Diclofenac Sodium Topical
Generic Name: diclofenac sodium topical
Brand Names:
Diclofenac Sodium 1.5%
11 DESCRIPTION Diclofenac Sodium Topical Solution USP, 1.5% w/w is a nonsteroidal anti-inflammatory drug, available as a clear, colorless to faintly pink orange solution for topical application. Diclofenac Sodium Topical Solution USP 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.
Overview
11 DESCRIPTION Diclofenac Sodium Topical Solution USP, 1.5% w/w is a nonsteroidal anti-inflammatory drug, available as a clear, colorless to faintly pink orange solution for topical application. Diclofenac Sodium Topical Solution USP 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.
Uses
1 INDICATIONS AND USAGE Diclofenac sodium is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). Diclofenac sodium is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).
Dosage
2 DOSAGE AND ADMINISTRATION 2.1 General 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.
Side Effects
6 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 (5.12)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adv...
Interactions
7 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.
Warnings
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL Events WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL Events See full prescribing information for complete boxed warning. · 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. 5 WARNINGS AND PERCAUTIONS 5.1 Cardiovascular 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. 4 CONTRAINDICATIONS Diclofenac sodium 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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16 HOW SUPPLIED/STORAGE AND HANDLING Diclofenac Sodium Topical Solution USP, 1.5% w/w is supplied as a clear, colorless to faintly pink orange solution containing 16.05 mg of diclofenac sodium per mL of solution, in a white high density polyethylene bottle with a white low density polyethylene dropper cap. NDC Number and Size 5 FL.OZ.
Frequently Asked Questions
What is Diclofenac Sodium Topical used for?▼
1 INDICATIONS AND USAGE Diclofenac sodium is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). Diclofenac sodium is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).
What are the side effects of Diclofenac Sodium Topical?▼
6 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 (5.12)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adv...
What are the important warnings for Diclofenac Sodium Topical?▼
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL Events WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL Events See full prescribing information for complete boxed warning. · 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. 5 WARNINGS AND PERCAUTIONS 5.1 Cardiovascular 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. 4 CONTRAINDICATIONS Diclofenac sodium 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.
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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.