Lida Mantle HC (Topical application, Rectal)

Lidocaine and hydrocortisone combination is used to relieve pain and itching from conditions like 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 make you unconscious like general anesthetics do when used for surgery.

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

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

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

If your symptoms do not improve within a few days or if they get worse, contact your doctor.

Using too much of this medicine or using it for a long time may increase your risk of problems with your adrenal glands. The risk is higher 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 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 your child's skin, watch the child closely 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 contact 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 and your doctor need to consider the risks and benefits. For this medicine, keep the following in mind:

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 have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

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

Geriatric

There is no information on how age affects the use of lidocaine and hydrocortisone combination in older patients. However, elderly patients may be more likely to have age-related liver issues, which may require caution when using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and 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 there is a potential interaction. If you are taking this medicine, it is important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are selected for their importance and may not be a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change 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 adjust the dose or frequency of one or both 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 medicines may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Cimetidine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating or with certain foods as interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to inform your doctor about any other medical problems, especially:

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

• Infection at or near the application site or
• Large sores, broken skin, or severe injury at the application area—This may increase the chance of side effects.

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.

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.