Diclofenac Sodium Topical Solution 20 mg/g
Diclofenac Sodium Topical Solution · SOLUTION · Direct_Rx
Diclofenac Sodium Topical Solution is a solution containing diclofenac sodium topical solution at 20 mg/g, taken topical. Manufactured by Direct_Rx.
Key Facts
- Brand Name
- Diclofenac Sodium Topical Solution
- Generic Name
- Diclofenac Sodium Topical Solution
- NDC Code (Product)
72189-575- Manufacturer
- Direct_Rx
- Strength
- 20 mg/g
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA208021
- Marketing Start
- 09/16/2024
Recall History
Direct Rx
Defective Container: Leaking containers.
Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Teligent Pharma, Inc.
Defective Container
Preferred Pharmaceuticals, Inc.
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Ingenus Pharmaceuticals Llc
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Teligent Pharma, Inc.
Defective Container
ALEMBIC PHARMACEUTICALS, INC.
Defective Delivery System
Preferred Pharmaceuticals, Inc.
Defective container: Out of specification for container integrity leading to bottles leaking.
Full Prescribing Information
Indications & Usage
Diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s).
Dosage & Administration
2.1 General Dosing Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS (5.2)]. For relief of the pain of osteoarthritis (OA) of the knee(s), the recommended dose is 40 mg of diclofenac sodium (2 pump actuations) on each painful knee, 2 times a day. Apply diclofenac sodium topical solution to clean, dry skin. The pump must be primed before first use. Instruct patients to fully depress the pump mechanism (actuation) 4 times while holding the bottle in an upright position. This portion should be discarded to ensure proper priming of the pump. No further priming of the bottle should be required. After the priming procedure, diclofenac sodium topical solution is properly dispensed by completely depressing the pump 2 times to achieve the prescribed dosage for one knee. Deliver the product directly into the palm of the hand and then apply evenly around front, back, and sides of the knee. 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. 2.2 Special Precautions Avoid showering/bath…
Contraindications
Diclofenac sodium topical solution 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)]
Drug Interactions
See Table 3 for clinically significant drug interactions with diclofenac. Table 3: 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 increased the 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 topical solution 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 (5.12)] 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 th…
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, 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. Diclofenac Sodium Topical Solution The data described below reflect exposure to diclofenac sodium topical solution of 130 patients treated for 4 weeks (mean duration of 28 days) in one Phase 2 controlled trial. This population’s mean age was approx…
Frequently Asked Questions
What is Diclofenac Sodium Topical Solution used for?
Diclofenac Sodium Topical Solution contains Diclofenac Sodium Topical Solution. It is a solution taken topical. Consult your doctor for specific uses.
Is Diclofenac Sodium Topical Solution a controlled substance?
Diclofenac Sodium Topical Solution is not classified as a controlled substance by the DEA.
What is the generic name for Diclofenac Sodium Topical Solution?
The generic name for Diclofenac Sodium Topical Solution is Diclofenac Sodium Topical Solution. There are no other listed brand versions of Diclofenac Sodium Topical Solution.
What is the NDC code for Diclofenac Sodium Topical Solution 20 mg/g?
The NDC (National Drug Code) for Diclofenac Sodium Topical Solution 20 mg/g is 72189-575, listed by Direct_Rx.
Other Diclofenac Sodium Topical Solution Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)