Diclofenac 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 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, 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 uncontrollable 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, 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 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 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.

Common Side Effects

Most people experience minimal or no side effects. However, if you encounter 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. 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 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.
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 essential to disclose all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. Verify that it is safe to take this medication with your existing 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 this with your doctor.

Drugs similar to this one have been associated with 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.

If you smoke, talk to your doctor about the potential implications for 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 dose 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. Be cautious and avoid injuries. To minimize the risk of bleeding, use a soft toothbrush and 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. Consult with your doctor to understand the potential risks.

If you are taking aspirin to prevent heart attacks, discuss this with your doctor.

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, potentially impacting fertility. However, this effect is reversible once 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 the potential risks to your baby.

• Other NSAIDs (increased risk of GI adverse events)
• Aspirin (concomitant use with diclofenac is not recommended due to increased risk of GI bleeding)
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., warfarin, heparin) - increased risk of bleeding
• Antiplatelet agents (e.g., clopidogrel) - increased risk of bleeding
• 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
• 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
• Digoxin - increased digoxin levels

• Corticosteroids - increased risk of GI ulceration/bleeding
• Pemetrexed - increased pemetrexed levels (avoid in patients with renal impairment)
• Phenytoin - increased phenytoin levels
• Cholestyramine/Colestipol - may reduce diclofenac absorption (separate administration)

• Not available

• 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 impairment (e.g., decreased urine output, swelling in ankles/feet, unusual fatigue)
• Symptoms of liver injury (e.g., nausea, fatigue, lethargy, itching, jaundice, right upper quadrant tenderness, flu-like symptoms)
• Skin reactions (e.g., rash, blisters, peeling skin)
• Fluid retention/edema
• Unusual bruising or bleeding
• Vision changes
• Hearing changes (tinnitus)

Use of NSAIDs, including diclofenac, during pregnancy is associated with risks. Avoid use after 20 weeks gestation due to the risk of fetal renal dysfunction leading to oligohydramnios, and potential for neonatal pulmonary hypertension. Use in the third trimester is contraindicated due to the risk of premature closure of the fetal ductus arteriosus.

Diclofenac is excreted in breast milk in small amounts. The American Academy of Pediatrics considers it compatible with breastfeeding. However, due to potential for adverse effects in the infant (e.g., GI bleeding, renal effects), use with caution, especially in preterm infants or those with underlying conditions. Monitor infant for adverse effects.

Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended for chronic conditions in children. Specific formulations (e.g., topical) may be used for certain indications in older children under strict medical supervision.

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

• Always use the lowest effective dose for the shortest duration consistent with individual patient treatment goals to minimize risks.
• Advise patients to take diclofenac DR with food or milk to reduce GI upset, and to swallow tablets whole without crushing or chewing.
• Educate patients on the signs and symptoms of serious GI and cardiovascular adverse events, and to seek immediate medical attention if they occur.
• Regularly monitor blood pressure, renal function, and liver function, especially in patients on long-term therapy or with pre-existing conditions.
• Avoid concomitant use with other NSAIDs, including aspirin (unless low-dose aspirin for cardioprotection, in which case monitor closely for GI bleeding).
• Be aware of potential drug interactions, especially with anticoagulants, diuretics, ACE inhibitors, ARBs, lithium, and methotrexate.
• Consider a proton pump inhibitor (PPI) or H2-blocker for patients at high risk of GI complications (e.g., history of ulcer, concomitant corticosteroids/anticoagulants, elderly).

• Other NSAIDs (e.g., ibuprofen, naproxen, celecoxib)
• Acetaminophen (for pain and fever, but not inflammation)
• 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 analgesics (e.g., topical diclofenac, capsaicin, lidocaine)
• Non-pharmacological therapies (e.g., physical therapy, exercise, heat/cold therapy, acupuncture, massage)

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.