Diclofenac Sodium 50mg 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.

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 or seek immediate 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, 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 uncontrollable bleeding.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or 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, 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 changes, 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 upset or pain, 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: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek immediate medical help if you experience 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.

Other Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild side effects. If you encounter any of the following side effects or any other symptoms that concern you or persist, contact your doctor or seek medical help:

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

This is not an exhaustive list of possible 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 crucial 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.
A history of asthma triggered by salicylate drugs, such as aspirin, or NSAIDs.
Certain health conditions, including:
+ Gastrointestinal (GI) bleeding or kidney problems.
+ Heart failure (a weak heart) or a recent heart attack.
Concurrent use of other NSAIDs, salicylate drugs like aspirin, or pemetrexed.
Difficulty conceiving or undergoing fertility evaluation.
* Pregnancy, planned pregnancy, or pregnancy during treatment with this medication. This drug 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 under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.

To ensure safe treatment, it is essential to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. Verify that it is safe to take this medication with your other medications 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 long-term, 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 an increased risk of high blood pressure. 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, 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 dosage instructions provided by your doctor. Taking more than the recommended amount may increase your risk of severe side effects. Additionally, do not take this medication for longer than prescribed by your doctor.

This medication may affect your blood's ability to clot, making you more prone to bleeding. To minimize this risk, be cautious and avoid injury. Use a soft toothbrush and an electric razor to reduce the risk of bleeding.

The use of drugs like this one may increase the 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 potential 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 and heart-related death. Additionally, research has shown that people taking drugs like this one after a first heart attack were more likely to die within the following year compared to those not taking these medications. 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 on your treatment plan.

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

NSAIDs, like this medication, may affect ovulation, which could impact your ability to get pregnant. However, this effect is typically reversible when the medication is stopped. Discuss any concerns or questions you have with your doctor.

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

• Aspirin (high dose)
• Other NSAIDs (concurrent use)
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., Warfarin, Dabigatran, Apixaban, Rivaroxaban) - increased bleeding risk
• Antiplatelet agents (e.g., Clopidogrel, Aspirin low dose) - increased bleeding risk
• SSRIs/SNRIs - increased GI bleeding risk
• Lithium - increased lithium levels and toxicity
• Methotrexate - increased methotrexate levels and toxicity
• Cyclosporine - increased nephrotoxicity
• Tacrolimus - increased nephrotoxicity
• Diuretics (e.g., Furosemide, Hydrochlorothiazide) - reduced diuretic and antihypertensive effects, increased risk of renal impairment
• ACE Inhibitors/ARBs - reduced antihypertensive effects, increased risk of renal impairment
• Corticosteroids - increased GI bleeding risk
• Pemetrexed - increased pemetrexed levels and toxicity (avoid in patients with renal impairment)

• Beta-blockers - reduced antihypertensive effects
• Digoxin - increased digoxin levels
• Phenytoin - increased phenytoin levels
• Oral Hypoglycemics - potential for altered blood glucose control
• Cholestyramine/Colestipol - reduced diclofenac absorption (administer diclofenac 1 hour before or 4-6 hours after)

• Alcohol - increased risk of GI irritation/bleeding

• Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of cardiovascular events (e.g., chest pain, shortness of breath, weakness on one side of body, slurred speech)
• Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
• Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Signs of kidney problems (e.g., decreased urine output, swelling in ankles/feet, unusual fatigue)
• Unusual bruising or bleeding
• Persistent headache, stiff neck, fever, sensitivity to light (aseptic meningitis)
• Skin rash or blistering (severe skin reactions)

Diclofenac is contraindicated in 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 leading to oligohydramnios. Use in the first and second trimesters should be avoided unless the potential benefit outweighs the potential risk to the fetus, and only under strict medical supervision.

Diclofenac is excreted into breast milk in small amounts. While generally considered compatible with breastfeeding with caution, the lowest effective dose should be used, and the infant should be monitored for adverse effects (e.g., irritability, poor feeding, rash).

Delayed-release diclofenac tablets are generally not recommended for use in children under 18 years of age for general pain or inflammation due to lack of established safety and efficacy. Specific formulations (e.g., immediate-release, liquid) may be used for juvenile idiopathic arthritis under specialist supervision with careful dose titration.

Elderly patients are at increased risk for serious adverse reactions to NSAIDs, including gastrointestinal bleeding, cardiovascular thrombotic events, and renal impairment. Use the lowest effective dose for the shortest duration possible. Monitor renal function, GI symptoms, and blood pressure closely.

• Always take diclofenac DR tablets whole; crushing or chewing can lead to rapid release and increased risk of adverse effects.
• Advise patients to take with food or milk to minimize GI upset, but be aware that food may slightly delay absorption.
• Educate patients on the signs and symptoms of serious GI bleeding and cardiovascular 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 co-morbidities.
• Consider a proton pump inhibitor (PPI) or H2-blocker for patients at high risk of GI complications.
• Avoid concomitant use with other NSAIDs, including over-the-counter products, to prevent additive toxicity.
• In patients with heart failure or hypertension, monitor for fluid retention and worsening of these conditions.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Opioid analgesics (for severe pain, short-term use)
• Corticosteroids (for severe inflammation, short-term use)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions (e.g., Methotrexate, biologics)
• Topical NSAIDs (e.g., Diclofenac gel/patch for localized pain)
• Physical therapy, exercise, heat/cold therapy (non-pharmacological)

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.