Lidocaine and diclofenac sodium

FDA label, Advanced Rx of Tennessee, LLC, cutaneous, effective 2025-05-05. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Amide Local Anesthetic, Antiarrhythmic

Dosing in kidney impairment

Fetal Toxicity Avoid use of NSAIDs in pregnant women at about 30 weeks gestation and later. NSAIDs increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age. Use of NSAIDs at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some case, neonatal renal impairment.

Drug interactions

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Label text (2 paragraphs)

Drug Interactions Specific interaction studies between Diclona Gel and other topical or oral agents were not performed. Oral Nonsteroidal Anti-Inflammatory Drugs Although low, there is systemic exposure to diclofenac sodium following labeled use of Diclona Gel. Therefore, concomitant administration of Diclona Gel with oral NSAIDs or aspirin may result in increased NSAID adverse effects. Antiarrhythmic Drugs Diclona Gel 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.

Local Anesthetics When Diclona Gel 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 Gel 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. Impairment of Fertility The effect of Diclona Gel on fertility has not been studied. Pregnancy Teratogenic Effects Pregnancy Category B. Diclona Gel has not been studied in pregnancy.

Contraindications

Diclona™ 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.

Pregnancy and lactation

Pregnancy

Pregnancy Teratogenic Effects Pregnancy Category B. Diclona Gel has not been studied in pregnancy.

Lactation

Nursing Mothers Diclona Gel has not been studied in nursing mothers.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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