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ADVIL HEADACHE & MIGRAINE EXTRA STRENGTH is a brand name for Ibuprofen, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................6 ADVERSE…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations Do not take longer than 3 days for a fever or 5 days for pain unless directed by a physician. The safety issues to consider when developing a dosage regimen of Advil Headache & Migraine for individual patients are applicable to: Advil Headache & Migraine is not recommended for elderly patients older than 65 years who are frail or debilitated.
(See Warnings and Precautions, Special Populations, Geriatrics).
Recommended Dose and Dosage Adjustment Adults and Children 12 years and over:
Take 1 (every 4 hours) or 2 (every 6-8 hours) tablets or caplets, or 1 extra strength caplet every 6-8 hours as needed. Do not exceed six tablets or caplets or 3 extra strength caplets in 24 hours, unless directed by a physician. Missed Dose Take the missed dose as soon as you remember.
If it is almost time for your next dose, wait until then to take your medicine and skip your missed dose. Do not take twice the recommended dose following a missed dose. Administration See Recommended Dose and Dosage Adjustment. OVERDOSAGE Symptoms of Overdosage The toxicity of overdose is dependent upon the amount of drug ingested and the time elapsed since ingestion; individual responses may vary, thus making it necessary to evaluate each case separately.
Although uncommon, serious toxicity and death have been reported with ibuprofen overdosage. The most frequently reported symptoms of ibuprofen overdose include abdominal pain, nausea, vomiting, lethargy and drowsiness. Other CNS symptoms include headache, tinnitus, CNS depression and seizures.
Metabolic acidosis, coma, acute renal failure and apnoea (primarily in very young pediatric patients) may rarely occur. 35-37 Treatment of Overdosage In cases of acute overdose, the stomach should be emptied through induction of emesis (in alert patients only) or gastric lavage.
Due to the rapid absorption of ibuprofen from the gut, emesis is most effective if initiated within 30 minutes of ingestion. Orally administered activated charcoal may help in reducing the absorption of the drugs when given less than 2 hours following ingestion.
38 Inducing diuresis may be helpful. The Haleon Canada ULC Page 24 of 63 treatment of acute overdose is primarily supportive. Management of hypotension, acidosis and GI bleeding may be necessary. In pediatric patients, the estimated amount of ibuprofen ingested per body weight may be helpful to predict the potential for development of toxicity although each case must be evaluated.
General As with other anti-inflammatory drugs, ibuprofen may mask the usual signs of infection. (ADVIL Headache & Migraine) is NOT recommended for use with other NSAIDs because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions.
) Each 200 mg tablet/caplet contains 22 mg of sodium; and each 400 mg caplet contains 44 mg of sodium. This should be taken into consideration in a sodium restricted diet. Carcinogenesis and Mutagenesis Not applicable. 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 who might be prone to gastrointestinal tract irritation, particularly those with a history of diverticulosis, including those with a history of peptic ulcer or other inflammatory disease of the gastrointestinal tract such as ulcerative colitis and Crohn’s disease (See WARNINGS AND PRECAUTIONS, Gastrointestinal and DRUG INTERACTIONS, Coumarin-type anticoagulants).
Caution in patients at greatest risk of renal toxicity, such as those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and the elderly (See WARNINGS AND PRECAUTIONS, Renal). If persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria and cystitis occur, the drug should be stopped immediately (See WARNINGS AND PRECAUTIONS, Genitourinary).
Risk in Pregnancy: Caution should be exercised in prescribing Advil Headache & Migraine 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).
1,2 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. Patients who are hypersensitive to ibuprofen or to any ingredient in the formulation or component of the container.
For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph. The potential for cross-reactivity between different NSAIDs must be kept in mind. Ibuprofen containing products should not be used in patients with 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.
Fatal anaphylactoid reactions have occurred in such individuals. As well, individuals with the above medical problems are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse effects. Significant hepatic impairment or active liver disease.
Severely impaired or deteriorating renal function (creatinine clearance <30 mL/min). Individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored.
Ibuprofen is not recommended for use with other NSAIDs because of the absence of any evidence demonstrating synergistic benefits and the potential for additive side effects. e. 18 years of age and younger) 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 is contraindicated in patients with systemic lupus erythematosus, as an anaphylaxis-like reaction with fever may occur, particularly when ibuprofen has been administered previously. Known hyperkalemia (see Warnings and Precautions - Renal - Fluid and Electrolyte Balance).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Ingestion of less than 100 mg/kg is unlikely to produce toxicity. Pediatric patients ingesting 100 to 200 mg/kg may be managed with induced emesis and a minimal observation time of at least four hours. Pediatric patients ingesting 200 to 400 mg/kg of ibuprofen should have immediate gastric emptying and at least four hours observation.
Pediatric patients ingesting greater than 400 mg/kg require immediate medical referral, careful observation and appropriate supportive therapy. Induced emesis is not recommended in overdoses greater than 400 mg/kg because of the risk for convulsions and the potential for aspiration of gastric contents.
In adult patients, the dose reportedly ingested does not appear to be predictive of toxicity. The need for referral and follow-up must be judged by the circumstances at the time of the overdose ingestion. Symptomatic adults should be carefully evaluated, observed and supported.
39 He required dialysis for several months, at which point his renal function improved. 42 He was treated with gastric lavage, charcoal, and various supportive measures and recovered within 24 hours. 40 Prostaglandins are naturally occurring fatty acid derivatives that are widely distributed in the tissues.
They are believed to be a common factor in the production of pain, fever, and inflammation. Prostaglandins are believed to sensitize tissues to pain- and inflammation- producing mediators such as histamine, 5-hydroxytryptamine, and kinins.
The enzyme catalysing the committed step in prostaglandin biosynthesis is prostaglandin endoperoxide synthase, also known as cyclooxygenase. There is significant evidence that the main mechanism For management of a suspected drug overdose, contact your regional Poison Control Centre.
41 Other pharmacologic effects such as lysosome and plasma membrane stabilisation have been observed, but the potential relevance of these effects to ibuprofen-induced analgesia and antipyresis is unclear. A recent study has demonstrated that ibuprofen sodium tablets provide a faster onset of analgesia compared to other ibuprofen tablets for relief of dental pain7 Pharmacodynamics At non-prescription dose levels, ≤ 1200 mg daily, the analgesic and […]
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 Page 7 of 63 Cardiovascular Use of ibuprofen may precipitate congestive heart failure in patients with marginal cardiac function, elevated blood pressure and palpitations.
87 Dependence/Tolerance Not applicable. Ear/Nose/Throat Patients with complete or partial syndrome of nasal polyps should not use ADVIL. See Contraindications. Endocrine and Metabolism Patients with thyroid disease should not take this drug.
See Contraindications. Fluid and Electrolyte Balance Fluid retention and oedema have been observed in patients treated with ibuprofen. Therefore, as with many other NSAIDs, the possibility of precipitating congestive heart failure in elderly patients or those with compromised cardiac function should be borne in mind.
Advil Headache & Migraine 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 See Contraindications. Serious gastrointestinal (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 NSAIDs, 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 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. Advil Headache & Migraine should be given under close medical supervision to patients prone to GI tract irritation, particularly those with a history of peptic ulcer, diverticulosis or other Haleon Canada ULC Page 8 of 63 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 GI 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 bleeding and should inform the patients of the importance of this follow-up.
If ulceration is suspected or confirmed, or if GI bleeding occurs, Advil Headache & Migraine should be discontinued immediately, appropriate treatment instituted and the patient monitored closely. No studies, to date, have identified any group of patients not at risk of developing ulceration and bleeding.
The major risk factors are a prior history of serious GI events and increasing age. Possible risk factors include other factors […]
Immediately before or following heart surgery. In patients with thyroid disease. In patients with Raynaud’s Syndrome. Advil should not be used during the third trimester of pregnancy because of risk of premature closure of the ductus arteriosus, and prolonged parturition.
Haleon Canada ULC Page 6 of 63 WARNINGS AND PRECAUTIONS General As with other anti-inflammatory drugs, ibuprofen may mask the usual signs of infection. (ADVIL Headache & Migraine) is NOT recommended for use with other NSAIDs because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions.
) Each 200 mg tablet/caplet contains 22 mg of sodium; and each 400 mg caplet contains 44 mg of sodium. This should be taken into consideration in a sodium restricted diet. Carcinogenesis and Mutagenesis Not applicable. 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 who might be prone to gastrointestinal tract irritation, particularly those with a history of diverticulosis, including those with a history of peptic ulcer or other inflammatory disease of the gastrointestinal tract such as ulcerative colitis and Crohn’s disease (See WARNINGS AND PRECAUTIONS, Gastrointestinal and DRUG INTERACTIONS, Coumarin-type anticoagulants).
Caution in patients at greatest risk of renal toxicity, such as those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and the elderly (See WARNINGS AND PRECAUTIONS, Renal). If persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria and cystitis occur, the drug should be stopped immediately (See WARNINGS AND PRECAUTIONS, Genitourinary).
Risk in Pregnancy: Caution should be exercised in prescribing Advil Headache & Migraine 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 Page 7 of 63 Cardiovascular Use of ibuprofen may precipitate congestive heart failure in patients with marginal cardiac function, elevated blood pressure and palpitations.
87 Dependence/Tolerance Not applicable. Ear/Nose/Throat Patients with complete or partial syndrome of nasal polyps should not use ADVIL. See Contraindications. Endocrine and Metabolism Patients with thyroid disease should not take this drug.
See Contraindications. Fluid and Electrolyte Balance Fluid retention and oedema have been observed in patients treated with ibuprofen. Therefore, as with many other NSAIDs, the possibility of precipitating congestive heart failure in elderly patients or those with compromised cardiac function should be borne in mind.
Advil Headache & Migraine 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 […]