Definition and Uses:
Naproxen is a non-steroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.
Naproxen is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps. It can also be used to treat acute pain caused by other conditions not listed in this medication guide.
The delayed-release or extended-release tablets are slower-acting forms of naproxen that are used only for treating chronic conditions such as arthritis or ankylosing spondylitis. These forms will not work fast enough to treat acute pain.
Warnings:
You should not use naproxen if you have a history of allergic reaction to aspirin or other NSAID (nonsteroidal anti-inflammatory drug).
Naproxen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.
Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Get emergency medical help if you have swelling of the face or throat, chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance. Stop taking naproxen and notify your physician if you notice stomach pain, tiredness or weakness, yellow skin or eyes, nausea, vomiting, bloody or black and sticky bowel movements , skin rash , unexplained weight loss or weight gain, or swelling of the hands and feet.
Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.
Before taking this medicine:
Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.
You should not use naproxen if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.
Ask a doctor before giving naproxen to a child younger than 12 years old.
Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:
heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
a history of heart attack, stroke, or blood clot;
a history of stomach ulcers or bleeding;
asthma;
liver or kidney disease;
fluid retention: or
if you take aspirin to prevent heart attack or stroke.
If you are pregnant, you should not take naproxen unless your doctor tells you to.Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.
It may not be safe to breastfeed while using naproxen. Ask your doctor about any risk.
Naproxen is not approved for use by anyone younger than 2 years old. Do not give this medicine to a child without medical advice.
How should I take naproxen?
Use naproxen exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.
Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
If you change brands, strengths, or forms of this medicine, your dosage needs may change. Ask your pharmacist if you have any questions about the kind of naproxen you are using.
If a child is using this medicine, tell your doctor if the child has any changes in weight. Doses are based on weight in children, and any changes may affect your child's dose.
If you use this medicine long-term, you may need frequent medical tests.
This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using naproxen.
Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
What to avoid:
Avoid drinking alcohol. It may increase your risk of stomach bleeding.
Avoid taking aspirin or other NSAIDs unless your doctor tells you to.
Ask your doctor before taking any other medication for pain, arthritis, fever, or swelling. Many medicines available over the counter contain aspirin, salicylates, or other medicines similar to naproxen (such as ibuprofen or ketoprofen). Taking certain products together can cause you to get too much of this type of medication.
Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb naproxen.
Naproxen side effects:
Get emergency medical help if you have signs of an allergic reaction to naproxen (runny or stuffy nose, wheezing or trouble breathing, hives, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Stop using naproxen and seek medical treatment if you have a serious drug reaction that can affect many parts of your body.Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.
Stop using naproxen and call your doctor at once if you have:
shortness of breath (even with mild exertion);
swelling or rapid weight gain;
the first sign of any skin rash, no matter how mild;
signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common naproxen side effects may include:
indigestion, heartburn, stomach pain, nausea;
headache, dizziness, drowsiness;
bruising, itching, rash;
swelling; or
ringing in your ears.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
Dosage:
Usual Adult Dose for Ankylosing Spondylitis:
Immediate Release Tablets and Suspension:
250 mg to 500 mg (naproxen) or 275 mg to 550 mg (naproxen sodium) orally twice a day
Controlled Release:
750 mg to 1000 mg orally once a day
Delayed Release:
375 mg to 500 mg orally twice a day
Comments:
- May increase to 1500 mg orally once a day for a limited time up to 6 months in patients requiring higher levels of anti-inflammatory/analgesic activity.
- When treating patients, especially at higher doses, sufficient increased clinical benefit should be observed to offset the potential for increased risk of adverse events.
- Symptomatic improvement of arthritis is usually observed within 1 week; however, treatment for 2 weeks may be required to achieve therapeutic benefit.
Uses: For the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis
Usual Adult Dose for Osteoarthritis
Immediate Release Tablets and Suspension:
250 mg to 500 mg (naproxen) or 275 mg to 550 mg (naproxen sodium) orally twice a day
Controlled Release:
750 mg to 1000 mg orally once a day
Delayed Release:
375 mg to 500 mg orally twice a day
Comments:
- May increase to 1500 mg orally once a day for a limited time up to 6 months in patients requiring higher levels of anti-inflammatory/analgesic activity.
- When treating patients, especially at higher doses, sufficient increased clinical benefit should be observed to offset the potential for increased risk of adverse events.
- Symptomatic improvement of arthritis is usually observed within 1 week; however, treatment for 2 weeks may be required to achieve therapeutic benefit.
Uses: For the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis
Usual Adult Dose for Rheumatoid Arthritis :
Immediate Release Tablets and Suspension:
250 mg to 500 mg (naproxen) or 275 mg to 550 mg (naproxen sodium) orally twice a day
Controlled Release:
750 mg to 1000 mg orally once a day
Delayed Release:
375 mg to 500 mg orally twice a day
Comments:
- May increase to 1500 mg orally once a day for a limited time up to 6 months in patients requiring higher levels of anti-inflammatory/analgesic activity.
- When treating patients, especially at higher doses, sufficient increased clinical benefit should be observed to offset the potential for increased risk of adverse events.
- Symptomatic improvement of arthritis is usually observed within 1 week; however, treatment for 2 weeks may be required to achieve therapeutic benefit.
Uses: For the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis
Usual Adult Dose for Pain
Immediate Release (naproxen sodium):
550 mg orally once, followed by 275 mg orally every 6 to 8 hours or 550 mg orally every 12 hours as needed
- Maximum dose: 1375 mg/day initial total daily dose; thereafter, not to exceed 1100 mg/day
- Naproxen (Naprosyn[R]) may also but used, however, the delayed release tablets (EC-Naprosyn[R]) are not recommended for initial treatment of acute pain due to delayed absorption.
1000 mg orally once a day
- For patients requiring additional analgesia, may increase to 1500 mg orally once a day for a limited time; thereafter, total daily dose should not exceed 1000 mg/day
220 mg orally every 8 to 12 hours while symptoms persist
- May take 440 mg orally once in the first hour if needed
Uses: For the relief of mild to moderate pain
Usual Adult Dose for Fever
Over the Counter:
220 mg orally every 8 to 12 hours while symptoms persist
- May take 440 mg orally once in the first hour if needed
Use: For the temporary reduction of fever
Usual Pediatric Dose for Fever
Over the Counter:
12 years or older: 220 mg orally every 8 to 12 hours while symptoms persist
- May take 440 mg orally once in the first hour if needed
Uses: For the relief of minor aches and pains and for the temporary reduction of fever.
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