Aflaxen

Name: Aflaxen

Aflaxen Drug Class

Aflaxen is part of the drug classes:

  • Antiinflammatory preparations, non steroids for topical use

  • Antiinflammatory products for vaginal administration

  • Propionic acid derivatives

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 Aflaxen. 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.

Aflaxen 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:

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

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.

Usual Adult Dose for Dysmenorrhea

Immediate Release (naproxen sodium):
550 mg orally once, followed by 275 mg orally every 6 to 8 hours or 550 mg orally every 12 hours as needed
-Maximum dose: 1375 mg/day initial total daily dose; thereafter, not to exceed 1100 mg/day

Comments:
-Naproxen (Naprosyn[R]) may also but used, however, the delayed release tablets (EC-Naprosyn[R]) are not recommended for initial treatment of acute pain due to delayed absorption.

Controlled Release:
1000 mg orally once a day
-For patients requiring additional analgesia, may increase to 1500 mg orally once a day for a limited time; thereafter, total daily dose should not exceed 1000 mg/day

Over the Counter:
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 management of primary dysmenorrhea

Precautions

US BOXED WARNINGS: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS:
-Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
-This drug is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
-NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.

Immediate Release:
Safety and efficacy have not been established in patients younger than 2 years.

Over the Counter:
Safety and efficacy have not been established in patients younger than 12 years.

Controlled and Delayed Release Tablets:
Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Naproxen Pregnancy Warnings

Animal studies have revealed evidence of an increased risk of miscarriage, pre- and post-implantation loss, gastroschisis, embryo-fetal lethality, and cardiac malformation following use of prostaglandin synthesis inhibitors in early pregnancy. Administration of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy may cause significant adverse effects, including premature closure of the fetal ductus arteriosus, pulmonary hypertension, fetal renal impairment, oligohydramnios, and inhibition of platelet aggregation. There are no controlled data in human pregnancy. Administration during labor and delivery is not recommended; onset of labor may be delayed and duration increased with greater bleeding tendency in mother and child. NSAIDs may impair female fertility; withdrawal of NSAID therapy should be considered in women with difficulties conceiving or who are undergoing investigation of infertility. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Avoid use during last trimester of pregnancy. Prior to 30 weeks gestation: Use only if potential benefit justifies the potential risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: Not assigned. Risk Summary: Use of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Comments: -Avoid use during third trimester as it may cause premature closure of the ductus arteriosus. -Not recommended in women attempting to conceive as may impair female fertility.

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