DICLOFENAC SODIUM 16.05 mg/mL Solution, 150 mL
Other active recalls for Diclofenac Sodium (different manufacturers) — 3 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Nonprescription (over-the-counter) diclofenac topical gel (Voltaren Arthritis Pain) is used to relieve pain from arthritis in certain joints such as those of the knees, ankles, feet, elbows, wrists, and hands. Prescription diclofenac topical solution (Pennsaid) is used to relieve osteoarthritis pain in the knees. Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of a substance that causes pain. Diclofenac is also available as a 3% gel (Solaraze; generic) that is applied to the skin to treat actinic keratosis...
Read the full MedlinePlus article ↗- An actinic keratosis — often just called an AK — is a rough, scaly patch on the skin caused by years of sun exposure. These patches are considered precancerous, meaning they could...
- What exactly is an actinic keratosis, and why do I need a prescription gel for it?
- The typical treatment course runs 60 to 90 days of twice-daily application — that's a solid commitment, but it's necessary for the gel to do its job. Here's the thing: even after y...
- How long do I need to use this gel, and how will I know it's working?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Diclofenac Sodium — tap one for details:
Diclofenac Sodium may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII YOW8V9698H
Dimethyl sulfoxide is a clear liquid solvent derived from wood pulp. In medicines, it helps dissolve or carry active ingredients and improve how the body absorbs the drug.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2500 | $37.50 / 150 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Diclofenac Sodium 16.05 mg/mL 51672-1358-02 | Sun | 1 bottle | $0.135 | AT | Availability likely | — |
| Diclofenac Sodium 16.05 mg/mL 65162-0911-74 | Amneal | 1 bottle | $0.135 | AT | Availability likely | — |
| Diclofenac Sodium 1.5% 16.05 mg/mL 70512-0038-05 | SOLA | 1 bottle | $0.135 | AT | Availability likely | — |
| Diclofenac Sodium 16.05 mg/mL 70512-0810-05 | SOLA | 1 bottle | $0.135 | AT | Availability likely | — |
| Diclofenac Sodium 16.05 mg/mL 40032-0016-61 | Novel | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 50090-3316-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 50090-6713-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 55700-0591-15 | Quality | 1 bottle | — | — | FDA listed | — |
| Lixofen 59088-0804-00 | PureTek | 1 kit | — | — | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 63187-0791-15 | Proficient | 150 ml | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 68788-7270-01 | Preferred | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 68788-7715-01 | Preferred | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 70518-2811-00 | REMEDYREPACK | 1 bottle | — | AT | FDA listed | — |
| Diclofenac sodium 16.05 mg/mL 71205-0062-15 | Proficient | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 71205-0450-15 | Proficient | 1 bottle | — | — | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 71205-0579-15 | Proficient | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 1.5% 16.05 mg/mL 71205-0640-15 | Proficient | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 71205-0811-15 | Proficient | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 72162-2031-02 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 72189-0075-05 | DIRECT | 150 ml | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 72189-0273-05 | DIRECT | 150 ml | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mLthis 72189-0319-05 | DirectRx | 150 ml | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 72189-0454-05 | Direct_Rx | 150 ml | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 72189-0527-05 | Direct_Rx | 150 ml | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 76420-0012-30 | Asclemed | 150 ml | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 76420-0134-05 | Asclemed | 150 ml | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 76420-0919-02 | Asclemed | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 80425-0237-01 | Advanced | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 80425-0240-01 | Advanced | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 80425-0361-01 | Advanced | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 80425-0368-01 | Advanced | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 1.5% 16.05 mg/mL 85509-1038-01 | PHOENIX | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 85509-1911-01 | PHOENIX | 1 bottle | — | AT | FDA listed | — |
| Diclofenac Sodium 16.05 mg/mL 43386-0016-61 | Lupin | 150 ml | — | AT | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72189-0319-05 You're viewing this | 150 mL in 1 BOTTLE, DROPPER (72189-319-05) | 2022-01-19 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
Diclofenac sodium topical solution, USP is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).
⏱️ Dosage and Administration ▾
2.1General Dosing Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNING AND PRECAUTIONS (5.2)] For the relief of the signs and symptoms of osteoarthritis of the knee(s), the recommended dose is 40 drops per knee, 4 times a day. Apply diclofenac sodium topical solution to clean, dry skin. To avoid spillage, dispense diclofenac sodium topical solution 10 drops at a time either directly onto the knee or first into the hand and then onto the knee.
Spread diclofenac sodium topical solution evenly around front, back and sides of the knee. Repeat this procedure until 40 drops have been applied and the knee is completely covered with solution. To treat the other knee, if symptomatic, repeat the procedure.
Application of diclofenac sodium topical solution in an amount exceeding or less than the recommended dose has not been studied and is therefore not recommended.
2.2Special Precautions Avoid showering/bathing for at least 30 minutes after the application of diclofenac sodium topical solution to the treated knee. Wash and dry hands after use. Do not apply diclofenac sodium topical Solution USP, to open wounds.
Avoid contact of diclofenac sodium topical solution with eyes and mucous membranes. Do not apply external heat and/or occlusive dressings to treated knees. Avoid wearing clothing over the diclofenac sodium topical solutiontreated knee(s) until the treated knee is dry.
Protect the treated knee(s) from natural or artificial sunlight. Wait until the treated area is dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to the same knee you have just treated with diclofenac sodium topical solution. Until the treated knee(s) is completely dry, avoid skin-to-skin contact between other people and the treated knee(s).
Do not use combination therapy with diclofenac sodium and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.
Diclofenac sodium topical solution USP, 1.5% w/w
⛔ Contraindications ▾
Diclofenac sodium topical solution, USP is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product. [see WARNINGS AND PRECAUTIONS (5.7, 5.9)]. History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see WARNINGS AND PRECAUTIONS (5.7, 5.8)].
In the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS AND PRECAUTIONS (5.1)].
⚠️ Warnings and Cautions ▾
5.1Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.
However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious gastrointestinal (GI) events [see WARNINGS AND PRECAUTIONS (5.2)]. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke [see CONTRAINDICATIONS (4)].
Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAIDtreated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.
Avoid the use of diclofenac sodium in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If diclofenac sodium is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
5.2Gastrointestinal Bleeding, Ulceration and Perforation NSAIDs, including diclofenac, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic.
Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3 to 6 months, and in about 2 % to 4% of patients treated for one year. However, even short-term NSAID therapy is not without risk. Risk Factors for GI Bleeding, Ulceration, and Perforation Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors.
Other factors that increase the risk of GI bleeding in patients tr…
🤒 Adverse Reactions ▾
The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS (5.1)] GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS (5.2)] Hepatotoxicity [see WARNINGS AND PRECAUTIONS (5.3)] Hypertension [see WARNINGS AND PRECAUTIONS (5.4)] Heart Failure and Edema [see WARNINGS AND PRECAUTIONS (5.5)] Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS (5.6)] Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS (5.7)] Serious Skin Reactions [see WARNINGS AND PRECAUTIONS (5.9)] Hematologic Toxicity [see WARNINGS AND PRECAUTIONS (5.11)]
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to diclofenac sodium topical solution of 911 patients treated between 4 and 12 weeks (mean duration of 49 days) in seven Phase 3 controlled trials, as well as exposure of 793 patients treated in an open-label study, including 463 patients treated for at least 6 months, and 144 patients treated for at least 12 months.
The population mean age was approximately 60 years, 89% of patients were Caucasians, 64% were females, and all patients had primary osteoarthritis. The most common adverse events with diclofenac sodium topical solution were application site skin reactions. These events were the most common reason for withdrawing from the studies.
Application Site Reactions In controlled trials, the most common treatment-related adverse events in patients receiving diclofenac sodium topical solution were application site skin reactions. Application site reactions were characterized by one or more of the following: dryness, erythema, induration, vesicles, paresthesia, pruritus, vasodilation, acne, and urticaria. The most frequent of these reactions were dry skin (32%), contact dermatitis characterized by skin erythema and induration (9%), contact dermatitis with vesicles (2%) and pruritus (4%).
In one controlled trial, a higher rate of contact dermatitis with vesicles (4%) was observed after treatment of 152 subjects with the combination of diclofenac sodium topical solution and oral diclofenac. In the open label uncontrolled long-term safety study, contact dermatitis occurred in 13% and contact dermatitis with vesicles in 10% of patients, generally within the first 6 months of exposure, leading to a withdrawal rate for an application site event of 14%. Adverse Events Common to the NSAID Class In controlled trials, subjects treated with diclofenac sodium topical solution experienced some adverse events associated with the NSAID class more frequently than subjects using placebo (constipation, diarrhea, dyspepsia, nausea, flatulence, abdominal pain, edema; see TABLE 1).
The combination of diclofenac sodium topical solution and oral diclofenac, compared to oral diclofenac alone, resulted in a higher rate of rectal hemorrhage (3% vs. less than 1%), and more frequent abnormal creatinine (12% vs. 7%), urea (20% vs. 12%), and hemoglobin (13% vs.
9%), but no difference in elevation of liver transaminases. Table 1 lists all adverse reactions occurring in ≥1% of patients receiving diclofenac sodium topical solution, where the rate in the diclofenac sodium topical solution group exceeded placebo, from seven controlled studies conducted in patients with osteoarthritis. Since these trials were of different durations, these percentages do not capture cumulative rates of occurrence.
Table 1: Adverse reactions occurring in ≥1% of patients treated with Diclofenac Sodium Topical Solution in placebo and oral diclofenaccontrolled trials. Treatment Group: Diclofenac Sodium Topical Solution N=911 Topical Placebo N=332 Adverse Reaction* N (%) N (%) * Preferred Term according to CO…
🔄 Drug Interactions ▾
See TABLE 2 for clinically significant drug interactions with diclofenac. Table 2: Clinically Significant Drug Interactions with Diclofenac Drugs That Interfere with Hemostasis Clinical Impact: Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.
Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of diclofenac sodium with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see WARNINGS AND PRECAUTIONS (5.11)] Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone.
In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of NSAID alone [see WARNINGS AND PRECAUTIONS (5.2)] Intervention: Concomitant use of diclofenac sodium and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS (5.11)]. Diclofenac Sodium is not a substitute for low dose aspirin for cardiovascular protection. ACE inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or betablockers (including propranolol).
In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Intervention: During concomitant use of diclofenac sodium and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
During concomitant use of diclofenac sodium and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [see WARNINGS AND PRECAUTIONS (5.6)] When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients.
This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. Intervention: During concomitant use of diclofenac sodium with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see WARNINGS AND PRECAUTIONS (5.6)]. Digoxin Clinical Impact: The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life digoxin.
Intervention: During concomitant use of diclofenac sodium and digoxin, monitor serum digoxin levels. Lithium Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%.
This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis. Intervention:…
👥 Use in Specific Populations ▾
8.1Pregnancy Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation. Risk Summary Use of NSAIDs, including diclofenac sodium, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including diclofenac sodium, in pregnant women starting at 30 weeks of gestation (third trimester).
There are no adequate and well-controlled studies of diclofenac sodium in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss.
Published reproductive and developmental studies of dimethyl sulfoxide (DMSO, the solvent used in Diclofenac Sodium) are equivocal as to potential teratogenicity. In animal reproduction studies, no evidence of teratogenicity was observed in mice, rats, or rabbits given diclofenac daily during the period of organogenesis at doses up to approximately 0.6, 0.6, and 1.3 times, respectively, the maximum recommended human dose (MRHD) of diclofenac sodium, despite the presence of maternal and fetal toxicity at these doses [see DATA].
Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as diclofenac, resulted in increased pre- and post-implantation loss. Clinical Considerations Labor or Delivery There are no studies on the effects of diclofenac sodium during labor or delivery.
In animal studies, NSAIDs, including diclofenac, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Animal data Reproductive and developmental studies in animals demonstrated that diclofenac sodium administration during organogenesis did not produce teratogenicity despite the induction of maternal toxicity and fetal toxicity in mice at oral doses up to 20 mg/kg/day (approximately 0.6 times the maximum recommended human dose [MRHD] of diclofenac sodium, 154 mg/day, based on body surface area (BSA) comparison), and in rats and rabbits at oral doses up to 10 mg/kg/day (approximately 0.6 and 1.3 times, respectively, the MRHD based on BSA comparison).
Published reproductive and developmental studies of dimethyl sulfoxide (DMSO, the solvent used in diclofenac sodium) are equivocal as to potential teratogenicity. In rats, maternally toxic doses of diclofenac were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival.
8.2Lactation Risk Summary Based on available data, diclofenac may be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CATAFLAM and any potential adverse effects on the breastfed infant from the CATAFLAM or from the underlying maternal condition. Data One woman treated orally with a diclofenac salt, 150 mg/day, had a milk diclofenac level of 100 mcg/L, equivalent to an infant dose of about 0.03 mg/kg/day.
Diclofenac was not detectable in breast milk in 12 women using diclofenac (after either 100 mg/day orally for 7 days or a single 50 mg intramuscular dose administered in the immediate postpartum period).
8.3Females and Males of Reproductive Potential Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including diclofenac sodium, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Published animal studies have shown that administration prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture requ…
🆘 Overdosage ▾
Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare. [see WARNINGS AND PRECAUTIONS (5.1, 5.2.
5.4, 5.6)]. Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes.
Emesis is not recommended due to a possibility of aspiration and subsequent respiratory irritation by DMSO contained in diclofenac sodium. Consider activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
For additional information about overdose treatment, contact a poison control center (1-800-222-1222).
🧬 Clinical Pharmacology ▾
12.1Mechanism of Action Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac sodium, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro.
Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation.
Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
12.3Pharmacokinetics After topical administration to healthy human volunteers of single and multiple maximum doses of diclofenac sodium topical solution, 40 drops (approximately 1.2 mL) to each knee (80 drops total dose), the following diclofenac pharmacokinetic parameters were obtained: (see TABLE 2). Table 2: Single-Dose (80 drops) and Multiple Dose (80 drops four times daily for 7 days) Diclofenac Sodium Topical Solution Pharmacokinetic Parameters Diclofenac Sodium Pharmacokinetic Parameters Normal Adults [N=18] (Age: 18 to 55 years) Normal Adults [N=19] (Age: 18 to 55 years) Single Dose Multiple Dose Four times daily for 7 days * Apparent total body clearance AUC0-t 177.5 ± 72.6 ng∙h/mL 695.4 ± 348.9 ng∙h/mL AUC0-inf 196.3 ± 68.5 ng∙h/mL 745.2 ± 374.7 ng∙h/mL Plasma Cmax 8.1 ± 5.9 ng/mL 19.4 ± 9.3 ng/mL Plasma Tmax (h) 11.0 ± 6.4 4.0 ±
6.5Plasma t1/2 (h) 36.7 ± 20.8 79.0 ±
38.1Kel (h-1) 0.024 ± 0.010 0.011 ± 0.004 CL/F (L/h) 244.7 ± 84.7* -- Absorption Diclofenac systemic exposure from diclofenac sodium topical solution application (4 times daily for 1 week) was approximately 1/3 of the diclofenac systemic exposure from the diclofenac topical gel application (twice daily for 4 weeks). Distribution Diclofenac is more than 99% bound to human serum proteins, primarily to albumin. Diclofenac diffuses into and out of the synovial fluid.
Diffusion into the joint occurs when plasma levels are higher than those in the synovial fluid, after which the process reverses and synovial fluid levels are higher than plasma levels. It is not known whether diffusion into the joint plays a role in the effectiveness of diclofenac. Elimination Metabolism Five diclofenac metabolites have been identified in human plasma and urine.
The metabolites include 4'hydroxy-, 5-hydroxy-, 3'-hydroxy-, 4',5-dihydroxy- and 3'-hydroxy-4'-methoxy diclofenac. The major diclofenac metabolite, 4'-hydroxy-diclofenac, has very weak pharmacologic activity. The formation of 4'-hydroxy diclofenac is primarily mediated by CPY2C9.
Both diclofenac and its oxidative metabolites undergo glucuronidation or sulfation followed by biliary excretion. Acylglucuronidation mediated by UGT2B7 and oxidation mediated by CPY2C8 may also play a role in diclofenac metabolism. CYP3A4 is responsible for the formation of minor metabolites, 5-hydroxy and 3'-hydroxy-diclofenac.
Excretion Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of the glucuronide and the sulfate conjugates of the metabolites. Little or no free unchanged diclofenac is excreted in the urine. Special Populations Pediatric: The pharmacokinetics of diclofenac sodium topical solution has not been investigated in pediatric patients.
Race: Pharmacokinetic differences due to race have not been studied. Drug Interaction Studies Aspirin: When NSAIDs were administered with aspirin, the protein binding of NSAIDs were reduced, although the clearance of free NSAID was not altered. The clinical significance of this interaction is not known.
See TABLE 1 for clinically significant drug interactions of NSAIDs with aspirin [see DRUG INTERACTIONS (7)]. CLOSE
📦 How Supplied / Storage and Handling ▾
Diclofenac sodium topical solution USP, 1.5% w/w is supplied as a clear, colorless to slightly pink-orange solution containing 16.05 mg of diclofenac sodium per mL of solution, in a white bottle with a white dropper cap. NDC Number & Size Bottle 60 mL NDC 51672-1358-4 Bottle 150 mL NDC 51672-1358-2 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
📋 Description ▾
Diclofenac sodium topical solution USP, 1.5% is a nonsteroidal antiinflammatory drug, available as a clear, colorless to faintly pink-orange solution for topical application. Diclofenac sodium topical solution contains 1.5% w/w diclofenac sodium, a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug (NSAID), designated chemically as 2-[(2,6-dichlorophenyl)amino]-benzeneacetic acid, monosodium salt. The molecular weight is 318.14.
Its molecular formula is C14H10Cl2NNaO2 and it has the following structural formula: [Chemical Structure] Each 1 mL of solution contains 16.05 mg of diclofenac sodium. In addition, diclofenac sodium topical solution contains the following inactive ingredients: dimethyl sulfoxide USP (DMSO, 45.5% w/w), ethanol, glycerin, propylene glycol and purified water.
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 7/2019 Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDs: if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. right before or after heart bypass surgery.
Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems have high blood pressure have asthma are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy. are breastfeeding or plan to breast feed.
Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.
What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See "WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT MEDICINES CALLED NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)?" new or worse high blood pressure liver problems including liver failure low red blood cells (anemia) life-threatening allergic reactions heart failure kidney problems including kidney failure life-threatening skin reactions Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.
Get emergency help right away if you get any of the following symptoms: shortness of breath or trouble breathing chest pain weakness in one part or side of your body slurred speech swelling of the face or throat Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: nausea more tired or weaker than usual diarrhea itching your skin or eyes look yellow indigestion or stomach pain flu-like symptoms vomit blood there is blood in your bowel movement or it is black and sticky like tar unusual weight gain skin rash or blisters with fever swelling of the arms, legs, hands and feet If you take too much of your NSAID, call your healthcare provider or get medical help right away.
These are not all the possible si…