DICLOFENAC SODIUM gel

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

diclofenac sodium (UNII: QTG126297Q) (diclofenac - UNII:144O8QL0L1)

Tillgänglig från:

Pharmaceutica North America, Inc

INN (International namn):

diclofenac sodium

Sammansättning:

diclofenac sodium 30 mg in 1 g

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Diclofenac Sodium Gel is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy. Diclofenac Sodium Gel is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 350 and/or hyaluronate sodium.

Produktsammanfattning:

Diclofenac Sodium Gel, 3% is available in 100 g (NDC 45861-063-01) tubes. Each gram of gel contains 30 mg of diclofenac sodium. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from heat. Avoid freezing.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
PHARMACEUTICA NORTH AMERICA, INC
----------
DICLOFENAC
SODIUM GEL, 3%
RX ONLY
FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
Diclofenac Sodium Gel, 3%, contains the active ingredient, diclofenac
sodium, in a clear, transparent,
colorless to slightly yellow gel base. Diclofenac sodium is a white to
slightly yellow crystalline
powder. It is freely soluble in methanol, soluble in ethanol,
sparingly soluble in water, slightly soluble
in acetone, and partially insoluble in ether. The chemical name for
diclofenac sodium is:
Sodium [o-(2,6-dichloranilino) phenyl] acetate
Diclofenac sodium has a molecular weight of 318.13.
The CAS number is CAS-15307-79-6. The structural formula is
represented below:
Diclofenac Sodium Gel, 3% also contains benzyl alcohol, hyaluronate
sodium, polyethylene glycol
monomethyl ether, and purified water.
1 g of Diclofenac Sodium Gel contains 30 mg of the active substance,
diclofenac sodium.
CLINICAL PHARMACOLOGY
The mechanism of action of diclofenac sodium in the treatment of
actinic keratoses (AK) is unknown.
The contribution to efficacy of individual components of the vehicle
has not been established.
PHARMACOKINETICS
Absorption
When diclofenac sodium gel is applied topically, diclofenac is
absorbed into the epidermis. In a study
in patients with compromised skin (mainly atopic dermatitis and other
dermatitic conditions) of the hands,
arms or face, approximately 10% of the applied dose (2 grams of 3% gel
over 100 cm ) of diclofenac
was absorbed systemically in both normal and compromised epidermis
after seven days, with four times
daily applications.
After topical application of 2 g diclofenac sodium gel three times
daily for six days to the calf of the
leg in healthy subjects, diclofenac could be detected in plasma. Mean
bioavailability parameters were
AUC
9±19 ng/hr/mL (mean±SD) with a C
of 4±5 ng/mL and a T
of 4.5±8 hours. In comparison,
2
0-t
max
max
® 1
a single oral 75 mg dose of diclofenac (Voltaren ) produced an AUC of
160