naproxen

N

na-PROX-en

Oral route(Tablet;Tablet, Enteric Coated;Suspension)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Naproxen is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

Aflaxen Aleve Aleve Arthritis Anaprox Anaprox DS EC Naprosyn Naprelan Naprelan 500 Naprelan Dose Card Naprosyn

In Canada

Naxen

Available Dosage Forms:

Tablet Suspension Tablet, Enteric Coated Tablet, Extended Release

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For naproxen

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis) such as inflammation, swelling, stiffness, and joint pain. Naproxen also helps relieve symptoms of ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. However, naproxen does not cure arthritis and will help you only as long as you continue to take it.

naproxen may also be used to treat mild to moderate pain, including acute gout and other painful conditions such as bursitis, tendonitis, or menstrual cramps.

naproxen is available only with your doctor's prescription.

Before Using naproxen

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For naproxen, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to naproxen or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of naproxen controlled-release tablets in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of naproxen delayed release tablets, suspension, and tablets in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naproxen in the elderly. However, elderly patients may be more sensitive to the effects of naproxen than younger adults, and are more likely to have age-related kidney or stomach problems, which may require caution and an adjustment in the dose for patients receiving naproxen.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking naproxen, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using naproxen with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ketorolac Pentoxifylline

Using naproxen with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab Ardeparin Argatroban Aspirin Beclamide Beta Glucan Bivalirudin Caramiphen Carbamazepine Certoparin Chlormethiazole Cilostazol Citalopram Clopidogrel Clovoxamine Dabigatran Etexilate Dalteparin Danaparoid Desirudin Diazepam Dipyridamole Enoxaparin Escitalopram Ethotoin Felbamate Femoxetine Flesinoxan Fluoxetine Fluvoxamine Fondaparinux Fosphenytoin Gabapentin Ginkgo Heparin Lacosamide Lepirudin Mephenytoin Mephobarbital Methotrexate Nadroparin Nefazodone Oxcarbazepine Paraldehyde Paramethadione Parnaparin Paroxetine Pemetrexed Phenacemide Phenobarbital Phenytoin Piracetam Pregabalin Protein C Reviparin Rivaroxaban Rufinamide Sertraline Sibutramine Stiripentol Tacrolimus Tiagabine Ticlopidine Tinzaparin Tirofiban Topiramate Trimethadione Valproic Acid Vigabatrin Vilazodone Warfarin Zimeldine Zonisamide

Using naproxen with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol Acetohexamide Alacepril Alprenolol Amiloride Arotinolol Atenolol Azilsartan Medoxomil Azosemide Befunolol Bemetizide Benazepril Bendroflumethiazide Benzthiazide Betaxolol Bevantolol Bisoprolol Bopindolol Bucindolol Bumetanide Bupranolol Buthiazide Candesartan Cilexetil Canrenoate Captopril Carteolol Carvedilol Celiprolol Chlorothiazide Chlorpropamide Chlorthalidone Cilazapril Clopamide Cyclopenthiazide Cyclosporine Delapril Desvenlafaxine Dilevalol Duloxetine Enalaprilat Enalapril Maleate Eprosartan Esmolol Ethacrynic Acid Fosinopril Furosemide Gliclazide Glimepiride Glipizide Gliquidone Glyburide Hydrochlorothiazide Hydroflumethiazide Imidapril Indapamide Irbesartan Labetalol Landiolol Levobetaxolol Levobunolol Lisinopril Lithium Losartan Mepindolol Methyclothiazide Metipranolol Metolazone Metoprolol Milnacipran Moexipril Nadolol Nebivolol Nipradilol Olmesartan Medoxomil Oxprenolol Penbutolol Pentopril Perindopril Pindolol Piretanide Polythiazide Propranolol Quinapril Ramipril Sotalol Spirapril Spironolactone Talinolol Tasosartan Telmisartan Temocapril Tertatolol Timolol Tolazamide Tolbutamide Torsemide Trandolapril Triamterene Trichlormethiazide Valsartan Venlafaxine Xipamide Zofenopril Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of naproxen. Make sure you tell your doctor if you have any other medical problems, especially:

Anemia or Bleeding problems or Blood clots or Edema (fluid retention or body swelling) or Heart attack, history of or Heart disease (e.g., congestive heart failure) or Hypertension (high blood pressure) or Kidney disease or Liver disease (e.g., hepatitis) or Stomach or intestinal ulcers or bleeding, history of or Stroke, history of—Use with caution. May make these conditions worse. Aspirin-sensitive asthma or Aspirin sensitivity, history of—Should not be used in patients with these conditions. Heart surgery (e.g., coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery. Proper Use of naproxen

For safe and effective use of naproxen, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of naproxen may increase the chance of unwanted effects, especially in elderly patients.

naproxen should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, naproxen must be taken regularly as ordered by your doctor in order for it to help you. naproxen usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of naproxen.

Check with your doctor first before changing dosage forms (e.g., tablets, suspension). These forms are very different from each other.

Swallow the delayed-release tablet whole. Do not crush, break, or chew it.

If you are using the suspension, shake it gently before using it. Use the marked measuring cup included in the package to measure the dose.

Dosing

The dose of naproxen will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of naproxen. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For naproxen (e.g., Naprosyn®) tablet and oral suspension dosage forms: For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis: Adults—At first, 250 milligrams (mg) (10 milliliters (mL)/2 teaspoonfuls), 375 mg (15 mL/3 teaspoonfuls), or 500 mg (20 mL/4 teaspoonfuls) two times a day, in the morning and evening. Your doctor may increase your dose, as needed, up to a total of 1500 mg per day. Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 milligrams (mg) per kilogram (kg) of body weight two times a day. Children younger than 2 years of age—Use and dose must be determined by your doctor. For bursitis, tendonitis, menstrual cramps, and other kinds of pain: Adults—500 milligrams (mg) for the first dose, then 250 mg every 6 to 8 hours as needed. Children—Use and dose must be determined by your doctor. For acute gout: Adults—750 milligrams (mg) for the first dose, then 250 mg every 8 hours until the attack is relieved. Children—Use and dose must be determined by your doctor. For naproxen controlled-release tablet (e.g., Naprelan®) dosage form: For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis: Adults—At first, 750 milligrams (mg) (taken as one 750 mg or two 375 mg tablets) or 1000 mg (taken as two 500 mg tablets) once a day. Your doctor may adjust your dose as needed, up to a total of 1500 mg (taken as two 750 mg or three 500 mg tablets) per day. Children—Use and dose must be determined by your doctor. For bursitis, tendonitis, menstrual cramps, and other kinds of pain: Adults—At first, 1000 milligrams (mg) (taken as two 500 mg tablets) once a day. Some patients may need 1500 mg (taken as two 750 mg or three 500 mg tablets) per day, for a limited period. However, the dose is usually not more than 1000 mg per day. Children—Use and dose must be determined by your doctor. For acute gout: Adults—1000 to 1500 milligrams (mg) (taken as two to three 500 mg tablets) once a day for the first dose, then 1000 mg (taken as two 500 mg tablets) once a day until the attack is relieved. Children—Use and dose must be determined by your doctor. For naproxen delayed-release tablet (e.g., EC-Naprosyn®) dosage form: For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis: Adults—At first, 375 or 500 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg per day. Children—Use and dose must be determined by your doctor. For naproxen sodium (e.g., Anaprox®, Anaprox® DS) tablet dosage form: For rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis: Adults—At first, 275 or 550 milligrams (mg) two times a day, in the morning and evening. Your doctor may increase the dose, if necessary, up to a total of 1500 mg per day. Children—Use and dose must be determined by your doctor. For bursitis, tendonitis, menstrual cramps, and other kinds of pain: Adults—550 milligrams (mg) for the first dose, then 550 mg every 12 hours or 275 mg every 6 to 8 hours as needed. Your doctor may increase the dose, if necessary, up to a total of 1375 mg per day. Children—Use and dose must be determined by your doctor. For acute gout: Adults—825 milligrams (mg) for the first dose, then 275 mg every 8 hours until the attack is relieved. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of naproxen, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using naproxen

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

naproxen may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use naproxen for a long time might also have a higher risk.

naproxen may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid or a blood thinner).

Serious skin reactions can occur during treatment with naproxen. Check with your doctor right away if you have any of the following symptoms while taking naproxen: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

Possible warning signs of some serious side effects that can occur during treatment with naproxen may include swelling of the face, fingers, feet, or lower legs; severe stomach pain, black, tarry stools, or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; unusual bleeding or bruising; or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Stop taking naproxen and check with your doctor immediately if you notice any of these warning signs.

naproxen may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using naproxen during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor immediately if blurred vision, difficulty with reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Before having any kind of surgery or medical tests, tell your doctor that you are taking naproxen. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

naproxen may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to naproxen before you drive, use machines, or do anything else that could be dangerous if you are not alert. .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

naproxen Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Belching bruising difficult or labored breathing feeling of indigestion headache itching skin large, flat, blue, or purplish patches in the skin pain in the chest below the breastbone shortness of breath skin eruptions stomach pain swelling tightness in the chest wheezing Less common Bloating bloody or black, tarry stools blurred or loss of vision burning upper abdominal or stomach pain cloudy urine constipation decrease in urine output or decrease in urine-concentrating ability disturbed color perception double vision fast, irregular, pounding, or racing heartbeat or pulse halos around lights indigestion loss of appetite nausea or vomiting night blindness overbright appearance of lights pale skin pinpoint red or purple spots on the skin severe and continuing nausea severe stomach burning, cramping, or pain skin rash swelling or inflammation of the mouth troubled breathing with exertion tunnel vision unusual bleeding or bruising unusual tiredness or weakness vomiting of material that looks like coffee grounds weight loss Rare Anxiety back or leg pains bleeding gums blindness blistering, peeling, or loosening of the skin blood in the urine or stools blue lips and fingernails canker sores change in the ability to see colors, especially blue or yellow chest pain or discomfort clay-colored stools cold sweats coma confusion cool, pale skin cough or hoarseness coughing that sometimes produces a pink frothy sputum cracks in the skin darkened urine decreased vision depression diarrhea difficult, burning, or painful urination difficult, fast, or noisy breathing difficulty with swallowing dilated neck veins dizziness dry cough dry mouth early appearance of redness, or swelling of the skin excess air or gas in the stomach extreme fatigue eye pain fainting fever with or without chills fluid-filled skin blisters flushed, dry skin frequent urination fruit-like breath odor greatly decreased frequency of urination or amount of urine hair loss high fever hives increased hunger increased sensitivity of the skin to sunlight increased sweating increased thirst increased urination increased volume of pale, dilute urine irregular breathing joint or muscle pain large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs late appearance of rash with or without weeping blisters that become crusted, especially in sun-exposed areas of skin, may extend to unexposed areas light-colored stools lightheadedness loss of heat from the body lower back or side pain nervousness nightmares no blood pressure no breathing no pulse nosebleeds numbness or tingling in the hands, feet, or lips pain in the ankles or knees pain or burning in the throat pain or discomfort in the arms, jaw, back, or neck painful, red lumps under the skin, mostly on the legs pains in the stomach, side, or abdomen, possibly radiating to the back pale or blue lips, fingernails, or skin pounding in the ears puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue rapid, shallow breathing red, irritated eyes red skin lesions, often with a purple center red-green color blindness redness or other discoloration of the skin redness, swelling, or soreness of the tongue scaly skin seizures severe sunburn shakiness skin thinness slurred speech sneezing sore throat sores, ulcers, or white spots on the lips or tongue or inside the mouth sores, welting, or blisters spots on your skin resembling a blister or pimple stiff neck or back stomach cramps or tenderness stomach upset swelling in the legs and ankles swelling of the face, fingers, feet, or lower legs swollen, painful, or tender lymph glands in the neck, armpit, or groin tiny bumps on the inner lining of the eyelid unexplained weight loss unpleasant breath odor watery or bloody diarrhea weakness or heaviness of the legs weight gain yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose Bleeding under the skin confusion about identity, place, and time muscle tremors restlessness sleepiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Continuing ringing or buzzing or other unexplained noise in the ears hearing loss Less common Acid or sour stomach change in hearing feeling of constant movement of self or surroundings passing gas sensation of spinning stomach soreness or discomfort Rare Appetite changes burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings burning, dry, or itching eyes difficulty with moving discharge, excessive tearing general feeling of discomfort or illness lack or loss of strength menstrual changes muscle aching, cramping, stiffness, or weakness not able to concentrate redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid seeing, hearing, or feeling things that are not there shakiness in the legs, arms, hands, or feet sleeplessness swollen joints trembling or shaking of the hands or feet trouble getting pregnant trouble performing routine tasks trouble sleeping unable to sleep unusual drowsiness, dullness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: naproxen side effects (in more detail)

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naproxen

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