Diclofenac Sodium 100mg ER 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.

Urgent 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 immediately or seek emergency medical attention:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Bleeding: Vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden significant 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 significant 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: Difficulty 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 life-threatening and have occurred with similar medications.)
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.

Other Possible Side Effects

Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

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. 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 conditions to ensure safe treatment:

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.
Allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
A history of asthma triggered by salicylate medications, such as aspirin, or NSAIDs.
Certain health conditions, including:
+ Gastrointestinal (GI) bleeding or kidney problems.
+ Heart failure (weak heart) or a recent heart attack.
Concurrent use of other NSAIDs, salicylate medications like aspirin, or pemetrexed.
Difficulty conceiving or undergoing fertility evaluation.
* Pregnancy, planned pregnancy, or pregnancy during treatment. This medication may harm an unborn baby if taken after 20 weeks of gestation. If you are between 20 and 30 weeks pregnant, only take this medication under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.

To ensure your safety, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. Verify that it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dosage 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 any concerns or questions you have with your doctor.

Drugs similar to this one have been associated with high blood pressure. To minimize this risk, follow your doctor's instructions for monitoring your blood pressure.

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

If you smoke, it is crucial to discuss this with your doctor, as smoking may affect your treatment or increase your risk of side effects.

If you have asthma, inform your doctor, as you may be more sensitive to this medication and require closer monitoring.

To avoid severe side effects, adhere to the dosage instructions provided by your doctor. Do not take more than the prescribed amount, and do not take this medication for longer than recommended.

As this drug may increase your risk of bleeding, take precautions to avoid injury. Use a soft toothbrush and an electric razor to minimize this risk.

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 these risks with your doctor.

In people who have recently experienced a heart attack, the use of drugs like this one may increase the risk of another heart attack or heart-related death. Additionally, research has shown that people taking these medications after a first heart attack may have a higher risk of death in the following year compared to those not taking these medications. It is essential to discuss these risks with your doctor.

If you are taking aspirin to prevent heart attacks, inform your doctor, as this may affect your treatment plan.

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

NSAIDs, such as this medication, may affect ovulation, which can impact fertility. However, this effect is typically reversible when the medication is stopped. Discuss any concerns about fertility with your doctor.

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

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
• Severe renal impairment (CrCl < 30 mL/min)
• Severe hepatic impairment
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

• Anticoagulants (e.g., warfarin, heparin, dabigatran, rivaroxaban) - increased bleeding risk
• Antiplatelet agents (e.g., aspirin, clopidogrel) - increased bleeding risk
• Corticosteroids - increased GI ulceration/bleeding risk
• SSRIs/SNRIs - increased GI bleeding risk
• Lithium - increased lithium levels/toxicity
• Methotrexate - increased methotrexate levels/toxicity
• Cyclosporine - increased nephrotoxicity
• Digoxin - increased digoxin levels
• ACE inhibitors/ARBs - reduced antihypertensive effect, increased risk of renal impairment
• Diuretics (e.g., furosemide, hydrochlorothiazide) - reduced diuretic/antihypertensive effect, increased risk of renal impairment

• Beta-blockers - reduced antihypertensive effect
• Phenytoin - increased phenytoin levels
• Cholestyramine/Colestipol - reduced diclofenac absorption
• Oral hypoglycemics - potential for altered blood glucose control
• Alcohol - increased risk of GI irritation/bleeding

• Not available

• Signs of gastrointestinal bleeding (black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of cardiovascular events (chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of renal impairment (decreased urine output, swelling in ankles/feet, unusual fatigue)
• Signs of liver injury (yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Signs of allergic reaction (rash, hives, itching, swelling of face/lips/tongue, difficulty breathing)
• Unusual bruising or bleeding
• Weight gain or swelling (fluid retention)

Avoid use in the third trimester of pregnancy (after 20 weeks gestation) due to the risk of premature closure of the fetal ductus arteriosus and renal dysfunction in the fetus. Use in the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus, and at the lowest effective dose for the shortest duration possible.

Diclofenac is excreted in breast milk in small amounts. While the amount is generally considered low, caution should be exercised. Consider the infant's age, health, and the amount of milk consumed. Monitor the infant for adverse effects.

Diclofenac extended-release tablets are not approved for use in pediatric patients. Safety and effectiveness have not been established in this population. Other formulations of diclofenac (e.g., immediate-release, topical) may be used in specific pediatric conditions under medical supervision.

Elderly patients are at increased risk for serious adverse reactions to NSAIDs, including gastrointestinal bleeding, ulceration, perforation, cardiovascular thrombotic events, and renal impairment. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects, especially renal and GI toxicity.

• Always take Diclofenac ER with food or milk to minimize GI upset, even though it's an ER formulation.
• Remind patients that NSAIDs, including diclofenac, carry significant cardiovascular and gastrointestinal risks, especially with long-term use or in high-risk patients.
• Educate patients on the signs of GI bleeding (black, tarry stools; coffee-ground vomit) and cardiovascular events (chest pain, shortness of breath) and to seek immediate medical attention if they occur.
• Monitor renal function, liver function, and blood pressure regularly, particularly in elderly patients or those with pre-existing conditions.
• Diclofenac ER is not for acute pain relief where rapid onset is needed; it's designed for chronic conditions requiring sustained pain and inflammation control.
• Avoid concomitant use with other NSAIDs (including aspirin for pain/fever) to prevent additive toxicity without increased efficacy.

• Other NSAIDs (e.g., ibuprofen, naproxen, celecoxib)
• Acetaminophen (for pain/fever without inflammation)
• Opioid analgesics (for severe pain, short-term)
• Corticosteroids (for severe inflammation, short-term)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions (e.g., methotrexate, biologics)
• Topical NSAIDs (e.g., diclofenac gel) for localized pain

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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 details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.