AgonEaze

Lidocaine and prilocaine topical cream is used on the skin or in the genital area to cause numbness or loss of feeling before certain medical procedures. It is used to prevent pain caused by an injection, the drawing of blood from a vein, or minor surgeries such as removing warts. This medicine contains a mixture of two topical local anesthetics (numbing medicines). It deadens the nerve endings in the skin.

This medicine is available only with your doctor's prescription.

This section provides information on the proper use of a number of products that contain lidocaine and prilocaine. It may not be specific to AgonEaze. Please read with care.

A nurse or other trained health care professional will apply this medicine to you or your child before a medical procedure in a hospital or clinic.

You may be taught how to apply this medicine to yourself or your child at home before the medical procedure. Use this medicine exactly as directed by your doctor. Do not use it for any other condition without first checking with your doctor. This medicine may cause unwanted effects if too much is used, because more of it is absorbed through the skin.

Do not apply this medicine to open wounds, burns, or broken or inflamed skin, unless directed otherwise by your doctor.

Be careful not to get any of this medicine in the eyes, because it can cause severe eye irritation. If any of the medicine does get into your eye, do not rub or wipe the eye, even if it hurts. Wash the eye with water and call your doctor right away.

Be careful not to get any of this medicine in the ears, because it can cause serious hearing problems. If any of the medicine does get into your ear, wash the ear with water and call your doctor right away.

Be careful not to get any of this medicine in the mouth. Serious unwanted effects may occur if the medicine is swallowed.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use:

• Wash your hands with soap and water before and after applying the medicine.
• Apply a thick layer of medicine to the area where numbness is needed. Do not spread the medicine on the skin.
• Cover the medicine with a special bandage called an occlusive dressing. This will keep the medicine in place. Your doctor will give you the bandage or tell you what to use.
• Seal the edges of the bandage to keep the medicine from leaking. Do not lift the bandage or disturb it. Keeping the medicine tightly covered helps it work properly.
• For babies or young children, a second covering may be used to prevent them from touching the medicine.
• Carefully watch your baby or child while the medicine is in place. Do not let them loosen or remove the bandage, touch the medicine, or put it in the mouth, eyes, nose, or ears.
• Keep the bandage in place until you or your child arrive at the hospital or clinic.
• Your doctor will remove the bandage and wipe the medicine off the skin before the medical procedure.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream):
  • For preventing pain caused by medical procedures:
    • Adults and teenagers—Apply 1 to 2.5 grams in a thick layer to the skin area. The size of the area to be covered and the length of time the medicine is kept in place will depend on the procedure. Cover the area with a bandage. The medicine may need to stay on the skin for up to 2 hours. Your doctor will remove the bandage and wipe the medicine off the skin before the medical procedure.
    • Children—Dose is based on body weight and must be determined by your doctor. The cream is applied in a thick layer to the skin area. The size of the area to be covered and the length of time the medicine is kept in place will depend on the procedure. Cover the area with a bandage. Your doctor will remove the bandage and wipe the medicine off the skin before the medical procedure.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Cough
• difficulty with swallowing
• large, hive-like swellings on the eyelids, face, lips, or tongue
• severe dizziness or feeling faint
• shortness of breath
• skin rash, itching, or hives
• stuffy nose
• tightness in the chest
• troubled breathing
• wheezing

• Blisters on skin at application site
• blue or blue-purple color of lips, fingernails, mouth, or skin
• blurred or double vision
• convulsions
• dark urine
• dizziness or drowsiness
• fainting
• feeling hot, cold, or numb
• headache
• irregular or fast heartbeat
• muscle twitching or trembling
• nausea or vomiting
• ringing or buzzing in the ears
• shortness of breath or troubled breathing
• unusual excitement, nervousness, or restlessness
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning, swelling, itching, or skin rash at application site
• white or red skin at the application site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Applies to lidocaine / prilocaine topical: topical cream, topical film, topical kit

Local

Local side effects have included erythema, edema, and abnormal sensation. Local effects observed in the trials of the cream on intact skin have included paleness (37%), erythema (30%), alterations in temperature sensations (7%), edema (6%), itching (2%), and rash (

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

In a study, the effect of prilocaine on pre- and postnatal development was examined in rats treated with up to 2.8 times the maximum recommended human dose of prilocaine in lidocaine-prilocaine gel from day 6 of gestation to weaning. There was no evidence of altered postnatal development, viability, or reproductive capacity in any offspring.

Lidocaine-prilocaine topical cream has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of impaired fertility or fetal harm. There are no controlled data in human pregnancy. Lidocaine-prilocaine topical cream is only recommended for use during pregnancy when benefit outweighs risk.