DermacinRx Lexitral PharmaPak (topical)

Capsaicin is the active ingredient in chili peppers that makes them hot. Capsaicin is used in medicated creams and lotions to relieve muscle or joint pain.

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID).

DermacinRx Lexitral PharmaPak (topical) is a combination medicine used to treat joint pain, stiffness, and swelling caused by osteoarthritis of the knees. DermacinRx Lexitral PharmaPak may not be effective in treating arthritis pain elsewhere in the body.

DermacinRx Lexitral PharmaPak may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. DermacinRx Lexitral PharmaPak is for use only on the skin. If this medicine gets in your eyes, nose, or mouth, rinse with water.

Do not apply to open wounds or to sunburned, chapped, irritated, or infected skin. Do not cover treated skin with a bandage or expose it to heat from a hot tub, heating pad, or sauna.

Apply the solution only to clean, dry skin. Spread the solution over the front, back, and sides of the knee.

Wash your hands after applying this medicine. Wait at least 30 minutes before you bathe or shower.

Wait until the solution is completely dry before covering treated skin with clothing or applying any other skin products (cosmetics, sunscreen, lotions, insect repellant, or other medicated skin products).

Do not allow others to touch the area where you have applied the medicine.

Capsaicin can cause a burning sensation wherever it is applied. This sensation is usually mild and should gradually lessen over time with continued regular use of the medicine.

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.

If you use this medicine long-term, you may need frequent medical tests.

Call your doctor if your arthritis symptoms do not improve after 7 days of treatment, or if your symptoms get better and then worse within a few days.

Store at room temperature away from moisture and heat.

DermacinRx Lexitral PharmaPak solution is flammable. Do not use near high heat or open flame. Do not smoke until the gel has completely dried on your skin.

Diclofenac can raise your chances of having a fatal heart attack or stroke. Do not use DermacinRx Lexitral PharmaPak right before or after heart bypass surgery (coronary artery bypass graft, or CABG). Diclofenac may also lead to stomach or intestinal bleeding, which can be deadly.

Diclofenac can increase your risk of a fatal heart attack or stroke, even if you do not have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Diclofenac may also cause stomach or intestinal bleeding, which can be fatal. These issues can happen without warning while you are using DermacinRx Lexitral PharmaPak, especially in older adults.

You should not use this medicine if you are allergic to capsaicin or diclofenac, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Tell your doctor if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• asthma;
• liver or kidney disease; or
• fluid retention.

If you are pregnant, you should not use DermacinRx Lexitral PharmaPak unless your doctor tells you to. Using an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

This medicine is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you notice signs of an allergic reaction (sneezing, runny or stuffy nose, hives, wheezing or trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Serious side effects are not common when DermacinRx Lexitral PharmaPak is used on the skin, but may happen if the medicine gets into your bloodstream.

Get emergency medical help if you notice signs of a heart attack or stroke: chest pain that spreads to your jaw or shoulder, sudden numbness or weakness on one side of your body, slurred speech, feeling short of breath.

This medicine may cause serious side effects. Stop using this medicine and call your doctor right away if you have:

• a skin rash, no matter how mild;
• shortness of breath (even with mild activity), swelling, rapid weight gain;
• signs of stomach bleeding—bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems—loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems—little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
• low red blood cells (anemia)—pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects of DermacinRx Lexitral PharmaPak may include:

• skin rash, itching, redness, blistering, tingling, or other irritation where the medicine was applied; or
• dryness or hardening of treated skin.

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.

Since DermacinRx Lexitral PharmaPak is used as needed, you might not have a set dosing schedule. If you miss a dose and it’s close to the time for your next dose, just skip the missed dose. Do not take two doses at once.

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

Do not expose treated skin to heat, sunlight, or tanning beds.

Do not take a bath or shower within 30 minutes before or after you apply DermacinRx Lexitral PharmaPak to your skin. Also, do not do vigorous exercise. Warm water or sweating can make the burning sensation from capsaicin worse.

Do not get this medicine in your eyes, nose, or mouth.

Do not drink alcohol. It may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may have ingredients similar to diclofenac (like aspirin, ibuprofen, ketoprofen, or naproxen).

Tell your doctor about all your other medicines, especially:

• cyclosporine;
• lithium;
• methotrexate;
• a blood thinner (warfarin, Coumadin, Jantoven);
• heart or blood pressure medication, including a diuretic or "water pill"; or
• steroid medicine (prednisone and others).

This list is not complete. Other drugs may affect DermacinRx Lexitral PharmaPak, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.