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:
Incidence not known
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:
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.
It is very important that your doctor check you or your child closely for any problems or unwanted effects that may be caused by this medicine.
Do not use this medicine on a baby younger than 3 months of age unless your child’s doctor tells you to. Young babies may have more unwanted effects if too much is used and absorbed through the skin. If you use this medicine on a baby younger than 3 months of age, blood tests may be needed to check for unwanted effects.
This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of the hands, face, or mouth after you receive the medicine.
This medicine may cause a rare, but serious blood problem called methemoglobinemia. Remove the cream and call your doctor right away if you or your child develop a blue or bluish purple color on the lips, fingernails, or skin, or have headaches, dizziness, fainting, sleepiness, or trouble with breathing.
Using too much of this medicine or using it on a large area of your skin can cause serious unwanted effects. Remove the cream and contact your doctor right away if you or your child have any of these symptoms: lightheadedness, dizziness, vision problems, an irregular or slow heartbeat, difficulty with breathing, or convulsions.
During the time that the skin feels numb, serious injury can occur. Be especially careful to avoid injury until the numbness wears off and you or your child have normal feeling in the area. Do not scratch or rub the area, and do not allow very hot or very cold objects to touch it.
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.
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.
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.
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 this medicine, the following should be considered:
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 prilocaine topical cream in children. However, because of this medicine’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.
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.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
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.