Naprelan Dose Card

Name: Naprelan Dose Card

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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)

Uses For Naprelan Dose Card

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, this medicine does not cure arthritis and will help you only as long as you continue to take it.

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

This medicine is available only with your doctor's prescription.

Before Using Naprelan Dose Card

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

Proper Use of naproxen

This section provides information on the proper use of a number of products that contain naproxen. It may not be specific to Naprelan Dose Card. Please read with care.

For safe and effective use of this medicine, 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 this medicine may increase the chance of unwanted effects, especially in elderly patients.

This medicine 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, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine 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 this medicine.

Check with your doctor first before changing dosage forms (eg, 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 this medicine 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 this medicine. 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 (eg, 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 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 (eg, 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, tendinitis, 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 (eg, 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 (eg, 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, tendinitis, 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 this medicine, 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 Naprelan Dose Card

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.

This medicine 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 this medicine for a long time might also have a higher risk.

This medicine 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).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loose 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 this medicine 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. Check with your doctor immediately if you notice any of these warning signs.

This medicine 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, 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 this medicine during the later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

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 this medicine. 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.

This medicine 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 this medicine 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.

Naprelan Dose Card 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
skin eruptions
stomach pain
swelling
tightness in the chest

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: