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ADVIL PEDIATRIC is a brand name for Ibuprofen, supplied as a drops. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................4 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
General In common with other anti-inflammatory drugs, ibuprofen may mask the usual signs of infection. Carcinogenesis and Mutagenesis Not applicable Cardiovascular Use of ibuprofen may precipitate congestive heart failure in patients with marginal cardiac function, elevated blood pressure and palpitations.
Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg or more daily) and in long-term treatment may be associated with a small increased Serious Warnings and Precautions Use with caution in patients with heart failure, hypertension or other conditions predisposing to fluid retention (See WARNINGS AND PRECAUTIONS, Cardiovascular and Fluid and Electrolyte Balance; and DRUG INTERACTIONS, Antihypertensives).
Caution in patients prone to gastrointestinal tract irritation, including those with a history of peptic ulcer (See WARNINGS AND PRECAUTIONS, Gastrointestinal and DRUG INTERACTIONS, Coumarin-type anticoagulants). Patients at greatest risk of renal toxicity are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and the elderly (See WARNINGS AND PRECAUTIONS, Renal).
If urinary symptoms, hematuria and cystitis occur, the drug should be stopped immediately (See WARNINGS AND PRECAUTIONS, Genitourinary). Risk in Pregnancy: Caution should be exercised in prescribing Children’s Advil, Children’s Advil Fever from Colds or Flu, Children’s Advil Chewable Tablets, Junior Strength Advil or Junior Strength Advil Fever from Colds or Flu during the first and second trimesters of pregnancy or breastfeeding.
Use of NSAIDS at approximately 20 weeks of gestation or later may cause oligohydramnios, and renal dysfunction including renal failure (See Oligohydramnios/Neonatal Renal Impairment, Pregnant Women and Breast-feeding). Ibuprofen is contraindicated for use during the third trimester because of risk of premature closure of the ductus arteriosus and uterine inertia (prolonged parturition) (see CONTRAINDICATIONS).
> Haleon Canada ULC. , myocardial infarction or stroke). 116,117 Long term continuous use may increase the risk of heart attack or stroke. Dependence/Tolerance Not applicable. Ear/Nose/Throat Patients with complete or partial syndrome of nasal polyps should not use Children’s Advil, Children’s Advil Fever from Colds or Flu, Children’s Advil Chewable Tablets, Junior Strength Advil, Junior Strength Advil Fever from Colds or Flu, Advil Pediatric Drops or Advil Pediatric Drops Fever from Colds or Flu (See Contraindications).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ibuprofen in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Endocrine and Metabolism Not applicable. Fluid and Electrolyte Balance Fluid retention and oedema have been observed in patients treated with ibuprofen. Therefore, as with many other nonsteroidal anti-inflammatory drugs, the possibility of precipitating congestive heart failure in elderly patients or those with compromised cardiac function should be borne in mind.
Children’s Advil, Children’s Advil Fever from Colds or Flu, Children’s Advil Chewable Tablets, Junior Strength Advil, Junior Strength Advil Fever from Colds or Flu, Advil Pediatric Drops or Advil Pediatric Drops Fever from Colds or Flu should be used with caution in patients with heart failure, hypertension or other conditions predisposing to fluid retention.
With nonsteroidal anti-inflammatory treatment there is a potential risk of hyperkalemia, particularly in patients with conditions such as diabetes mellitus or renal failure; elderly patients; or in patients receiving concomitant therapy with B-adrenergic blockers, angiotensin converting enzyme inhibitors or some diuretics.
Serum electrolytes should be monitored periodically during long-term therapy, especially in those patients who are at risk. Gastrointestinal Serious GI toxicity, such as peptic ulceration, perforation and gastrointestinal bleeding, sometimes severe and occasionally fatal, can occur at any time, with or without symptoms in patients treated with NSAIDs including ibuprofen.
Minor upper GI problems, such as dyspepsia, are common, usually developing early in therapy. Physicians should remain alert for ulceration and bleeding in patients treated with non-steroidal anti-inflammatory drugs, even in the absence of previous GI tract symptoms.
In patients observed in clinical trials of such agents, symptomatic upper GI ulcers, gross bleeding, or perforation appear to occur in approximately 1% of patients treated for 3-6 months Haleon Canada ULC Page 8 of 62 and in about 2-4% of patients treated for one year.
The risk continues beyond one year and possibly increases. The incidence of these complications increases with increasing dose. Children’s Advil, Children’s Advil Fever from Colds or Flu, Children’s Advil Chewable Tablets, Junior Strength Advil, Junior Strength Advil Fever from Colds or Flu, Advil Pediatric Drops or Advil Pediatric Drops Fever from Colds or Flu should be given under close medical supervision to patients prone to gastrointestinal tract irritation, particularly those with a history of peptic ulcer, diverticulosis or other inflammatory disease of the gastrointestinal tract such as ulcerative colitis and Crohn's disease.
In these cases the physician must weigh the benefits of treatment against the possible hazards. Physicians should inform patients about the signs and/or symptoms of serious GI toxicity and instruct them to contact a physician immediately if they experience persistent dyspepsia or other symptoms or signs suggestive of gastrointestinal ulceration or bleeding.
Because serious GI tract ulceration and bleeding can occur without warning symptoms, physicians should follow chronically treated patients by checking their haemoglobin periodically and by being vigilant for the signs and symptoms of ulceration and […]