Naprosyn

Name: Naprosyn

What is the dosage for naproxen?

The usual adult dose for pain is 250 every 6 to 8 hours or 500 mg twice daily using regular naproxen tablets. The usual dose for Naprelan controlled release tablets is 750 to 1000 mg given once daily. For EC-Naprosyn, the usual dose is 375-500 mg twice daily.

Naproxen should be given with food to reduce upset stomach. The dose for rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis is 500 to 1000 mg every 12 hours. Dysmenorrhea is treated with 250 mg every 6 to 8 hours after an initial dose of 500 mg.

Naprosyn Overview

Naprosyn is a prescription medication used to reduce pain, redness, swelling, and heat (inflammation) from conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Naprosyn belongs to a class of drugs called non-steroidal anti-inflammatory drugs, or NSAIDs. These work by stopping substances in your body that cause inflammation and pain.

Naprosyn comes as a regular tablet and suspension (liquid) to take by mouth. The tablets and suspension are usually taken twice a day for arthritis. The tablets and suspension is usually taken every 8 hours for gout, and every 6 to 8 hours as needed for pain. If you are taking Naprosyn on a regular basis, you should take it at the same time(s) every day.

Common side effects of Naprosyn include stomach pain, heartburn, nausea, and gas. Naprosyn can aslo cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how this medication will affect you.

Uses of Naprosyn

Naprosyn is used to treat the following:

  • pain and redness
  • swelling and inflammation from conditions such as different types of arthritis and gout 
  • menstrual cramps
  • other types of short-term pain

This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

Naprosyn Dosage

Take Naprosyn exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Dosing may vary according to age and severity of symptoms and pain. In addition, different forms may not be equivalent; a change in dose may be needed if changing from a tablet to a suspension.

The typical dosing range with Naprosyn is 250 to 500 twice daily. The maximum recommended daily dose of Naprosyn is 1500 mg in adults.

Naprosyn FDA Warning

Cardiovascular Risk

  • 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 as NAPROSYN, EC-NAPROSYN, ANAPROX, ANAPROX DS or NAPROSYN Suspension 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 are at greater risk for serious gastrointestinal events.

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
  • Capsule, Liquid Filled
  • Capsule

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Before Using Naprosyn

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Naproxen

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

Naproxen Sodium

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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 this medicine, 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 this medicine 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

Using this medicine 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
  • Aceclofenac
  • Acemetacin
  • Acenocoumarol
  • Amiloride
  • Amineptine
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Amtolmetin Guacil
  • Anagrelide
  • Apixaban
  • Ardeparin
  • Argatroban
  • Aspirin
  • Balsalazide
  • Bemiparin
  • Bendroflumethiazide
  • Benzthiazide
  • Betamethasone
  • Betrixaban
  • Bismuth Subsalicylate
  • Bivalirudin
  • Bromfenac
  • Budesonide
  • Bufexamac
  • Bumetanide
  • Cangrelor
  • Celecoxib
  • Ceritinib
  • Certoparin
  • Chlorothiazide
  • Chlorthalidone
  • Choline Magnesium Trisalicylate
  • Choline Salicylate
  • Cilostazol
  • Citalopram
  • Clomipramine
  • Clonixin
  • Clopamide
  • Clopidogrel
  • Cortisone
  • Cyclopenthiazide
  • Cyclosporine
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Deflazacort
  • Desipramine
  • Desirudin
  • Desmopressin
  • Desvenlafaxine
  • Dexamethasone
  • Dexibuprofen
  • Dexketoprofen
  • Diazoxide
  • Dibenzepin
  • Diclofenac
  • Diflunisal
  • Digoxin
  • Dipyridamole
  • Dipyrone
  • Dothiepin
  • Doxepin
  • Droxicam
  • Duloxetine
  • Edoxaban
  • Enoxaparin
  • Eplerenone
  • Epoprostenol
  • Eptifibatide
  • Escitalopram
  • Ethacrynic Acid
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Feverfew
  • Floctafenine
  • Flufenamic Acid
  • Fluocortolone
  • Fluoxetine
  • Flurbiprofen
  • Fluvoxamine
  • Fondaparinux
  • Furosemide
  • Ginkgo
  • Gossypol
  • Heparin
  • Hydrochlorothiazide
  • Hydrocortisone
  • Hydroflumethiazide
  • Ibuprofen
  • Iloprost
  • Imipramine
  • Indapamide
  • Indomethacin
  • Ketoprofen
  • Lepirudin
  • Levomilnacipran
  • Lithium
  • Lofepramine
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Magnesium Salicylate
  • Meadowsweet
  • Meclofenamate
  • Mefenamic Acid
  • Melitracen
  • Meloxicam
  • Mesalamine
  • Methotrexate
  • Methyclothiazide
  • Methylprednisolone
  • Metolazone
  • Milnacipran
  • Morniflumate
  • Nabumetone
  • Nadroparin
  • Naproxen
  • Nefazodone
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Nortriptyline
  • Olsalazine
  • Opipramol
  • Oxaprozin
  • Oxyphenbutazone
  • Paramethasone
  • Parecoxib
  • Parnaparin
  • Paroxetine
  • Pemetrexed
  • Pentosan Polysulfate Sodium
  • Pentoxifylline
  • Phenindione
  • Phenprocoumon
  • Phenylbutazone
  • Phenyl Salicylate
  • Piketoprofen
  • Piroxicam
  • Pixantrone
  • Polythiazide
  • Pralatrexate
  • Prasugrel
  • Prednisolone
  • Prednisone
  • Probenecid
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Protein C
  • Protriptyline
  • Reboxetine
  • Reviparin
  • Rivaroxaban
  • Rofecoxib
  • Salicylamide
  • Salicylic Acid
  • Salsalate
  • Sertraline
  • Sibutramine
  • Sodium Salicylate
  • Spironolactone
  • Sulfasalazine
  • Sulindac
  • Tacrolimus
  • Tenoxicam
  • Tianeptine
  • Tiaprofenic Acid
  • Ticagrelor
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Tolfenamic Acid
  • Tolmetin
  • Torsemide
  • Treprostinil
  • Triamterene
  • Trichlormethiazide
  • Trimipramine
  • Trolamine Salicylate
  • Valdecoxib
  • Venlafaxine
  • Vilazodone
  • Vorapaxar
  • Vortioxetine
  • Warfarin
  • Xipamide

Using this medicine 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
  • Alacepril
  • Atenolol
  • Azilsartan
  • Azilsartan Medoxomil
  • Benazepril
  • Betaxolol
  • Bisoprolol
  • Candesartan
  • Captopril
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Cilazapril
  • Delapril
  • Enalapril
  • Enalaprilat
  • Eprosartan
  • Esmolol
  • Fosinopril
  • Imidapril
  • Irbesartan
  • Labetalol
  • Levobunolol
  • Lisinopril
  • Losartan
  • Metipranolol
  • Metoprolol
  • Moexipril
  • Nadolol
  • Nebivolol
  • Olmesartan
  • Oxprenolol
  • Penbutolol
  • Pentopril
  • Perindopril
  • Pindolol
  • Practolol
  • Propranolol
  • Quinapril
  • Ramipril
  • Sotalol
  • Spirapril
  • Telmisartan
  • Temocapril
  • Timolol
  • Trandolapril
  • Valsartan
  • 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Tobacco

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. 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, recent or history of or
  • Heart disease (eg, congestive heart failure) or
  • Hyperkalemia (high potassium levels in the blood) or
  • Hypertension (high blood pressure) or
  • Kidney disease or
  • Liver disease (eg, 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 (eg, coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

How is Naprosyn Supplied

Naprosyn Tablets: 250 mg: round, yellow, biconvex, engraved with NPR LE 250 on one side and scored on the other. Packaged in light-resistant bottles of 100.

100’s (bottle): NDC 69437-313-01.

375 mg: pink, biconvex oval, engraved with NPR LE 375 on one side. Packaged in light-resistant bottles of 100.

100’s (bottle): NDC 69437-314-01.

500 mg: yellow, capsule-shaped, engraved with NPR LE 500 on one side and scored on the other. Packaged in light-resistant bottles of 100.

100’s (bottle): NDC 69437-316-01.

Store at 15° to 30°C (59° to 86°F) in well-closed containers; dispense in light-resistant containers.

Naprosyn Suspension: 125 mg/5 mL (contains 39 mg sodium, about 1.5 mEq/teaspoon): Available in 1 pint (473 mL) light-resistant bottles (NDC 69437-028-28).

Store at 15° to 30°C (59° to 86°F); avoid excessive heat, above 40°C (104°F). Dispense in light-resistant containers. Shake gently before use.

EC-Naprosyn Delayed-Release Tablets: 375 mg: white, oval biconvex coated tablets imprinted with NPR EC 375 on one side. Packaged in light-resistant bottles of 100.

100’s (bottle): NDC 69437-415-01.

500 mg: white, oblong coated tablets imprinted with NPR EC 500 on one side. Packaged in light-resistant bottles of 100.

100’s (bottle): NDC 69437-416-01.

Store at 15° to 30°C (59° to 86°F) in well-closed containers; dispense in light-resistant containers.

ANAPROX Tablets: Naproxen sodium 275 mg: light blue, oval-shaped, engraved with NPS-275 on one side. Packaged in bottles of 100.

100’s (bottle): NDC 69437-202-01.

Store at 15° to 30°C (59° to 86°F) in well-closed containers.

ANAPROX DS Tablets: Naproxen sodium 550 mg: dark blue, oblong-shaped, engraved with NPS 550 on one side and scored on both sides. Packaged in bottles of 100.

100’s (bottle): NDC 69437-203-01.

Store at 15° to 30°C (59° to 86°F) in well-closed containers.

Revised: April 2016

Medication Guide
for
Non-steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID medicines.)

_____________________________________________________________

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

  • with longer use of NSAID medicines
  • in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

  • can happen without warning symptoms
  • may cause death

The chance of a person getting an ulcer or bleeding increases with:

  • taking medicines called “corticosteroids” and “anticoagulants”
  • longer use
  • smoking
  • drinking alcohol
  • older age
  • having poor health

NSAID medicines should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

________________________________________________________

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

  • different types of arthritis
  • menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

  • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
  • for pain right before or after heart bypass surgery

Tell your healthcare provider:

  • about all of your medical conditions.
  • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. 
  • if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy. 
  • if you are breastfeeding. Talk to your doctor. 

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effects include: Other side effects include:
• heart attack • stomach pain
• stroke • constipation
• high blood pressure • diarrhea
• heart failure from body swelling (fluid retention) • gas
• kidney problems including kidney failure • heartburn
• bleeding and ulcers in the stomach and intestine • nausea
• low red blood cells (anemia) • vomiting
• life-threatening skin reactions •dizziness
• life-threatening allergic reactions
• liver problems including liver failure
• asthma attacks in people who have asthma

Get emergency help right away if you have any of the following symptoms:

• shortness of breath or trouble breathing
• slurred speech
• chest pain • swelling of the face or throat
• weakness in one part or side of your body

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

• nausea • there is blood in your bowel movement or it is black and sticky like tar
• more tired or weaker than usual • unusual weight gain
• itching • skin rash or blisters with fever
• your skin or eyes look yellow • swelling of the arms and legs, hands and feet
• stomach pain
• flu-like symptoms
• vomit blood

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Canton Laboratories, LLC at 1-844-302-5227.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):

  • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

Generic Name Tradename
Celecoxib Celebrex®
Diclofenac Cataflam®, Voltaren®, Arthrotec™ (combined with misoprostol)
Diflunisal Dolobid®
Etodolac Lodine®, Lodine®XL
Fenoprofen Nalfon®, Nalfon®200
Flurbirofen Ansaid®
Ibuprofen Motrin®, Tab-Profen®, Vicoprofen®* (combined with hydrocodone), Combunox™ (combined with oxycodone)
Indomethacin Indocin®, Indocin®SR, Indo-Lemmon™, Indomethagan™
Ketoprofen Oruvail®
Ketorolac Toradol®
Mefenamic Acid Ponstel®
Meloxicam Mobic®
Nabumetone Relafen®
Naproxen Naprosyn®, Anaprox®, Anaprox®DS, EC-Naprosyn®, Naprelan®, Naprapac® (copackaged with lansoprazole)
Oxaprozin Daypro®
Piroxicam Feldene®
Sulindac Clinoril®
Tolmetin Tolectin®, Tolectin DS®, Tolectin®600

*Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAID, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Medication Guide Revised: October 2010

All registered trademarks in this document are the property of their respective owners.

Made for:
Atnahs Pharma
Miles Gray Road
Basildon Essex SS14 3FR
United Kingdom

Distributed by:
Canton Laboratories, LLC
Alpharetta, GA 30004-5945
United States

What happens if I miss a dose?

Since Naprosyn is sometimes used only when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What should I avoid while taking Naprosyn?

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin while you are taking Naprosyn.

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.

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