Country: United States
Language: English
Source: NLM (National Library of Medicine)
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1), LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
Terrain Pharmaceuticals
TOPICAL
PRESCRIPTION DRUG
Diclona Patch 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 Patch is contraindicated in patients with a known hypersensitivity to diclofenac sodium. Diclona Patch is contraindicated in patients in the setting of coronary artery bypass graft (CABG) surgery.
Diclona Patch is available as the following: 15 patches: 3 patches per re-sealable pouch, 5 total pouches NDC 53225-1076-1 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Manufactured for: Terrain Pharmaceuticals Reno, NV 89501 For more information, contact Terrain Pharmaceuticals: info@terrainrx.com Printed in the U.S.A.
unapproved drug other
DICLONA PATCH- LIDOCAINE 4.5%, DICLOFENAC 1.25% PATCH 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._ ---------- DICLONA PATCH DICLONA PATCH (Diclofenac Sodium 1.25%, Lidocaine 4.5%) RX ONLY DESCRIPTION Diclona Patch (Diclofenac Sodium 1.25%, Lidocaine 4.5%) is a topical pain relief patch containing local arthritis reliever 1.25% Diclofenac Sodium and local anesthetic Lidocaine 4.5%. INACTIVE INGREDIENTS: Aloe Vera Gel, Arnica Extract, Boswellia Extract, Dihydroxyaluminum Aminoacetate, Dimethyl Sulfone, Glycerol, Methylparaben, Polyacrylic Acid, Polysorbate 80, Pure Water, Sodium Polyacrylate, Sorbitol, Vitamin E. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Lidocaine is an amide-type local anesthetic agent. The penetration of lidocaine into intact skin after application of Diclona Patch 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 Patch is directly related to both the duration of application and the surface area over which it is applied. When Diclona Patch 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 Patch, 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. METABOLIS Read the complete document