QUTENZA- capsaicin

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)

Available from:

Acorda Therapeutics, Inc.

INN (International Name):

capsaicin

Composition:

capsaicin 640 ug in 1 cm2

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Qutenza is indicated for the management of neuropathic pain associated with postherpetic neuralgia. None. Teratogenic effects: Pregnancy Category B There are no adequate and well-controlled studies evaluating Qutenza in pregnant women. There was no evidence of fetal teratogenicity in embryofetal developmental toxicological studies conducted in pregnant rats and rabbits in which Qutenza patches (rats) or liquid (rabbits) were applied once daily for a 3 hour duration during the period of fetal organogenesis up to doses corresponding to an 11-fold (rat, 32 mg capsaicin patch/day) and 37-fold (rabbit, 260 mg capsaicin/day) margin over the maximum recommended human dose [MRHD] based on a C max exposure comparison. In a peri- and post-natal reproduction toxicology study, pregnant female rats were treated with Qutenza patches at doses up to 32 mg capsaicin patch/rat/day applied once daily for a 3 hours duration during gestation and lactation (from gestation day 7 through day 28 postpartum). Analyses of milk samples

Product summary:

Qutenza (capsaicin) 8% patch is a single-use patch stored in a sealed pouch (NDC 10144-920-00). Each individual patch is printed with "capsaicin 8%". Cleansing Gel is provided in a 50 g tube. Qutenza is available in the following presentations : Carton of 1 patch and 50 g tube of Cleansing Gel (NDC 10144-928-01). Carton of 2 patches and 50 g tube of Cleansing Gel (NDC 10144-929-01). Store carton between 20° to 25°C (68° to 77°F). Excursions between 15°C and 30°C (59°F and 86°F) are allowed. Keep the patch in the sealed pouch until immediately before use. Qutenza contains capsaicin capable of producing severe irritation of eyes, skin, respiratory tract and mucous membranes. Do not dispense Qutenza to patients for self-administration. It is critical that health care professionals who administer Qutenza have completely familiarized themselves with proper dosing, handling, and disposal procedures before handling Qutenza to avoid accidental or inadvertent capsaicin exposure to themselves or others [ see Dosage and Administration (2) ].

Authorization status:

New Drug Application

Summary of Product characteristics

QUTENZA- CAPSAICIN
ACORDA THERAPEUTICS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUTENZA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR QUTENZA.
QUTENZA (CAPSAICIN) 8% PATCH
INITIAL U.S. APPROVAL: 2009
INDICATIONS AND USAGE
Qutenza is a TRPV1 channel agonist indicated for the management of
neuropathic pain associated with postherpetic
neuralgia (PHN). ( 1)
DOSAGE AND ADMINISTRATION
Only physicians or health care professionals under the close
supervision of a physician are to administer Qutenza. ( 2.1)
Do not use Qutenza on broken skin. ( 2.1)
Apply Qutenza to the most painful skin areas, using up to four
patches. ( 2.2)
Apply Qutenza for 60 minutes and repeat every 3 months or as warranted
by the return of pain (not more frequently
than every three months). ( 2.2)
Use only nitrile (not latex) gloves when handling Qutenza and when
cleaning treatment areas. ( 2.1)
Before patch application, a physician must identify and mark the
painful area, including areas of hypersensitivity and
allodynia. ( 2.3)
Apply a topical anesthetic before Qutenza application. ( 2.3)
Apply Qutenza by placing on the skin while slowly removing the release
liner from underneath. ( 2.3)
Remove the Qutenza patches by gently and slowly rolling them inward. (
2.3)
After removal of Qutenza, apply Cleansing Gel for one minute and then
remove it with a dry wipe. ( 2.3)
Treat acute pain during and following the procedure with local cooling
and/or analgesics. ( 5.4)
Dispose of patches and other treatment materials immediately after use
in accordance with local biomedical waste
procedures. ( 2.1)
The treated area may be sensitive for a few days to heat (e.g., hot
showers/baths, direct sunlight, vigorous exercise). (
2.3)
DOSAGE FORMS AND STRENGTHS
Qutenza patch contains 8% capsaicin (640 mcg/cm
). Each patch contains a total of 179 mg of capsaicin. ( 3)
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Do not use near eyes or mucous membranes. ( 5.1)
Inhalation o