DICLONA GEL- lidocaine 4.5%, diclofenac 1% gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1), LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

Available from:

Terrain Pharmaceuticals

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diclona Gel is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product. Diclona Gel is contraindicated in patients with a known hypersensitivity to diclofenac sodium. Diclona Gel is contraindicated in patients in the setting of coronary artery bypass graft (CABG) surgery.

Product summary:

Diclona Gel is available as the following: 1 tube, 3.5oz NDC 53225-1070-1 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. For more information, contact Terrain Pharmaceuticals. [e-mail] Manufactured for: Terrain Pharmaceuticals Reno, NV 89501 Printed in the U.S.A

Authorization status:

unapproved drug other

Summary of Product characteristics

DICLONA GEL- LIDOCAINE 4.5%, DICLOFENAC 1% GEL
TERRAIN PHARMACEUTICALS
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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DICLONA GEL
DICLONA GEL
(Lidocaine 4.5%, Diclofenac Sodium 1%)
Rx only
DESCRIPTION
Diclona Gel (Lidocaine 4.5%, Diclofenac 1%) is comprised of a gel
inside of a 3.5oz tube
containing 4.5% Lidocaine and 1% Diclofenac Sodium.
Inactive ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Arnica
Montana Flower
Extract, Boswellia Serrata Extract, Carbomer, Dimethyl Sulfoxide,
Ethylhexylglycerin,
Eucalyptus Globulus Leaf Oil, Methylsulfonylmethane, Phenoxyethanol,
Prunus
Amygdalus Dulcis (Sweet Almond) Oil, SD Alcohol 40-B, Sorbitol,
Triethanolamine, Water.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Lidocaine is an amide-type local anesthetic agent. The penetration of
lidocaine into intact
skin after application of Diclona Gel is sufficient to produce
analgesic effect, but less
than the amount necessary to produce a complete sensory block. 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
The amount of lidocaine systemically absorbed from Diclona Gel is
directly related to
both the duration of application and the surface area over which it is
applied. When
Diclona Gel is applied topically, diclofenac sodium is absorbed into
the epidermis. The
systematic bioavailability after topical application of diclofenac
sodium is lower than after
oral dosing.
DISTRIBUTION
At concentrations produced by application of Diclona Gel,
approximately 70% of the
lidocaine dose is reported to be bound to plasma proteins, primarily
alpha-1-acid
glycoprotein. At higher plasma concentrations (1 to 4 mcg/mL of free
base), the plasma
protein binding of lidocaine is concentration dependent. Diclofenac
sodium binds