Diclofenac Sodium Gel 30 mg/g Gel, 1 g
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Diclofenac topical gel (Solaraze) is used to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure). Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). The way diclofenac gel works to treat actinic keratosis is not known. Diclofenac is also available as a liquid (Pennsaid) and a gel (Voltaren) that are applied to the skin to treat arthritis pain. This monograph only gives information about diclofenac gel (Solaraze) for actinic keratosis. If you are using either of the products for osteoarthritis, read the monograph e...
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
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.
-
UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
-
UNII YSE9PPT4TH
Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
-
UNII ENK4Y6S66X
A synthetic liquid polymer derived from petroleum that acts as a solvent and humectant. It helps dissolve active ingredients, improves product flow, and prevents moisture loss in liquid and semi-solid medicines.
-
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.
4 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
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 g | 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 | $0.5711 | $0.57 / 1 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Diclofenac Sodium 30 mg/g 00472-1783-10 | Actavis | 1 tube | $0.370 | AB | Availability likely | — |
| diclofenac sodium 30 mg/g 45802-0111-01 | Padagis | 1 tube | $0.370 | AB | Availability likely | — |
| Diclofenac Sodium 30 mg/g 62332-0581-31 | Alembic | 1 tube | $0.370 | AB | Availability likely | — |
| Diclofenac Sodium 30 mg/g 68462-0355-94 | GLENMARK | 1 tube | $0.370 | AB | Availability likely | — |
| Diclofenac Sodium 30 mg/g 00115-1483-56 | Amneal | 1 tube | — | — | Discontinued | — |
| Diclofenac Sodium 30 mg/g 45865-0260-01 | Medsource | 100 g | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 46708-0581-31 | Alembic | 1 tube | — | AB | FDA listed | — |
| Diclofenac sodium 30 mg/g 51672-1363-03 | Sun | 1 tube | — | AB | FDA listed | — |
| diclofenac sodium 30 mg/g 63629-2526-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 68071-3516-01 | NuCare | 1 tube | — | AB | FDA listed | — |
| Diclofenac sodium 30 mg/g 68071-3688-01 | NuCare | 1 tube | — | AB | FDA listed | — |
| diclofenac sodium 30 mg/g 68071-4859-01 | NuCare | 100 g | — | AB | FDA listed | — |
| Diclofenac sodium 30 mg/g 68788-8236-01 | Preferred | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 68788-8456-01 | Preferred | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 68788-9435-01 | Preferred | 1 tube | — | AB | FDA listed | — |
| diclofenac sodium 30 mg/g 70518-2526-00 | REMEDYREPACK | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 70518-3315-00 | REMEDYREPACK | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 70518-3779-00 | REMEDYREPACK | 1 tube | — | AB | FDA listed | — |
| Diclofenac sodium 30 mg/g 71205-0538-00 | Proficient | 1 tube | — | AB | FDA listed | — |
| diclofenac sodium 30 mg/g 71205-0692-00 | Proficient | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 71205-0752-00 | Proficient | 1 tube | — | AB | FDA listed | — |
| diclofenac sodium 30 mg/g 72162-1391-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 72189-0040-01 | Direct_Rx | 1 g | — | AB | FDA listed | — |
| Diclofenac Sodium Gel 30 mg/g 72189-0379-01 | Direct_Rx | 1 g | — | AB | FDA listed | — |
| Diclofenac Sodium Gel 30 mg/gthis 72189-0473-01 | Direct_Rx | 1 g | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 76420-0025-01 | Asclemed | 100 g | — | — | FDA listed | — |
| Diclofenac Sodium 30 mg/g 76420-0132-01 | Asclemed | 100 g | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 76420-0261-01 | Asclemed | 1 tube | — | AB | FDA listed | — |
| Diclofenac sodium 30 mg/g 76420-0275-01 | Asclemed | 100 g | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 80425-0234-01 | Advanced | 1 tube | — | — | FDA listed | — |
| Diclofenac Sodium 30 mg/g 80425-0235-01 | Advanced | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 80425-0236-01 | Advanced | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 80425-0338-01 | Advanced | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 82804-0052-00 | Proficient | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 82804-0250-00 | Proficient | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 85509-1581-01 | PHOENIX | 1 tube | — | AB | FDA listed | — |
| Diclofenac Sodium 30 mg/g 87063-0165-01 | ASCLEMED | 1 tube | — | AB | 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?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72189-0473-01 You're viewing this | 1 g in 1 TUBE (72189-473-01) | 2023-05-19 | 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
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.4)]. Diclofenac sodium topical gel is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.4)].
Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events [see Warnings and Precautions (5.5) ].
🎯 Indications and Usage ▾
Diclofenac sodium topical gel is indicated for the topical treatment of actinic keratoses (AK).
⏱️ Dosage and Administration ▾
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)]. Apply diclofenac sodium topical gel gently to lesion areas twice daily to adequately cover each lesion. Use 0.5 g of gel (pea size) on each 5 cm x 5 cm lesion site.
The recommended duration of therapy is from 60 days to 90 days. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. Lesions that do not respond to therapy should be re-evaluated and management reconsidered.
Avoid contact of diclofenac sodium topical gel with eyes and mucous membranes.
💊 Dosage Forms and Strengths ▾
Topical gel, 3%. Each gram of diclofenac sodium topical gel contains 30 mg of diclofenac sodium in a clear, transparent, colorless to slightly yellow or orange gel base. Diclofenac sodium topical gel, 3% is supplied in 100 g tubes.
⛔ Contraindications ▾
Diclofenac sodium topical gel is contraindicated in the following patients: With known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see Warnings and Precautions (5.1, 5.3, 5.10) and Description (11)] With the 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 (5.1, 5.2)] Application on damaged skin resulting from any etiology, including exudative dermatitis, eczema, infected lesions, burns or wounds [see Warnings and Precautions (5.3)] In the setting of coronary bypass graft (CABG) surgery [see Warnings and Precautions (5.4)]
⚠️ Warnings ▾
5.1Anaphylactic Reactions Diclofenac has been associated with anaphylactic reactions in patients with and without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma [see Contraindications (4) and Warnings and Precautions (5.2)]. Seek emergency help if an anaphylactic reaction occurs.
5.2Exacerbation of Asthma Related to Aspirin Sensitivity A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs. Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, diclofenac sodium topical gel is contraindicated in patients with this form of aspirin sensitivity. When diclofenac sodium topical gel is used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma.
5.3Serious Skin Reactions NSAIDs, including diclofenac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of diclofenac sodium topical gel at the first appearance of skin rash or any other sign of hypersensitivity.
Diclofenac sodium topical gel is contraindicated in patients with previous serious skin reactions to NSAIDs. Do not apply diclofenac sodium topical gel to open skin wounds, infections, or exfoliative dermatitis, as it may affect absorption and tolerability of the drug [see Contraindications (4)].
5.4Cardiovascular 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. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10–14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.
NSAIDs are contraindicated in the setting of CABG. 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…
🤒 Adverse Reactions ▾
The following adverse reactions are discussed in greater detail in other sections of the labeling: Anaphylactic Reactions [see Warnings and Precautions (5.1)] Exacerbation of Asthma Related to Aspirin Sensitivity [see Warnings and Precautions (5.2)] Serious Skin Reactions [see Warnings and Precautions (5.3)] Cardiovascular Thrombotic Events [see Warnings and Precautions (5.4)] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.5)] Hepatotoxicity [see Warnings and Precautions (5.6)] Hypertension [see Warnings and Precautions (5.7)] Heart Failure and Edema [see Warnings and Precautions (5.8)] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.9)] DRESS [see Warnings and Precautions (5.10)] Hematologic Toxicity [see Warnings and Precautions (5.12)] Photosensitivity [see Warnings and Precautions (5.15)]
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. Of the 423 subjects evaluable for safety in adequate and well-controlled trials, 211 were treated with diclofenac sodium topical gel drug product and 212 were treated with a vehicle gel. Eighty-seven percent (87%) of the diclofenac sodium topical gel-treated subjects (183 subjects) and 84% of the vehicle-treated subjects (178 subjects) experienced one or more adverse events (AEs) during the trials.
The majority of these reactions were mild to moderate in severity and resolved upon discontinuation of therapy. Of the 211 subjects treated with diclofenac sodium topical gel, 172 (82%) experienced AEs involving skin and the application site compared to 160 (75%) vehicle-treated subjects. Application site reactions (ASRs) were the most frequent AEs in both diclofenac sodium topical gel- and vehicle-treated groups.
Of note, four reactions, contact dermatitis, rash, dry skin and exfoliation (scaling) were significantly more prevalent in the diclofenac sodium topical gel group than in the vehicle-treated subjects. Eighteen percent of diclofenac sodium topical gel-treated subjects and 4% of vehicle-treated subjects discontinued from the clinical trials due to adverse events (whether considered related to treatment or not). These discontinuations were mainly due to skin irritation or related cutaneous adverse reactions.
Table 1 below presents the AEs reported at an incidence of >1% for subjects treated with either diclofenac sodium topical gel or vehicle (60- and 90-day treatment groups) during the phase 3 trials. Table 1. Adverse Events Reported (>1% in Any Treatment Group) During Diclofenac sodium topical gel Phase 3 Clinical Trials Incidences for 60-Day and 90-Day Treatments 60-day Treatment 90-day Treatment Diclofenac sodium topical gel (%) Gel Vehicle (%) Diclofenac sodium topical gel (%) Gel Vehicle (%) N=48 N=49 N=114 N=114 BODY AS A WHOLE 21 20 20 18 Abdominal Pain 2 0 1 0 Accidental Injury 0 0 4 2 Allergic Reaction 0 0 1 3 Asthenia 0 0 2 0 Back Pain 4 0 2 2 Chest Pain 2 0 1 0 Chills 0 2 0 0 Flu Syndrome 10 6 1 4 Headache 0 6 7 6 Infection 4 6 4 5 Neck Pain 0 0 2 0 Pain 2 0 2 2 CARDIOVASCULAR SYSTEM 2 4 3 1 Hypertension 2 0 1 0 Migraine 0 2 1 0 Phlebitis 0 2 0 0 DIGESTIVE SYSTEM 4 0 6 8 Constipation 0 0 0 2 Diarrhea 2 0 2 3 Dyspepsia 2 0 3 4 METABOLIC AND NUTRITIONAL DISORDERS 2 8 7 2 Creatine Phosphokinase Increased 0 0 4 1 Creatinine Increased 2 2 0 1 Edema 0 2 0 0 Hypercholesteremia 0 2 1 0 Hyperglycemia 0 2 1 0 SGOT Increased 0 0 3 0 SGPT Increased 0 0 2 0 MUSCULOSKELETAL SYSTEM 4 0 3 4 Arthralgia 2 0 0 2 Arthrosis 2 0 0 0 Myalgia 2 0 3 1 NERVOUS SYSTEM 2 2 2 5 Anxiety 0 2 0 1 Dizziness 0 0 0 4 Hypokinesia 2 0 0 0 RESPIRATORY SYSTEM 8 8 7 6 Asthma 2 0 0 0 Dyspnea 2 0 2 0 Pharyngitis 2 8 2 4 Pneumonia 2 0 0 1 Rhinitis 2 2 2 2 Sinusitis 0 0 2 0 SKIN AND APPENDAGES 75 86 86 71 Acne 0 2 0 1 Application Site Re…
👥 Use in Specific Populations ▾
8.1Pregnancy Risk Summary Use of NSAIDs, including diclofenac sodium topical gel, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of diclofenac sodium topical gel use between about 20 and 30 weeks of gestation and avoid diclofenac sodium topical gel use at about 30 weeks of gestation and later in pregnancy. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.
Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including diclofenac sodium topical gel, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, no evidence of malformations was observed in mice, rats, or rabbits given diclofenac during the period of organogenesis at doses at least 15 times, the maximum recommended human dose (MRHD) of diclofenac sodium topical gel (see Data).
Based on published animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization, and administration of prostaglandin synthesis inhibitors such as diclofenac sodium, resulted in increased pre- and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses.
The background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including diclofenac sodium topical gel, can cause premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment If after careful consideration of alternative treatment options for actinic keratoses, an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible.
If diclofenac sodium topical gel treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue diclofenac sodium topical gel and follow up according to clinical practice. Labor or Delivery There are no studies on the effects of diclofenac sodium topical gel during labor or delivery.
In animal studies, NSAIDS, including diclofenac, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Human Data Premature Closure of Fetal Ductus Arteriosus Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Published studies and postmarketing reports describe maternal NSAID use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.
These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infr…
🆘 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, hypertension, acute renal failure, respiratory depression, and coma have been reported. [see Warnings and Precautions (5.4, 5.5, 5.7, 5.9)]. Manage patients with symptomatic and supportive care following an NSAID overdosage.
There are no specific antidotes. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. In the event of oral ingestion, resulting in significant systemic side effects, it is recommended that the stomach be emptied by vomiting or lavage.
In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption of diclofenac. For additional information about overdosage treatment, call a poison control center (1-800-222-1222).
🧬 Clinical Pharmacology ▾
12.1Mechanism of Action The mechanism of action of diclofenac sodium in the treatment of actinic keratoses (AK) is unknown.
12.2Pharmacodynamics The pharmacodynamics of diclofenac sodium topical gel in the treatment of actinic keratosis has not been assessed.
12.3Pharmacokinetics Absorption Diclofenac levels were measured at the end of treatment from 60 patients with AK lesions treated with diclofenac sodium topical gel in three adequate and well-controlled clinical trials. Each patient was administered 0.5 g of diclofenac sodium topical gel twice a day for up to 105 days. There were up to three 5 cm x 5 cm treatment sites per patient on the face, forehead, hands, forearm, and scalp.
Serum concentrations of diclofenac were, on average, at or below 20 ng/mL. Distribution Diclofenac binds tightly to serum albumin. Metabolism Biotransformation of diclofenac following oral administration involves conjugation at the carboxyl group of the side chain or single or multiple hydroxylations resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates.
Two of these phenolic metabolites are biologically active, however to a much smaller extent than diclofenac. Metabolism of diclofenac following topical administration is thought to be similar to that after oral administration. The small amounts of diclofenac and its metabolites appearing in the plasma following topical administration makes the quantification of specific metabolites imprecise.
Elimination Diclofenac and its metabolites are excreted mainly in the urine after oral dosing.
📦 How Supplied / Storage and Handling ▾
Available in tubes of 100 g (NDC 72189-473-01). Each gram of topical gel contains 30 mg of diclofenac sodium.
📦 Storage and Handling ▾
Storage: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). Protect from heat. Avoid freezing.
📋 Description ▾
Diclofenac sodium topical gel, 3%, intended for dermatologic use, contains the active ingredient, diclofenac sodium, in a clear, transparent, colorless to slightly yellow or orange gel base. Diclofenac sodium is a white or slightly yellowish hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water, slightly soluble in acetone, and partially insoluble in ether.
The chemical name for diclofenac sodium is: Sodium [o-(2,6-dichloranilino) phenyl] acetate Diclofenac sodium has a molecular weight of 318.13. The CAS number is CAS-15307-79-6. The structural formula is represented below: [Image] Diclofenac sodium topical gel, 3% also contains benzyl alcohol, sodium hyaluronate, polyethylene glycol monomethyl ether, and purified water.
1 g of diclofenac sodium topical gel, 3% contains 30 mg of the active substance, diclofenac sodium.
💬 Medication Guide ▾
MEDICATION GUIDE Diclofenac Sodium Topical Gel, 3% (dye kloe' fen ak soe' dee um) What is the most important information I should know about diclofenac sodium topical gel and 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 or use 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 or use 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 is diclofenac sodium topical gel ?
Diclofenac sodium topical gel is an NSAID that is used on the skin (topical) to treat a skin condition called actinic keratosis. Diclofenac sodium topical gel is not for use in children. Do not use diclofenac sodium topical gel : ● if you have had an allergic reaction to any of the ingredients in diclofenac sodium topical gel.
See the end of this Medication Guide for a complete list of ingredients in diclofenac sodium topical gel. ● if you have a history of asthma, hives, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe allergic reactions that can sometimes lead to death, have happened in people with a history of these types of allergic reactions to NSAIDs. ● on skin that is inflamed, or has eczema, infected sores (lesions), burns or wounds. ● right before or after heart bypass surgery. Before using diclofenac sodium topical gel, 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.
Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy. ● are breastfeeding or plan to breastfeed.
You and your healthcare provider should decide if you will use diclofenac sodium topical gel or breastfeed. 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. How should I use diclofenac sodium topical gel ? ● Use diclofenac sodium topical gel exactly as your healthcare provider tells you to use it. ● Apply diclofenac sodium topical gel 2 times a day. ● Apply enough diclofenac sodium topical gel to cover each skin lesion (usually a pea-sized amount) and gently rub in. ● Diclofenac sodium topical gel may be used for 60 to 90 days. You may not see improvement of skin lesions for up to 30 days after stopping treatment.
See your healthcare provider if lesions do not respond to treatment. ● Av…