Naproxen Sodium 275mg Tablets
WARNING: This drug may raise the risk of heart and blood vessel problems like heart attack and stroke. These effects can be deadly. The risk may be greater if you have heart disease or risks for heart disease. However, it can also be raised even if you do not have heart disease or risks for heart disease. The risk can happen within the first weeks of using this drug and may be greater with higher doses or long-term use. Do not use this drug right before or after bypass heart surgery.This drug may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. @ COMMON USES: It is used to ease pain, swelling, and fever.It is used to ease painful period (menstrual) cycles.It is used to treat some types of arthritis. It is used to treat ankylosing spondylitis.It is used to treat gout attacks.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Nonsteroidal Anti-inflammatory Drug (NSAID)
Pharmacologic Class
Cyclooxygenase (COX) Inhibitor
Pregnancy Category
Category C (1st/2nd trimester), Category D (3rd trimester)
FDA Approved
Jun 1976
DEA Schedule
Not Controlled
Overview
What is this medicine?
Naproxen sodium is a medicine called a nonsteroidal anti-inflammatory drug, or NSAID. It works by reducing substances in the body that cause pain, fever, and inflammation (swelling and redness). It's used to treat pain from conditions like arthritis, menstrual cramps, muscle aches, and headaches.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort. Be sure to swallow the medication with a full glass of water.
It's essential to avoid taking certain medications with this drug, including cholestyramine, sucralfate, or antacids that contain magnesium or aluminum, as they may interact with your medication.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication, or participate in a drug take-back program in your area, if available.
What to Do If You Miss a Dose
If you take this medication on a regular schedule, take the missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort. Be sure to swallow the medication with a full glass of water.
It's essential to avoid taking certain medications with this drug, including cholestyramine, sucralfate, or antacids that contain magnesium or aluminum, as they may interact with your medication.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication, or participate in a drug take-back program in your area, if available.
What to Do If You Miss a Dose
If you take this medication on a regular schedule, take the missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Take with food or milk to reduce stomach upset.
- Do not lie down for at least 10 minutes after taking to prevent esophageal irritation.
- Avoid alcohol, as it can increase the risk of stomach bleeding.
- Stay hydrated, especially if you have kidney problems.
- Limit prolonged sun exposure as NSAIDs can increase sun sensitivity (photosensitivity).
Available Forms & Alternatives
Available Strengths:
- Naproxen 125mg/5ml Suspension
- Naproxen Dr/ec 375mg Tablets
- Naproxen 250mg Tablets
- Naproxen 500mg Tablets
- Naproxen 375mg Tablets
- Naproxen Sodium 550mg Tablets
- Naproxen Sodium 275mg Tablets
- Naproxen Sodium 220mg Tablets
- Naproxen Sodium CR 375mg Tabs (24h)
- Naproxen Sod 500mg CR Tablets
- Naproxen Sodium 550mg Tablets
- Naproxen Dr/ec 500mg Tablets
- Naproxen Sodium ER 375mg Tabs (24h)
- Naproxen Sod 500mg ER Tablets
- Naproxen 750mg ER Tablets
- Naproxen Dr/ec 500mg Tablets
- Naproxen Dr/ec 375mg Tablets
- Naproxen Sodium CR 375mg Tabs (24h)
- Naproxen Sod 500mg CR Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
275 mg or 550 mg orally every 8 to 12 hours as needed, not to exceed 1375 mg on the first day and 1100 mg thereafter.
Dose Range:
275 - 1375 mg
Condition-Specific Dosing:
mildToModeratePain:
550 mg orally once, then 275 mg every 6-8 hours or 550 mg every 12 hours as needed, not to exceed 1375 mg on day 1, then 1100 mg/day.
dysmenorrhea:
550 mg orally once, then 275 mg every 6-8 hours as needed, not to exceed 1375 mg on day 1, then 1100 mg/day.
rheumatoidArthritisOsteoarthritisAnkylosingSpondylitis:
275 mg or 550 mg orally twice daily (every 12 hours). May increase to 1650 mg/day for limited periods if needed, divided doses.
acuteGout:
825 mg orally once, then 275 mg every 8 hours until attack subsides.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for general pain/fever. For Juvenile Idiopathic Arthritis (JIA): 10-15 mg/kg/day orally in 2 divided doses (max 1000 mg/day).
Adolescent:
For Juvenile Idiopathic Arthritis (JIA): 10-15 mg/kg/day orally in 2 divided doses (max 1000 mg/day). For pain/dysmenorrhea, adult dosing may be considered for adolescents >12 years and >50 kg.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor renal function.
Moderate:
Avoid use if possible. If necessary, use lowest effective dose and monitor renal function closely.
Severe:
Contraindicated due to risk of worsening renal function.
Dialysis:
Not recommended. Naproxen is highly protein-bound and not readily dialyzable.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function.
Moderate:
Consider dose reduction (e.g., 50% reduction) and monitor liver function closely.
Severe:
Avoid use due to risk of hepatic decompensation.
Pharmacology
Mechanism of Action
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic, anti-inflammatory, and antipyretic activities. Its mechanism of action is believed to be due to inhibition of prostaglandin synthesis, primarily through the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. This reduces the formation of prostaglandins, which are mediators of inflammation, pain, and fever.
Pharmacokinetics
Absorption:
Bioavailability:
95%
Tmax:
1-4 hours (for naproxen sodium)
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
0.16 L/kg
ProteinBinding:
>99%
CnssPenetration:
Limited
Elimination:
HalfLife:
12-17 hours
Clearance:
Not available
ExcretionRoute:
Urine (approximately 95% as naproxen, 6-O-desmethyl naproxen, and their conjugates); Feces (less than 3%)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour
PeakEffect:
2-4 hours
DurationOfAction:
Up to 12 hours
Safety & Warnings
BLACK BOX WARNING
CARDIOVASCULAR THROMBOTIC EVENTS: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Naproxen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. GASTROINTESTINAL RISK: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Side 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:
Signs of an 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.
Signs of 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.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of high potassium levels: abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Chest pain or pressure, or rapid heartbeat.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Extreme fatigue or weakness.
Ringing in the ears.
Severe back pain.
Flu-like symptoms.
Liver Problems and Severe Skin Reactions
In rare cases, this medication can cause liver problems, 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, pale-colored stools, vomiting, or yellowing of the skin or eyes.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, can occur with this medication. These reactions can affect other organs and be life-threatening. Seek medical help right away if you notice: 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.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that concern you, contact your doctor:
Stomach pain or heartburn.
Nausea or 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.
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:
Signs of an 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.
Signs of 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.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of high potassium levels: abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Chest pain or pressure, or rapid heartbeat.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Extreme fatigue or weakness.
Ringing in the ears.
Severe back pain.
Flu-like symptoms.
Liver Problems and Severe Skin Reactions
In rare cases, this medication can cause liver problems, 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, pale-colored stools, vomiting, or yellowing of the skin or eyes.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, can occur with this medication. These reactions can affect other organs and be life-threatening. Seek medical help right away if you notice: 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.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that concern you, contact your doctor:
Stomach pain or heartburn.
Nausea or 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.
Seek Immediate Medical Attention If You Experience:
- Severe stomach pain, black or tarry stools, vomit that looks like coffee grounds (signs of stomach bleeding)
- Chest pain, shortness of breath, sudden weakness on one side of the body, slurred speech (signs of heart attack or stroke)
- Swelling in your hands or feet, sudden weight gain (signs of fluid retention or kidney problems)
- Yellowing of skin or eyes, dark urine, persistent nausea/vomiting, unusual tiredness (signs of liver problems)
- Skin rash, blistering, peeling, or hives (signs of severe skin reaction or allergic reaction)
- Difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat (signs of severe allergic reaction)
Before Using This Medicine
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 medication 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 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 if your doctor has instructed you to do so. Do not take this medication if you are more than 30 weeks pregnant.
To ensure your safety, it is crucial to inform your doctor and pharmacist about:
All medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have.
Your doctor will help you determine whether 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 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 medication 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 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 if your doctor has instructed you to do so. Do not take this medication if you are more than 30 weeks pregnant.
To ensure your safety, it is crucial to inform your doctor and pharmacist about:
All medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have.
Your doctor will help you determine whether 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.
Precautions & Cautions
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 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 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. If you are breastfeeding, discuss the potential risks to your baby with your doctor.
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 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 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. If you are breastfeeding, discuss the potential risks to your baby with your doctor.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Nausea
- Vomiting
- Epigastric pain
- Lethargy
- Dizziness
- Indigestion
- Heartburn
- Acute renal failure (rare)
- Hypotension (rare)
- Respiratory depression (rare)
- Coma (rare)
- Seizures (rare)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. Gastric lavage and/or activated charcoal may be considered if ingestion is recent (within 1 hour).
Drug Interactions
Contraindicated Interactions
- Aspirin (high dose, for antiplatelet effect)
- Other NSAIDs (increased risk of GI bleeding/ulceration)
- Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
Major Interactions
- Anticoagulants (e.g., Warfarin, Heparin) - increased bleeding risk
- Antiplatelet agents (e.g., Clopidogrel, Aspirin low dose) - increased bleeding risk
- Corticosteroids - increased GI ulceration/bleeding risk
- SSRIs/SNRIs - increased GI bleeding risk
- Lithium - increased lithium levels/toxicity
- Methotrexate - increased methotrexate toxicity
- Cyclosporine - increased nephrotoxicity
- Tacrolimus - increased nephrotoxicity
- Diuretics (e.g., Furosemide, Thiazides) - reduced diuretic and antihypertensive effects, increased renal toxicity risk
- ACE Inhibitors/ARBs - reduced antihypertensive effect, increased renal impairment risk
- Digoxin - increased digoxin levels
Moderate Interactions
- Beta-blockers - reduced antihypertensive effect
- Hydantoins (e.g., Phenytoin) - increased hydantoin levels
- Sulfonylureas - altered glucose control
- Probenecid - increased naproxen levels
- Cholestyramine - delayed naproxen absorption
Minor Interactions
- Antacids - may delay absorption but not significantly affect extent
Monitoring
Baseline Monitoring
Complete Blood Count (CBC)
Rationale: To assess for baseline anemia or other hematologic abnormalities, and to monitor for potential blood dyscrasias.
Timing: Prior to initiation of long-term therapy.
Renal Function (BUN, Creatinine, eGFR)
Rationale: To assess baseline renal function, as NSAIDs can cause renal impairment.
Timing: Prior to initiation of therapy, especially in patients with pre-existing renal impairment or risk factors.
Liver Function Tests (ALT, AST, Bilirubin)
Rationale: To assess baseline hepatic function, as NSAIDs can cause liver injury.
Timing: Prior to initiation of therapy, especially in patients with pre-existing hepatic impairment or risk factors.
Blood Pressure (BP)
Rationale: To establish baseline BP, as NSAIDs can cause new onset hypertension or worsen pre-existing hypertension.
Timing: Prior to initiation of therapy.
Routine Monitoring
Renal Function (BUN, Creatinine, eGFR)
Frequency: Periodically (e.g., every 6-12 months) for long-term therapy, more frequently in high-risk patients (elderly, heart failure, diuretic use).
Target: Within normal limits or stable from baseline.
Action Threshold: Significant increase in creatinine (>20-30% from baseline) or decrease in eGFR; consider dose reduction or discontinuation.
Liver Function Tests (ALT, AST)
Frequency: Periodically (e.g., every 6-12 months) for long-term therapy, or if symptoms of liver dysfunction develop.
Target: Within normal limits or stable from baseline.
Action Threshold: Significant elevation (>3x ULN); discontinue naproxen.
Blood Pressure (BP)
Frequency: Regularly, especially in patients with hypertension or cardiovascular risk factors.
Target: Individualized target BP.
Action Threshold: Sustained increase in BP; consider antihypertensive adjustment or naproxen discontinuation.
Complete Blood Count (CBC)
Frequency: Periodically (e.g., annually) for long-term therapy.
Target: Within normal limits.
Action Threshold: Significant decrease in hemoglobin/hematocrit or platelet count; investigate and consider discontinuation.
Occult Blood Test (Stool)
Frequency: Periodically for long-term therapy, especially in patients with GI risk factors.
Target: Negative.
Action Threshold: Positive test; investigate for GI bleeding.
Symptom Monitoring
- 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, right upper quadrant pain)
- Signs of allergic reaction (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
- Unexplained weight gain or edema
- Changes in vision or hearing (rare)
Special Patient Groups
Pregnancy
Avoid use during the third trimester due to risk of premature closure of the fetal ductus arteriosus and renal dysfunction in the fetus. Use during the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for increased risk of miscarriage and cardiac malformations. Category C.
Second Trimester:
Limited data, generally considered Category C. Use lowest effective dose for shortest duration.
Third Trimester:
Contraindicated. Risk of premature closure of fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, and fetal renal dysfunction leading to oligohydramnios.
Lactation
Naproxen is excreted into breast milk in small amounts. Generally considered compatible with breastfeeding when used at low doses for short periods, but monitor infant for adverse effects.
Infant Risk:
L3 (Moderately Safe). Potential for adverse effects in the infant (e.g., GI upset, drowsiness) is low but possible. Consider alternative if infant is premature or has underlying conditions.
Pediatric Use
Not recommended for children under 2 years of age. For children 2 years and older, dosing is primarily established for Juvenile Idiopathic Arthritis. Use with caution and specific dosing guidelines.
Geriatric Use
Increased risk of serious adverse cardiovascular, gastrointestinal, and renal events. Use the lowest effective dose for the shortest duration. Monitor renal function, GI symptoms, and blood pressure closely.
Clinical Information
Clinical Pearls
- Naproxen sodium has a faster onset of action than naproxen base due to better solubility, making it suitable for acute pain.
- Despite the faster onset, the half-life is similar to naproxen base, allowing for twice-daily dosing.
- Always advise patients to take with food, milk, or antacids to minimize GI upset.
- Educate patients on the signs and symptoms of GI bleeding and cardiovascular events, and when to seek immediate medical attention.
- Avoid concomitant use with other NSAIDs (including OTC ibuprofen or aspirin for pain) to prevent additive toxicity.
- Consider a proton pump inhibitor (PPI) or H2 blocker for patients at high risk of GI complications (e.g., history of ulcers, concomitant corticosteroid use, elderly).
Alternative Therapies
- Other NSAIDs (e.g., Ibuprofen, Diclofenac, Celecoxib)
- Acetaminophen (for pain and fever, no anti-inflammatory effect)
- 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., RICE therapy, physical therapy, heat/cold packs)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (for generic Naproxen Sodium 275mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
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 overdose, including the medication taken, the quantity, and the time it occurred, to facilitate prompt and appropriate treatment.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
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 overdose, including the medication taken, the quantity, and the time it occurred, to facilitate prompt and appropriate treatment.