Diclofenac 25mg Capsules

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 primarily due to the inhibition of prostaglandin synthesis 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.

Serious Side Effects: Seek Medical Help Immediately

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 right away:

Allergic reactions: Rash, hives, itching, redness, swelling, blistering, or peeling skin with or without fever; wheezing; tightness in the chest or throat; difficulty breathing, swallowing, or speaking; 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; gum bleeding; 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, fainting, numbness, tingling, or shortness of breath.
High blood pressure: Severe headache, 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 issues: Difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Extreme fatigue or weakness.
Urinary problems: Pain while urinating or blood in the urine.
Liver problems: Dark urine, fatigue, decreased appetite, stomach pain, 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), and other serious reactions, which can be life-threatening. Seek medical help immediately 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 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 or seek medical attention:

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, 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 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.
Fertility issues or ongoing fertility evaluation.
* Pregnancy, planned pregnancy, or suspected pregnancy. 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 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 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 long-term, 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. If you smoke, talk to your doctor about the potential interactions. Additionally, if you have asthma, consult with your doctor, as you may be more sensitive to 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 a longer duration than specified by your doctor.

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.

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 potential 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, individuals taking this type of medication after a first heart attack may have a higher likelihood of death within the following year compared to those not taking this medication. Consult with your doctor to understand these risks.

If you are taking aspirin to prevent a heart attack, discuss the potential interactions with your doctor.

Individuals 65 years or older should use this medication with caution, as they 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 reversible when the medication is stopped. Discuss this potential risk with your doctor.

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

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

• Anticoagulants (e.g., Warfarin, Dabigatran, Rivaroxaban, Apixaban) - increased risk of bleeding
• Antiplatelet agents (e.g., Clopidogrel, Ticagrelor, Prasugrel) - increased risk of bleeding
• SSRIs/SNRIs (e.g., Fluoxetine, Sertraline, Venlafaxine) - increased risk of GI bleeding
• Diuretics (e.g., Furosemide, Hydrochlorothiazide) - reduced diuretic effect, increased risk of renal impairment
• ACE Inhibitors/ARBs (e.g., Lisinopril, Valsartan) - reduced antihypertensive effect, increased risk of renal impairment
• Methotrexate - increased methotrexate levels and toxicity
• Lithium - increased lithium levels and toxicity
• Cyclosporine - increased nephrotoxicity
• Digoxin - increased digoxin levels
• Phenytoin - increased phenytoin levels
• Pemetrexed - increased pemetrexed toxicity (avoid in patients with renal impairment)

• Corticosteroids (e.g., Prednisone) - increased risk of GI ulceration/bleeding
• Sulfonylureas (e.g., Glyburide) - potential for altered glucose control
• Cholestyramine/Colestipol - may reduce diclofenac absorption
• Voriconazole/Fluconazole (CYP2C9 inhibitors) - may increase diclofenac exposure
• Rifampin (CYP2C9 inducer) - may decrease diclofenac exposure

• Not specifically categorized as minor for diclofenac, as most interactions have significant clinical implications.

• 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 the body, slurred speech)
• Signs of renal impairment (e.g., decreased urine output, swelling in ankles/feet, unusual fatigue)
• Signs of liver injury (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue, right upper quadrant pain)
• Signs of allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
• Signs of fluid retention/edema (e.g., swelling in extremities, sudden weight gain)
• Changes in vision or hearing (rare, but reported with NSAIDs)

Diclofenac is classified as Pregnancy Category C during the first and second trimesters, meaning animal studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans. It is classified as Category D in the third trimester due to the known effects of NSAIDs on the fetal cardiovascular system (closure of the ductus arteriosus). Avoid use in the third trimester and generally not recommended unless absolutely necessary in early pregnancy.

Diclofenac is excreted into breast milk in small amounts. The American Academy of Pediatrics considers diclofenac to be compatible with breastfeeding. However, due to the potential for serious adverse reactions in nursing infants from NSAIDs, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Monitor infant for adverse effects.

Safety and effectiveness of diclofenac oral capsules in pediatric patients have not been established. Use in children is generally not recommended due to potential for serious adverse effects and lack of specific dosing guidelines for this formulation. Other formulations (e.g., topical, ophthalmic) may have pediatric indications.

Elderly patients are at greater risk for serious adverse events from 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, especially renal function and GI symptoms.

• Diclofenac is a potent NSAID, often used when other NSAIDs are insufficient, but carries significant GI and CV risks.
• Always prescribe the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
• Consider co-prescribing a proton pump inhibitor (PPI) or misoprostol for patients at high risk of GI complications (e.g., history of ulcer, concomitant corticosteroid/anticoagulant use, elderly).
• Advise patients to take diclofenac with food or milk to minimize GI upset.
• Be aware of the potential for diclofenac to cause asymptomatic elevations in liver enzymes; monitor LFTs periodically.
• Patients with a history of asthma, urticaria, or other allergic-type reactions to aspirin or other NSAIDs should not take diclofenac due to risk of severe, potentially fatal, anaphylactoid reactions.
• Diclofenac can cause fluid retention and edema; use with caution in patients with heart failure, hypertension, or other conditions predisposing to fluid retention.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Celecoxib)
• Acetaminophen (for pain and fever, no 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)
• Topical analgesics (e.g., topical diclofenac, capsaicin, lidocaine patches)
• Physical therapy, heat/cold therapy, exercise (non-pharmacological)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.