Aflaxen

Name: Aflaxen

Aflaxen Interactions

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.

 

Other Requirements

Store naproxen tablets and suspension at room temperature and protect from light.

Keep this and all medicines out of the reach of children.

For the Consumer

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 Aflaxen) 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:

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 while taking naproxen:

Symptoms of overdose
  • 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:

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
  • 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

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
Maximum dose: 440 mg (in any 8 to 12 hour period); 660 mg (in any 24 hour period)

Uses: For the relief of minor aches and pains and for the temporary reduction of fever

Dialysis

Data not available

Naproxen Levels and Effects while Breastfeeding

Summary of Use during Lactation

Limited information indicates that levels of naproxen in breastmilk are low and adverse effects in breastfed infants are apparently uncommon. However, because of naproxen's long half-life and reported serious adverse reaction in a breastfed neonate, other agents may be preferred while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. Peak milk naproxen levels in a 5-month postpartum patient were 1.1 to 1.3 mg/L while taking oral naproxen 250 mg twice daily and 2.4 mg/L with a dose of 375 mg twice daily. Peak milk levels occurred 4 to 5 hours after the dose and fell slowly over 12 to 24 hours. From urinary excretion data the authors estimated that the infant received 0.26% of the mother's total dose or 1.9% of the maternal weight-adjusted dosage.[1] Using the peak milk level data, the estimated maximum intake of an exclusively breastfed infant would be 2.2 to 2.8% of the maternal weight-adjusted dosage, not including the contribution of any glucuronide metabolite.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Naproxen possibly caused prolonged bleeding time, thrombocytopenia and acute anemia in one 7-day-old infant in a mother also taking bacampicillin.[2]

In one telephone follow-up study of 20 infants exposed to naproxen during breastfeeding, 2 mothers reported drowsiness and 1 reported vomiting in their infants. None of the reactions required medical attention.[3]

Effects on Lactation and Breastmilk

A randomized study compared naproxen and tramadol for post-cesarean section pain. Patients received the drugs either on a fixed schedule or as needed. No difference in breastfeeding rates were seen among the groups.[5]

Alternate Drugs to Consider

Acetaminophen, Flurbiprofen, Ibuprofen, Indomethacin, Piroxicam

References

1. Jamali F, Tam YK, Stevens RD. Naproxen excretion in breast milk and its uptake by suckling infant. Drug Intell Clin Pharm. 1982;16:475. Abstract. PMID: 6653409

2. Jamali F, Stevens DR. Naproxen excretion in milk and its uptake by the infant. Drug Intell Clin Pharm. 1983;17:910-1. Letter. PMID: 6653409

3. Fidalgo I, Correa R, Gomez Carrasco JA et al. [Acute anemia, rectorrhagia and hematuria caused by ingestion of naproxen]. An Esp Pediatr. 1989;30:317-9. PMID: 2787136

4. Ito S, Blajchman A, Stephenson M et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. PMID: 8498418

5. Sammour RN, Ohel G, Cohen M, Gonen R. Oral naproxen versus oral tramadol for analgesia after cesarean delivery. Int J Gynaecol Obstet. 2011;113:144-7. PMID: 21435642

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