Naproxen Dr/ec 375mg Tablets

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that exerts its anti-inflammatory, analgesic, and antipyretic effects by reversibly inhibiting cyclooxygenase (COX-1 and COX-2) enzymes. This inhibition leads to a reduction in the synthesis of prostaglandins, which are mediators of 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 reactions: 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, 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, sudden weight gain, or swelling in the arms or legs.
Cardiovascular concerns: Chest pain or pressure, rapid heartbeat, or weakness on one side of the body.
Neurological symptoms: Trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Extreme fatigue or weakness: Feeling very tired or weak.
Other severe symptoms: Ringing in the ears, severe back pain, flu-like symptoms, or liver problems (indicated by dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin and eyes).
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or other serious reactions, which may also affect internal organs. 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.

Common 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 symptoms or if they persist or bother you, contact your doctor:

Stomach pain or heartburn
Upset stomach
Constipation
Dizziness or headache
Drowsiness

Reporting Side Effects

This is not an exhaustive list of potential 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 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 medication, 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 after 20 weeks of 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 inform your doctor and pharmacist about all the medications you are taking, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Share information about your health problems to ensure it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose 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.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and lab personnel that you are taking this drug. There is a risk of developing high blood pressure with medications like this one, so your doctor may advise you to have your blood pressure checked regularly.

Before consuming alcohol, discuss the potential risks with your doctor. If you smoke, talk to your doctor about the potential interactions between smoking and this medication. It is vital to follow your doctor's instructions regarding the dosage and duration of treatment. Taking more than the prescribed amount or using this medication for longer than recommended may increase your risk of severe side effects.

If you have asthma, consult your doctor before taking this medication, as you may be more sensitive to its effects. This medication may also increase your risk of bleeding, so be cautious and avoid injuries. To minimize the risk of bleeding, use a soft toothbrush and an electric razor.

The use of medications like this one may increase the risk of heart failure, particularly in people who already have heart failure. This may lead to a higher risk of heart attack, hospitalization for heart failure, and death. Discuss these risks with your doctor. Additionally, people who have had a recent heart attack may have a higher risk of heart attack and heart-related death when taking medications like this one. In fact, studies have shown that people taking these medications after a first heart attack were more likely to die within a year compared to those not taking these medications.

If you are taking aspirin to prevent heart attacks, consult your doctor about potential interactions. If you are on a low-sodium or sodium-free diet, inform your doctor, as some formulations of this medication may contain sodium.

Older adults (60 years or older) should use this medication with caution, as they may be more susceptible to side effects. Women of childbearing age should be aware that NSAIDs like this medication may affect ovulation, which can impact fertility. However, this effect is reversible when the medication is stopped. If you are planning to become pregnant or are already pregnant, discuss the potential risks with your doctor.

Breastfeeding mothers should also consult their doctor about the potential risks of this medication to their baby. Your doctor will help you weigh the benefits and risks of using this medication while breastfeeding.

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
• Severe renal impairment
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

• Anticoagulants (e.g., Warfarin, Dabigatran, Rivaroxaban): Increased risk of bleeding.
• Antiplatelet agents (e.g., Aspirin, Clopidogrel): Increased risk of bleeding.
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• Lithium: Increased lithium plasma concentrations and toxicity.
• Methotrexate: Increased methotrexate plasma concentrations and toxicity.
• Diuretics (e.g., Furosemide, Thiazides): Reduced natriuretic and antihypertensive effects, potential for renal impairment.
• ACE Inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment (especially in elderly or volume-depleted patients).
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Cyclosporine, Tacrolimus: Increased risk of nephrotoxicity.
• Digoxin: Increased digoxin plasma concentrations.

• Beta-blockers: Reduced antihypertensive effect.
• Hydantoins (e.g., Phenytoin): Increased hydantoin levels.
• Sulfonylureas: Increased hypoglycemic effect.
• Probenecid: Increased naproxen plasma levels and half-life.
• Cholestyramine: May delay naproxen absorption.

• Antacids: May delay absorption but generally not clinically significant.

• 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., jaundice, dark urine, persistent nausea/vomiting, fatigue)
• Signs of allergic reaction (e.g., rash, hives, itching, swelling of face/lips/tongue, difficulty breathing)
• Unexplained weight gain or edema
• Vision changes (rare, but reported with NSAIDs)

Use of NSAIDs, including naproxen, during pregnancy should be avoided, especially during the third trimester due to the risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction. Use in the first and second trimesters should only be considered if the potential benefit justifies the potential risk to the fetus.

Naproxen is excreted into breast milk in small amounts. While the amount is generally considered low and unlikely to cause adverse effects in a healthy, full-term infant, caution is advised. Monitor the infant for potential adverse effects such as drowsiness, poor feeding, or gastrointestinal upset.

The safety and effectiveness of naproxen delayed-release tablets have not been established in pediatric patients under 16 years of age. Immediate-release naproxen is used for Juvenile Idiopathic Arthritis in children 2 years and older, but the delayed-release formulation is generally not suitable for acute pain in children due to its delayed onset of action.

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

• Naproxen DR/EC is designed to reduce GI irritation by delaying drug release until it reaches the intestine. However, this does not eliminate the risk of GI bleeding or ulceration, especially with long-term use or in high-risk patients.
• Due to its delayed onset of action, this formulation is not suitable for acute pain relief where rapid onset is desired.
• The long half-life of naproxen (12-17 hours) allows for twice-daily dosing, which can improve patient adherence compared to more frequent dosing regimens.
• Always advise patients to swallow the tablets whole and not to crush or chew them, as this will compromise the enteric coating.
• Educate patients on the signs and symptoms of serious adverse events (GI bleeding, cardiovascular events, renal impairment) and when to seek immediate medical attention.
• Consider a proton pump inhibitor (PPI) or H2-blocker for GI protection in patients at high risk for NSAID-induced GI complications (e.g., history of ulcer, concomitant corticosteroid or anticoagulant use, elderly).

• Other NSAIDs (e.g., Ibuprofen, Celecoxib, Diclofenac, Meloxicam)
• Acetaminophen (for pain and fever, without anti-inflammatory effects)
• Opioid analgesics (for severe pain, with higher risk of side effects and dependence)
• Disease-modifying antirheumatic drugs (DMARDs) for inflammatory conditions like RA
• Corticosteroids (for severe inflammation, short-term use)
• Topical NSAIDs (e.g., diclofenac gel, for localized pain with lower systemic absorption)
• Non-pharmacologic therapies (e.g., physical therapy, heat/cold therapy, exercise, acupuncture)

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 you receive a refill of this medication. 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. When reporting the overdose, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.