Capzasin (capsaicin/menthol)

No dosing information is available for this tab.

Capsaicin 8% is commercially available as a single-use topical system stored in a foil pouch; each topical system contains 179 mg of capsaicin. Apply capsaicin 8% topical system to affected areas of the skin. The topical system 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.

Use nitrile gloves when handling the topical system; do not use latex gloves. Use of a face mask and protective glasses is also advised for healthcare professionals.

Store capsaicin 8% topical system at 20-25degreesC (excursions permitted between 15-30degreesC) in its 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 topical system 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 topical system 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 topical system; do not shave the hair. The topical system may be cut to match the size and shape of the treatment area before removing the protective release liner. Up to 4 topical systems may be used during a single treatment session to cover larger areas. Once the topical system 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 topical system to ensure that it maintains contact with the treatment area.

At the end of the treatment session, use nitrile gloves to remove the topical system by gently and slowly rolling the topical system 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 is available for this tab.

No dosing information is available for this tab.

No clinical drug interaction studies have been performed with capsaicin 8% topical system. In vitro studies indicate that the drug does not inhibit or induce cytochrome P-450 (CYP) enzymes at concentrations that far exceed those in blood concentrations of patients receiving capsaicin 8% topical system; therefore, drug interactions with systemic medications are unlikely.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*None.

There are no contraindication contraindications for this drug.

• Burns

There are no moderate contraindications for this drug.

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

Rare or Very Rare

• Burns
• Burns
• Hypertension
• Severe burns

More Frequent

• Blistering skin
• Contact dermatitis

Less Frequent

• Acute pain at drug application site
• Application site skin reactions
• Erythema
• Pruritus of skin
• Stinging of skin

Rare or Very Rare

• Cough
• Dysgeusia
• Headache disorder
• Ocular pain
• Reduced sensation of skin
• Stinging of skin

No enhanced messaging available.

The safety and effectiveness of capsaicin 8% topical system in pediatric patients younger than 18 years of age have not been established.

Maternal use of capsaicin 8% topical system 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 observed when capsaicin was administered daily by the topical route 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) at 716 mg capsaicin per day (4 topical systems containing 179 mg/topical system). In a peri- and postnatal development study, no adverse effects were observed when capsaicin was administered daily 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% topical system 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 topical system directly to the nipple and areola. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for capsaicin and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

No dosage adjustments are required in geriatric patients.

In controlled clinical trials of capsaicin 8% topical system in patients with postherpetic neuralgia, 75% of patients were 65 years of age and older and 43% of patients were 75 years of age and older. The safety and effectiveness were similar in geriatric patients and younger patients.