Trust Advil Pediatric Drops to act fast and last long in relieving pediatric fever and pain1
Advil Pediatric Drops act fast and last long to relieve fever and pain1
With clinically proven safety and efficacy when used as directed, fast acting Advil Pediatric Drops are available in an oral suspension containing 40 mg/mL ibuprofen. The drops are designed for infants and toddlers to help manage fever and pain due to colds, sore throat, immunization and earache.1
Formulated for infants and toddlers 4 months to 3 years old. Available in 2 flavours including fruit and grape (with a dye-free option) to suit your patients’ preference and needs.1
Ibuprofen is the non-steroidal anti-inflammatory ingredient in Advil Pediatric Drop products.1
Overall & GI Tolerability Profile in Children
Ibuprofen has a similar safety profile to acetaminophen in children
Ibuprofen has been studied widely in children with over 100,000 enrolled in clinical trials.1-3 The clinically studied safety profile in children was comparable to acetaminophen. Ibuprofen is well tolerated in children at doses of 20–30 mg/kg/day and higher as demonstrated in the Boston University Fever Study. Ideally dosing should be based on weight (see Advil Pediatric Drops product details for dosing chart). Studies conducted to date have not demonstrated pediatric-specific problems that would limit the usefulness of ibuprofen in children 4 months and older.1 The safety findings of the Boston University Fever Study (BUFS) are concordant with those of the Children’s Analgesic Medicine Project (CAMP)**:1
Children’s Analgesic Medicine Project (CAMP), 1999 (Ashraf et al.)2**
- Within both age groups, <2 years and ≥2 to <12 years, the incidence rates for specific adverse effects (AE) for ibuprofen and acetaminophen, including abdominal pain, insomnia, and hyperkinesia were rare and generally <1%.
- The absence of serious adverse events and rare, non-serious events in children including those <2 and those ≥2 years of age confirms the safety of ibuprofen
Boston University Fever Study (BUFS), 2003 (Lesko et al.)3**
- Among ibuprofen-treated children (n=55,785), the observed risk of gastrointestinal bleeding, 7.2 per 100,000 (95% confidence interval, 2 to 18 per 100,000), was not significantly different (8.2 per 100,000, p=0.31) from the risk among acetaminophen-treated children (n=28,130), 0 per 100,000 (95% confidence interval, 0 to 11 per 100,000).
- There were no hospitalizations for acute renal failure or anaphylaxis; the upper 95% confidence bound for the risk of either of these outcomes was 5.4 per 100,000 ibuprofen-treated children.
GI = gastrointestinal
** Ashraf et al., 1999 conducted a multicentre, all-comers, open-label, nonrandomized, multiple dose, actual use prospective study comparing the safety of ibuprofen suspension with acetaminophen suspension in children with fever and/or pain. A total of 424 pediatricians enrolled children at 69 US clinics; 14,281 were <2 years of age and 15,863 were 2 to <12 years of age. Children aged 1 month to 18 years were studied.
Lesko et al., 2003 conducted a randomized, double-blind study that assessed the risk of rare but serious adverse events after the use of ibuprofen suspension in febrile children between 6 months and 12 years of age. The study evaluated a total of 83,915 children enrolled by 1735 pediatricians, family physicians, and general practitioners in the United States. Children were randomly assigned to receive ibuprofen suspension 5 mg/kg (N=27,948), ibuprofen suspension 10 mg/kg (N=27,837), or acetaminophen suspension 12 mg/kg (N=28,130). Medications were given every 4 to 6 hours, as needed, for a total of up to five doses per day. The study recorded hospitalizations for acute GI bleeding, acute renal failure, and anaphylaxis and monitored for the occurrence of Reye’s syndrome. Four weeks after enrolment, parents were contacted to ascertain the occurrence of serious adverse medical events.
GI bleeding profile in Children
No significant difference in hospitalizations for gastrointestinal (GI) bleeding between ibuprofen and acetaminophen was observed:1
Pediatrics, 1999 (Lesko et al.)4*
- The risk of hospitalization with acute gastrointestinal bleeding among all Children <2 years old, regardless of antipyretic assignment, was 11 per 100,000 (95% CI, 2.2–32 per 100,000). Among children randomized to ibuprofen, the risk was 17 per 100,000 (95% CI, 3.5–49 per 100,000).
- This risk did not vary significantly by ibuprofen dose, nor was it significantly greater than the corresponding risk among children randomized to receive acetaminophen (0 per 9127; 95% CI, 0–33 per 100 000; P 5.6).
* A practitioner-based, randomized clinical trial. A total of 27,065 febrile children were randomized to receive acetaminophen (12 mg/kg), ibuprofen (5 mg/kg), or ibuprofen (10 mg/kg). Rates of hospitalization for acute gastrointestinal bleeding, acute renal failure, anaphylaxis, Reye’s syndrome, asthma, bronchiolitis, and vomiting/gastritis were compared by randomization group. The risk of hospitalization with any diagnosis in the 4 weeks after enrolment was 1.4% (95% confidence interval, 1.3%–1.6%) and did not vary by antipyretic assignment. These data do not provide any information on the safety of these medications when used for prolonged periods or when used together, regardless of duration.
Anaphylaxis profile
Observed risk for anaphylaxis in children treated with ibuprofen:
Boston University Fever Study (BUFS), 2003 (Lesko et al.)3**
- Observed risk of anaphylaxis for each among 55,785 children was 0 per 100,000 (95% CI, 0–5.4 per 100,000)
Children’s Analgesic Medicine Project (CAMP), 1999 (Ashraf et al.)2**
- Amongst the study participants: 14,281 children <2 years old or 15,863 children ≥2 or <12; there were no reported cases of anaphylaxis in the ibuprofen or acetaminophen treatment groups
** Lesko et al., 1995 conducted a randomized, double-blind study that assessed the risk of rare but serious adverse events after the use of ibuprofen suspension in febrile children between 6 months and 12 years of age. The study evaluated a total of 83,915 children enrolled by 1735 pediatricians, family physicians, and general practitioners in the United States. Children were randomly assigned to receive ibuprofen suspension 5 mg/kg (N=27,948), ibuprofen suspension 10 mg/kg (N=27,837), or acetaminophen suspension 12 mg/kg (N=28,130). Medications were given every 4 to 6 hours, as needed, for a total of up to five doses per day. The study recorded hospitalizations for acute GI bleeding, acute renal failure, and anaphylaxis and monitored for the occurrence of Reye’s syndrome. Four weeks after enrolment, parents were contacted to ascertain the occurrence of serious adverse medical events.
Ashraf et al., 1999 conducted a multicentre, all-comers, open-label, nonrandomized, multiple dose, actual use prospective study comparing the safety of ibuprofen suspension with acetaminophen suspension in children with fever and/or pain. A total of 424 pediatricians enrolled children at 69 US clinics; 14,281 were <2 years of age and 15,863 were 2 to <12 years of age. Children aged 1 month to 18 years were studied.
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Renal Safety Profile in Children
There was no observable risk of acute renal failure in children treated with ibuprofen:
Boston University Fever Study (BUFS), 2003 (Lesko et al.)3**
- Observed risk of acute renal failure for each among 55,785 children was 0 per 100,000 (95% CI, 0–5.4 per 100,000)
- Renal impairment in adult ibuprofen users occurs primarily among patients with preexisting renal disease or other conditions associated with low intravascular volume or low cardiac output.
- It is unclear how this data applies to children and is often not comparable due to the absence of many factors (i.e., tobacco, alcohol, diuretic use, chronic renal failure, and congestive heart failure).
Children’s Analgesic Medicine Project (CAMP), 1999 (Ashraf et al.)2**
- Amongst the study participants: 14,281 children <2 years old or 15,863 children ≥2 or <12; there were no reported cases of acute renal failure in the ibuprofen or acetaminophen treatment groups
** Lesko et al., 2003 conducted a randomized, double-blind study that assessed the risk of rare but serious adverse events after the use of ibuprofen suspension in febrile children between 6 months and 12 years of age. The study evaluated a total of 83,915 children enrolled by 1735 pediatricians, family physicians, and general practitioners in the United States. Children were randomly assigned to receive ibuprofen suspension 5 mg/kg (N=27,948), ibuprofen suspension 10 mg/kg (N=27,837), or acetaminophen suspension 12 mg/kg (N=28,130). Medications were given every 4 to 6 hours, as needed, for a total of up to five doses per day. The study recorded hospitalizations for acute GI bleeding, acute renal failure, and anaphylaxis and monitored for the occurrence of Reye’s syndrome. Four weeks after enrolment, parents were contacted to ascertain the occurrence of serious adverse medical events.
Ashraf et al., 1999 conducted a multicentre, all-comers, open-label, nonrandomized, multiple dose, actual use prospective study comparing the safety of ibuprofen suspension with acetaminophen suspension in children with fever and/or pain. A total of 424 pediatricians enrolled children at 69 US clinics; 14,281 were <2 years of age and 15,863 were 2 to <12 years of age. Children aged 1 month to 18 years were studied.
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Clinically proven efficacy for acute pain and fever in children1
Multiple studies using a dose range from 5–10 mg/kg of ibuprofen has been shown to lower fever in children, including fever due to colds and flu.1 Many studies have been conducted evaluating the efficacy of ibuprofen in managing mild to moderate pain arising from:1
- Sore throat pain
- Otitis media
- Immunization
- Post surgery
Pediatric ibuprofen provides up to 8 hours of fever relief, which results in less frequent dosing vs. acetaminophen (every 4–6 hours).1,5
Pediatric ibuprofen can be taken for fever for not more than 3 days or for pain, not more than 5 days, unless directed by a physician.
First time mother wants safe, fast, and effective relief for her son’s fever.
Max is an 8 month old active baby. His mother has observed that he is experiencing a fever and fatigue over the past day or two. His mother is concerned about what she can give him that is safe, effective and convenient so Max can get the rest he needs to feel better.*
Main symptoms: fever and fatigue
Advil Pediatric Drops and Advil Pediatric Drops Fever from Colds or Flu act fast to relieve fever and pain in children 4 months of age to 3 years old, including if these symptoms are due to colds, sore throat, immunization or earache1
* Fictional case study.
Recommend Children’s Advil to manage your pediatric patients’ acute pain and fever
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Advil Pediatric Drops
Advil Pediatric Drops act fast and last long to relieve fever and pain1
Children’s Advil — helping parents relieve children’s fever and pain
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Children’s Advil Oral Suspension Products
Access information about the Children’s Advil Oral Suspension product family
Advil — for all your patients’ acute pain relief needs
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