Diclofenac Sodium 75mg 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 experience 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 looks like coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that get bigger, 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 like passing out, 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, changes in balance, 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, nausea or stomach pain, light-colored stools, vomiting, or yellow skin or 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 other organs.

Other Possible Side Effects

Most people experience few or no side effects while taking this medication. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

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

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 drugs, 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 drugs like aspirin, or pemetrexed.
Fertility issues or ongoing 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 issues. 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 risks, have your blood pressure checked as directed by your doctor.

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

If you smoke, discuss this with your doctor, as it may impact your treatment or increase your risk of side effects.

If you have asthma, talk to your doctor, as you may be more sensitive to this medication.

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 drug for longer than prescribed by your doctor.

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

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 due to 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 similar to this one may increase the risk of another heart attack and heart-related death. Furthermore, studies have shown that individuals taking these drugs after a first heart attack were more likely to die within the year following the heart attack compared to those not taking these medications. It is crucial to discuss these risks with your doctor.

If you are taking aspirin to prevent heart attacks, consult with your doctor to understand how this medication may interact with your aspirin regimen.

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

NSAIDs, like this drug, may affect ovulation, potentially impacting fertility. However, this effect is reversible and typically returns to normal once 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.

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

• Anticoagulants (e.g., Warfarin, Dabigatran): Increased risk of bleeding.
• Antiplatelet agents (e.g., Aspirin, Clopidogrel): Increased risk of GI bleeding.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• Methotrexate: Increased methotrexate levels and toxicity.
• Lithium: Increased lithium plasma concentrations 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 effect, increased risk of renal impairment and hyperkalemia.
• Beta-blockers: Reduced antihypertensive effect.
• Digoxin: Increased digoxin plasma concentrations.

• Sulfonylureas: Potential for altered blood glucose levels (rare, but monitor).
• Phenytoin: Increased phenytoin levels.
• Cholestyramine/Colestipol: May reduce diclofenac absorption (separate administration by several hours).
• P-glycoprotein inhibitors (e.g., Amiodarone, Quinidine): May increase diclofenac exposure (minor effect).

• Not typically listed as minor for NSAIDs in this context, as most interactions carry significant risk.

• Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
• Signs of cardiovascular events (e.g., chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of fluid retention/edema (e.g., swelling in ankles, feet, hands)
• Signs of liver injury (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Signs of kidney injury (e.g., decreased urine output, swelling, unusual fatigue)
• Unexplained weight gain
• Vision changes
• Persistent headache

Contraindicated in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction. Avoid use in the first and second trimesters unless the potential benefit justifies the potential risk to the fetus.

Diclofenac is excreted in breast milk in small amounts. 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 in pediatric patients (under 18 years of age) have not been established for the delayed-release tablet formulation for general indications. Specific formulations (e.g., oral solution, topical) are approved for juvenile idiopathic arthritis in some countries, but generally, NSAIDs should be used with caution and under specialist supervision in children.

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

• Always take diclofenac delayed-release 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, despite the delayed-release formulation.
• Educate patients on the signs and symptoms of serious GI and cardiovascular adverse events, and when to seek immediate medical attention.
• Remind patients that NSAIDs can mask signs of infection due to their antipyretic and anti-inflammatory effects.
• For chronic pain management, consider the lowest effective dose for the shortest duration to minimize risks.
• Patients with a history of asthma, urticaria, or other allergic-type reactions to aspirin or other NSAIDs should not take diclofenac due to the risk of cross-reactivity.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib)
• Acetaminophen (for pain and fever, without 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
• Physical therapy, exercise, heat/cold therapy, topical analgesics

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 is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about your 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 consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.