Diclofenac Sodium 25mg DR Tablets

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities. Its mechanism of action, like that of other NSAIDs, is believed to be due to the inhibition of prostaglandin synthesis, primarily through the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. This reduces the formation of prostaglandin precursors, which are involved in inflammation, pain, and fever.

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Bleeding: Vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrolled bleeding.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
High Potassium Levels: Abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Respiratory Issues: Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Cardiovascular Issues: Chest pain or pressure, rapid heartbeat, or weakness on one side of the body.
Neurological Issues: Trouble speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Extreme Fatigue: Feeling very tired or weak.
Urinary Problems: Pain while urinating or blood in the urine.
Liver Problems: Dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes. (Note: Liver problems can be fatal, so seek medical attention immediately if you experience any of these symptoms.)
Severe Skin Reactions: Red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands. These reactions can be life-threatening and may affect internal organs.

Common Side Effects

Most people experience few or no side effects while taking this medication. However, if you notice any of the following side effects and they bother you or persist, contact your doctor:

Constipation, diarrhea, stomach pain, upset stomach, or vomiting.
Heartburn.
Gas.
Dizziness or drowsiness.
Headache.
Excessive sweating.
* Common cold symptoms.

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
If you are allergic to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
If you have ever experienced asthma triggered by a salicylate medication, such as aspirin, or an NSAID.
If you have a history of gastrointestinal (GI) bleeding or kidney problems.
If you have heart failure (a weak heart) or have recently had a heart attack.
If you are currently taking another NSAID, a salicylate medication like aspirin, or pemetrexed.
If you are having difficulty getting pregnant or are undergoing fertility testing.
If you are pregnant, plan to become pregnant, or become pregnant while taking this medication. This medication may harm an unborn baby if taken after 20 weeks of pregnancy. If you are between 20 and 30 weeks pregnant, only take this medication if your doctor has instructed you to do so. Do not take this medication if you are more than 30 weeks pregnant.

Additionally, it is crucial to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure that it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition. Be sure to discuss this with your doctor.

Drugs similar to this one have been associated with high blood pressure. Follow your doctor's instructions for checking your blood pressure regularly.

Before consuming alcohol, consult with your doctor to discuss any potential risks or interactions.

If you smoke, talk to your doctor about the potential effects on your health while taking this medication.

If you have asthma, consult with your doctor, as you may be more sensitive to this drug.

Adhere to the prescribed dosage and do not exceed the recommended amount, as taking more than directed may increase your risk of severe side effects. Additionally, do not take this medication for longer than your doctor has prescribed.

Be aware that this medication may increase your risk of bleeding easily. To minimize this risk, be cautious and avoid injury, use a soft toothbrush, and consider using an electric razor.

The use of drugs like this one has been linked to an increased risk of heart failure. If you already have heart failure, your risk of heart attack, hospitalization for heart failure, and death may be higher. Discuss this with your doctor.

In people who have recently experienced a heart attack, the use of drugs like this one has been associated with an increased risk of heart attack and heart-related death. Furthermore, individuals taking this type of medication after a first heart attack were more likely to die within the following year compared to those not taking this medication. Talk to your doctor about these potential risks.

If you are taking aspirin to help prevent a heart attack, consult with your doctor to discuss any potential interactions or effects.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Medications like this one, known as NSAIDs, may affect ovulation, which could impact fertility. However, this effect is typically reversible when the medication is stopped. Discuss this with your doctor if you have concerns.

If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.

• Aspirin (concomitant use increases risk of GI adverse events)
• Other NSAIDs (increased risk of adverse events)
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., Warfarin, Heparin, DOACs) - increased bleeding risk
• Antiplatelet agents (e.g., Clopidogrel, Aspirin) - increased bleeding risk
• SSRIs/SNRIs - increased risk of GI bleeding
• Lithium - increased lithium levels and toxicity
• Methotrexate - increased methotrexate levels and toxicity
• Cyclosporine - increased nephrotoxicity
• Tacrolimus - increased nephrotoxicity
• ACE inhibitors/ARBs - reduced antihypertensive effect, increased risk of renal impairment
• Diuretics (e.g., Furosemide, Thiazides) - reduced diuretic and antihypertensive effect, increased risk of renal impairment
• Digoxin - increased digoxin levels

• Corticosteroids - increased risk of GI ulceration/bleeding
• Pemetrexed - increased myelosuppression, renal, and GI toxicity (avoid in patients with renal impairment)
• Cholestyramine/Colestipol - reduced diclofenac absorption
• CYP2C9 inhibitors (e.g., Fluconazole, Amiodarone) - increased diclofenac exposure
• CYP2C9 inducers (e.g., Rifampin) - decreased diclofenac exposure

• Alcohol - increased risk of GI irritation/bleeding
• Herbal supplements (e.g., Ginkgo biloba, Garlic) - potential increased bleeding risk

• Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Symptoms of cardiovascular events (e.g., chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of renal dysfunction (e.g., decreased urine output, swelling in ankles/feet, unusual fatigue)
• Symptoms of liver injury (e.g., nausea, fatigue, dark urine, yellowing of skin/eyes, right upper quadrant pain)
• Signs of allergic reactions or severe skin reactions (e.g., rash, hives, blistering, swelling of face/throat, difficulty breathing)
• Unexplained weight gain or edema
• Vision changes

Avoid use during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and potential for renal dysfunction in the fetus. Use during the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus.

Diclofenac is excreted in breast milk in low concentrations. Generally considered compatible with breastfeeding, but use with caution and monitor the infant for adverse effects (e.g., irritability, rash, GI upset).

Safety and effectiveness have not been established in pediatric patients for the delayed-release tablet formulation. Use is generally not recommended for children under 18 years of age.

Elderly patients are at increased risk for serious cardiovascular, gastrointestinal, and renal adverse events associated with NSAID use. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects, especially GI bleeding and renal impairment.

• Diclofenac DR is often preferred for chronic inflammatory conditions due to its sustained release profile.
• Always prescribe the lowest effective dose for the shortest duration consistent with individual patient treatment goals to minimize risks.
• Patients should be advised to take diclofenac with food or milk to minimize GI upset, despite it being a delayed-release formulation.
• Counsel patients on the signs and symptoms of serious cardiovascular and gastrointestinal adverse events and to seek immediate medical attention if they occur.
• Regular monitoring of blood pressure, renal function, and liver function is crucial, especially in patients on long-term therapy or with pre-existing conditions.
• Avoid concomitant use with other NSAIDs, including over-the-counter products, to prevent additive toxicity.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib, Meloxicam)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Opioid analgesics (for severe pain, with higher risk of side effects and dependence)
• Corticosteroids (for severe inflammation, with different side effect profile)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions like RA or AS
• Non-pharmacological therapies (e.g., physical therapy, heat/cold therapy, exercise, lifestyle modifications)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable resource for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.