Qutenza patches contain capsaicin. Capsaicin is the active ingredient in chili peppers that makes them hot.

Qutenza patches are used to treat nerve pain (neuralgia) in people who have had herpes zoster, or "shingles."

Qutenza patches are also used to treat nerve pain (neuralgia) associated with diabetic peripheral neuropathy (DPN) of the feet.

Qutenza patches must be applied only by a healthcare professional.

Do not use Qutenza if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Capsaicin can cause a burning sensation wherever it is applied. If you have significant discomfort or skin redness, it can be treated with an ice pack or pain relieving medication.

Get medical attention right away if you have severe burning, pain, swelling, or blistering of the skin where you applied the Qutenza patches.

Before using this medicine

Do not use Qutenza if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Ask a doctor or pharmacist about using Qutenza if you have any allergies (especially to plants), or if you have a serious medical condition.

It is not known whether Qutenza will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether capsaicin topical passes into breast milk or if it could harm a nursing baby. Do not apply Qutenza to your breast area if you are breast-feeding a baby.

Do not use this medication on anyone younger than 18 years old without the advice of a doctor.

Use Qutenza exactly as directed. Qutenza patches must be applied only by a healthcare professional.

Do not touch Qutenza, treatment areas, and all used supplies or other materials placed in contact with the treatment area without wearing nitrile gloves.

Do not take by mouth. This medicine is for use only on the skin.

Do not use Qutenza on open wounds or on sunburned, windburned, dry, chapped, or irritated skin. If this medicine gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

Make sure your skin is clean and dry before you apply the patch.

Pre-treat the area with a topical anesthetic to reduce discomfort associated with the application of Qutenza.

Apply topical anesthetic to the entire treatment area and surrounding 1 to 2 cm, and keep the local anesthetic in place until the skin is anesthetized prior to the application of a Qutenza patch.

Qutenza patches must be applied only by a healthcare professional. Tear open the pouch along the three dashed lines and remove the patch.

Inspect the patch and identify the outer surface backing layer with the printing on one side and the capsaicin-containing adhesive on the other side. The adhesive side of the patch is covered by a clear, unprinted, diagonally-cut release liner.

Cut the patch before removing the protective release liner. The diagonal cut in the release liner is to aid in its removal. Peel a small section of the release liner back, and place the adhesive side of the patch on the treatment area.

While you slowly peel back the release liner from under the patch with one hand, use your other hand to smooth the patch down on to the skin.

Once the Qutenza patch is applied, leave in place for 60 minutes for postherpetic neuralgia, and 30 minutes for diabetic peripheral neuropathy of the feet.

To keep the medication from getting on your hands when you apply it, use nitrile gloves. Wear nitrile gloves at all times while handling Qutenza and cleaning treatment areas.

Capsaicin can cause a burning sensation wherever it is applied.

If the burning sensation is painful or causes significant discomfort, wash the treated skin area with soap and cool water. Get medical attention right away if you have severe burning, pain, swelling, or blistering.

Do not cover treated skin with a bandage or heating pad, which can increase the burning sensation. You may cover the skin with clothing.

Avoid taking a bath or shower within 1 hour before or after you apply capsaicin to your skin. Also avoid direct sunlight, swimming or vigorous exercise. Warm water or perspiration can increase the burning sensation caused by capsaicin.

Avoid getting Qutenza in your eyes or near your nose where you might inhale it. If it does get into any of these areas, rinse thoroughly with water.

Use only nitrile gloves when handling Qutenza, and when cleaning capsaicin residue from the skin. Do not use latex gloves as they do not provide adequate protection.

Also avoid getting this medication on contact lenses, dentures, and other items that come into contact with sensitive areas of your body.

For best results, keep using the medication as directed. Pain relief should occur gradually as the substance P in your body is decreased in the nerve cells.

Call your doctor if your pain does not improve after using this medication for 7 days, or if your symptoms get worse or get better and then come back in a few days.

Store Qutenza at room temperature away from moisture and heat, in a place where children and pets cannot get to it.

Usual Adult Dose for Postherpetic Neuralgia:

Up to 4 patches applied to intact, non-irritated, dry skin, and allowed to remain in place for 30 minutes for the feet and 60 minutes for other locations

Comments:
-Treatment may be repeated not more frequently than every three months.
-The patch should be applied by a physician or by a health care professional under the supervision of a physician.

Usual Adult Dose for Diabetic Peripheral Neuropathy (DPN) of the Feet:

Up to 4 patches applied to intact, non-irritated, dry skin, and allowed to remain in place for 30 minutes.

Comments:
-Treatment may be repeated not more frequently than every three months.
-The patch should be applied by a physician or by a health care professional under the supervision of a physician.

Do not use Qutenza if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Ask a doctor or pharmacist about using Qutenza if you have any allergies (especially to plants), or if you have a serious medical condition.

It is not known whether Qutenza will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether capsaicin topical passes into breast milk or if it could harm a nursing baby. Do not apply Qutenza to your breast area if you are breast-feeding a baby.

Do not use this medication on anyone younger than 18 years old without the advice of a doctor.

A missed dose of Qutenza will not cause harm but may make the medication less effective reducing substance P and relieving your pain.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222, especially if anyone has accidentally swallowed it.

Accidental swallowing of capsaicin can cause severe burning in or around the mouth, watery eyes, runny nose, and trouble swallowing or breathing.

Excessive use of Qutenza can cause severe burning or redness.

Avoid inhaling the odor or dried residue of Qutenza. Inhaling capsaicin can cause coughing, sneezing, or watery eyes, and can irritate your throat or lungs.

Avoid touching your eyes, mouth, nose, genitals, or rectum until the medication has been washed off your hands. Also avoid handling food while the medication is still on your hands.

Avoid exposing treated skin to sunlight, sunlamps, tanning beds, or a hot tub. Capsaicin can cause a burning sensation that may be made worse by heat.

Do not use other medicated skin products, including muscle pain creams or lotions, on areas where you have applied Qutenza, unless your doctor has told you to.

Get emergency medical help if you have signs of an allergic reaction to Qutenza patches: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Wash the skin and get medical attention right away if you have severe burning, pain, swelling, or blistering of the skin where you applied this medication.

Stop using Qutenza and call your doctor at once if you have:

• skin redness where the medicine was applied; or

• trouble breathing or swallowing (after accidental inhalation of capsaicin odor or dried residue).

Less serious side effects may include a mild burning sensation that can last for several hours or days, especially after your first use of Qutenza.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

It is not likely that other drugs you take orally or inject will have an effect on topically applied capsaicin. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.