Diclona Gel

Generic name: lidocaine, diclofenac
Dosage form: gel

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

Diclona Gel

(Lidocaine 4.5%, Diclofenac Sodium 1%)

Rx only

Diclona Gel 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.

Diclona Gel - 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 tightly to serum albumin.

Metabolism

It is not known if Diclona Gel is metabolized in the skin. Metabolism of diclofenac sodium following topical administration is thought to be similar to that after oral administration. The small amounts of diclofenac sodium and its metabolites appearing i...