Mencaps

Drug overview for MENCAPS (capsaicin/menthol):

Generic name: capsaicin/menthol (kap-SAY-i-sin/MEN-thol)
Drug class:
Therapeutic class: Dermatological

Capsaicin is a transient receptor potential vanilloid 1 (TRPV1) receptor agonist.

Capsaicin is used topically for the treatment of pain. Capsaicin 8% topical system (i.e., patch) is FDA-labeled for the treatment of neuropathic pain associated withpostherpetic neuralgia (PHN) and for the treatment of neuropathic pain associated with diabeticperipheral neuropathy (DPN) of the feet. Capsaicin is also available in various over-the-counter (OTC) topical preparations for the treatment of pain due to diabetic neuropathy, herpes zoster, or arthritis; preparations available for OTC use contain lower concentrations of capsaicin (e.g., 0.025-0.15%) than the capsaicin 8% patch.

DRUG IMAGES

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The following indications for MENCAPS (capsaicin/menthol) have been approved by the FDA:

Indications:
None.

Professional Synonyms:
None.

The following dosing information is available for MENCAPS (capsaicin/menthol):

Dosing
Administration
Dosing Information
Generic

No enhanced Dosing information available for this drug.

Apply capsaicin 8% topical system to affected areas of the skin. The patches should be applied by a healthcare professional in a controlled setting to avoid severe irritation to the eyes, mucous membranes, respiratory, and skin from unintended exposure (see Handling and Disposal under Dosage and Administration). Use nitrile gloves when handling the patches; do not use latex gloves.

Use of a face mask and protective glasses is also advised for healthcare professionals. Store the patches at 20-25degreesC (excursions permitted between 15-30degreesC) in their sealed pouch until immediately before use. Inspect the pouch prior to use; do not use if the pouch has been damaged or torn.

Apply the patches to dry, intact (unbroken) skin; do not apply to the face, eyes, mouth, nose, or scalp. A physician or healthcare professional should identify and mark the treatment area (areas of hypersensitivity and allodynia). In patients with diabetic neuropathy, the patch may be wrapped around the dorsal, lateral, and plantar surfaces of each foot to completely cover the treatment area.

If necessary, hair around the treatment area can be clipped to promote adhesion of the patches; do not shave the hair. The patches may be cut to match the size and shape of the treatment area. The patches should be cut before removing the protective release liner.

Up to 4 patches may be used during a single treatment session to cover larger areas. Once the patch is applied, leave on for 60 minutes (for the treatment of postherpetic neuralgia (PHN)) or 30 minutes (for the treatment of DPN of the feet). A dressing such as rolled gauze may be used to cover the patch to ensure that it maintains contact with the treatment area.

At the end of the treatment session, use nitrile gloves to remove the patch by gently and slowly rolling the patch inward. After removal, apply the manufacturer-supplied cleansing gel to the treatment area and leave on for at least 1 minute. Remove the gel with a dry wipe and gently wash the area with mild soap and water; dry thoroughly.

The treatment area may be sensitive for a few days to heat (e.g., hot showers/baths, direct sunlight, vigorous exercise).

No dosing information available.

No generic dosing information available.

Severe List
Burns

The following adverse reaction information is available for MENCAPS (capsaicin/menthol):

Overview
Severe
Less Severe

Adverse reaction overview.

The most common adverse reactions (>=5%) reported with capsaicin 8% patch in clinical studies were application site erythema, application site pain, and application site pruritus.

There are 3 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Burns Hypertension Severe burns

There are 12 less severe adverse reactions.

More Frequent	Less Frequent
Blistering skin Contact dermatitis	Acute pain at drug application site Erythema Pruritus of skin Stinging of skin

Rare/Very Rare
Cough Dysgeusia Headache disorder Ocular pain Reduced sensation of skin Stinging of skin

The following precautions are available for MENCAPS (capsaicin/menthol):

Pediatric
Pregnant
Lactation
Geriatric

The safety and effectiveness of capsaicin 8% patch in pediatric patients younger than 18 years of agehave not been established.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Maternal use of capsaicin 8% patches is not expected to result in fetal exposure; systemic absorption of the drug following topical administration is negligible. In animal reproductive studies, no evidence of malformations were observedwhen capsaicin was administered daily by the topical route to pregnant rats and rabbitsduring the period of organogenesis at doses of up to 11- and 37-times, respectively, themaximum recommended human dose (MRHD) at 716 mg capsaicin perday (4 topical systems containing 179 mg/topical systems). In a peri- and postnataldevelopment study, no adverse effects were observed when capsaicin was administereddaily by the topical route to rats during implantation to weaning at doses of up to 11-times the MRHD.

Breastfeeding is not expected to result in fetal exposure of capsaicin; systemic absorption from topical application of capsaicin 8% patch is negligible. There are no data on the effects of capsaicin on human milk production. To minimize potential direct exposure of capsaicin to the breastfed infant, avoid applying the patches directly to the nipple andareola. Consider the developmental and health benefits of breastfeeding along withthe mother's clinical need for capsaicin and any potential adverse effects on thebreastfed infant from the drug or from the underlying maternal condition.

In controlled clinical trials of capsaicin 8% patch in patients with postherpeticneuralgia, 75% of patients were 65 years of age and older and 43% of patients were 75 yearsof age and older. The safety and effectiveness were similar in geriatric patients and youngerpatients.