Diclofenac Sodium Gel
Generic Name: diclofenac sodium gel
Brand Names:
Diclofenac Sodium Gel
Diclofenac Sodium Topical Gel, 3%, intended for dermatologic use, contains the active ingredient, diclofenac sodium, USP in a clear, transparent, colorless to slightly yellow gel base. Diclofenac sodium, USP is a white to slightly yellowish, hygroscopic crystalline powder, and melts at about 284°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water, slightly soluble in acetone, and partially insoluble in chloroform and ether.
Overview
Diclofenac Sodium Topical Gel, 3%, intended for dermatologic use, contains the active ingredient, diclofenac sodium, USP in a clear, transparent, colorless to slightly yellow gel base. Diclofenac sodium, USP is a white to slightly yellowish, hygroscopic crystalline powder, and melts at about 284°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water, slightly soluble in acetone, and partially insoluble in chloroform and ether.
Uses
Diclofenac sodium gel is indicated for the topical treatment of actinic keratoses (AK).
Dosage
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)]. Apply diclofenac sodium 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 gel with eyes and mucous membranes.
Side Effects
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)] • Hematologic Toxicity [see Warnings and Precautions (5.12)] • Photosensitivity [see Warnings...
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.
Warnings
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)]. 5.1 Anaphylactic 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. 5.2 Exacerbation 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. Diclofenac sodium 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) and Description (11)] • With the history of asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDs.
Storage
Each gram of Diclofenac Sodium Topical Gel, 3% contains 30 mg of diclofenac sodium, USP. Diclofenac Sodium Gel, 3% is available as follows: NDC 68462-355-94 100 g tube (1 tube per carton) Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from heat. Avoid freezing.
Frequently Asked Questions
What is Diclofenac Sodium Gel used for?▼
Diclofenac sodium gel is indicated for the topical treatment of actinic keratoses (AK).
What are the side effects of Diclofenac Sodium Gel?▼
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)] • Hematologic Toxicity [see Warnings and Precautions (5.12)] • Photosensitivity [see Warnings...
What are the important warnings for Diclofenac Sodium Gel?▼
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)]. 5.1 Anaphylactic 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. 5.2 Exacerbation 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. Diclofenac sodium 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) and Description (11)] • With the history of asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDs.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.