metvixia- methyl aminolevulinate hydrochloride cream

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

methyl aminolevulinate hydrochloride (UNII: 7S73606O1A) (methyl aminolevulinate - UNII:585NM85KYM)

Commercializzato da:

Penn Pharmaceutical Services Ltd.

INN (Nome Internazionale):

methyl aminolevulinate hydrochloride

Forma farmaceutica:

CREAM

Composizione:

168 mg in 1 g

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Metvixia Cream in combination with 570 to 670 nm wavelength red light illumination using the CureLight BroadBand Model CureLight 01 lamp is indicated for treatment of non-hyperkeratotic actinic keratoses of the face and scalp in immunocompetent patients when used in conjunction with lesion preparation (debridement using a sharp dermal curette) in the physician’s office when other therapies are unacceptable or considered medically less appropriate. Metvixia Cream is contraindicated in patients with cutaneous photosensitivity, or known allergies to porphyrins, and in patients with known sensitivities to any of the components of Metvixia Cream, which includes peanut and almond oil (See WARNINGS regarding sensitivity to Metvixia Cream). This product contains refined peanut oil (See PRECAUTIONS).

Dettagli prodotto:

Metvixia Cream, 16.8%, is available as the following: NDC 63069-401-01, 2 gram aluminum tube, box of 1 Keep out of reach of children For topical use only by physicians in the physician’s office. Rx Only Store refrigerated, 2-8°C (36-46°F). Use contents within one week after opening. Should not be used after 24 hours out of refrigerator. Metvixia Cream is a registered trade name of PhotoCure ASA. PhotoCure ASA, Hoffsveien 48, N-0377 Oslo, Norway USA Contact: Cato Research, Westpark Corporate Center, 4364 South Alston Avenue, Durham NC 27713 Revision: September 5, 2007

Scheda tecnica

METVIXIA- METHYL AMINOLEVULINATE HYDROCHLORIDE CREAM
PENN PHARMACEUTICAL SERVICES LTD.
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METVIXIA™ (METHYL AMINOLEVULINATE) CREAM, 16.8%
FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE
MUST BE DISPENSED TO AND APPLIED BY A PHYSICIAN.
DESCRIPTION
Metvixia Cream is an oil in water emulsion. Metvixia Cream contains
methyl aminolevulinate
hydrochloride equivalent to168 mg/g of methyl aminolevulinate.
Methyl aminolevulinate hydrochloride is a white to slightly yellow
powder that is freely soluble in
water and methanol, soluble in ethanol and practically insoluble in
most organic solvents.
The chemical formula for methyl aminolevulinate HCl is C H NO ·HCl
(MW=181.62) and it has the
following structural formula:
Metvixia Cream contains glyceryl monostearate, cetostearyl alcohol,
polyoxyl stearate, cholesterol and
oleyl alcohol as emulsifying agents. It also contains glycerin, white
petrolatum, isopropyl myristate,
refined peanut oil, refined almond oil as emollients, edetate disodium
as a chelating agent and
methylparaben and propylparaben as preservatives.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Photosensitization following application of Metvixia Cream occurs
through the metabolic conversion
of methyl aminolevulinate (prodrug) to photoactive porphyrins (PAP),
which accumulates in the skin
lesions to which Metvixia Cream has been applied. When exposed to
light of appropriate wavelength
and energy, the accumulated photoactive porphyrins produce a
photodynamic reaction, resulting in a
cytotoxic process dependent upon the simultaneous presence of oxygen.
The absorption of light results
in an excited state of porphyrin molecules, and subsequent spin
transfer from photoactive porphyrins to
molecular oxygen generates singlet oxygen, which can further react to
form superoxide and hydroxyl
radicals. Photosensitization of actinic (solar) keratosis lesions
using Metvixia Cream, plus illumination
with a CureLight BroadBand Model CureLight 01 (a red light of 570 to
670 nm wavelength) at 75
J/cm ,