Naprelan

• Bryant Ranch Prepack

• Elan Pharmaceuticals, Inc.

• IPI Pharmaceuticals

• Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC

• Nucare Pharmaceuticals, Inc.

• PD-Rx Pharmaceuticals, Inc.

• Pharma Pac (A Service Of H.J. Harkins Co., Inc.)

• Physician Partner

• Quality Care Pharmaceuticals

• Quality Care Products, LLC

• Rebel Distributors Corp..

• Shionogi Inc.

• Stat Rx Usa Llc

• Victory Pharma, Inc.

Naprelan is part of the drug classes:

• Antiinflammatory preparations, non steroids for topical use

• Antiinflammatory products for vaginal administration

• Propionic acid derivatives

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.  Especially tell your doctor if you take:

• ACE inhibitors such as lisinopril (Zestril, Prinivil), ramipril (Altace), quinapril (Accupril), captopril (Capoten), benazepril (Lotensin), and enalapril (Vasotec)
• angiotensin receptor blockers (ARBs) such as losartan (Cozaar), irbesartan (Avapro), olmesartan (Benicar), candesartan (Atacand), and valsartan (Diovan)
• beta-blockers such as propranolol (Inderal), timolol (Timoptic), atenolol (Tenormin), and metoprolol (Lopressor, Toprol)
• antacids such as Tums, Citrical, or Rolaids
• sucralfate (Carafate)
• aspirin (Ecotrin)
• diuretics such as furosemide (Lasix), hydrochlorothiazide (Microzide), and chlorthalidone (Thalitone)
• cholestyramine (Questran)
• lithium
• methotrexate (Trexall)
• warfarin (Coumadin, Jantoven)
• selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac), sertraline (Zoloft), and escitalopram (Lexapro)

This is not a complete list of naproxen interactions.  Ask your doctor or pharmacist for more information.

Before taking naproxen, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have kidney problems
• have liver problems
• have heart problems
• have clotting problems or are taking anticoagulation medications
• have had a stomach bleed or ulcer (hole in the lining of the stomach) in the past
• have asthma
• are pregnant or are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy.  Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Naproxen falls into category C. This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

In addition, naproxen is known to cause heart defects on the developing fetus. Use during pregnancy, especially during late pregnancy, should be avoided.

Take naproxen 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 naproxen is 250 to 500 twice daily. The maximum daily dose of naproxen recommended is 1500 mg in adults.

The recommended total daily dose of naproxen for children 2 years and older is approximately 10 mg/kg given in 2 divided doses.

In all cases, treatment should be adjusted to give the lowest effective dose for the shortest duration possible in order to reduce the chance of side effects.

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [see Warnings and Precautions (5.1, 5.2,5.4,5.6,)].

A few patients have experienced seizures, but it is not clear whether or not these were drug-related. It is not known what dose of the drug would be life threatening.

Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

For additional information about overdosage treatment contact a poison control center (1-800-222-1222).

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

Avoid taking aspirin while you are taking naproxen.

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.

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

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 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. You may report side effects to FDA at 1-800-FDA-1088.

Applies to naproxen: oral capsule liquid filled, oral suspension, oral tablet, oral tablet enteric coated, oral tablet extended release

Along with its needed effects, naproxen (the active ingredient contained in Naprelan) 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 while taking naproxen:

• 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

• 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

• 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 while taking naproxen:

• Bleeding under the skin
• confusion about identity, place, and time
• muscle tremors
• restlessness
• sleepiness

Some side effects of naproxen 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:

• Continuing ringing or buzzing or other unexplained noise in the ears
• hearing loss

• Acid or sour stomach
• change in hearing
• feeling of constant movement of self or surroundings
• passing gas
• sensation of spinning
• stomach soreness or discomfort

• 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
• swollen joints
• trembling or shaking of the hands or feet
• trouble getting pregnant
• trouble performing routine tasks
• trouble sleeping
• unusual drowsiness, dullness, or feeling of sluggishness