Naproxen Dr/ec 500mg Tablets

Naproxen is a non-steroidal 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 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 significant 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 significant 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.
Other Symptoms: Ringing in the ears, severe back pain, or flu-like symptoms.

Liver Problems: This medication can cause liver damage, which may be fatal. Seek immediate medical attention if you experience dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin or eyes.

Severe Skin Reactions: This medication can cause life-threatening skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe reactions. Seek immediate medical attention if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other symptoms that bother you or do not resolve, contact your doctor:

Stomach pain or heartburn
Upset stomach
Constipation
Dizziness or headache
* Drowsiness

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 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 issues, 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, including difficulty getting pregnant or ongoing fertility evaluations.
* 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 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.

This medication may interfere with certain laboratory tests, so be sure 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 crucial to follow your doctor's instructions regarding 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 this risk, 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 can 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 be at a higher risk of heart attack and heart-related death when taking this medication. In fact, studies have shown that people 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.

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 breastfeeding, discuss the potential risks to your baby with your doctor.

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., warfarin, heparin): Increased risk of bleeding.
• Antiplatelet agents (e.g., aspirin, clopidogrel): Increased risk of bleeding.
• Other NSAIDs (including COX-2 inhibitors): Increased risk of adverse effects, especially GI.
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• Lithium: Increased lithium plasma concentrations and toxicity.
• Methotrexate: Increased methotrexate plasma concentrations and toxicity.
• Cyclosporine: Increased nephrotoxicity.
• Tacrolimus: Increased nephrotoxicity.
• ACE inhibitors (e.g., lisinopril) and Angiotensin Receptor Blockers (ARBs, e.g., losartan): Reduced antihypertensive effect and increased risk of renal impairment.
• Diuretics (e.g., furosemide, hydrochlorothiazide): Reduced diuretic and antihypertensive effects, increased risk of renal impairment.

• SSRIs (e.g., fluoxetine) and SNRIs (e.g., venlafaxine): Increased risk of GI bleeding.
• Beta-blockers: Reduced antihypertensive effect.
• Hydantoins (e.g., phenytoin): Increased plasma concentrations of hydantoins.
• Sulfonylureas (e.g., glipizide): Increased hypoglycemic effect.
• Probenecid: Increased naproxen plasma concentrations and half-life.
• Cholestyramine: Delayed absorption of naproxen.

• Antacids: May delay absorption but not extent.

• Abdominal pain (especially upper abdominal pain)
• Heartburn
• Nausea
• Vomiting
• Indigestion
• Black, tarry stools
• Vomiting blood or material that looks like coffee grounds
• Unusual bleeding or bruising
• Swelling of ankles, feet, or hands (edema)
• Sudden or unexplained weight gain
• Chest pain
• Shortness of breath
• Weakness on one side of the body
• Slurred speech
• Sudden vision changes
• Severe headache
• Skin rash, blistering, or peeling
• Yellowing of skin or eyes (jaundice)
• Unusual fatigue or weakness
• Flu-like symptoms

Naproxen is classified as Pregnancy Category C during the first and second trimesters, meaning it should be used only if the potential benefit justifies the potential risk to the fetus. It is classified as Pregnancy Category D during the third trimester and should be avoided due to the risk of premature closure of the fetal ductus arteriosus and potential for persistent pulmonary hypertension of the newborn. It may also inhibit uterine contractions and delay labor.

Naproxen is excreted into breast milk in small amounts. The American Academy of Pediatrics considers naproxen to be compatible with breastfeeding. However, due to its long half-life and potential for adverse effects in infants (e.g., bleeding, renal effects), it should be used with caution, especially in preterm or jaundiced infants.

The enteric-coated formulation of naproxen is generally not recommended for use in children under 16 years of age due to lack of established safety and efficacy data for this specific formulation. For pediatric patients, naproxen suspension or immediate-release tablets are typically used, with dosing based on weight and specific indications (e.g., juvenile idiopathic arthritis). Close monitoring for adverse effects is crucial.

Elderly patients are at increased risk for serious adverse effects from NSAIDs, including gastrointestinal bleeding, renal impairment, and cardiovascular events. Use the lowest effective dose for the shortest possible duration. Monitor renal function, blood pressure, and signs of GI bleeding closely. Concomitant medications and comorbidities should be carefully reviewed.

• Enteric-coated (EC) formulation is designed to reduce gastric irritation, but it does not eliminate the risk of serious GI adverse events (e.g., bleeding, ulceration, perforation). These can occur at any time during therapy.
• Naproxen has a relatively long half-life (12-17 hours), allowing for twice-daily dosing, which can improve patient adherence compared to more frequent dosing NSAIDs.
• Patients should be educated on the signs and symptoms of GI bleeding (black, tarry stools; coffee-ground emesis) and cardiovascular events (chest pain, shortness of breath, sudden weakness) and instructed to seek immediate medical attention if these occur.
• Hydration is crucial, especially in patients at risk for renal impairment, as NSAIDs can cause acute kidney injury.
• Avoid concomitant use with other NSAIDs (including OTC products like ibuprofen or aspirin for pain relief) to prevent additive toxicity.
• For patients requiring low-dose aspirin for cardiovascular protection, naproxen may interfere with aspirin's antiplatelet effect. Consider taking naproxen at least 30 minutes after or 8 hours before immediate-release aspirin. Consult a healthcare professional for specific guidance.

• Other NSAIDs (e.g., ibuprofen, diclofenac, celecoxib, meloxicam)
• Acetaminophen (for pain and fever, without anti-inflammatory effects)
• Opioid analgesics (for severe pain, with higher risk of side effects and dependence)
• Topical NSAIDs (e.g., diclofenac gel, for localized pain)
• Non-pharmacological therapies (e.g., physical therapy, ice/heat, massage, acupuncture, exercise, lifestyle modifications)

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. Be prepared to provide detailed information about the incident, including the medication taken, the quantity, and the time it occurred.