Capsagel (Topical)

Capsaicin is used to help relieve a specific type of pain called neuralgia, which is a shooting or burning pain in the nerves. Capsaicin is also used to help relieve minor pain related to rheumatoid arthritis or muscle sprains and strains. The Qutenza® patch is also used to treat nerve pain caused by diabetic peripheral neuropathy in the feet. It will not cure any of these conditions.

Neuralgia is pain that comes from the nerves close to the surface of your skin. This pain may happen after an infection with herpes zoster (shingles or postherpetic neuralgia). Capsaicin can help relieve the pain of postherpetic neuralgia, but it will not cure the condition.

Qutenza® should only be given by your doctor. Zostrix® is available both over-the-counter (OTC) and with your doctor's prescription.

If you use the Qutenza® patch:

• Your doctor will monitor you closely for any issues or side effects (e.g., loss of sensory function) that may be caused by this medicine.
• Your blood pressure will be measured while the patch is on your skin and after it is removed. If you notice any change in your blood pressure at home, call your doctor immediately. If you have questions about this, speak with your doctor.
• You may experience some skin redness, burning, or a stinging sensation at the site where the patch is applied. Heat, humidity, bathing in warm water, or sweating may make the burning sensation worse. If this irritation is severe or does not go away, contact your doctor.
• Your skin may be more sensitive to heat and sunlight. Use sunscreen when you are outside. Avoid sunlamps and tanning beds.
• Contact your doctor immediately if you have coughing, sneezing, or any breathing problems after the patch is removed.
• If skin that is not meant to be treated comes into contact with the patch, apply cleansing gel for 1 minute and wipe off with gauze. Then wash with soap and water.
• You may feel pain and a burning sensation during the application and after the patch is removed, even after using a numbing medicine on the affected area. Your doctor may provide you with an ice pack or oral pain medicine to help with this pain.

If you use the cream, gel, lotion, or ointment:

• You may experience some skin redness, burning, or a stinging sensation at the site of application. Although this usually goes away after the first several days, it may last 2 to 4 weeks. Heat, humidity, bathing in warm water, or sweating may increase the burning sensation. If this irritation is severe or does not go away, contact your doctor.
• The burning sensation will not improve or go away if you reduce the number of doses you use each day. Using fewer doses may also lessen the pain relief you receive.
• Your skin may be more sensitive to heat and sunlight. Use sunscreen when you are outside. Avoid sunlamps and tanning beds.
• Contact your doctor immediately if you have coughing or any breathing problems after the medicine has dried on your skin.

In deciding to use a medicine, you and your doctor need to weigh the risks of the medicine against the benefits it provides. Consider the following for this medicine:

Allergies

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

Pediatric

Studies have not been done to understand how capsaicin affects children. Its safety and effectiveness for children have not been established.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the use of capsaicin.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction is possible. In these cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food, as interactions may happen. Using alcohol or tobacco with certain medicines can also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to tell your doctor if you have other medical problems, especially:

• Recent brain or blood vessel problems
• Recent heart or blood vessel problems
• Unstable or poorly controlled hypertension (high blood pressure)—Use the Qutenza® patch with caution. It may increase the risk of more serious side effects (e.g., heart or blood vessel problems).

• Infection at the area where you apply the medicine
• Large sores, broken, or irritated skin at the application area
• Problems with sensory function—Use with caution. It may worsen side effects.

Along with its needed effects, this medicine may cause some unwanted effects. Not all side effects may happen, but if they do, you may need medical attention.

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

More common - all forms

• Burning, itching, dryness, pain, redness, swelling, or soreness at the application site

Less common - all forms

• Body aches or pain
• chest tightness
• chills
• cough
• difficulty with breathing
• dry or productive cough
• ear congestion
• fever
• headache
• loss of voice
• sneezing
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

Less common - patch only

• Blurred vision
• breakdown of the skin
• dizziness
• nervousness
• pain in the arms or legs
• pounding in the ears
• slow or fast heartbeat

Incidence not known - patch only

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• eye irritation or pain
• increased sensitivity to pain or touch
• scarring of the skin
• stabbing pain
• throat irritation
• unusual weight gain or loss

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how 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:

Less common - patch only

• Muscle aches
• nausea
• pain or tenderness around the eyes and cheekbones
• vomiting

Incidence not known - patch only

• Abnormal skin odor
• change in or loss of taste

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.

• Arthricare For Women
• Capsagel
• Capsagesic-HP Arthritis Relief
• Capsin
• Double Cap
• Icy Hot Arthritis Therapy
• Pain Enz
• Rid-A-Pain
• Sportsmed
• Therapatch Warm
• Trixaicin
• Zostrix

Available Dosage Forms:

• Cream
• Lotion
• Patch, Extended Release
• Solution

Therapeutic Class: Analgesic

A doctor or other trained healthcare professional will apply the topical Qutenza® patch to the affected area of your body in a medical facility.

During the patch application:

• Your doctor may apply a numbing medicine to the treatment area to help lessen the discomfort during the patch application.
• Leave the patch in place for at least 60 minutes for postherpetic neuralgia or 30 minutes for diabetic peripheral neuropathy. Do not touch the patch while it is on your skin. Your doctor may also cover the treatment area with a rolled gauze or dressing to keep the patch in place.
• Your doctor will apply a cleansing gel for at least 1 minute after removing the patch.

If you are using the topical cream, gel, lotion, or ointment for neuralgia, muscle pain, or arthritis, follow the instructions on the medicine label.

Be careful not to get any of this medicine into your eyes, because it can cause severe eye irritation. If the medicine does get in your eyes, wash the eyes with water and check with your doctor right away.

If capsaicin gets on your face, scalp, or in your mouth, it may cause a burning sensation. Wash these areas with warm (not hot) soapy water.

If you are using the cream, gel, lotion, or ointment:

• Do not put the medicine on wounds or irritated skin.
• Apply a small amount of medicine and use your fingers to rub it in well so very little or no medicine is left on the skin.
• Wash your hands with soap and water after applying the medicine to avoid getting it into your eyes or on other sensitive areas of the body.
• If you are using capsaicin for arthritis in your hands, do not wash your hands for at least 30 minutes after applying it.
• If a bandage is being used on the treated area, do not wrap it tightly.
• Use the medicine regularly every day as directed. It may take a full 2 weeks before your pain goes away.
• If your condition gets worse, or does not improve after one month, check with your doctor.

Do not use any other topical medicine on the same area where you are using capsaicin. Do not use cosmetics or other skin care products on the treated skin areas.

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, gel, lotion, or ointment):For arthritis, muscle pain, or neuralgia: Adults—Apply 3 or 4 times a day and rub it in well. 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.

• Does Qutenza contain red chili peppers?