Naproxen Sodium CR 375mg Tabs (24h)

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities. Its mechanism of action is thought 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 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: Difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Extreme Fatigue: Feeling extremely tired or weak.
Other Symptoms: Ringing in the ears, severe back pain, or flu-like symptoms.

Liver Problems: In rare cases, medications like this one can cause liver damage, which can be life-threatening. If you experience any of the following symptoms, contact your doctor immediately: dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellowing of the skin or eyes.

Severe Skin Reactions: This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek medical help right away 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 possible 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 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 evaluations.
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, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications.
Natural products and vitamins.
Existing health problems.

Verify with your doctor that it is safe to take this medication with your other medications and health conditions. Do not initiate, 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 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 possible effects on your health. It is vital 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, as you may be more sensitive to this medication. Additionally, this drug may affect your blood's ability to clot, making you more prone to bleeding. To minimize this risk, be cautious and avoid injuries, use a soft toothbrush, and consider using an electric razor.

The use of medications like this one may increase the risk of heart failure, particularly in people with pre-existing heart failure. This can lead to a higher risk of heart attack, hospitalization for heart failure, and death. Discuss these risks with your doctor. Furthermore, people who have had a recent heart attack may have a higher risk of heart attack and heart-related death when taking this medication. In fact, studies have shown that 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.

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, potentially impacting fertility. However, this effect is reversible when the medication is stopped. If you are planning to become pregnant or are already pregnant, discuss the risks and benefits with your doctor.

Breastfeeding mothers should also consult their doctor, as they will need to discuss the potential risks and benefits of taking this medication while nursing their baby.

• Aspirin (high-dose, for antiplatelet effect)
• Other NSAIDs (concurrent use)
• Ketorolac
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

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

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

• Antacids: May delay absorption but not extent.

• 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)
• Signs of liver injury (e.g., jaundice, dark urine, fatigue, nausea, right upper quadrant pain)
• Skin reactions (e.g., rash, blistering, peeling)
• Unusual bruising or bleeding
• Swelling (edema)
• Weight gain
• Vision changes
• Hearing changes (tinnitus)

Avoid use from 20 weeks gestation and contraindicated from 30 weeks gestation due to risks of fetal renal dysfunction leading to oligohydramnios and premature closure of the fetal ductus arteriosus. Use during the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus.

Naproxen is excreted into breast milk in small amounts. Generally considered compatible with breastfeeding, but use with caution, especially in preterm infants or those with underlying conditions. Monitor infant for adverse effects (e.g., irritability, drowsiness, poor feeding).

The safety and effectiveness of naproxen sodium extended-release tablets have not been established in pediatric patients. Immediate-release naproxen is used in children for specific conditions like juvenile idiopathic arthritis under specialist supervision.

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

• Naproxen Sodium CR is an extended-release formulation designed for once-daily dosing, providing 24-hour pain and inflammation control.
• Despite its convenience, it carries the same serious cardiovascular and gastrointestinal risks as other NSAIDs, including a Black Box Warning.
• Patients should be educated on the signs and symptoms of GI bleeding and cardiovascular events.
• Renal function and blood pressure should be monitored, especially in elderly patients or those with pre-existing conditions.
• Avoid concomitant use with other NSAIDs, including OTC products like ibuprofen or aspirin (unless low-dose aspirin for antiplatelet effect, but with increased bleeding risk).
• Not suitable for acute pain where rapid onset is critical, due to its extended-release profile and longer Tmax.

• Other NSAIDs (e.g., Ibuprofen, Diclofenac, Celecoxib)
• Acetaminophen (for pain/fever without 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 NSAIDs (e.g., Diclofenac gel) for localized pain

If your symptoms or health issues persist or worsen, it is 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 crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.