Pronunciation:

kap-SAY-sin

Brand Names:

• 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

Dosage Forms:

• Cream
• Lotion
• Patch, Extended Release
• Solution

Classifications:

Therapeutic—

Analgesic

Uses of This Medicine:

Capsaicin is used to help relieve a certain type of pain known as neuralgia (shooting or burning pain in the nerves). Capsaicin is also used to help relieve minor pain associated with rheumatoid arthritis or muscle sprains and strains. Qutenza® patch is also used to treat nerve pain caused by diabetic peripheral neuropathy of the feet. It will not cure any of these conditions.

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

Qutenza® is to be given only by your doctor. Zostrix® is available both over-the-counter (OTC) and 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 have not been performed on the relationship of age to the effects of capsaicin in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of capsaicin in the elderly.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Brain or blood vessel problems, recent history of or
• Heart or blood vessel problems, recent history of or
• Hypertension (high blood pressure), unstable or poorly controlled—Use the Qutenza® patch with caution. May increase risk for more serious side effects (eg, heart or blood vessel problems).

• Infection at the application area or
• Large sores, broken, or irritated skin at the application area or
• Sensory function problems—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

If you use the Qutenza® patch:

• Your doctor will check you closely for any problems or unwanted effects (eg, 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 has been removed. If you notice any change to your recommended blood pressure at home, call your doctor right away. If you have questions about this, talk to your doctor.
• You may have some skin redness, burning, or a stinging sensation at the application site. Heat, humidity, bathing in warm water, or sweating may increase the burning sensation. If this irritation is severe or does not go away, call your doctor.
• Your skin may be more sensitive to heat and sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
• Check with your doctor right away if you have coughing, sneezing, or any breathing problems after the patch is removed.
• If skin not intended to be treated got exposed to the patch, apply cleansing gel for 1 minute and wipe off with gauze. Wash with soap and water.
• You may feel pain and a burning feeling during application and after removal of the patch, even after using a numbing medicine on the affected area. Your doctor may give you an ice pack or oral pain medicine to treat this pain.

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

• You may have some skin redness, burning, or a stinging sensation at the application site. Although this usually disappears 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, call 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 reduce the amount of pain relief you get.
• Your skin may be more sensitive to heat and sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
• Check with your doctor right away if you have coughing or any breathing problems after the medicine has dried on the skin.

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:

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 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:

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.