Version December 2023
Diabetic neuropathy: Topical:
Cream (0.075%) (off-label use): Apply 4 times/day (Ref).
Patch (Qutenza): Apply patch to most painful areas of the feet for 30 minutes. Up to 4 patches may be applied in a single application. Treatment may be repeated ≥3 months as needed for return of pain (do not apply more frequently than every 3 months).
Muscle/joint pain: Topical:
Cream, gel, liquid, lotion: Apply thin film to affected areas 3 to 4 times daily.
Patch: 0.025%, 0.03%, 0.0375%: Apply 1 patch to affected area for up to 8 hours (maximum: 4 patches/day); do not use for >5 consecutive days (product specific).
Neuropathic pain: Topical: Patch (Qutenza): Apply patch to most painful area for 60 minutes. Up to 4 patches may be applied in a single application. Treatment may be repeated ≥3 months as needed for return of pain (do not apply more frequently than every 3 months).
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
(For additional information see "Capsaicin: Pediatric drug information")
Muscle ache and joint pain, minor: Topical:
Lotion 0.025% (DiabetAid Tingling and Pain Relief): Children ≥8 years and Adolescents: Topical: Apply to affected area not more than 3 to 4 times/day.
Patch: Note: With OTC products, approved ages and uses may vary; consult product-specific labeling.
Product strength <0.05%:
Children ≥12 years and Adolescents: Topical:
Flexin (0.0375%): Apply 1 patch to affected area; may change 2 to 3 times/day; maximum daily dose: 3 patches/day.
Levatio (0.03%): Apply 1 patch to affected area for up to 8 hours; change patch 1 to 2 times daily; maximum daily dose: 4 patches/day; do not use for >5 consecutive days.
MenCaps (0.0225%): Apply 1 patch to affected area for up to 8 hours; may change patch up to 3 times daily.
Releevia MC (0.0375%), Renovo (0.0375%): Apply 1 patch to affected area; may change patch 1 to 2 times daily; maximum daily dose: 3 patches/day.
Salonpas Pain Relieving Hot Patch (0.025%): Apply 1 patch to affected area for up to 8 hours; may change patch up to 3 to 4 times daily.
Product strength 0.05%: Adolescents ≥16 years: Topical: Allevess patch: Apply 1 patch to affected area; may change patch 1 to 2 times daily.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. The following adverse events occurred with topical patch administration.
>10%:
Local: Application-site burning (14%), application-site erythema (2% to 63%), application-site pain (10% to 42%)
Neuromuscular & skeletal: Limb pain (11%)
1% to 10%:
Cardiovascular: Hypertension (2%)
Dermatologic: Excoriation of skin (2%), papule of skin (application site: 6%), pruritus (2%)
Gastrointestinal: Nausea (5%), vomiting (3%)
Local: Application-site edema (2% to 4%), application-site pruritus (6%), local dryness of skin (application site: 2%)
Nervous system: Headache (3%)
Respiratory: Bronchitis (2%), cough (2%), nasopharyngitis (4%), sinusitis (3%), upper respiratory tract infection (4%)
<1%:
Cardiovascular: Palpitations, tachycardia
Dermatologic: Skin blister
Local: Application-site reaction (includes dermatitis, hyperesthesia, paresthesia, urticaria)
Nervous system: Dizziness, dysesthesia
Ophthalmic: Eye pruritus
Postmarketing:
Dermatologic: Burn (second and third degree), cicatrix of skin,
Nervous system: Abnormal sensory symptoms
Hypersensitivity to capsaicin, menthol, or any component of the formulation.
OTC labeling: When used for self-medication, do not use on wounds, damaged, broken, irritated skin, or into skin folds; do not cover with bandage; do not apply within 1 hour before or after bath, shower, hot tub, or sauna; do not use in combination with external heat source (eg, heating pad); do not use concurrently with other topical analgesics.
Concerns related to adverse effects:
• Burns: May cause serious burns (eg, first- to third-degree chemical burns) at the application site. In some cases, hospitalization has been required. Discontinue use and seek medical attention if signs of skin injury (eg, pain, swelling, or blistering) occur following application (FDA Drug Safety Communication 2012).
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).
• Irritation (8% patch): Severe irritation to the eyes, mucous membranes, respiratory tract, or skin may occur due to unintended capsaicin exposure. If irritation of the eyes or mucous membranes occurs, remove the individual from the area of the capsaicin patch and flush eyes and mucous membranes with cool water. If respiratory tract irritation (eg, coughing, sneezing) occurs, remove the individual from the area of the capsaicin patch and provide supportive care if shortness of breath develops; if respiratory irritation worsens or does not resolve, do not re-expose affected individual to capsaicin. Ensure procedures (eg, avoiding unnecessary contact with items in room, including horizontal surfaces and bedsheets, administering in well-ventilated area) and protective measures (eg, face mask, nitrile gloves, protective glasses) are used during administration. If skin not intended to be treated is exposed to the patch, apply cleansing gel for 1 minute and remove with dry gauze; after cleansing gel has been removed, wash the area with soap and water; postapplication pain should be treated with local cooling methods (ice pack) and/or analgesics. Clean all areas that had contact with capsaicin
• Sensory function reduction (8% patch): Decreased sensory function, including to thermal and other harmful stimuli, has been reported; effects are usually minor and temporary. Patients with preexisting sensory deficits should be assessed for sensory deterioration or loss prior to each patch application. Continued use should be reevaluated for new onset or worsening of existing sensory deficits.
Disease-related concerns:
• Cardiovascular disease: Use the 8% patch with caution in patients with uncontrolled hypertension or a history of cardiovascular events; transient increases in BP due to treatment-related pain have occurred during and after application. Monitor BP periodically during and following treatment.
• Cerebrovascular disease: Use the 8% patch with caution in patients with a history of cerebrovascular events; transient increases in BP due to treatment-related pain have occurred during and after application of RX patch. Monitor BP periodically during and following treatment.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.
• Patch (8%): Avoid inhaling airborne material from dried residue. Remove patches gently and slowly to decrease risk of aerosolization; inhalation of airborne capsaicin may result in coughing or sneezing.
Other warnings/precautions:
• Appropriate use: For external use only; avoid contact with eyes, mouth, genitals, or any or other mucous membranes. Do not use immediately before or after activities such as bathing, swimming, showering, sunbathing, strenuous exercise, steam bath, sauna, or other heat or sunlight exposure to the treated area. Stop use and consult a health care provider if excessive redness, blistering burning or irritation develops, symptoms get worse, symptoms persist for >7 days, symptoms resolve and then recur, or if difficulty breathing or swallowing occurs. Do not handle contact lenses for 1 hour after handling, applying, or removing capsaicin (product specific).
• OTC labeling: Transient burning may occur and generally disappears after several days.
• RX labeling: Do not cover with bandage or compression. Use only on intact skin; do not use on wounds, damaged, broken, infected, sensitive, or inflamed skin. Do not apply to face or scalp. Do not use concurrently with other external pain-relieving products.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External:
Arthritis Pain Relieving: 0.075% (57 g) [odor free; contains benzyl alcohol, cetyl alcohol]
Axsain: 0.25% (60 g [DSC]) [contains benzyl alcohol, cetyl alcohol]
Capsaicin HP: 0.1% (60 g) [contains cetearyl alcohol, propylene glycol, trolamine (triethanolamine)]
Capzix: 0.1% (56.6 g) [contains benzyl alcohol, cetyl alcohol]
Circata: 0.05% (57 g) [contains cetearyl alcohol]
DermacinRx Circatrix: 0.05% (57 g) [contains cetearyl alcohol]
DermacinRx Penetral: 0.025% (118 mL, 237 mL) [contains capsicum oleoresin, trolamine (triethanolamine)]
Sure Result SR Relief: 0.025% (118 mL) [contains cetearyl alcohol, trolamine (triethanolamine)]
Zostrix HP: 0.1% (56.6 g [DSC]) [odor free; contains benzyl alcohol, cetyl alcohol]
Zostrix HP: 0.1% (56.6 g) [odorless; contains benzyl alcohol, cetyl alcohol]
Zostrix Natural Pain Relief: 0.033% (56.6 g) [odor free; contains benzyl alcohol, cetyl alcohol]
Generic: 0.025% (25 g, 50 g, 60 g, 120 g); 0.075% (120 g); 0.1% (42.5 g)
Kit, External:
Qutenza: 8% [packaged with cleansing gel] [contains edetate (edta) disodium, polyethylene glycol (macrogol)]
Qutenza (2 Patch): 8% [packaged with cleansing gel] [contains edetate (edta) disodium, polyethylene glycol (macrogol)]
Qutenza (4 Patch): 8% [packaged with cleansing gel] [contains edetate (edta) disodium, polyethylene glycol (macrogol)]
Lotion, External:
Bio-Therm Pain Relieving: 0.002 % (113.4 g [DSC]) [contains cetearyl alcohol, trolamine (triethanolamine)]
Castiva Warming: 0.035% (113 g) [contains cetyl alcohol, methylparaben, propylene glycol, propylparaben, sd alcohol 40b]
Douleurin: 0.025% (120 mL) [contains cetyl alcohol, propylene glycol, trolamine (triethanolamine)]
Limencin: 0.025% (120 mL) [contains cetyl alcohol, iodopropynyl butylcarbamate, methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]
New Terocin: 0.025% (10 mL, 120 mL) [contains cetyl alcohol, methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]
Patch, External:
Alivio: 0.03% [contains menthol 5%] (15 ea) [contains polysorbate 80]
Allevess: 0.05% [contains menthol 5%] (15 ea)
Asperflex Hot Pain Relieving: 0.025% [contains menthol 1.25%] (6 ea) [contains edetate (edta) disodium, propylene glycol]
Capsaicin Topical Pain Patch: 0.025% (5 ea) [contains edetate (edta) disodium, polysorbate 80, propylene glycol]
Capsiderm: 0.0375% [contains menthol 5%] (15 ea) [contains polysorbate 80]
Flexin: 0.0375% [contains menthol 5%] (15 ea [DSC]) [contains edetate (edta) disodium, methylparaben, polysorbate 80, propylparaben]
Levatio: 0.03% [contains menthol 5%] (15 ea) [contains polysorbate 80]
MenCaps: 0.0225 % (15 ea) [contains disodium edta, methylparaben, polysorbate 80, propylparaben]
Menthozen Hydrogel: 0.03% [contains menthol 4%] (5 ea) [contains edetate (edta) disodium, methylparaben, polysorbate 80]
Reliever: 0.05% [contains menthol 5%] (15 ea)
Renovo: 0.0375% [contains menthol 5%] (3 ea [DSC], 15 ea [DSC]) [contains edetate (edta) disodium, methylparaben, polysorbate 80, propylparaben]
Salonpas Gel-Patch Hot: 0.025% [contains menthol 1.25%] (6 ea [DSC]) [contains edetate (edta) disodium, propylene glycol]
Salonpas Pain Rel Gel-Ptch Hot: 0.025% [contains menthol 1.25%] (6 ea) [contains edetate (edta) disodium, propylene glycol]
Salonpas-Hot: 0.025% (3 ea)
Generic: 0.025% (5 ea, 10 ea); 0.0225 % (15 ea [DSC])
Stick, External:
Zostrix-HP: 0.075% (1 g [DSC]) [contains propylene glycol, triclosan]
May be product dependent
Cream (Capsaicin External)
0.025% (per gram): $6.84 - $7.08
0.075% (per gram): $5.30
0.1% (per gram): $0.33
Cream (Circata External)
0.05% (per gram): $33.77
Cream (DermacinRx Circatrix External)
0.05% (per gram): $33.77
Cream (DermacinRx Penetral External)
0.025% (per mL): $11.44
Cream (Zostrix HP External)
0.1% (per gram): $0.23
Cream (Zostrix Natural Pain Relief External)
0.033% (per gram): $0.34
Kit (Qutenza (2 Patch) External)
8% (per each): $2,091.18
Kit (Qutenza (4 Patch) External)
8% (per each): $4,182.37
Kit (Qutenza External)
8% (per each): $1,045.60
Lotion (Castiva Warming External)
0.035% (per gram): $0.11
Lotion (Douleurin External)
0.025-10-25% (per mL): $3.29
Patch (Alivio External)
0.03-5% (per each): $59.83
Patch (Asperflex Hot Pain Relieving External)
0.025-1.25% (per each): $0.79
Patch (Capsaicin External)
0.025% (per each): $52.20 - $52.60
Patch (Menthozen Hydrogel External)
0.03-4% (per each): $48.00
Patch (Salonpas Pain Rel Gel-Ptch Hot External)
0.025-1.25% (per each): $1.73
Patch (Salonpas-Hot External)
0.025% (per each): $1.84
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Topical products (cream, gel, liquid, lotion): Avoid contact with eyes and mucous membranes. Gently rub into painful area until thoroughly absorbed. Wash hands with soap and water immediately after applying (unless hands are part of the treatment area). If applying cream to hands, wait 30 minutes before washing hands.
Topical patch:
≤0.05% products: Apply patch externally to clean and dry affected area. Remove protective film prior to application. May cut patch to desired size prior to removing the film (product specific). Do not use within 1 hour prior to a bath or immediately after bathing. Do not use with a heating pad.
8% product (Qutenza): Patch should only be applied by a health care provider in a well-ventilated area. The treatment area must be identified and marked by the health care provider. May cut patch (prior to removing the protective release liner) to match size/shape of treatment area. If necessary, excessive hair present on and surrounding the treatment area may be clipped (not shaved). Prior to application, the treatment area should be cleansed with mild soap and water and dried thoroughly. If needed, the treatment area and surrounding 1 to 2 cm may be anesthetized with a topical anesthetic prior to patch application to reduce application discomfort; keep the local anesthetic in place until the skin is anesthetized and then remove with a dry wipe; cleanse area again with soap/water and dry thoroughly. Keep patch in sealed pouch until immediately before use; patch may then be applied to dry, intact skin using nitrile gloves (latex gloves should not be used). Use of a face mask and protective glasses are also recommended during application. During administration, avoid unnecessary contact with items in room (eg, items patient may later have contact with, including bedsheets, horizontal surfaces). If applying to feet, examine feet to detect skin lesions prior to patch application. During application, slowly peel back the release liner under the patch and use other hand to smooth patch onto skin. If applying to feet, patch may be wrapped around the dorsal, lateral, and plantar surfaces of each foot to completely cover treatment area. Patch should remain in place for 30 minutes if applying to feet or 60 minutes for all other areas; to ensure patch remains on treatment area, a dressing (eg, rolled gauze) may be used. Remove patches gently and slowly by rolling adhesive side inward. Following patch removal, apply cleansing gel to the treatment area and leave in place for at least 1 minute. Remove cleansing gel with a dry wipe and gently wash the area with mild soap and water and dry thoroughly. Clean all areas that came in contact with patch; all treatment materials (including used and unused cut patches, associated packaging, cleansing gel, gloves, other treatment materials) should be disposed of according to biomedical waste procedures.
Topical:
Cream, gel, liquid, and lotion: Avoid contact with eyes and mucous membranes. Avoid applying on wounds, damaged, or irritated skin. Gently rub into painful area until thoroughly absorbed. Wash hands with soap and water immediately after applying (unless hands are part of the treatment area). If applying cream to hands, wait 30 minutes before washing hands. Do not use with a heating pad. Avoid direct exposure of treated area to heat or sunlight. Do not bandage.
Patch: Product strength ≤0.05%: Avoid contact with face, scalp, eyes, mouth, and mucous membranes. Avoid applying on wounds or damaged or sensitive skin. Apply patch externally to clean and dry affected area. Remove protective film prior to application. May cut patch to desired size prior to removing the film (product specific). Do not use within 1 hour prior to a bath or immediately after bathing. Do not use with a heating pad or any compression bandage or device. Wash hands with soap and water after applying.
Muscle/Joint pain: Temporary relief of minor aches and pains of muscles and joints associated with simple backache, muscle strains, sprains, arthritis, bruises, or cramps.
Neuropathic pain (8% patch): Management of neuropathic pain associated with postherpetic neuralgia and diabetic peripheral neuropathy of the feet in adults.
Burning mouth syndrome (topical); Diabetic neuropathy; Pain associated with psoriasis and intractable pruritus
Zostrix may be confused with Zestril, Zovirax
Substrate of CYP2E1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
There are no known significant interactions.
Systemic absorption is limited following topical administration of the patch, and fetal exposure is not expected following maternal use; plasma concentrations are below the limit of detection 3 to 6 hours after the patch is removed.
Systemic absorption is limited following topical administration of the 8% patch, and exposure via breast milk is not expected following maternal use.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. To minimize potential exposure to a breastfed infant, avoid application to the nipple and surrounding area.
8% patch: BP periodically during and following treatment; sensory deficits.
Capsaicin is an agonist for the transient receptor potential vanilloid 1 receptor (TRPV1), an ion channel-receptor complex expressed on nociceptive nerve fibers in the skin. Topical administration of capsaicin causes an initial enhanced stimulation of the TRPV1-expressing cutaneous nociceptors that may be associated with painful sensations followed by pain relief mediated by a reduction in TRPV1-expressing nociceptive nerve endings, a process that has been described as nociceptor defunctionalization (Anand 2011).
Onset of action: OTC products (capsaicin 0.025% to 0.1%): 2 to 4 weeks of continuous therapy; Qutenza patch: 1 week after application
Absorption: Topical patch (capsaicin 8%): Systemic absorption is transient and low (<5 ng/mL) in approximately one-third of patients when measured following 60-minute application. In patients with quantifiable concentrations, most fell below the limit of quantitation at 3 to 6 hours post application.
Half-life elimination: Topical patch (capsaicin 8%): 1.64 hours (Babbar 2009)
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