Naproxen Sodium 550mg Tablets

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic, anti-inflammatory, and antipyretic activities. Its mechanism of action is thought to be due to inhibition of prostaglandin synthesis, primarily through the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. Inhibition of COX-1 contributes to gastrointestinal and platelet-related side effects, while inhibition of COX-2 contributes to anti-inflammatory effects.

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, difficulty 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 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.
General Weakness: 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 fatal. If you experience any of the following symptoms, contact your doctor immediately: dark urine, fatigue, decreased appetite, nausea or stomach pain, pale-colored stools, vomiting, or yellow 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. These reactions can be life-threatening and may affect other organs. Seek medical help right away if you notice: 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 go away, 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, 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.
Gastrointestinal (GI) bleeding or kidney problems.
Heart failure (weak heart) or a recent heart attack.
Current use of other NSAIDs, salicylate drugs like aspirin, or pemetrexed.
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 pregnancy. 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 of the following to your doctor and pharmacist:

All prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems

Verify that it is safe to take this medication with your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor. This list is not exhaustive, and your doctor and pharmacist need to be aware of all your medications and health issues to provide optimal care.

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, 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 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. Discuss any concerns with your doctor.

If you are breastfeeding, consult your doctor to discuss the potential risks to your baby.

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
• Severe uncontrolled heart failure
• Active gastrointestinal bleeding or ulceration
• Severe renal impairment (CrCl <30 mL/min)
• Severe hepatic impairment

• Anticoagulants (e.g., Warfarin): Increased risk of bleeding.
• Antiplatelet agents (e.g., Aspirin, Clopidogrel): Increased risk of bleeding.
• Other NSAIDs (including COX-2 inhibitors): Increased risk of GI adverse events.
• 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 diuretic effects.
• ACE Inhibitors/ARBs: Reduced antihypertensive effect and 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 concentrations of hydantoins.
• Sulfonylureas: Increased hypoglycemic effect.
• Probenecid: Increased naproxen plasma concentrations and half-life.
• Cholestyramine: May delay naproxen absorption.
• Digoxin: May increase digoxin plasma concentrations.

• Antacids: May delay absorption but not extent.

• Signs of gastrointestinal bleeding (black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of cardiovascular events (chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of renal impairment (decreased urine output, swelling in ankles/feet, unusual fatigue)
• Signs of liver injury (yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Allergic reactions (rash, hives, itching, swelling of face/lips/tongue/throat, difficulty breathing)
• Fluid retention/edema
• Unusual weight gain
• Vision changes
• Headache, dizziness

Avoid use in the third trimester due to the risk of premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension. Use in the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus, and at the lowest effective dose for the shortest duration.

Naproxen is excreted in breast milk in small amounts. Generally considered moderately safe (L3). Monitor the infant for adverse effects.

Not recommended for general pain or fever in children under 2 years of age. Specific dosing exists for Juvenile Idiopathic Arthritis (JIA) in children 2 years and older, but 550mg strength is typically too high for pediatric use. Use with caution due to increased risk of adverse effects, especially GI and renal.

Increased risk of serious adverse effects, particularly gastrointestinal bleeding, renal impairment, and cardiovascular events. Start with the lowest effective dose and monitor closely for adverse reactions. Consider alternative analgesics if possible.

• Always take naproxen with food, milk, or an antacid to minimize gastrointestinal irritation.
• Advise patients to stay well-hydrated to reduce the risk of renal adverse effects.
• Educate patients on the signs and symptoms of GI bleeding and cardiovascular events, and to seek immediate medical attention if they occur.
• Naproxen sodium (e.g., 550mg) is absorbed faster than naproxen base, leading to quicker pain relief, but the duration of action is similar.
• Avoid concomitant use with other NSAIDs (including OTC ibuprofen or aspirin for pain) to prevent additive toxicity.
• For chronic use, periodic monitoring of renal function, blood pressure, and CBC is crucial.

• Other NSAIDs (e.g., Ibuprofen, Diclofenac, Celecoxib)
• Acetaminophen (for pain and fever without inflammation)
• Opioid analgesics (for severe pain, short-term use)
• Topical analgesics (e.g., topical NSAIDs, capsaicin, lidocaine)
• Non-pharmacological therapies (e.g., RICE therapy, physical therapy, acupuncture, massage)

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 is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your 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. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.