Diclofenac Potassium 50mg 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 inhibition 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 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 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 Problems: Chest pain or pressure, rapid heartbeat, or weakness on one side of the body.
Neurological Symptoms: 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 Damage: Dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes. (Note: Liver problems can be fatal and require immediate medical attention.)
Severe Skin Reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or other serious reactions, which can be life-threatening. Seek 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 people experience no side effects or only mild ones. However, if you notice any of the following side effects or if they persist or bother you, contact your doctor:

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 concerns or questions, 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 drug, 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 drug 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 drug may harm an unborn baby if taken at 20 weeks or later in 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 discuss all of your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. 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 first. This list is not exhaustive, and you must verify that it is safe to take this medication with all of your medications and health problems.

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.

You should also have your blood pressure checked regularly, as directed by your doctor, since medications like this one can cause high blood pressure. Before consuming alcohol, discuss the potential risks with your doctor. Additionally, if you smoke, have asthma, or have any other health concerns, talk to your doctor, as you may be more sensitive to the effects of this medication.

To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount can increase your chances of experiencing adverse effects. Furthermore, do not take this medication for longer than your doctor has advised.

As this medication may affect your blood's ability to clot, you may bleed more easily. To reduce the risk of injury, be cautious and use a soft toothbrush and an electric razor.

It is crucial to be aware that the use of medications like this one can 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 medications like this one can increase the risk of another heart attack and heart-related death. Additionally, research has shown that individuals taking medications 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 prevent a heart attack, inform your doctor, as they can help you weigh the benefits and risks.

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

It is also important to note that NSAIDs, like this medication, can affect ovulation, which may impact fertility. However, this effect is typically reversible when the medication is stopped. Discuss any concerns with your doctor.

Finally, if you are breastfeeding, inform your doctor, as they will need to assess the potential risks to your baby and discuss alternative options with you.

• Aspirin (high dose, due to increased GI bleeding risk)
• Other NSAIDs (due to increased GI bleeding risk)
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., Warfarin, Heparin, Dabigatran, Rivaroxaban, Apixaban, Edoxaban) - increased bleeding risk
• Antiplatelet agents (e.g., Clopidogrel, Ticagrelor, Prasugrel) - 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 effect, increased risk of renal impairment and hyperkalemia
• Pemetrexed - increased pemetrexed levels and toxicity (avoid in patients with renal impairment)
• Digoxin - increased digoxin levels

• Corticosteroids - increased GI bleeding risk
• Sulfonylureas - potential for altered glucose control
• Cholestyramine/Colestipol - reduced diclofenac absorption
• Phenytoin - increased phenytoin levels
• Voriconazole/Fluconazole (CYP2C9 inhibitors) - increased diclofenac exposure
• Rifampin (CYP2C9 inducer) - decreased diclofenac exposure

• Antacids - may delay absorption but not significantly affect extent

• 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, right upper quadrant pain)
• Signs of allergic reaction (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
• Unexplained weight gain or edema
• Severe skin reactions (rash, blistering, peeling skin)
• Vision changes

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

Diclofenac is excreted in breast milk in small amounts. Use with caution. Monitor infant for adverse effects (e.g., irritability, poor feeding, rash).

Safety and efficacy have not been established in pediatric patients under 18 years of age. Use is generally not recommended.

Elderly patients are at greater risk for serious adverse events, including GI bleeding, cardiovascular events, and renal impairment. Use the lowest effective dose for the shortest duration possible. Monitor renal function, blood pressure, and for signs of GI bleeding closely.

• Diclofenac potassium (immediate-release) is preferred for acute pain due to its faster absorption and quicker onset of action compared to diclofenac sodium.
• Always advise patients to take with food or milk if GI upset occurs, despite the potential for delayed absorption.
• Emphasize the importance of the lowest effective dose for the shortest duration to minimize risks, especially cardiovascular and GI.
• Educate patients on the signs and symptoms of serious adverse events (GI bleeding, cardiovascular events, renal/hepatic toxicity) and when to seek immediate medical attention.
• Remind patients that NSAIDs can mask signs of infection due to their antipyretic and anti-inflammatory effects.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib)
• Acetaminophen (for pain/fever without anti-inflammatory effect)
• Opioid analgesics (for severe pain, short-term use)
• Topical NSAIDs (e.g., Diclofenac gel/patch for localized pain)
• Non-pharmacological therapies (e.g., RICE, physical therapy, acupuncture)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. 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 receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for guidance.

In the event of a suspected overdose, seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide crucial details, including the name of the medication taken, the amount consumed, and the time it occurred.