Peripheral neuropathic pain

Active Ingredient: Capsaicin

Indication for Capsaicin

Population group: only adults (18 years old or older)

Capsaicin is indicated for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain.

For this indication, competent medicine agencies globally authorize below treatments:

179-716 mg daily

Route of admnistration

Cutaneous

Defined daily dose

179 - 716 mg

Dosage regimen

From 44.75 To 179 mg 4 time(s) per day every day

Detailed description

Capsaicin should be applied to the most painful skin areas (using up to a maximum of 4 patches). The painful area should be determined by the physician and marked on the skin.

Capsaicin must be applied to intact, non-irritated, dry skin, and allowed to remain in place for 30 minutes for the feet (e.g. HIV-associated neuropathy) and 60 minutes for other locations (e.g. postherpetic neuralgia). Capsaicin treatments may be repeated every 90 days, as warranted by the persistence or return of pain.

The capsaicin cutaneous patch should be applied by a physician or by a health care professional under the supervision of a physician.

Nitrile gloves should be worn at all times while handling capsaicin and cleaning treatment areas. Latex gloves should NOT be worn as they do not provide adequate protection.

The treatment area should be pre-treated with a topical anaesthetic prior to application of capsaicin to reduce application related discomfort. The topical anaesthetic should be applied to cover the entire capsaicin treatment area and surrounding 1 to 2 cm. The topical anaesthetic should be used in accordance with the product’s instructions for use. In clinical trials, patients were pre-treated with topical lidocaine (4%) or lidocaine (2.5%)/prilocaine (2.5%) for 60 minutes.

Active ingredient

Capsaicin

Capsaicin, or 6-nonenamide, N-[(4-hydroxy-3-methoxyphenyl) methyl]-8-methyl, (6E), is a highly selective agonist for the transient receptor potential vanilloid 1 receptor (TRPV1). The initial effect of capsaicin is the activation of TRPV1-expressing cutaneous nociceptors, which results in pungency and erythema due to the release of vasoactive neuropeptides.

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