The Coxib and traditional NSAID Trialists' Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. Avoid the use of Diclona Patch in patients with severe heart failure unless benefits are expected to outweigh the risk of worsening heart failure. If Diclona Patch is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Diclona Patch should be used with caution in patients with active gastrointestinal ulceration or bleeding and severe renal or hepatic impairments. Diclona Patch should not be applied to open skin wounds, infections, or exfoliative dermatitis.
Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine, because of their inability to metabolize lidocaine normally.
Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine. However, Diclona Patch should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.
Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of lidocaine from increased absorption. Diclona Patch is only recommended for use on intact skin.
Placement of external heat sources, such as heating pads or electric blankets, over Diclona Patch is not recommended as this has not been evaluated and may increase plasma lidocaine levels.
The contact of Diclona Patch with eyes, although not studied, should be avoided based on the findings of severe eye irritation with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.
Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.
Specific interaction studies between Diclona Patch and other topical or oral agents were not performed.
Although low, there is systemic exposure to diclofenac sodium following labeled use of Diclona Patch. Therefore, concomitant administration of Diclona Patch with oral NSAIDs or aspirin may result in increased NSAID adverse effects.
Diclona Patch should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.
When Diclona Patch is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
Drugs That May Cause Methemoglobinemia When Used with Diclona Patch
Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics:
Examples of Drugs Associated with Methemoglobinemia:
Class Examples
Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics
articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine
Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase, antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides, antimalarials chloroquine, primaquine anticonvulsants, phenobarbital, phenytoin, sodium valproate, opher drugs acetaminophen, metoclopramide, quinine, sulfasalazine carcinogenesis, mutagenesis.
The effect of Diclona Patch on fertility has not been studied.
Diclona Patch has not been studied in labor and delivery.
Diclona Patch has not been studied in nursing mothers.
Safety and effectiveness in pediatric patients have not been established.
Reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.