Pronunciation:

LYE-doe-kane hye-droe-KLOR-ide, hye-droe-KOR-ti-sone AS-e-tate

Brand Names:

• AnaMantle HC
• Lida Mantle HC
• LidaMantle HC Relief
• LidoCort
• Peranex HC

Dosage Forms:

• Lotion
• Cream
• Gel/Jelly

Classifications:

Therapeutic—

Corticosteroid Combination

Pharmacologic—

Hydrocortisone

Chemical—

Lidocaine

Uses of This Medicine:

Lidocaine and hydrocortisone combination is used to relieve pain and itching caused by conditions such as hemorrhoids, sunburn, minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, minor cuts, or scratches.

Lidocaine belongs to a group of medicines known as topical local anesthetics. It deadens the nerve endings in the skin. This medicine does not cause unconsciousness as general anesthetics do when used for surgery.

Hydrocortisone is a corticosteroid (cortisone-like medicine) that is used to relieve the redness, itching, and swelling caused by skin conditions.

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

Before Using This Medicine:

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:

Allergies—

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lidocaine and hydrocortisone combination 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.

Older adults—

No information is available on the relationship of age to the effects of lidocaine and hydrocortisone combination in geriatric patients. However, elderly patients are more likely to have age-related liver problems, which may require caution in patients receiving lidocaine and hydrocortisone combination.

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.

Other 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 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
• Hydroxychloroquine
• 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

Other interactions—

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:

• Chickenpox infection or
• Fungal infection or
• Herpes simplex infection or
• Liver disease, severe or
• Tuberculosis, active—Should not be used in patients with these conditions.

• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar)—Use with caution. May make these conditions worse.

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

Proper Use of This Medicine:

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 it is used too much, because more of it is absorbed into the body through the skin.

Wash your hands with soap and water before and after using this medicine.

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

This medicine should only be used for problems being treated by your doctor. Check with your doctor before using it for other problems, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.

Be careful not to get any of this medicine in your nose, mouth, ears, and especially in your eyes, because it can cause severe eye irritation. If any of the medicine does get in these areas, wash the area with water for at least 15 minutes and check with your doctor right away.

To use the Anamantle® HC kit:

• Remove the cap from the tube of cream and firmly screw the applicator tip on to the end of the tube.
• Squeeze the tube until a small amount of cream comes out. Lubricate the end of the applicator tip with the cream.
• Gently insert the applicator tip with the attached tube into the anal area.
• Continue squeezing the tube until the cream is applied to the affected areas.
• Do not insert the applicator tip and tube completely into the anus or deep into the rectum.
• Gently remove the applicator tip and throw it in the trash. Make sure to dispose of it out of the reach of children and pets.

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 forms (cream, lotion):
  • For pain and itching from hemorrhoids or minor skin conditions:
    • Adults—Apply a thin film to the affected area two or three times a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits for any problems or unwanted effects that may be caused by this medicine.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and for patients who use large amounts for a long time. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

After applying this medicine to the skin of your child, watch the child carefully to make sure that he or she does not get any of the medicine in the eyes or mouth. This medicine can cause serious side effects, especially in children, if it gets into the mouth and is swallowed.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated skin areas.

Side Effects of This Medicine:

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

Burning or stinging sensation of the skin

paleness or redness of the skin

swelling of the skin

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.