capsaicin transdermal (Rx, OTC)

Brand and Other Names:Qutenza, Salonpas Gel Patch
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

transdermal patch (Rx, Qutenza)

  • 8%; contains 640mcg/sq.cm (179mg/patch)

transdermal patch (OTC, Salonpas Gel Patch)

  • 0.025%
  • 0.075%

Neuropathic Pain

Qutenza only

Indicated for neuropathic pain associated with postherpetic neuralgia (PHN) or diabetic peripheral neuropathy (DPN) of the feet

PHN: Apply up to 4 patches to affected area(s) for 60 min

DPN: Apply up to 4 patches for 30 min on feet

Repeat every 3 months or as warranted by the return of pain; not to exceed every 3 months

Skeletomuscular Pain

Salonpas Gel Patch (OTC): Apply patch to affected area up to 3-4 times daily for 7 days; patch may remain in place for up to 8 hr

Safety and efficacy not established

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Adverse Effects

>10%

Qutenza (PHN)

  • Transient increased pain at application site (63%)
  • Application site erythema (42%)

Qutenza transdermal patch (DPN)

  • Burning sensation at application site (14%)
  • Pain in extremity (11%)

1-10%

Qutenza (PHN)

  • Papules at application site (6%)
  • Pruritus at application site (6%)
  • Nausea (5%)
  • Application site edema (4%)
  • Nasopharyngitis (4%)
  • Vomiting (3%)
  • Sinusitis (3%)
  • Pruritus (2%)
  • Bronchitis (2%)
  • Hypertension (2%)
  • Application site swelling (2%)
  • Skin dryness at application site (2%)

Qutenza transdermal patch (DPN)

  • Pain at application site (10%)
  • Upper respiratory tract infection (4%)
  • Headache (3%)
  • Excoriation (2%)
  • Erythema at application site (2%)
  • Cough (2%)
  • Hypertension (2%)

<1%

Qutenza (PHN)

  • Palpitations
  • Tachycardia
  • Eye pruritus
  • Application site reactions (ie, urticaria, paresthesia, dermatitis, hyperesthesia)

Qutenza (DPN)

  • Dizziness
  • Dysesthesia
  • Blister

Postmarketing Reports

Second-degree burn and scarring; accidental exposure (including eye pain, cough, eye and throat irritation)

Sensory function reduction

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Warnings

Contraindications

Hypersensitivity

Cautions

Monitor for at least 1 hour after patch application because of risk for increased blood pressure

Remove patch gently to avoid aerosolization (airborne capsaicin can result in coughing or sneezing)

Treated area may be sensitive to heat for several days (eg, hot water, direct sunlight, vigorous exercise)

Substantial procedural pain and burning upon application and following patch removal have occurred; prepare to treat acute pain during and following application procedure with local cooling (such as an ice pack) and/or appropriate analgesic medication

Transient increases in blood pressure may occur with treatment; monitor blood pressure during and following treatment procedure

Reductions in sensory function have been reported following administration; if sensory deterioration or loss is detected or pre-existing sensory deficit worsens, reconsider continuing treatment

Severe irritation with unintended capsaicin exposure

  • Do not apply to the face, eyes, mouth, nose, or scalp to avoid risk of exposure to eyes or mucous membranes
  • Accidental exposure to the eyes and mucous membranes can occur from touching patch or items exposed to capsaicin and then touching the eyes and mucous membrane
  • Wear nitrile gloves and avoid touching items or surfaces that the patient may later touch
  • Inhalation of airborne capsaicin can result in coughing or sneezing; if irritation of eyes or airway occurs, remove affected individual from vicinity and flush mucous membranes or eyes with water
  • If skin not intended to be treated comes into contact with medication, apply cleansing gel and then wipe off with dry gauze
  • Thoroughly clean all areas and items exposed to medication and dispose of properly
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Pregnancy & Lactation

Pregnancy

Capsaicin is negligibly absorbed systemically following topical administration, and maternal use is not expected to result in fetal exposure

Animal data

  • No evidence of malformations observed when capsaicin was topically administered daily to pregnant rats and rabbits during organogenesis at doses of up to 11- and 37-times, respectively, the maximum recommended human dose (MRHD) at 716 mg capsaicin per day (4 patches containing 179 mg/patch)

Lactation

Negligible systemic absorption following topical administration

Breastfeeding is not expected to result in infant exposure

To minimize potential direct exposure to the breast infant, avoid applying directing to the nipple or areola

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Transient receptor potential vanilloid-1 (TRPV1) agonist; topical application causes initial TRPV1 stimulation that may cause pain, followed by pain relief by reduction in TRPV1-expressing nociceptive nerve endings

Absorption

Qutenza

  • Systemic absorption negligible
  • Peak plasma concentration: Transient, low (<5 ng/mL) systemic exposure in one-third of patients following 60-min application; 4.6 ng/mL was highest level detected

Elimination

Qutenza

  • Half-life: 1.64 hr
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Administration

Transdermal Administration (Qutenza)

Do not dispense to patients for self-administration or handling

Only physicians or healthcare professionals under the close supervision of a physician are to administer and handle patch

Administer in a well-ventilated treatment area

Use nitrile gloves during application process; do not use latex gloves as they do not provide adequate protection

Use of a face mask and protective glasses recommended

Keep patch in sealed pouch until immediately before use

Use only on dry, intact (unbroken) skin

DPN: Carefully examine feet before each application to detect skin lesions related to underlying neuropathy or vascular insufficiency

During administration, avoid unnecessary contact with any items in the room, including items that the patient may later have contact with, such as horizontal surfaces and bedsheets

Patch removal

  • Gently remove and slowly roll them inward (avoid aerosolization)
  • Cleanse skin by generously applying cleansing gel (supplied with patch) to affected area, leave on for at least 1 minute, then remove with dry wipe and gently wash area with mild soap and water
  • Immediately after use, clean all areas that had contact with drug and properly dispose patch
  • If patch is cut, ensure unused pieces are disposed properly

Storage

Store carton between 20-25ºC (68-77ºF), excursions to 15-30ºC (59-86ºF)

Keep in the sealed pouch until immediately before use

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.