Naproxen 125mg/5ml Suspension

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:

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, difficulty 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 significant weight gain.
Signs of high potassium levels: irregular 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, significant weight gain, or swelling in the arms or legs.
Chest pain or pressure, or a 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, which can be fatal, have been associated with medications like this one. 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 be life-threatening and may affect internal organs. 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. However, if you notice any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical attention:

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, 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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to 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. It is crucial to note that 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 vital 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. Never start, stop, or change the dose 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 it is crucial to notify all your healthcare providers and lab personnel that you are taking this drug. Additionally, be aware that drugs like this one can cause high blood pressure. Follow your doctor's instructions for monitoring your blood pressure.

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 adhere to the prescribed dosage and not exceed the recommended amount, as taking more than directed may increase the risk of severe side effects. Do not take this medication for longer than your doctor has prescribed.

If you have asthma, consult with your doctor, as you may be more sensitive to this medication. Be cautious and avoid injuries, as this drug can increase the risk of bleeding. To minimize this risk, use a soft toothbrush and an electric razor.

The use of drugs like this one can increase the risk of heart failure. If you already have heart failure, the risk of heart attack, hospitalization for heart failure, and death may be higher. Discuss these risks with your doctor. Furthermore, people taking drugs like this one after a recent heart attack may have a higher risk of heart attack and heart-related death. In fact, studies have shown that people taking these medications after a first heart attack were more likely to die within the year following the heart attack compared to those not taking these medications. Talk to your doctor about these potential risks.

If you are taking aspirin to prevent a heart attack, consult with your doctor. Additionally, if you are on a low-sodium or sodium-free diet, inform your doctor, as some formulations of this medication may contain sodium.

If you are 60 years or older, use this medication with caution, as you may be more susceptible to side effects. It is also important to note that NSAIDs like this drug can affect ovulation, which may impact fertility. However, this effect is reversible when the medication is stopped. Discuss any concerns with your doctor.

Finally, if you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.

• Other NSAIDs (increased risk of GI adverse events)
• Aspirin (high-dose, for pain/inflammation, due to increased risk of GI bleeding; low-dose aspirin for cardioprotection should be used with caution and monitored)
• Ketorolac (concurrent use)

• Anticoagulants (e.g., Warfarin, Heparin): Increased risk of bleeding.
• Antiplatelet agents (e.g., Clopidogrel, Ticagrelor): Increased risk of bleeding.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Lithium: Increased lithium levels and toxicity.
• Methotrexate: Increased methotrexate levels and toxicity.
• Diuretics (e.g., Furosemide, Thiazides): Reduced diuretic and antihypertensive effects; risk of renal impairment.
• ACE Inhibitors/ARBs: Reduced antihypertensive effects; increased risk of renal impairment.
• Cyclosporine/Tacrolimus: Increased risk of nephrotoxicity.
• Digoxin: Increased digoxin levels.
• Pemetrexed: Increased pemetrexed toxicity (especially with renal impairment).

• Beta-blockers: Reduced antihypertensive effects.
• Hydantoins (e.g., Phenytoin): Increased hydantoin levels.
• Sulfonylureas: Increased hypoglycemic effect.
• Probenecid: Increased naproxen levels and half-life.
• Cholestyramine: Delayed naproxen absorption.
• Corticosteroids: Increased risk of GI ulceration and bleeding.

• Antacids: May delay absorption but do not significantly affect bioavailability.

• 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 allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
• Signs of liver problems (yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Signs of kidney problems (decreased urination, swelling in ankles/feet, unusual fatigue)
• Unexplained weight gain or swelling (edema)
• Vision changes or ringing in ears (tinnitus)

Avoid use during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction. Use during the first and second trimesters should be limited to situations where the potential benefit outweighs the potential risk, and at the lowest effective dose for the shortest duration possible.

Naproxen is excreted in breast milk in low concentrations. Generally considered compatible with breastfeeding, but use with caution, especially in preterm infants or those with underlying conditions. Monitor the infant for adverse effects (e.g., drowsiness, poor feeding, GI upset).

Not recommended for use in infants under 2 years of age. Dosing for children over 2 years should be based on weight and specific indication (e.g., juvenile idiopathic arthritis). Close monitoring for adverse effects, especially GI and renal, is crucial.

Elderly patients are at increased risk for serious adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, and renal impairment. Use the lowest effective dose for the shortest duration possible. Monitor renal function, blood pressure, and for signs of GI bleeding more frequently.

• Always shake the oral suspension well before administering to ensure uniform dosing.
• Advise patients to take naproxen with food, milk, or an antacid to minimize gastrointestinal irritation.
• Educate patients on the signs and symptoms of serious cardiovascular and gastrointestinal adverse events, and when to seek immediate medical attention.
• For chronic conditions, consider co-prescribing a proton pump inhibitor (PPI) or H2-blocker for patients at high risk of GI complications.
• Naproxen has a longer half-life than ibuprofen, allowing for twice-daily dosing, which can improve adherence for chronic conditions.
• Caution patients about the potential for fluid retention and elevated blood pressure, especially those with pre-existing cardiovascular conditions.

• Other NSAIDs (e.g., Ibuprofen, Diclofenac, Celecoxib)
• Acetaminophen (for pain/fever without anti-inflammatory effect)
• Opioid analgesics (for severe pain, short-term)
• Corticosteroids (for severe inflammation, short-term)
• Non-pharmacological therapies (e.g., RICE therapy, physical therapy, heat/cold packs)

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, it's crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.