Naproxen 250mg 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 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.
General Symptoms: Extreme fatigue or weakness, ringing in the ears, severe back pain, or flu-like symptoms.
Liver Problems: Dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellow skin and eyes. (Note: Liver problems can be fatal and have occurred with similar medications.)
Severe Skin Reactions: These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can affect internal organs and be life-threatening. Seek immediate medical help 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 Possible Side Effects

While many people may not experience side effects or may only have mild ones, it's essential to be aware of the following:

Stomach pain or heartburn
Upset stomach
Constipation
Dizziness or headache
Drowsiness

If any of these side effects or other symptoms bother you or persist, contact your doctor for guidance. Remember, this is not an exhaustive list of potential side effects.

Reporting 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, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. Verify that it is safe to take this medication with your existing treatments and health issues. 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 with your doctor, as you may be more sensitive to this medication. This drug 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 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 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 a year compared to those not taking this medication.

If you are taking aspirin to prevent heart attacks, consult with 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.

• Anticoagulants (e.g., Warfarin): Increased risk of bleeding.
• Antiplatelet agents (e.g., Aspirin, Clopidogrel): Increased risk of GI bleeding.
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• Lithium: Increased plasma lithium concentrations and toxicity.
• Methotrexate: Increased plasma methotrexate concentrations and toxicity.
• ACE inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment.
• Diuretics (e.g., Furosemide, Thiazides): Reduced diuretic and antihypertensive effects, increased risk of renal impairment.
• Cyclosporine/Tacrolimus: Increased risk of nephrotoxicity.
• SSRIs/SNRIs: Increased risk of GI bleeding.

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

• 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., fatigue, nausea, dark urine, yellowing of skin/eyes)
• Signs of allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
• Unusual weight gain or swelling (edema)

Avoid use after 20 weeks gestation due to risk of fetal renal dysfunction and oligohydramnios. Contraindicated in the third trimester (after 30 weeks gestation) due to risk of premature closure of the fetal ductus arteriosus.

Considered generally compatible with breastfeeding. Naproxen is excreted into breast milk in small amounts. Monitor infant for adverse effects.

Approved for use in children 2 years and older for Juvenile Idiopathic Arthritis (JIA). Use with caution for other indications, and follow age-appropriate dosing guidelines. Increased risk of adverse effects in very young children.

Increased risk of serious adverse effects, particularly gastrointestinal bleeding, renal impairment, and cardiovascular events. Use the lowest effective dose for the shortest duration possible. Monitor renal function, blood pressure, and for signs of GI bleeding closely.

• Always take naproxen with food, milk, or an antacid to minimize gastrointestinal upset and reduce the risk of ulcers.
• Patients should be advised to report any signs of GI bleeding (e.g., black, tarry stools) or cardiovascular events (e.g., chest pain, shortness of breath) immediately.
• Long-term use, especially in elderly patients or those with pre-existing conditions, requires regular monitoring of renal function, liver function, and blood pressure.
• Naproxen has a longer half-life than ibuprofen, allowing for twice-daily dosing, which may improve adherence for some patients.
• Avoid concomitant use with other NSAIDs (including OTC ibuprofen or aspirin for pain) to prevent additive toxicity without increased efficacy.
• Inform patients about the potential for fluid retention and edema, especially in those with heart failure or hypertension.

• Other NSAIDs (e.g., Ibuprofen, Diclofenac, Celecoxib)
• Acetaminophen (for pain and fever, without anti-inflammatory effect)
• Opioid analgesics (for severe pain, with different risk profile)
• Corticosteroids (for severe inflammation, with different risk profile)
• Non-pharmacological therapies (e.g., RICE - Rest, Ice, Compression, Elevation; physical therapy, heat/cold therapy, massage, 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 incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.