin around the selected teeth using the blunt tipped applicator included in the package. Wait 30 seconds, then fill the periodontal pockets with lidocaine-prilocaine liquid using the blunt tipped applicator until the gel becomes visible at the gingival margin. Wait another 30 seconds before starting treatment. A longer waiting time does not enhance the anesthesia. Anesthetic effect, as assessed by probing of pocket depths, has a duration of approximately 20 minutes. If the anesthesia starts to wear off, lidocaine-prilocaine liquid may be reapplied if needed. The maximum recommended dose of lidocaine-prilocaine liquid at one treatment session is 5 cartridges.

Usual Pediatric Dose for Anesthesia:

Neonatal:
Topical:
Gestational Age (GA): Less than 37 weeks: 0.5 g/dose has been most frequently reported. One study of 30 preterm neonates (GA: greater than or equal to 30 weeks) showed application to the heel for 1 hour resulted in no measurable changes in methemoglobin levels; others have reported similar findings
GA: greater than or equal to 37 weeks:
Painful procedures (i.e.,, intramuscular injections): Apply 1 g/site for at least 60 minutes
Circumcision: Apply 1 to 2 g to prepuce and occlude for 60 to 90 minutes prior to procedure
Manufacturer recommended maximum dose and application area (based on application to intact skin): Weight less than 5 kg:
Maximum total dose of 1 g
Maximum application area: 10 cm2
Maximum application time: 1 hour

Dosage based on age, weight, application area, and application times - maximum recommended:
Less than or equal to 3 months (or less than 5 kg): 1 g, 10 cm2, 1 hour
Greater than 3 to less than or equal to 12 months: (and greater than 5 kg): 2 g, 20 cm2, 4 hours
1 to 6 years (and greater than 10 kg): 10 g, 100 cm2, 4 hours
7 to 12 years (and greater than 20 kg): 20 g, 200 cm2, 4 hours