Drugplain

Diclofenac Sodium DR 75 mg/1

Diclofenac Sodium · TABLET, DELAYED RELEASE · Advanced Rx Pharmacy of Tennessee, LLC

No Recall History
Plain English

Diclofenac Sodium DR is a tablet, delayed release containing diclofenac sodium at 75 mg/1, taken oral. Manufactured by Advanced Rx Pharmacy of Tennessee, LLC.

Key Facts

Brand Name
Diclofenac Sodium DR
Generic Name
Diclofenac Sodium
NDC Code (Product)
80425-0189
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Strength
75 mg/1
Dosage Form
TABLET, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA075185
Marketing Start
11/13/1998

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Indications and Usage Section Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). Diclofenac is indicated: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

Dosage & Administration

Dosage and Administration DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION) . After observing the response to initial therapy with diclofenac, the dose and frequency should be adjusted to suit an individual patient's needs. For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses (50 mg twice a day or three times a day, or 75 mg twice a day). For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses (50 mg three times a day. or four times a day, or 75 mg twice a day.). For the relief of ankylosing spondylitis, the recommended dosage is 100-125 mg/day, administered as 25 mg four times a day, with an extra 25-mg dose at bedtime if necessary.

Warnings

Warnings 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. 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,…

Contraindications

Contraindications Diclofenac sodium delayed-release tablets are 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; ANAPHYLACTIC REACTIONS, SERIOUS SKIN REACTIONS). 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; ANAPHYLACTIC REACTION, EXACERBATION OF ASTHMA RELATED TO ASPIRIN SENSITIVITY). In the setting of coronary artery bypass graft (CABG) surgery ( see WARNINGS; CARDIOVASCULAR THROMBOTIC EVENTS).

Adverse Reactions

Adverse Reactions Section ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events (see WARNINGS) GI Bleeding, Ulceration and Perforation (see WARNINGS) Hepatotoxicity (see WARNINGS) Hypertension (see WARNINGS) Heart Failure and Edema (see WARNINGS) Renal Toxicity and Hyperkalemia (see WARNINGS) Anaphylactic Reactions (see WARNINGS) Serious Skin Reactions (see WARNINGS) Hematologic Toxicity (see WARNINGS) 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. In patients taking diclofenac sodium delayed-release tablets, or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1%-10% of patients are: Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting. Abnormal renal function, anemia, di…

Frequently Asked Questions

What is Diclofenac Sodium DR used for?

Diclofenac Sodium DR contains Diclofenac Sodium. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.

Is Diclofenac Sodium DR a controlled substance?

Diclofenac Sodium DR is not classified as a controlled substance by the DEA.

What is the generic name for Diclofenac Sodium DR?

The generic name for Diclofenac Sodium DR is Diclofenac Sodium. There are 12 other brand versions of Diclofenac Sodium.

What is the NDC code for Diclofenac Sodium DR 75 mg/1?

The NDC (National Drug Code) for Diclofenac Sodium DR 75 mg/1 is 80425-0189, listed by Advanced Rx Pharmacy of Tennessee, LLC.

Product NDC

80425-0189

Package NDC

80425-0189-1

Other Diclofenac Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)