LidoCort (Topical application, Rectal)

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

Lidocaine is part of a group of medicines called topical local anesthetics. It numbs the nerve endings in the skin. This medicine does not cause unconsciousness like general anesthetics do when used for surgery.

Hydrocortisone is a corticosteroid (cortisone-like medicine) that helps reduce redness, itching, and swelling caused by skin conditions.

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

It is very important that your doctor checks 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.

In deciding to use a medicine, you must balance the risks of taking it against the benefits it may provide. This decision will be made between you and your doctor. For this medicine, please consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies done so far have not shown any specific problems in children that would limit the use of lidocaine and hydrocortisone combination. However, due to the potential toxicity of this medicine, it should be used cautiously after considering or finding other treatments ineffective. Do not exceed the recommended doses, and the patient should be monitored closely during treatment.

Geriatric

There is no information available about how age affects the use of lidocaine and hydrocortisone combination in elderly patients. However, older patients are more likely to have liver problems related to age, which may require caution when using lidocaine and hydrocortisone combination.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. It is very important for your healthcare professional to know if you are taking any of the medicines listed below when you are using this medicine. The following interactions have been chosen based on their potential importance and may not include all possibilities.

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

• Dihydroergotamine
• Dronedarone
• Saquinavir
• Vernakalant

Using this medicine with any of the following medicines is usually not recommended, but may be necessary 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 increase the risk of certain side effects, but using both medications may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Cimetidine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around meal times or with specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Be sure to inform your doctor if you have any other medical problems, especially:

• Chickenpox infection or
• Fungal infection or
• Herpes simplex infection or
• Severe liver disease or
• Active tuberculosis—This medicine 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, as it may worsen these conditions.

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away 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 happen in some patients. If you notice any other effects, consult your healthcare professional.

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

In the U.S.

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

Available Dosage Forms:

• Cream
• Gel/Jelly

Therapeutic Class: Hemorrhoidal, Anesthetic/Anti-Inflammatory Combination

Pharmacologic Class: Hydrocortisone

Chemical Class: Lidocaine

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.