Diclofenac Sodium 75 mg Tablet, Delayed Release, 60-count — NDC 59651-843-60 (Billing 59651-0843-60)
This is a package of 60 tablets of Diclofenac Sodium 75 mg Tablet, Delayed Release from Aurobindo Pharma Limited, marketed since Apr 2025 and currently FDA-listed; retail pharmacies pay about $0.0619 per tablet (NADAC). It is the main listing for this product, which comes in 4 package sizes.
Other active recalls for Diclofenac Sodium (different manufacturers) — 3 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 008374
- GCN: 35852
- GPI-14 (Medi-Span): 66100007200630
- HICL (First Databank): 003733
- AHFS class code: 28:08.04.04
- RxCUI (RxNorm): 855906
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Diclofenac capsules (Zipsor, Zorvolex) and tablets (Cataflam) are used to relieve mild to moderate pain. Diclofenac extended-release tablets (Voltaren XR), tablets (Cataflam), and delayed-release tablets (available generically) are used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Diclofenac extended-release tablets and delayed-release tablets are also used to treat ankylosing spondylitis (arthritis that mainly affe...
Read the full MedlinePlus article ↗- It's an NSAID used for pain and inflammation. Depending on the form, that may be arthritis, period pain, acute pain, strains and sprains, or migraine attacks. Check that your produ...
- Take oral forms by mouth and apply gels, solutions and patches to the skin as directed. Use the lowest dose for the shortest time that works. Food won't change how much you absorb,...
- Stomach upset, nausea, gas, diarrhea or constipation, headache and dizziness are common. Skin products can cause dryness, redness or irritation where applied. Call me or your docto...
- Get emergency help for chest pain, trouble breathing, weakness on one side, black or bloody stools, vomiting blood, or swelling of the face or tongue. Stop it and call for a new ra...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Diclofenac Sodium — tap one for details:
Diclofenac Sodium may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.062 | $3.71 / 60 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2083 | $12.50 / 60 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.1933 | $11.60 / 60 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 59651-0843-01 59651-843-01 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE | $0.0619 / ea | $6.19 | 2025-04-17 | — | Active |
| 59651-0843-05 59651-843-05 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE | $0.0619 / ea | $30.97 | 2025-04-17 | — | Active |
| 59651-0843-60 You're viewing this Main listing | 60 TABLET, DELAYED RELEASE in 1 BOTTLE | $0.0619 / ea | $3.72 | 2025-04-17 | — | Active |
| 59651-0843-99 59651-843-99 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE | $0.0619 / ea | $61.94 | 2025-04-17 | — | Active |
You're viewing the smallest of 4 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 4 priced pack sizes ($0.0619 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 69% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 59651-0843-01?
What NDC number is used to bill for this package of Diclofenac Sodium 75 mg Tablet, Delayed Release?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Diclofenac Sodium 75 mg 00228-2551-06 | Actavis | 60 tablets | $0.062 | AB | Availability likely | — |
| Diclofenac Sodium 75 mg 16571-0201-06 | Rising | 60 tablets | $0.062 | AB | Availability likely | — |
| Diclofenac Sodium 75 mgthis 59651-0843-60 | Aurobindo | 60 tablets | $0.062 | AB | Availability likely | — |
| Diclofenac Sodium 75 mg 60687-0658-01 | American | 1 tablet | $0.062 | AB | Availability likely | — |
| Diclofenac Sodium Delayed Release 75 mg 61442-0103-01 | Carlsbad | 100 tablets | $0.062 | AB | Availability likely | — |
| Diclofenac Sodium Delayed Release 75 mg 61442-0227-01 | Carlsbad | 100 tablets | $0.062 | AB | Availability likely | — |
| Diclofenac Sodium 75 mg 68001-0281-00 | BluePoint | 100 tablets | $0.062 | AB | Availability likely | — |
| Diclofenac Sodium 75 mg 70512-0784-60 | SOLA | 60 tablets | $0.062 | AB | Availability likely | — |
| Diclofenac Sodium 75 mg 72603-0604-01 | NorthStar | 60 tablets | $0.062 | AB | Availability likely | — |
| Diclofenac Sodium 75 mg 72888-0111-00 | Advagen | 1000 tablets | $0.062 | AB | Availability likely | — |
| Diclofenac Sodium 75 mg 35356-0714-20 | Quality | 20 tablets | — | AB | Discontinued | — |
| Diclofenac Sodium 75 mg 42291-0231-10 | AvKARE | 1000 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 50090-0545-00 | A-S | 100 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 50090-6924-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 50090-7646-00 | A-S | 100 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 50090-7647-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 50090-7818-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 50090-7838-00 | A-S | 100 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 50090-7839-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 50090-7855-00 | A-S | 100 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 50090-7856-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 51407-0538-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 51407-0968-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 51655-0176-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 55289-0150-10 | PD-Rx | 10 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 60290-0084-01 | Umedica | 60 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 60429-0422-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 60760-0090-15 | St. | 15 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 61145-0102-06 | REPHARM | 60 tablets | — | AB | Discontinued | — |
| Diclofenac Sodium 75 mg 63187-0012-15 | Proficient | 15 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 63187-0222-15 | Proficient | 15 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 63187-0761-15 | Proficient | 15 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 63629-2011-01 | Bryant | 500 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 63629-2012-01 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 63629-2013-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 66267-0071-14 | NuCare | 14 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 67046-1482-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 67296-0990-01 | RedPharm | 21 tablets | — | AB | Discontinued | — |
| Diclofenac Sodium 75 mg 67296-1197-02 | RedPharm | 20 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 67296-2151-08 | Redpharm | 28 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 67296-2215-01 | Redpharm | 20 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 68071-4117-02 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 68071-4934-04 | NuCare | 14 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 68788-8193-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 68788-9806-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 70518-0627-00 | REMEDYREPACK | 30 tablets | — | AB | Discontinued | — |
| Diclofenac Sodium Delayed Release 75 mg 70518-1104-02 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 70518-4602-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release Delayed Release 75 mg 70882-0128-30 | Cambridge | 30 tablets | — | AB | Discontinued | — |
| Diclofenac Sodium Delayed Release 75 mg 71205-0991-00 | Proficient | 100 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 71335-0357-00 | Bryant | 40 tablets | — | AB | Discontinued | — |
| Diclofenac Sodium 75 mg 71335-0456-00 | Bryant | 40 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 71335-2684-00 | Bryant | 40 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 72162-1734-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 76420-0670-00 | Asclemed | 1000 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium DR 75 mg 80425-0055-01 | Advanced | 60 tablets | — | AB | FDA listed | — |
| Diclofenac DR 75 mg 80425-0056-01 | Advanced | 60 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium DR 75 mg 80425-0189-01 | Advanced | 60 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 80425-0564-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 85509-1103-03 | PHOENIX | 30 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 85509-1201-03 | PHOENIX | 30 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 85766-0010-01 | Sportpharm | 100 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 72789-0578-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium 75 mg 82868-0114-30 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Diclofenac Sodium Delayed Release 75 mg 68788-4194-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
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?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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.
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UNII 68401960MK
Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
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UNII 92RU3N3Y1O
Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
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UNII 6T47AS764T
Red 40 Lake is a synthetic colorant made by combining Red 40 dye with aluminum hydroxide. It's used to give tablets, capsules, and other medicines a red or pink color for identification and appearance.
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UNII GYP6Z2JR6Q
FD&C Yellow No. 6 Aluminum Lake is a yellow colorant made by combining FD&C Yellow No. 6 dye with aluminum salts. It's used to color tablets, capsules, and other medicines so they're easier to identify.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 36SFW2JZ0W
Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
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UNII 0VUT3PMY82
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
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UNII 1IVH67816N
Hypromellose 2910 is a plant-derived cellulose compound used as a thickener and film-former in medicines. It helps control how quickly the medication dissolves and creates protective coatings on tablets or capsules.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII NX76LV5T8J
A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 4R4HFI6D95
Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
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UNII Q662QK8M3B
Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
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UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
20 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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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 ). Diclofenac sodium delayed-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS , WARNINGS ).
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 greater risk for serious GI events (see WARNINGS ).
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac sodium delayed-release tablets are 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 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 sodium delayed-release tablets. 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 sodium delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of osteoarthritis, the recommended dosage is 100 to 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 to 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 to 125 mg/day, administered as 25 mg four times a day, with an extra 25 mg dose at bedtime if necessary.
Different formulations of diclofenac [(diclofenac sodium enteric-coated tablets); diclofenac sodium extended-release tablets; diclofenac potassium immediate-release tablets)] are not necessarily bioequivalent even if the milligram strength is the same.
⛔ 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 ).
⚠️ Warnings ▾
WARNINGS Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to 3 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 (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.
NSAIDs are contraindicated in the setting of CABG (see CONTRAINDICATIONS ). 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 week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients.
Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up. Avoid the use of diclofenac sodium delayed-release tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If diclofenac sodium delayed-release tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, including diclofenac, cause serious gastrointestinal (GI) adverse events, including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic.
Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for one year. However, even short-term therapy is not without risk. Risk Factors for GI Bleeding, Ulceration, and Perforation Patients with a prior history of peptic ulcer disease and/or GI bleeding who use NSAIDs had a greater than 10-fold increased risk for developing… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
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% to 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, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes, and tinnitus. Additional adverse experiences reported occasionally include: Body as a Whole: fever, infection, sepsis Cardiovascular System: congestive heart failure, hypertension, tachycardia, syncope Digestive System: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice Hemic and Lymphatic System: ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia Metabolic and Nutritional: weight changes Nervous System: anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo Respiratory System: asthma, dyspnea Skin and Appendages: alopecia, photosensitivity, sweating increased Special Senses: blurred vision Urogenital System: cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure Other adverse reactions, which occur rarely are: Body as a Whole: anaphylactic reactions, appetite changes, death Cardiovascular System: arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis Digestive System: colitis, eructation, fulminant hepatitis with and without jaundice, liver failure, liver necrosis, pancreatitis Hemic and Lymphatic System: agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia Metabolic and Nutritional: hyperglycemia Nervous System: convulsions, coma, hallucinations, meningitis Respiratory System: respiratory depression, pneumonia Skin and Appendages: angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, fixed drug eruption (FDE), urticaria Special Senses: conjunctivitis, hearing impairment
🔄 Drug Interactions ▾
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.
Intervention: Monitor patients with concomitant use of diclofenac sodium delayed-release tablets 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 PRECAUTIONS ; Hematological Toxicity ). 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 the use of NSAIDs alone.
In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Intervention: Concomitant use of diclofenac sodium delayed-release tablets and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding (see PRECAUTIONS : Hematological Toxicity ). Diclofenac sodium delayed-release tablets are not a substitute for low dose aspirin for cardiovascular protection.
ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, coadministration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.
Intervention: During concomitant use of diclofenac sodium delayed-release tablets and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of diclofenac sodium delayed-release tablets and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function (see WARNINGS; Renal Toxicity and Hyperkalemia). When these drugs are administered concomitantly, patients should be adequately hydrated.
Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.
Intervention: During concomitant use of diclofenac sodium delayed-release tablets with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy, including antihypertensive effects (see WARNINGS; Renal Toxicity and Hyperkalemia ). Digoxin Clinical Impact: The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of diclofenac sodium delayed-release tablets and digoxin, monitor serum digoxin levels.
Lithium Clinical Impact: NSAIDs have produced elevations in plasma… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
Pregnancy Risk Summary Use of NSAIDs, including diclofenac sodium delayed-release tablets, 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 delayed-release tablets use between about 20 and 30 weeks of gestation, and avoid diclofenac sodium delayed-release tablets use at about 30 weeks of gestation and later in pregnancy (see WARNINGS; Fetal Toxicity ).
Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including diclofenac sodium delayed-release tablets, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. 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. There are no adequate and well-controlled studies of diclofenac sodium delayed-release tablets in pregnant women.
Data from observational studies regarding potential embryo-fetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, no evidence of teratogenicity was observed in mice, rats, or rabbits given diclofenac during the period of organogenesis at doses up to approximately 0.5, 0.5, and 1 times, respectively, the maximum recommended human dose (MRHD) of diclofenac sodium delayed-release tablets, 200 mg/day, despite the presence of maternal and fetal toxicity at these doses (see Data) .
Based on published animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors, such as diclofenac, 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 estimated 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 delayed-release tablets, can cause premature closure of the fetal ductus arteriosus (see WARNINGS; Fetal Toxicity ).
Oligohydramnios/Neonatal Renal Impairment: If 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 delayed-release tablets treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue diclofenac sodium delayed-release tablets and follow up according to clinical practice (see WARNINGS; Fetal Toxicity ).
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 post-marketing 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… [Excerpted — this section continues on DailyMed.]
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects (see WARNINGS; Cardiovascular Thrombotic Events , Gastrointestinal Bleeding, Ulceration, and Perforation , Hepatotoxicity , Renal Toxicity and Hyperkalemia , PRECAUTIONS; Laboratory Monitoring ).
Diclofenac is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY , ADVERSE REACTIONS ).
🆘 Overdosage ▾
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 has occurred. Hypertension, acute renal failure, respiratory depression and coma have occurred, but were rare (see WARNINGS; Cardiovascular Thrombotic Events , Gastrointestinal Bleeding, Ulceration, and Perforation , Hypertension , Renal Toxicity and Hyperkalemia ).
Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdose (5 to 10 times the recommended dosage).
Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdosage treatment, contact a poison control center (1-800-222-1222).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac sodium delayed-release tablets, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro .
Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation.
Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues. Pharmacokinetics Absorption Diclofenac is 100% absorbed after oral administration compared to intravenous (IV) administration as measured by urine recovery. However, due to first-pass metabolism, only about 50% of the absorbed dose is systemically available (see Table 1).
Food has no significant effect on the extent of diclofenac absorption. However, there is usually a delay in the onset of absorption of 1 to 4.5 hours and a reduction in peak plasma levels of less than 20%. Table 1.
Pharmacokinetic Parameters for Diclofenac PK Parameter Normal Healthy Adults (20 to 48 years) Mean Coefficient of Mean Variation (%) Absolute bioavailability (%) [N = 7] 55 40 T max (hr) [N = 56] 2.3 69 Oral clearance (CL/F; mL/min) [N = 56] 582 23 Renal clearance (% unchanged drug in urine) [N = 7] < 1 — Apparent volume of distribution (V/F; L/kg) [N = 56] 1.4 58 Terminal half-life (hr) [N = 56] 2.3 48 Distribution The apparent volume of distribution (V/F) of diclofenac sodium is
1.4L/kg. Diclofenac is more than 99% bound to human serum proteins, primarily to albumin. Serum protein binding is constant over the concentration range (0.15 to 105 mcg/mL) achieved with recommended doses.
Diclofenac diffuses into and out of the synovial fluid. Diffusion into the joint occurs when plasma levels are higher than those in the synovial fluid, after which the process reverses and synovial fluid levels are higher than plasma levels. It is not known whether diffusion into the joint plays a role in the effectiveness of diclofenac.
Elimination Metabolism Five diclofenac metabolites have been identified in human plasma and urine. The metabolites include 4’-hydroxy-, 5-hydroxy-, 3’-hydroxy-, 4’,5-dihydroxy- and 3’-hydroxy-4’-methoxy diclofenac. The major diclofenac metabolite, 4'-hydroxy-diclofenac, has very weak pharmacologic activity.
The formation of 4’-hydroxy- diclofenac is primarily mediated by CYP2C9. Both diclofenac and its oxidative metabolites undergo glucuronidation or sulfation followed by biliary excretion. Acyl glucuronidation mediated by UGT2B7 and oxidation mediated by CYP2C8 may also play a role in diclofenac metabolism.
CYP3A4 is responsible for the formation of minor metabolites, 5-hydroxy- and 3’-hydroxy-diclofenac. In patients with renal dysfunction, peak concentrations of metabolites 4’-hydroxy- and 5-hydroxy-diclofenac were approximately 50% and 4% of the parent compound after single oral dosing compared to 27% and 1% in normal healthy subjects. Excretion Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of the glucuronide and the sulfate conjugates of the metabolites.
Little or no free unchanged diclofenac is excreted in the urine. Approximately 65% of the dose is excreted in the urine and approximately 35% in the bile as conjugates of unchanged diclofenac plus metabolites. Because renal elimination is not a significant pathway of elimination for unchanged diclofenac, dosing adjustment in patients with mild to moderate renal dysfunction is not necessary.
The terminal half-life of unchanged diclofenac is approximately 2 hours. Special Populations Pediatric: The pharmacokinetics of diclofenac sodium delayed-release tablets has not been investigated in pedi… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Diclofenac Sodium Delayed-Release Tablets, USP are available containing 50 mg or 75 mg of diclofenac sodium, USP. The 50 mg tablets are light brown, round, biconvex, enteric coated tablet imprinted “D50” in black ink on one side and plain on other side. They are available as follows: Bottles of 60 NDC 59651-842-60 Bottles of 100 NDC 59651-842-01 Bottles of 1,000 NDC 59651-842-99 The 75 mg tablets are pale pink, round, biconvex, enteric coated tablet imprinted “D75” in black ink on one side and plain on other side.
They are available as follows: Bottles of 60 NDC 59651-843-60 Bottles of 100 NDC 59651-843-01 Bottles of 500 NDC 59651-843-05 Bottles of 1,000 NDC 59651-843-99 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as described in the USP using a child-resistant closure. Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides.
Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 01/2025
📋 Description ▾
DESCRIPTION Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C.
The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C 14 H 10 Cl 2 NNaO 2 , and it has the following structural formula.
The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake.
The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze. Chemical Structure
💬 Information for Patients ▾
Information for Patients Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with diclofenac sodium delayed-release tablets and periodically during the course of ongoing therapy. Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately (see WARNINGS; Cardiovascular Thrombotic Events ).
Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for the signs and symptoms of GI bleeding (see WARNING; Gastrointestinal Bleeding, Ulceration, and Perforation ). Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and “flu-like” symptoms).
If these occur, instruct patients to stop diclofenac sodium delayed-release tablets and seek immediate medical therapy (see WARNINGS; Hepatotoxicity ). Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure, including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur (see WARNINGS; Heart Failure and Edema ). Anaphylactic Reactions Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat).
Instruct patients to seek immediate emergency help if these occur (see WARNINGS; Anaphylactic Reactions ). Serious Skin Reactions, Including DRESS Advise patients to stop diclofenac sodium delayed-release tablets immediately if they develop any type of rash or fever and contact their healthcare provider as soon as possible (see WARNINGS; Serious Skin Reactions ). Female Fertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including diclofenac sodium delayed-release tablets, may be associated with a reversible delay in ovulation (see PRECAUTIONS; Carcinogenesis, Mutagenesis, Impairment of Fertility ).
Fetal Toxicity Inform pregnant women to avoid use of diclofenac sodium delayed-release tablets and other NSAIDs, starting at 30 weeks gestation because of the risk of the premature closure of the fetal ductus arteriosus. If treatment with diclofenac sodium delayed-release tablets are needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours. (see WARNINGS; Fetal Toxicity , PRECAUTIONS , Pregnancy ).
Avoid Concomitant Use of NSAIDs Inform patients that the concomitant use of diclofenac sodium delayed-release tablets with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation and Drug Interactions ). Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia. Use of NSAIDS and Low-Dose Aspirin Inform patients not to use low-dose aspirin concomitantly with diclofenac sodium delayed-release tablets until they talk to their healthcare provider (see PRECAUTIONS; Drug Interactions ).
Masking of Inflammation and Fever The pharmacological activity of diclofenac sodium delayed-release tablets in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting in… [Excerpted — this section continues on DailyMed.]
💬 Medication Guide ▾
Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides. Medication Guide Diclofenac Sodium (dye kloe' fen ak soe' dee um) Delayed-Release Tablets, USP What is the most important information I should know about medicines called Non-Steroidal 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 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 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: any time 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 older age longer use of NSAIDs poor health smoking advanced liver disease drinking alcohol bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions, such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDs: if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. right before or after heart bypass surgery.
Before taking NSAIDs, 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. 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. What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?” new or worse high blood pressure heart failure liver problems, including liver failure kidney problems, including kidney failure low red blood cells (anemia) life-threatening skin reactions life-threatening allergic reactions Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, dizziness Get emergency help right away if you have any of the following symptoms: shortness of breath or trouble breathing slurred speech chest pain swelling of the face or throat weakness in one part or side of your body Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: nausea vomit blood more tired or weaker than usual there is blood in your bowel movement or it is black and sticky like tar diarrhea unusual weight gain itching skin rash or blisters with fever your skin or eyes look yellow swelling of t… [Excerpted — this section continues on DailyMed.]
⚠️ Precautions ▾
PRECAUTIONS General Diclofenac sodium delayed-release tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids and the patient should be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.
The pharmacological activity of diclofenac sodium delayed-release tablets in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions. Information for Patients Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with diclofenac sodium delayed-release tablets and periodically during the course of ongoing therapy.
Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately (see WARNINGS; Cardiovascular Thrombotic Events ). Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider.
In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for the signs and symptoms of GI bleeding (see WARNING; Gastrointestinal Bleeding, Ulceration, and Perforation ). Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop diclofenac sodium delayed-release tablets and seek immediate medical therapy (see WARNINGS; Hepatotoxicity ).
Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure, including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur (see WARNINGS; Heart Failure and Edema ). Anaphylactic Reactions Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur (see WARNINGS; Anaphylactic Reactions ).
Serious Skin Reactions, Including DRESS Advise patients to stop diclofenac sodium delayed-release tablets immediately if they develop any type of rash or fever and contact their healthcare provider as soon as possible (see WARNINGS; Serious Skin Reactions ). Female Fertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including diclofenac sodium delayed-release tablets, may be associated with a reversible delay in ovulation (see PRECAUTIONS; Carcinogenesis, Mutagenesis, Impairment of Fertility ).
Fetal Toxicity Inform pregnant women to avoid use of diclofenac sodium delayed-release tablets and other NSAIDs, starting at 30 weeks gestation because of the risk of the premature closure of the fetal ductus arteriosus. If treatment with diclofenac sodium delayed-release tablets are needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours. (see WARNINGS; Fetal Toxicity , PRECAUTIONS , Pregnancy ).
Avoid Concomitant Use of NSAIDs Inform patients that the concomitant use of diclofenac sodium delayed-release tablets with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is no… [Excerpted — this section continues on DailyMed.]
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term carcinogenicity studies in rats given diclofenac sodium up to 2 mg/kg/day (approximately 0.1 times maximum recommended human dose (MRHD) of diclofenac sodium delayed-release tablets, 200 mg/day, based on body surface area (BSA) comparison) have revealed no significant increases in tumor incidence. A 2-year carcinogenicity study conducted in mice employing diclofenac sodium at doses up to 0.3 mg/kg/day (approximately 0.007 times the MRHD based on BSA comparison) in males and 1 mg/kg/day (approximately 0.02 times the MRHD based on BSA comparison) in females did not reveal any oncogenic potential.
Mutagenesis Diclofenac sodium did not show mutagenic activity in in vitro point mutation assays in mammalian (mouse lymphoma) and microbial (yeast, Ames) test systems and was nonmutagenic in several mammalian in vitro and in vivo tests, including dominant lethal and male germinal epithelial chromosomal studies in mice, and nucleus anomaly and chromosomal aberration studies in Chinese hamsters. Impairment of Fertility Diclofenac sodium administered to male and female rats at 4 mg/kg/day (approximately 0.2 times the MRHD based on BSA comparison) did not affect fertility.
Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including diclofenac sodium delayed-release tablets, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation.
Consider withdrawal of NSAIDs, including diclofenac sodium delayed-release tablets, in women who have difficulties conceiving or who are undergoing investigation of infertility.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 mg (60 Tablet Bottle) NDC 59651-842-60 Rx only Diclofenac Sodium Delayed-Release Tablets, USP 50 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 60 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 mg (60 Tablet Bottle)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 75 mg (60 Tablet Bottle) NDC 59651-843-60 Rx only Diclofenac Sodium Delayed-Release Tablets, USP 75 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. AUROBINDO 60 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 75 mg (60 Tablet Bottle)