Version May 2024
Pain:
Gel: Topical: Apply directly to painful skin area up to 4 times daily.
Patch: Topical: Apply directly to painful skin area up to twice daily.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution in patients with severe impairment.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution in patients with severe impairment.
Refer to adult dosing.
The following adverse drug reactions are derived from product labeling unless otherwise specified. Also see individual agents.
Frequency not defined: Local: Application-site reaction
Postmarketing:
Cardiovascular: Flushing
Gastrointestinal: Dysgeusia, metallic taste, nausea, vomiting
Nervous system: Asthenia, confusion, disorientation, dizziness, drowsiness, headache, hyperesthesia, hypoesthesia, nervousness, paresthesia, tremor
Ophthalmic: Visual disturbance (including blurred vision)
Otic: Tinnitus
Hypersensitivity to diclofenac, local anesthetics of the amide type, or any component of the formulation; use in the setting of coronary artery bypass surgery.
Concerns related to adverse effects:
• Cardiovascular events: Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious (and potentially fatal) adverse cardiovascular thrombotic events, including myocardial infarction (MI) and stroke. Risk may occur early during treatment and may increase with duration of use. Relative risk appears to be similar in those with and without known cardiovascular disease or risk factors for cardiovascular disease; however, absolute incidence of serious cardiovascular thrombotic events (which may occur early during treatment) was higher in patients with known cardiovascular disease or risk factors. New-onset hypertension or exacerbation of hypertension may occur (NSAIDs may also impair response to angiotensin-converting enzyme inhibitors, thiazide diuretics, or loop diuretics); may contribute to cardiovascular events; use with caution in patients with hypertension. May cause sodium and fluid retention; use with caution in patients with edema. Avoid use in patients with heart failure (FDA 2015). Avoid use in patients with recent MI unless benefits outweigh risk of cardiovascular thrombotic events. Use the lowest effective dose for the shortest duration of time, consistent with individual patient goals, to reduce risk of cardiovascular events; alternate therapies should be considered for patients at high risk.
• Drug reaction with eosinophilia and systemic symptoms: Potentially serious, sometimes fatal, drug reaction with eosinophilia and systemic symptoms (DRESS), also known as multiorgan hypersensitivity reactions, has been reported with NSAIDs. Early symptoms of hypersensitivity reaction (eg, lymphadenopathy, fever) may occur without rash; discontinue therapy and further evaluate if DRESS is suspected.
• Hypersensitivity: Use with caution in patients with known drug sensitivities. Allergic reactions (cutaneous lesions, urticaria, edema, or anaphylactoid reactions) may be a result of sensitivity to lidocaine (rare) or preservatives used in formulations. Patients allergic to para-aminobenzoic acid (PABA) derivatives (eg, procaine, tetracaine, benzocaine) have not shown cross sensitivity to lidocaine.
• Methemoglobinemia: Has been reported with local anesthetics; clinically significant methemoglobinemia requires immediate treatment along with discontinuation of the anesthetic and other oxidizing agents. Onset may be immediate or delayed (hours) after anesthetic exposure. Patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, exposure to oxidizing agents or their metabolites, or infants <6 months of age are more susceptible and should be closely monitored for signs and symptoms of methemoglobinemia (eg, cyanosis, headache, rapid pulse, shortness of breath, lightheadedness, fatigue).
Disease-related concerns:
• GI disease: Use with caution in patients with active GI bleeding or ulceration.
• Hepatic impairment: Use with caution in patients with severe hepatic impairment; ability to metabolize systemically absorbed lidocaine may diminish, resulting in toxic lidocaine concentrations.
• Renal impairment: Use with caution in patients with severe renal impairment.
Dosage form specific issues:
• Flammability: The gel and patch are flammable; keep away from open flame. Do not heat, microwave, or add medicine to hot water. Do not apply external heat sources (eg, heating pads, electric heating pads) over the application site.
Other warnings/precautions:
• Appropriate use: For topical use to intact skin only; application to broken or inflamed skin may cause high lidocaine blood concentrations. Do not apply to exfoliative dermatitis, infections, or open skin wounds. Avoid contact with eyes. If using with other local anesthetic agents, consider the total amount being absorbed from all formulations. Avoidance of the sun is recommended during therapy.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, External:
Diclona: Diclofenac sodium 1% and lidocaine hydrochloride 4.5% (99 g) [contains trolamine (triethanolamine)]
Patch, External:
Diclona+: Diclofenac sodium 1.25% and lidocaine hydrochloride 4.5% (3 ea) [contains methylparaben, polysorbate 80]
Yes
Topical: For topical use to intact skin only; avoid contact with eyes. Do not apply to broken/inflamed skin, exfoliative dermatitis, infections, or open skin wounds. Avoid sun exposure during therapy. Clean and dry skin prior to use. If irritation occurs, wash product off skin and reapply once irritation has subsided. Wash hands before and after use. Clothing may be applied over the treatment area.
Patch: Do not leave patches on for >12 hours; patches may be cut into smaller sizes with scissors prior to removal of the protective film. Fold used patches so the adhesive side sticks to itself; dispose of used patches out of reach of children and pets.
Pain: Relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, and strains.
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alcohol (Ethyl): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (Topical). Specifically, the risk of GI bleeding may be increased with this combination. Risk C: Monitor therapy
Angiotensin II Receptor Blockers: Nonsteroidal Anti-Inflammatory Agents (Topical) may diminish the therapeutic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy
Angiotensin-Converting Enzyme Inhibitors: Nonsteroidal Anti-Inflammatory Agents (Topical) may diminish the therapeutic effect of Angiotensin-Converting Enzyme Inhibitors. Risk C: Monitor therapy
Antiarrhythmic Agents (Class IB): Lidocaine (Topical) may enhance the adverse/toxic effect of Antiarrhythmic Agents (Class IB). Risk C: Monitor therapy
Anticoagulants: Nonsteroidal Anti-Inflammatory Agents (Topical) may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy
Beta-Blockers: Nonsteroidal Anti-Inflammatory Agents (Topical) may diminish the therapeutic effect of Beta-Blockers. Risk C: Monitor therapy
Cimetidine: May increase the serum concentration of Lidocaine (Topical). Risk C: Monitor therapy
Corticosteroids (Systemic): Nonsteroidal Anti-Inflammatory Agents (Topical) may enhance the adverse/toxic effect of Corticosteroids (Systemic). Specifically, the risk of gastrointestinal bleeding, ulceration, and perforation may be increased. Risk C: Monitor therapy
CycloSPORINE (Systemic): Nonsteroidal Anti-Inflammatory Agents (Topical) may enhance the adverse/toxic effect of CycloSPORINE (Systemic). Specifically, the nephrotoxicity of cyclosporine (systemic) may be increased. Risk C: Monitor therapy
Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapy
Deferasirox: Nonsteroidal Anti-Inflammatory Agents (Topical) may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy
Digoxin: Nonsteroidal Anti-Inflammatory Agents (Topical) may increase the serum concentration of Digoxin. Risk C: Monitor therapy
Herbal Products with Anticoagulant/Antiplatelet Effects (eg, Alfalfa, Anise, Bilberry): May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (Topical). Risk C: Monitor therapy
Lithium: Nonsteroidal Anti-Inflammatory Agents (Topical) may increase the serum concentration of Lithium. Risk C: Monitor therapy
Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy
Loop Diuretics: Nonsteroidal Anti-Inflammatory Agents (Topical) may diminish the therapeutic effect of Loop Diuretics. Risk C: Monitor therapy
Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy
Methotrexate: Nonsteroidal Anti-Inflammatory Agents (Topical) may increase the serum concentration of Methotrexate. Risk C: Monitor therapy
Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: (Topical) may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the risk of gastrointestinal (GI) toxicity is increased. Management: Coadministration of systemic nonsteroidal anti-inflammatory drugs (NSAIDs) and topical NSAIDs is not recommended. If systemic NSAIDs and topical NSAIDs, ensure the benefits outweigh the risks and monitor for increased NSAID toxicities. Risk D: Consider therapy modification
Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy
Salicylates: Nonsteroidal Anti-Inflammatory Agents (Topical) may enhance the adverse/toxic effect of Salicylates. Specifically, the risk of gastrointestinal (GI) toxicity is increased. Management: Coadministration of salicylates and topical NSAIDs is not recommended. If salicylates and topical NSAIDs are coadministered, ensure the benefits outweigh the risks and monitor for increased NSAID toxicities. Risk D: Consider therapy modification
Selective Serotonin Reuptake Inhibitors: Nonsteroidal Anti-Inflammatory Agents (Topical) may enhance the antiplatelet effect of Selective Serotonin Reuptake Inhibitors. Risk C: Monitor therapy
Serotonin/Norepinephrine Reuptake Inhibitors: May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (Topical). Risk C: Monitor therapy
Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy
Tacrolimus (Systemic): Nonsteroidal Anti-Inflammatory Agents (Topical) may enhance the nephrotoxic effect of Tacrolimus (Systemic). Risk C: Monitor therapy
Tenofovir Products: Nonsteroidal Anti-Inflammatory Agents (Topical) may enhance the nephrotoxic effect of Tenofovir Products. Risk C: Monitor therapy
Thiazide and Thiazide-Like Diuretics: Nonsteroidal Anti-Inflammatory Agents (Topical) may diminish the therapeutic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy
Voriconazole: May increase the serum concentration of Diclofenac (Topical). Risk C: Monitor therapy
Refer to the Diclofenac (Topical) and Lidocaine (Topical) monographs.
Refer to the Diclofenac (Topical) and Lidocaine (Topical) monographs.
BP; signs and symptoms of methemoglobinemia; symptoms of worsening heart failure.
Diclofenac: Reversibly inhibits cyclooxygenase-1 and 2 (COX-1 and 2) enzymes, which results in decreased formation of prostaglandin precursors; has antipyretic, analgesic, and anti-inflammatory properties. Other proposed mechanisms not fully elucidated (and possibly contributing to the anti-inflammatory effect to varying degrees), include inhibiting chemotaxis, altering lymphocyte activity, inhibiting neutrophil aggregation/activation, and decreasing proinflammatory cytokine levels.
Lidocaine: Blocks both the initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions, which results in inhibition of depolarization with resultant blockade of conduction.
See individual agents.
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