A-G Profen

Name: A-G Profen

Uses For A-G Profen

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it .

In addition, ibuprofen can be used to treat fever, menstrual cramps, and other conditions as determined by your doctor .

This medicine is available both over-the-counter (OTC) and with your doctor's prescription .

For the Consumer

Applies to ibuprofen: oral capsule, oral capsule liquid filled, oral suspension, oral tablet, oral tablet chewable

Other dosage forms:

  • intravenous solution

Along with its needed effects, ibuprofen (the active ingredient contained in A-G Profen) 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 ibuprofen:

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 of ibuprofen 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

For Healthcare Professionals

Applies to ibuprofen: compounding powder, intravenous solution, oral capsule, oral suspension, oral tablet, oral tablet chewable

General

The most frequently reported adverse effects were gastrointestinal (GI) in nature and included nausea, vomiting, flatulence, and diarrhea.

Patent Ductus Arteriosus: The most frequently reported adverse effects were sepsis, anemia, intraventricular bleeding, apnea, GI disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, and respiratory failure.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 57%), vomiting (up to 22%), flatulence (up to 16%), diarrhea (up to 10%)
Common (1% to 10%): Dyspepsia, abdominal discomfort, epigastric pain, heartburn, abdominal distress, indigestion, constipation, abdominal cramps/pain, fullness of GI tract, bloating, GI hemorrhage, melena
Uncommon (0.1% to 1%): Abdominal distention, dyspepsia, gastritis
Very rare (less than 0.01%): Peptic ulcer, perforation, hematemesis, mouth ulceration, exacerbation of colitis, exacerbation of Crohn's disease
Frequency not reported: Dry mouth, duodenitis, esophagitis, gastric ulcer, duodenal ulcer, GI bleeding, glossitis, rectal bleeding, stomatitis, eructation, gingival ulcer, pancreatitis

Patent Ductus Arteriosus:
Very common (10% or more): GI disorders non-necrotizing enterocolitis (22%)
Common (1% to 10%): Necrotizing enterocolitis, intestinal perforation
Frequency not reported: Abdominal distension, gastroesophageal reflux, gastritis, ileus, inguinal hernia
Postmarketing reports: GI perforation[Ref]

Cardiovascular

Very common (10% or more): Hemorrhage (up to 10%), hypertension (10%), hypotension (10%)
Very rare (less than 0.01%): Cardiac failure
Frequency not reported: Congestive heart failure, tachycardia, arrhythmia, myocardial infarction, palpitations, vasculitis, sinus bradycardia, angina pectoris, thrombotic events

Patent Ductus Arteriosus:
Frequency not reported: Tachycardia, cardiac failure, hypotension[Ref]

Nervous system

Very common (10% or more): Headache (up to 12%)
Common (1% to 10%): Dizziness, nervousness
Very rare (less than 0.01%): Cerebrovascular accident
Frequency not reported: Syncope, drowsiness, paresthesia, somnolence, tremors, convulsions, coma

Patent Ductus Arteriosus:
Common (1% to 10%): Intraventricular hemorrhage, periventricular hemorrhage
Frequency not reported: Convulsions[Ref]

Renal

The number of total renal events in preterm infants within 30 days of therapy following IV use was 21% and included increased blood urea (7%), renal insufficiency/impairment (6%), reduced urine output (3%), increased blood creatinine (3%), renal failure (1%), and increased blood urea with hematuria (1%).[Ref]

Very rare (less than 0.01%): Acute renal failure, renal papillary necrosis, interstitial nephritis, nephrotic syndrome, renal failure, renal insufficiency
Frequency not reported: Cystitis, azotemia, creatinine clearance decreased, glomerulitis, tubular necrosis, nephrotoxicity

Patent Ductus Arteriosus:
Very common (10% or more): Renal events (21%)
Uncommon (0.1% to 1%): Acute renal failure[Ref]

Hematologic

The incidence of total bleeding events within 30 days of therapy with IV use in preterm infants was 32%. This percentage included grade 1 and 2 intraventricular hemorrhage (15%), grade 3 and 4 intraventricular hemorrhage (15%), and other bleeding (6%).[Ref]

Very common (10% or more): Anemia (up to 36%), eosinophilia (up to 26%), neutropenia (up to 13%), thrombocythemia (up to 10%)
Common (1% to 10%): Hemoglobin decreased
Very rare (less than 0.01%): Leukopenia, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, pancytopenia, hematocrit decreased
Frequency not reported: lymphadenopathy, bleeding episodes

Patent Ductus Arteriosus:
Very common (10% or more): Anemia (32%), total bleeding (32%), intraventricular hemorrhage (29%), Neutropenia, thrombocytopenia[Ref]

Dermatologic

Common (1% to 10%): Rash, maculopapular rash, pruritus
Very rare (less than 0.01%): Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis
Frequency not reported: Ecchymosis, purpura, alopecia, sweating, photosensitivity, angioedema, exfoliative dermatitis, urticaria, vesiculobullous eruptions, Henoch Schonlein vasculitis

Patent Ductus Arteriosus:
Very common (10% or more): Skin lesion/irritation (16%)[Ref]

Metabolic

Very common (10% or more): Hypokalemia (up to 19%), hypoproteinemia (up to 13%), blood urea increased (10%), hypernatremia (10%), hypoalbuminemia (10%)
Common (1% to 10%): Appetite decreased, fluid retention
Frequency not reported: Appetite changes, hyperglycemia, hypoglycemic reaction, acidosis

Patent Ductus Arteriosus:
Very common (10% or more): Hypoglycemia (12%), hypocalcemia (12%), blood creatinine increased, blood sodium decreased
Common (1% to 10%): Hypernatremia
Frequency not reported: Feeding problems, hyperglycemia[Ref]

Other

Very common (10% or more): Bacteremia (13%), blood LDH increased (up to 10%)
Common (1% to 10%): Peripheral edema, wound hemorrhage, tinnitus, hearing impairment, edema, fatigue
Very rare (less than 0.01%): Aseptic meningitis, vertigo, exacerbation of infection-related inflammations
Frequency not reported: Fever, infection, sepsis, weight changes, asthenia, malaise, pseudo-tumor, hearing loss, drowsiness

Patent Ductus Arteriosus:
Very common (10% or more): Sepsis (43%)
Common (1% to 10%): Edema, fluid retention
Frequency not reported: Various infections[Ref]

Respiratory

Very common (10% or more): Bacterial pneumonia (up to 10%)
Common (1% to 10%): Cough
Very rare (less than 0.01%): Asthma, bronchospasm, dyspnea, wheezing
Frequency not reported: Apnea, respiratory depression, pneumonia, rhinitis, epistaxis

Patent Ductus Arteriosus:
Very common (10% or more): Apnea (28%), respiratory infection (19%), respiratory failure (10%), bronchopulmonary dysplasia
Common (1% to 10%): Atelectasis, pulmonary hemorrhage
Uncommon (0.1% to 1%): Hypoxemia
Postmarketing reports: Pulmonary hypertension[Ref]

Hepatic

Very rare (less than 0.01%): Hepatitis, jaundice
Frequency not reported: Hepatorenal syndrome, liver necrosis, liver failure, abnormal liver function tests

Patent Ductus Arteriosus:
Frequency not reported: Cholestasis, jaundice[Ref]

Hypersensitivity

Hypersensitivity reactions have been reported and may consist of any of the following: a syndrome of abdominal pain, fever, chills, nausea, vomiting, and anaphylaxis; respiratory tract reactivity comprising bronchospasm, asthma/aggravated asthma, or dyspnea; skin reactions, which rarely included exfoliative and bullous dermatoses, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, pruritus, and urticaria.[Ref]

Frequency not reported: Anaphylactoid reactions, hypersensitivity reaction[Ref]

Ocular

Very rare (less than 0.01%): Visual disturbances
Frequency not reported: Blurred vision, amblyopia, diminished vision, scotomata, changes in color vision, conjunctivitis, dry eyes, diplopia, optic neuritis, cataracts, optic neuritis, toxic optic neuropathy[Ref]

Musculoskeletal

Frequency not reported: Lupus erythematosus syndrome[Ref]

Psychiatric

Frequency not reported: Anxiety, confusion, depression, dream abnormalities, insomnia, emotional lability, hallucinations[Ref]

Genitourinary

Common (1% to 10%): Urinary retention
Very rare (less than 0.01%): Proteinuria, hematuria
Frequency not reported: Dysuria, oliguria, polyuria, menorrhagia

Patent Ductus Arteriosus:
Very common (10% or more): Oliguria, hematuria
Common (1% to 10%): Urinary tract infection[Ref]

Immunologic

Frequency not reported: Serum sickness[Ref]

Local

Common (1% to 10%): Infusion site pain
Postmarketing reports: Transient sensation of burning in mouth/throat

Patent Ductus Arteriosus:
Frequency not reported: Injection site reactions[Ref]

Endocrine

Frequency not reported: Gynecomastia

Patent Ductus Arteriosus:
Common (1% to 10%): Adrenal insufficiency[Ref]

Some side effects of A-G Profen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Adult Dose for Dysmenorrhea

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:
-Treatment should begin at the earliest onset of pain.

Use: For the relief of signs and symptoms of primary dysmenorrhea

Usual Adult Dose for Rheumatoid Arthritis

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 Fever

IV Ibuprofen (Caldolor[R]):
-Initial dose: 400 mg IV once
-Following initial dose, 100, 200, or 400 mg IV every 4 to 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.

Oral:
Initial dose: 200 mg orally every 4 to 6 hours
-May increase to 400 mg every 4 to 6 hours if additional relief is needed
Maximum dose: 1200 mg/day

Use: For the reduction of fever

Usual Pediatric Dose for Pain

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.

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

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: 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
-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 or 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 mild to moderate pain

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

Oral Suspension (100 mg/5 mL):
6 months or older: 30 to 40 mg/kg/day orally in 3 to 4 divided doses; milder disease may use 20 mg/kg/day
-Maximum dose: 40 mg/kg/day

Comments:
-Doses greater than 40 mg/kg/day may increase risk of serious adverse effects; doses greater than 50 mg/kg/day have not been studied and are not recommended.
-With doses above 30 mg/kg/day or in patients with a history of abnormal liver function tests with previous NSAID therapy, closely monitor for signs/symptoms of early liver dysfunction.
-Therapeutic response may not be achieved for a few days or several weeks; the dosage should be lowered to the lowest effective dose once clinical effect is achieved.

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

Other Comments

Administration advice:
-Oral Tablets and Capsules: Take with food and fluid.
-Oral Suspensions: Shake well before use. Multiple concentrations are available; consult manufacturer product labeling for dosing reference tables. Use with dosing device provided; do not use any other device.
-Ibuprofen Lysine (NeoProfen[R]): For IV use only; must be diluted prior to use.
-IV Ibuprofen (Caldolor[R]): For IV use only; must be diluted prior to use to a concentration of 4 mg/mL or less.
-Administer IV formulations carefully to avoid extravasation.

Storage requirements:
-IV Injection (Caldolor[R]): Diluted solution stable up to 24 hours at ambient temperature (20C to 25C) and room lighting.
-Ibuprofen Lysine (NeoProfen[R]): Protect from light; store vials in carton until contents are used.

Reconstitution/preparation techniques:
-Consult the appropriate manufacturer product information.

IV Compatibility:
-Ibuprofen Lysine (NeoProfen[R]): Compatible with dextrose or saline. Do not administer simultaneously in the same IV line with TPN; if necessary, TPN should be interrupted for 15 minutes prior to and after drug administration; line patency should be maintained using dextrose or saline.
-IV Ibuprofen (Caldolor[R]): Compatible with 0.9% Sodium Chloride Injection (normal saline), 5% Dextrose Injection USP (D5W), or Lactated Ringers Solution.

General:
-Consult manufacturer product labeling for weight/age based dosing charts.
-Prior to initiating treatment, the potential benefits and risks of this drug should be weighed against other treatment options.
-The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
-There is an increased risk of heart attack, heart failure, and stroke when taking nonsteroidal anti-inflammatory drugs (NSAIDs); these events may occur at any time during treatment and risk increases with long term use, a history of cardiovascular (CV) disease or risk factors for CV disease, and higher doses.

Monitoring:
-Neonates: Monitor renal function and urinary output during therapy.
-Cardiovascular: Monitor blood pressure closely during initiation and throughout course of therapy.
-Gastrointestinal: Monitor for signs/symptoms of gastrointestinal bleeding.
-Renal function: Monitor renal status, especially in patients with conditions where renal prostaglandins have a supportive role in the maintenance of renal perfusion.
-Monitor blood counts, renal, and hepatic function periodically for patients receiving long-term therapy.

Patient advice:
-Patients should seek medical advice for signs and symptoms of gastrointestinal events, adverse skin reactions, allergic reactions, hepatotoxicity, or unexplained weight gain or edema.
-Patients should seek medical attention immediately if signs/symptoms of cardiovascular events occur including, shortness of breath, slurred speech, chest pain, or weakness on one side of the body.
-Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; this drug should not be used during pregnancy at 30 weeks gestation or later.
-Patients should contact a healthcare provider if symptoms persist for more than 3 days in pediatric patients and more than 10 days in adult patients.

Ibuprofen Levels and Effects while Breastfeeding

Summary of Use during Lactation

Because of its extremely low levels in breastmilk, short half-life and safe use in infants in doses much higher than those excreted in breastmilk, ibuprofen is a preferred choice as an analgesic or antiinflammatory agent in nursing mothers.

Drug Levels

Maternal Levels. Two early studies attempted measurement of ibuprofen in milk. In one, the patient's dose was 400 mg twice daily, while in the second study of 12 patients, the dose was 400 mg every 6 hours. Ibuprofen was undetectable in breastmilk in both studies (<0.5 and 1 mg/L, respectively).[1][2]

A later study using a more sensitive assay found ibuprofen in the breastmilk of one woman who took 6 doses of 400 mg orally over a 42.5 hours. A milk ibuprofen level of 13 mcg/L was detected 30 minutes after the first dose. The highest level measured was 180 mcg/L about 4 hours after the third dose, 20.5 hours after the first dose. The authors estimated that the infant would receive about 17 mcg/kg daily (100 mcg daily) with the maternal dose of approximately 1.2 grams daily. This dose represents 0.0008% of the maternal weight-adjusted dosage[3] and 0.06% of the commonly accepted infant dose of 30 mg/kg daily (10 mg/kg every 8 hours).

Single milk samples were taken from 13 women between 1.5 and 8 hours after the third dose of ibuprofen in a daily dosage regimen averaging 1012 mg daily (range 400 to 1200 mg daily). Of the 13 milk samples analyzed, the mean milk concentration was 361 mcg/L (range 164 to 590 mcg/L). The mean weight-adjusted percentage of the maternal dosage (relative infant dosage [RID]) was estimated to be <0.38%; however, the RID varied with the time postpartum and the milk protein content. The RID was highest in the colostral phase when the milk protein content was the highest (RID 0.6%). The estimated mean dosage for a fully breastfed infants was 68 mcg/kg daily or 0.2% of a pediatric dosage.[4]

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

Effects in Breastfed Infants

At least 23 cases are reported in the literature in which infants (ages not stated) were breastfed during maternal ibuprofen use with no adverse effects reported.[1][3][5]

Effects on Lactation and Breastmilk

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

Alternate Drugs to Consider

Acetaminophen, Flurbiprofen, Indomethacin, Naproxen, Piroxicam

References

1. Weibert RT, Townsend RJ, Kaiser DG et al. Lack of ibuprofen secretion into human milk. Clin Pharm. 1982;1:457-8. PMID: 7184678

2. Townsend RJ, Benedetti TJ, Erickson SH et al. Excretion of ibuprofen into breast milk. Am J Obstet Gynecol. 1984;149:184-6. PMID: 6720796

3. Walter K, Dilger C. Ibuprofen in human milk. Br J Clin Pharmacol. 1997;44:211-2. PMID: 9278216

4. Rigourd V, de Villepin B, Amirouche A et al. Ibuprofen concentrations in human mature milk-First data about pharmacokinetics study in breast milk with AOR-10127 "Antalait" study. Ther Drug Monit. 2014;36:590-6. PMID: 24695355

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

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