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Qutenza
Classes
Topical Counterirritants (selected)
Topical Neuropathic Pain agents
Administration
Accidental exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin. Avoid mucous membrane and ocular exposure to capsaicin. If capsaicin comes in contact with the eyes, rinse well with water; advise individuals to seek medical help if irritation persists. Ensure proper administration technique is followed for the capsaicin 8% patch to minimize the likelihood of accidental exposure.
Advise individuals using capsaicin to avoid conditions contributing to an elevated core body temperature, including the application of heat, the use of a heating pad or hot water bottle, or direct sunlight (UV) exposure to the area of product application immediately before, during, or after use. Do not use capsaicin within 1 hour before or after a bath, shower, hot tub, sauna, or strenuous exercise due to a potential for enhanced absorption. Treated areas may be sensitive to heat for a few days after treatment.
Do not apply to open wounds, infections, or irritated skin.
Do not apply external heat or occlusive dressings to treated areas.
Avoid contact with eyes and mucous membranes. If eye contact occurs, immediately wash out the eye with water or saline. Seek medial attention if irritation persists.
If the condition worsens or symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue therapy and seek medical attention.
Apply sparingly; rub well into the affected area until thoroughly absorbed.
Wash hands with soap or water after applying to avoid getting into eyes or other sensitive areas of the body. However, if used on arthritic hands, do not wash hands for at least 30 minutes after application.
The capsaicin 0.025% and 0.05% DermacinRx cream formulations are flammable. Avoid heat, flame, or smoking during and immediately following application of the foam.
Capsaicin 0.025% Transdermal Patch
Clean and dry intended treatment area prior to patch application.
Apply patch according to package instructions.
Wash hands with soap or water after applying to avoid getting into eyes or other sensitive areas of the body.
Capsaicin 0.035% Transdermal Patch
Clean and dry the intended treatment area prior to patch application.
Open the pouch and remove one patch.
Remove any protective film and apply directly to the affected area of pain. Apply immediately after removal from the protective envelope.
Wash hands with soap and water after handling the patches.
Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
Fold used patches so that the adhesive side sticks to itself and safely discard.
Capsaicin 8% Transdermal Patch
Do not allow self-administration of the capsaicin 8% topical patch; administration must only be undertaken by a care team familiar with proper dosing, handling, and disposal of the product.
Administer the patch in a well ventilated area.
Use nitrile gloves at all times while handling and disposing of capsaicin topical patch and while in contact with treatment area(s); do not use latex gloves as latex gloves do not provide full protection. It is advisable for providers to utilize a face mask and protective glasses.
Avoid unnecessary contact with items in the room, including items that the individual may later have contact with, such as horizontal surfaces and bedsheets. Accidental exposure to the eyes and mucus membrane can occur from touching the patch or items exposed to capsaicin and then touching the eyes and mucus membranes.
Do not hold medicated patch near eyes, nose, or mouth. Avoid application to the face, eyes, nose, or scalp to avoid exposure risk to the eyes or mucous membranes. If irritation of eyes or mucous membranes occurs, remove the affected individual from the vicinity of the patch and flush eyes and mucous membranes with cool water. If irritation of airways occurs, remove the affected individual from the vicinity of the patch. Provide supportive medical care if shortness of breath develops. If respiratory irritation worsens or does not resolve, do not re-expose the affected health care professional or patient to the patch.
Treatment location must be identified and marked on the skin by the treating physician. When used for diabetic neuropathy, examine the feet prior to patch application to detect skin lesions related to underlying neuropathy or vascular insufficiency.
Trim capsaicin topical patch to fit the size and shape of the treatment area as needed.
Prepare skin for treatment by clipping hair (do not shave) within the area and gently washing with mild soap. Next, apply a topical anesthetic prior to patch application in an effort to reduce capsaicin-induced discomfort. Apply the anesthetic to the entire treatment area, including the 1 to 2 cm surrounding the treatment area. Once the skin is anesthetized, remove the anesthetic with a dry wipe. Wash the treatment area with mild soap and water; dry thoroughly.
Apply the patch(es) by aligning the patch(es) with the treatment area(s), then slowly removing capsaicin release liner while smoothing patch down on to the skin. Patches can be wrapped around the dorsal, lateral, and plantar foot surfaces of each foot to completely cover the treatment area. Use a 30-minute application time for diabetic neuropathy and a 60-minute application time for postherpetic neuralgia.
A dressing, such as rolled gauze, may be used to maintain patch contact with skin.
Instruct people to avoid touching the patch or treatment area during treatment.
Aerosolization of capsaicin from the patch is possible if the patches are rapidly removed; take care to remove patches gently by slowly rolling the adhesive side inward.
Clean treatment area with the supplied cleansing gel. Apply gel over the entire area, leave the gel on for 1 minute, then gently remove gel with a dry wipe and wash area with mild soap and water. If skin not intended to be treated is exposed to the patch, apply the supplied cleansing gel for 1 minute and wipe off with dry gauze. After the cleansing gel has been wiped off, wash the area with soap and water.
Thoroughly clean all areas that had contact with the patch and dispose of used and unused cleansing gel, patch(es), and other treatment materials in accordance with local biomedical waste procedures.
Acute pain during and after the procedure may also be managed with a local cooling or analgesic medication. Use refrigerated cooling packs (not from the freezer) to reduce the potential risk for frostbite with excessive cooling. Avoid direct application of cooling packs to the application site.
Advise people to seek medical attention if they experience persistent severe pain or skin lesions such as blisters after the application procedure.
Topical Solution
Massage into the affected area until thoroughly absorbed.
Avoid taking a bath, shower, or swim within 1 hour before or after application.
Try not to touch any surfaces or liquids and avoid contact with the eyes, lips, nose, genitalia, and other mucous membranes.
Roll-on Topical Solution
Lightly shake and invert bottle to allow product into applicator.
Remove cap to expose applicator.
Invert the bottle and apply liberally to affected area(s) and do not use hands to rub in.
Allow treated area(s) to dry naturally for best results.
Place cap back on and wash hands thoroughly with soap and water.
Do not tightly wrap, bandage treated area(s), or apply heat or direct sunlight to the treated area(s) immediately before or after use.
Adverse Reactions
erythema / Early / 2.0-63.0
edema / Delayed / 4.0-4.0
hypertension / Early / 2.0-2.0
burns / Early / 0-0.5
contact dermatitis / Delayed / Incidence not known
hyperesthesia / Delayed / Incidence not known
peripheral edema / Delayed / Incidence not known
peripheral neuropathy / Delayed / Incidence not known
pruritus / Rapid / 2.0-6.0
maculopapular rash / Early / 6.0-6.0
nausea / Early / 5.0-5.0
infection / Delayed / 4.0-4.0
vomiting / Early / 3.0-3.0
headache / Early / 3.0-3.0
xerosis / Delayed / 2.0-2.0
cough / Delayed / 2.0-2.0
throat irritation / Early / 0-1.0
dizziness / Early / 0-1.0
dysesthesia / Delayed / 0-1.0
drug-induced body odor / Delayed / Incidence not known
ecchymosis / Delayed / Incidence not known
paresthesias / Delayed / Incidence not known
skin irritation / Early / Incidence not known
urticaria / Rapid / Incidence not known
sinusitis / Delayed / Incidence not known
pharyngitis / Delayed / Incidence not known
nasal irritation / Early / Incidence not known
sneezing / Early / Incidence not known
dysgeusia / Early / Incidence not known
hypoesthesia / Delayed / Incidence not known
Common Brand Names
Arthricare for Women, Arthritis Pain Relieving, Capsimide, Capzasin P, Capzasin-HP, Castiva Warming, Circatrix, DermacinRx, DermacinRx Capsaicin, DermacinRx Circata, DermacinRx Penetral, DiabetAid, Qutenza, ZESTAMA, Zostrix, Zostrix HP, Zostrix Maximum Strength, Zostrix Neuropathy
Dea Class
OTC, Rx
Description
External topical analgesic
Available over-the-counter for the temporary relief of pain from arthritis, myalgias, arthralgias, and neuralgias; prescription only patch approved for postherpetic neuralgia and diabetic neuropathy of the feet
Most common adverse effect is transient skin irritation and/or paresthesias (e.g., burning, stinging, warm sensation) at the site of application; the severity of this effect appears to be dose-related
Dosage And Indications
Apply topically to affected joints 3 to 4 times daily; for best results use 3 to 4 times daily continuously.
Apply topically to affected area(s) 3 to 4 times daily as needed.
Apply topically to affected area(s) 3 to 4 times daily as needed.
Apply topically to affected area(s) 3 to 4 times daily as needed.
Apply topically to affected area(s) 3 to 4 times daily as needed.
Apply topically to affected area(s) 3 to 4 times daily as needed.
Apply topically to affected area(s) 3 to 4 times daily as needed.
Apply topically to affected area(s) 3 to 4 times daily as needed.
Apply topically to affected area(s) 3 to 4 times daily as needed.
Apply 1 patch topically to the affected area for up to 12 hours.
Apply 1 patch topically to the affected area for up to 12 hours.
Apply 1 patch topically to the affected area 1 to 3 times daily as needed. Do not leave patch on for more than 8 hours at a time.
Fourteen patients applied capsaicin 0.025% topically 4 to 5 times per day for 4 weeks. A few patients who did not respond to the 0.025% cream were switched to 0.075% capsaicin applied 4 to 5 times per day. Of those completing the study, 8 patients were either pain free or had only mild pain. At least 50% improvement was observed in 12 of 14 patients. Burning upon initial application of capsaicin was reported to be insignificant.
Apply up to 4 patches per application; patches should be applied for 30 minutes and repeated no more frequently than every 3 months as needed.
Apply to the affected areas topically 2 to 4 times daily.
Several controlled studies have shown topical capsaicin 0.075% to be significantly more effective than vehicle cream in reducing neuropathic pain in patients with diabetic neuropathy who were unresponsive or intolerant to conventional therapy. In these studies, capsaicin 0.075% was applied topically to painful areas 4 times per day.
Apply up to 4 patches per application; patches should be applied for 60 minutes and repeated no more frequently than every 3 months as needed.
Apply 3 to 4 times daily to the affected areas topically for 4 to 6 weeks to achieve the desired effect on nociceptors.
Dosing Considerations
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
Drug Interactions
There are no drug interactions associated with Capsaicin products.
How Supplied
Arthricare for Women/Arthritis Pain Relieving/Capsaicin/Capzasin-HP/Circatrix/DermacinRx/DermacinRx Capsaicin/DermacinRx Circata/DermacinRx Penetral/Zostrix/Zostrix HP/Zostrix Maximum Strength/Zostrix Neuropathy Topical Cream: 0.025%, 0.035%, 0.05%, 0.075%, 0.1%, 0.25%
Capsaicin/Capsimide/Qutenza Topical Film: 0.025%, 0.035%, 8%
Capsaicin/Castiva Warming/DiabetAid Topical Lotion: 0.025%, 0.035%
Capzasin P/ZESTAMA Topical Sol: 0.075%, 0.15%
Maximum Dosage
Capsaicin 8% patch: up to 4 patches/treatment, wait a minimum of 3 months before repeat application. Capsaicin 0.025% patch: 1 patch/day for up to 12 hours. Capsaicin 0.035% patch: 1 to 3 patches per day; each patch may be worn for up to 8 hours. Solutions, lotions, and creams: 4 applications/day; the 0.025% and 0.075% concentrations have been used off-label up to 5 times/day for postmastectomy pain syndrome.
Capsaicin 8% patch: up to 4 patches/treatment, wait a minimum of 3 months before repeat application. Capsaicin 0.025% patch: 1 patch/day for up to 12 hours. Capsaicin 0.035% patch: 1 to 3 patches per day; each patch may be worn for up to 8 hours. Solutions, lotions, and creams: 4 applications/day; the 0.025% and 0.075% concentrations have been used off-label up to 5 times/day for postmastectomy pain syndrome.
Capsaicin 0.025% and 0.035% lotion: 4 topical applications/day. Capsaicin 0.025% patch: 1 patch/day for up to 12 hours. Capsaicin 0.075% topical solution: 4 applications/day. Safety and efficacy of capsaicin 8% patch, topical creams, and other topical solutions have not been established.
12 years: Capsaicin 0.025% and 0.035% lotion: 4 topical applications/day. Capsaicin 0.025% patch: 1 patch/day for up to 12 hours. Capsaicin 0.075% topical solution: 4 applications/day. Safety and efficacy of capsaicin 8% patch, topical creams, and other topical solutions have not been established.
8 to 11 years: Capsaicin 0.025% lotion: 4 topical applications/day. Capsaicin 0.025% patch: 1 patch/day for up to 12 hours. Safety and efficacy of capsaicin 8% patch, capsaicin 0.035% lotion, topical creams, and topical solutions have not been established.
1 to 7 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Mechanism Of Action
Capsaicin depletes and prevents reaccumulation of substance P in peripheral sensory neurons. Substance P is found in slow-conducting, unmyelinated type C neurons that innervate the dermis and epidermis. Substance P is thought to be the primary chemical mediator of pain impulses from the periphery to the central nervous system. It can also be released into joint tissues, where it activates inflammatory substances involved in the development of rheumatoid arthritis. By depleting substance P, capsaicin renders skin and joints insensitive to pain since local pain impulses cannot be transmitted to the brain. When capsaicin therapy is discontinued, substance P reaccumulates and neuronal sensitivity returns to normal.
Pharmacokinetics
Capsaicin is administered topically. Capsaicin binds to the TRPV1 proteins located on pain and heat neurons. Capsaicin is metabolized by CYP450 enzymes and carboxyesterase class enzymes; metabolites possess less potential at VR1 receptors.
Affected cytochrome P450 isoenzymes (Capsaicin): CYP1A1, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4
Capsaicin is extensively metabolized by CYP450 isoenzymes; however, clinically significant drug interactions are not expected.
Following the topical application of capsaicin, systemic exposure is minimal. Application of a single capsaicin 8% topical patch resulted in low systemic exposure to capsaicin in one-third of an unstated number of studied patients; Cmax was less than 5 ng/mL in all patients and occurred at 60 minutes after patch application. The capsaicin plasma concentration of most patients was undetectable within 3 to 6 hours following patch removal. Use of a single 60 minute patch results in >= 30% relief of postherpetic neuralgia in as soon as 1 week and persisting for up to 12 weeks following application.
Pregnancy And Lactation
Capsaicin topical use appears to be of low risk during pregnancy. Capsaicin is negligibly absorbed systemically following topical administration, and maternal use is not expected to result in fetal exposure to capsaicin. In animal reproductive studies, no evidence of malformations was observed when capsaicin was administered by the topical route (patches or topical solution) to pregnant rats and rabbits during the period of organogenesis at doses of up to 11- and 37-times, respectively, the maximum recommended human dose (MRHD) of 716 mg/day capsaicin via skin patch.
Topical use of capsaicin appears to be compatible with breast-feeding. Capsaicin is negligibly absorbed systemically following topical administration, and breast-feeding is not expected to result in exposure of the infant to capsaicin. There are no data on the effects of capsaicin on milk production. To minimize potential direct exposure of capsaicin to the breastfed infant, avoid applying capsaicin directly to the nipple and areola.