A-G Profen

Name: A-G Profen

Commonly used brand name(s)

In the U.S.

  • Addaprin
  • Advil
  • A-G Profen
  • Bufen
  • Genpril
  • Haltran
  • Ibu
  • Ibu-2
  • Ibu-200
  • Ibu-4
  • Ibu-6
  • Ibu-8
  • Ibuprohm
  • Ibu-Tab
  • I-Prin
  • Midol
  • Motrin
  • Nuprin
  • Proprinal
  • Q-Profen

In Canada

  • Actiprofen
  • Advil Children's
  • Advil Pediatric
  • Children's Motrin
  • Children's Motrin Berry Flavor
  • Children's Motrin Bubble Gum Flavor
  • Children's Motrin Grape Flavor
  • Equate Children's Ibuprofen - Berry
  • Equate Children's Ibuprofen - Berry - Dye Free
  • Infants' Motrin
  • Option+ Children's Ibuprofen - Berry
  • Option+ Children's Ibuprofen - Grape

Available Dosage Forms:

  • Suspension
  • Tablet
  • Capsule, Liquid Filled
  • Tablet, Chewable
  • Capsule

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Proper Use of ibuprofen

This section provides information on the proper use of a number of products that contain ibuprofen. It may not be specific to A-G Profen. 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 .

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 .

To lessen stomach upset, you may take this medicine with food or milk .

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 oral dosage form (tablets and suspension):
    • For fever:
      • Children over 2 years of age—Use and dose must be determined by your doctor.
      • Children 6 months of age up to 2 years—Dose is based on body weight and body temperature, and must be determined by your doctor. For fever lower than 102.5 °F (39.2 °C), the dose usually is 5 milligrams (mg) per kilogram (kg) (about 2.2 mg per pound) of body weight. For higher fever, the dose usually is 10 mg per kg (about 4.5 mg per pound) of body weight. The medicine may be given every six to eight hours, as needed, up to 40 mg per kg per day.
      • Infants younger than 6 months of age—Use and dose must be determined by your doctor .
    • For menstrual cramps:
      • Adults—400 milligrams (mg) every four hours, as needed.
      • Children—Use and dose must be determined by your doctor .
    • For mild to moderate pain:
      • Adults and teenagers—400 milligrams (mg) every four to six hours, as needed.
      • Children over 6 months of age—Dose is based on body weight and must be determined by your doctor. The dose usually is 10 milligrams (mg) per kilogram (kg) of body weight every six to eight hours, as needed, up to 40 mg per kg per day.
      • Infants younger than 6 months of age—Use and dose must be determined by your doctor .
    • For osteoarthritis and rheumatoid arthritis:
      • Adults and teenagers—1200 milligrams (mg) up to 3200 mg per day divided into three or four equal doses.
      • Children—Dose is based on body weight and must be determined by your doctor. The dose usually is 30 milligrams (mg) to 40 mg per kilogram (kg) of body weight per day, divided into three or four doses.
      • Infants younger than 6 months of age—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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

A-G Profen 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
  • Abdominal pain
  • acid or sour stomach
  • belching
  • bloating
  • cloudy urine
  • decrease in amount of urine
  • decrease in urine output or decrease in urine-concentrating ability
  • diarrhea
  • difficulty having a bowel movement (stool)
  • excess air or gas in stomach or intestines
  • full feeling
  • heartburn
  • indigestion
  • itching skin
  • pain or discomfort in chest, upper stomach, or throat
  • pale skin
  • passing gas
  • nausea
  • noisy, rattling breathing
  • rash with flat lesions or small raised lesions on the skin
  • shortness of breath
  • swelling of face, fingers, hands, feet, lower legs, or ankles
  • troubled breathing at rest
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • weight gain
Less common
  • Abdominal cramps
  • stomach soreness or discomfort
Rare
  • Agitation
  • back, leg, or stomach pains
  • bleeding gums
  • blistering, peeling, loosening of skin
  • blood in urine or stools
  • bloody, black, or tarry stools
  • blurred vision
  • burning feeling in chest or stomach
  • change in vision
  • chest pain
  • chills
  • clay-colored stools
  • coma
  • confusion
  • constipation
  • cough or hoarseness
  • dark urine
  • decreased urine output
  • depression
  • difficulty breathing
  • difficulty swallowing
  • dilated neck veins
  • dizziness
  • dry mouth
  • extreme fatigue
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fever with or without chills
  • frequent urination
  • general body swelling
  • general feeling of tiredness or weakness
  • hair loss, thinning of hair
  • headache
  • hives or welts
  • hostility
  • impaired vision
  • increased blood pressure
  • increased volume of pale, dilute urine
  • irregular breathing
  • irritability
  • itching
  • joint or muscle pain
  • lab results that show problems with liver
  • lethargy
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • muscle twitching
  • nosebleeds
  • painful or difficult urination
  • pains in stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness of skin
  • seizures
  • severe abdominal pain, cramping, burning
  • severe and continuing nausea
  • sore throat
  • sores, ulcers, or white spots in mouth or on lips
  • stiff neck or back
  • stomach upset
  • stupor
  • swollen or painful glands
  • tenderness in stomach area
  • thirst
  • tightness in chest
  • unpleasant breath odor
  • upper right abdominal pain
  • vomiting of blood
  • vomiting of material that looks like coffee grounds
  • wheezing
  • yellow eyes and skin
Symptoms of overdose
  • Bluish lips or skin
  • difficulty sleeping
  • disorientation
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • drowsiness to profound coma
  • hallucination
  • lightheadedness or fainting
  • mood or other mental changes
  • muscle tremors
  • not breathing
  • rapid, deep breathing
  • restlessness
  • slow or irregular heartbeat
  • stomach cramps
  • sudden fainting
  • sweating

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 ears
  • hearing loss
  • nervousness
Rare
  • Crying
  • depersonalization
  • discouragement
  • dry eyes
  • dysphoria
  • euphoria
  • feeling sad or empty
  • lack of appetite
  • loss of interest or pleasure
  • mental depression
  • paranoia
  • quick to react or overreact
  • rapidly changing moods
  • runny nose
  • sleepiness or unusual drowsiness
  • sleeplessness
  • sneezing
  • stuffy nose
  • trouble concentrating
  • trouble sleeping
  • unable to sleep

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 Osteoarthritis

1200 to 3200 mg orally per day in divided doses
Maximum dose: 3200 mg/day

Comments:
-Patients with rheumatoid arthritis may require higher doses than those with osteoarthritis.
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.
-Patients treated with 3200 mg orally per day should be observed for sufficient increased clinical benefits to offset potential increased risk.

Use: For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis

Usual Adult Dose for Pain

IV Ibuprofen (Caldolor[R]):
400 to 800 mg IV every 6 hours as needed
Maximum dose: 3200 mg/day

Comments:
-Patients should be well hydrated prior to infusion to reduce the risk of renal adverse events.
-Doses should be infused over at least 30 minutes.

Uses: For the management of mild to moderate pain; and the management of moderate to severe pain as an adjunct to opioid analgesics

Oral:
200 to 400 mg orally every 4 to 6 hours as needed
Maximum dose: 3200 mg/day (prescription strength); 1200 mg/day (over-the-counter)

Comment:
-Oral doses greater than 400 mg have not been shown to be any more effective than the 400 mg dose.

Use: For the relief of mild to moderate pain

Usual Pediatric Dose for Fever

IV Ibuprofen (Caldolor[R]):
6 months to less than 12 years: 10 mg/kg IV every 4 to 6 hours as needed
-Maximum dose: Single dose: 400 mg; Daily dose: 40 mg/kg or 2400 mg/day, whichever is less

12 to 17 years: 400 mg IV every 4 to 6 hours as needed
-Maximum dose: 2400 mg/day

Comments:
-Patients should be well hydrated prior to infusion to reduce the risk of renal adverse events.
-Doses should be infused over at least 10 minutes.

Oral Suspension (Infant drops: 50 mg/1.25 mL):
6 to 11 months; 12 to 17 pounds: 50 mg (1.25 mL) every 6 to 8 hours as needed
12 to 23 months; 18 to 23 pounds: 75 mg (1.875 mL) orally every 6 to 8 hours as needed
-Maximum dose: 4 doses per day

Oral Suspension (100 mg/5 mL):
6 months to 2 years:
-Baseline temperature less than 102.5F (39.2C): 5 mg/kg orally every 6 to 8 hours
-Baseline temperature 102.5F (39.2C) or greater: 10 mg/kg orally every 6 to 8 hours
-Maximum dose: 40 mg/kg/day

2 to 11 years: 5 to 10 mg/kg orally every 6 to 8 hours as needed
-Maximum dose: 40 mg/kg/day or 4 doses per day

Oral Chewable Tablets:
2 to 11 years: 5 to 10 mg/kg every 6 to 8 hours as needed
-Maximum dose: 40 mg/kg/day or 4 doses per day

Oral Capsules and Tablets:
12 years and older:
-Initial dose: 200 mg orally every 4 to 6 hours as needed
-May increase to 400 mg every 4 to 6 hours if additional analgesia is needed
Maximum dose: 1200 mg/day

Comment:
-There are multiple over-the-counter formulations with different concentrations of the oral suspension and capsule/tablet strengths; manufacturer labeling may be consulted for weight/age based dosing charts.

Use: For the relief of fever

Usual Pediatric Dose for Patent Ductus Arteriosus

Ibuprofen lysine (NeoProfen[R]):
Gestational age 32 weeks or less and weight between 500 and 1500 g:
-Initial dose: 10 mg/kg IV
-Following initial dose, two doses of 5 mg/kg each, after 24 and 48 hours
-If anuria or marked oliguria (urinary output less than 0.6 mL/kg/hr) is evident at time of the second or third dose, hold drug until laboratory studies indicate renal function has returned to normal.

Comments:
-A course of therapy is defined as 3 doses; if ductus arteriosus closes or has significantly reduced in size after completion of the first course, no further doses are needed.
-If during continued medical management the ductus arteriosus fails to close or reopens, then a second course, alternative pharmacological therapy, or surgery may be needed.

Use: For the closure of a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective (e.g., fluid restriction, diuretics, respiratory support, etc.). The clinical trial was conducted in infants with asymptomatic PDA; however, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.

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.

IV Ibuprofen (Caldolor[R]) and Oral Suspension:
Safety and efficacy have not been established in patients younger than 6 months.

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

Over the Counter Chewable Tablets and Suspension:
Safety and efficacy have not been established in patients younger than 6 months.

Oral Prescription Tablets:
Safety and efficacy have not been established in patients younger than 18 years.

Ibuprofen Lysine (NeoProfen[R]): Safety and efficacy have not been established in patients younger than 32 weeks gestational age.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Administrative Information

LactMed Record Number

142

Last Revision Date

20160204

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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