Trust Advil Pediatric Drops to act fast and last long in relieving pediatric fever and pain1

Advil Pediatric Drops

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

Ibuprofen molecule

Advil Pediatric Drops contains ibuprofen – a nonsteroidal anti-inflammatory drug (NSAID)

Ibuprofen is the active ingredient in Advil Pediatric Drops that relieves pain and reduces fever. Like all NSAIDs, ibuprofen is an analgesic, antipyretic, and anti-inflammatory.1

Clinical study statement on tolerability

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.

Acute GI Bleeding Icon

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

Anaphylaxis icon

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.

Renal Safety Profile in Children

[Icons of Kidney with copy as stated beside]

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.

Clinically Proven Efficacy

[Max with teddy bear]

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.

What can Advil do for Max?

[Max with teddy bear]

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

Advil Pediatric Drops

Advil Pediatric Drops

Advil Pediatric Drops act fast and last long to relieve fever and pain1

Advil Pediatric Drops and Advil Pediatric Drops Fever from Colds or Flu1

  • Ingredients

    Active ingredients: Ibuprofen 40 mg/mL Oral Suspension, USP

    Non-medicinal ingredients:

    Dye-Free Grape Flavour: Citric acid, disodium EDTA, flavour, glycerin, microcrystalline cellulose, polysorbate 80, sodium benzoate, sodium carboxymethylcellulose, sorbitol, sucrose, water, xanthan gum.

    Fruit Flavour: Citric acid, disodium EDTA, FD&C Red No.40, flavour, glycerin, microcrystalline cellulose, polysorbate 80, sodium benzoate, sodium carboxymethylcellulose, sorbitol, sucrose, water, xanthan gum.

    Grape Flavour: Citric acid, disodium EDTA, FD&C Blue No. 1, FD&C Red No.40, flavour, glycerin, microcrystalline cellulose, polysorbate 80, sodium benzoate, sodium carboxymethylcellulose, sorbitol, sucrose, water, xanthan gum.

  • Indications and Directions

    Indications: Fever and pain due to colds, sore throat, immunization, and earache.

    Dosage and method of use: Children 4 months to 3 years of age:

    Age Weight Dosage
    (kg) (lbs.)
    0–3 months 2.5–5.4 5.5–11.9 5 mg/kg To be calculated 
    4–11 months 5.5– 7.9 12–17.5 5 mg/kg 1.0 mL
    12–23 months 8.0–10.8 18–23 5 mg/kg 1.4 mL
    2–3 years 10.9–15.9 24–35 10 mg/kg 3.0 mL

    This chart outlines dose selection by using either a child’s age or weight. If possible, it is preferable to dose more accurately using a child’s weight; otherwise use age.

    Shake well before use. Use only with enclosed oral syringe. Doses above may be repeated every 6–8 hours while symptoms persist, up to 3 doses a day, or as directed by a physician. Do not use more than the recommended amount.

  • Warnings & Precautions

    Serious Warnings and Precautions:Use with caution in patients with heart failure, hypertension or other conditions predisposing to fluid retention.

    Use with caution in patients prone to gastrointestinal tract irritation, including those with a history of peptic ulcer.

    Patients at greatest risk of renal toxicity are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and the elderly. If urinary symptoms, hematuria and cystitis occur, the drug should be stopped immediately.Ibuprofen use during pregnancy/nursing should be avoided.

  • Contraindications

    Active peptic ulcer, a history of recurrent ulceration or active inflammatory disease of the gastrointestinal system.

    Known or suspected hypersensitivity to ibuprofen or other non-steroidal anti-inflammatory drugs or any ingredient in the formulation.

    Should not be used in patients with the complete or partial syndrome of nasal polyps, or in whom asthma, anaphylaxis, urticarial/angioedema, rhinitis or other allergic manifestations are precipitated by ASA or other nonsteroidal anti-inflammatory agents.

    Significant hepatic impairment or active liver disease.

    Severely impaired or deteriorating renal function (creatinine clearance <30 mL/min). Children with kidney disease and children who have suffered significant fluid loss due to vomiting, diarrhea or lack of fluid intake, should not be given ibuprofen.

    Ibuprofen should not be used during the third trimester of pregnancy.

    Ibuprofen should not be used right before or after heart surgery.

    Ibuprofen is contraindicated in patients with systemic lupus erythematosus, as an anaphylaxis-like reaction with fever may occur, particularly when ibuprofen has been administered previously.

    Ibuprofen is not recommended for use with other NSAIDs.

    Ibuprofen should not be used in the presence of known hyperkalemia.

  • Adverse events

    See Product Monograph for complete details.If patient experiences any of the following, they should discontinue use and contact a doctor: abdominal pain, heartburn, nausea or vomiting, bloating, diarrhea or constipation, ringing or buzzing in the ears, nervousness, sleeplessness, dizziness or any change in vision, itching, fluid retention, shortness of breath, wheezing, any trouble breathing or chest tightness, hives, swelling or itching, skin rashes, skin reddening, blisters, blood in vomit, bloody or black stools, jaundice (yellowing of the eyes or skin due to liver problem). Side effects may be minimized by using the smallest dose for the shortest duration of time.

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