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IBUPROFEN is a brand name for Ibuprofen, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE.....................................................................................3 CONTRAINDICATIONS .........................................................................................................4 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Post-Market Adverse Drug Reactions (Prescription Experience) The following adverse reactions have been noted in patients treated with prescription doses (≥1200 mg/day).
Note:
Reactions listed below under Causal Relationship Unknown are those which occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, the possibility of a relationship to ibuprofen cannot be excluded.
Gastrointestinal The adverse reactions most frequently seen with prescribed ibuprofen therapy involve the gastrointestinal system. Incidence 3 to 9%: nausea, epigastric pain, heartburn Incidence 1 to 3%: diarrhoea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of the gastrointestinal tract (bloating or flatulence).
Incidence less than 1%: gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal haemorrhage, melena, hepatitis, jaundice, abnormal liver function (SGOT, serum bilirubin and alkaline phosphatase). Allergic Incidence less than 1%: anaphylaxis (see CONTRAINDICATIONS).
Causal relationship unknown: fever, serum sickness, lupus erythematosus. Central Nervous System Incidence 3 to 9%: dizziness Incidence 1 to 3%: headache, nervousness Incidence less than 1%: depression, insomnia Causal relationship unknown: paresthesias, hallucinations, dream abnormalities Aseptic meningitis and meningoencephalitis, in one case accompanied by eosinophilia in the cerebrospinal fluid, have been reported in patients who took ibuprofen intermittently and did not have any connective tissue disease.
Dermatologic Incidence 3 to 9%: rash (including maculopapular type). Incidence 1 to 3%: pruritus Incidence less than 1%: vesiculobullous eruptions, urticaria, erythema multiforme Causal relationship unknown: alopecia, Stevens-Johnson syndrome.
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 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 Ibuprofen products 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 Breastfeeding). • 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).
General In common with other anti-inflammatory drugs, ibuprofen may mask the usual signs of infection. IBUPROFEN CAPSULES, 200 mg 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.
(See Drug Interactions, Drug/Drug Interactions, Acetylsalicylic acid (ASA) or other NSAIDs) 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.
• Active peptic ulcer, a history of recurrent ulceration or active inflammatory disease of the gastrointestinal system. • Known or suspected hypersensitivity to the drug or other non -steroidal anti-inflammatory drugs. Patients who are hypersensitive to this drug 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 CAPSULES, 200 mg 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.
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. • 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 because of risk of premature closure of the ductus arteriosus, and prolonged parturition. • 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Cardiovascular Incidence less than 1%: congestive heart failure in patients with marginal cardiac function , elevated IBUPROFEN CAPSULE,200 mg Product Monograph Page 13 of 37 blood pressure. Causal relationship unknown: arrhythmias (sinus tachycardia, sinus bradycardia, palpitations) .
Special Senses Incidence 1 to 3%: tinnitus Incidence less than 1%: amblyopia (blurred and/or diminished vision, scotomata and/or changes in colour vision). Any patient with eye complaints during ibuprofen therapy should have an ophthalmological examination.
Causal relationship unknown: conjunctivitis, diplopia, optic neuritis. Hematologic Incidence less than 1%: leukopenia, and decreases in haemoglobin and hematocrit. , purpura, epistaxis, hematuria, menorrhagia). Renal Causal relationship unknown: decreased creatinine clearance, polyuria, azotemia.
Like other non-steroidal anti-inflammatory drugs, ibuprofen inhibits renal prostaglandin synthesis, which may decrease renal function and cause sodium retention. Renal blood flow and glomerular filtration rate decreased in patients with mild impairment of renal function who took 1200 mg/day of ibuprofen for one week.
Renal papillary necrosis has been reported. A number of factors appear to increase the risk of renal toxicity (See WARNINGS AND PRECAUTIONS). Hepatic Incidence less than 1%: hepatitis, jaundice, abnormal liver function (SGOT, serum bilirubin, and alkaline phosphatase).
Endocrine Causal relationship unknown: gynecomastia, hypoglycaemic reaction. , for three days before menses. Metabolic Incidence 1 to 3%: decreased appetite, oedema, fluid retention. Fluid retention generally responds promptly to drug discontinuation (See WARNINGS AND PRECAUTIONS).
87 Of a total of 96 randomized and blinded trials, there were 10 trials of seven days' duration or less where the safety of both drugs was directly compared. In three of these trials, the incidence of adverse events was higher with acetaminophen; there were no reported adverse events in six trials; and one trial reported a higher incidence with ibuprofen.
In this subset of 10 studies, it was reported that gastrointestinal adverse events were found to be the most common type of event reported and were predominantly dyspepsia, nausea, or vomiting. None of the GI events appeared to warrant follow-up from which the author inferred there were no serious gastrointestinal events.
88 Gastrointestinal adverse experiences were similar in the placebo and ibuprofen groups (67 out of […]
Long term continuous use may increase the risk of heart attack or stroke. 130 Dependence/Tolerance Not applicable. Ear/Nose/Throat Patients with complete or partial syndrome of nasal polyps should not use IBUPROFEN CAPSULES, 200 mg (See CONTRAINDICATIONS).
IBUPROFEN CAPSULE,200 mg Product Monograph Page 6 of 37 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.
IBUPROFEN CAPSULES, 200 mg 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 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. IBUPROFEN CAPSULES, 200 mg 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 bleeding and should inform the patients of the importance of this follow-up.
If ulceration is suspected or confirmed, or if GI bleeding occurs, IBUPROFEN CAPSULES, 200 mg should be discontinued immediately, appropriate treatment instituted and the patient monitored closely. IBUPROFEN CAPSULE,200 mg Product Monograph Page 7 of 37 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 such as Helicobacter pylori infection, excess alcohol intake, smoking, female gender and concomitant oral steroid and anticoagulant, anti-coagulants, anti-platelet agents (including ASA) or selective serotonin reuptake inhibitors (SSRI’s) have been associated with increased risk.
Studies to date show that all NSAIDs can cause GI tract adverse events. Although […]
• Known hyperkalemia (see Warning and Precautions – Renal – Fluid and Electrolyte Balance) • Children and adolescents (see Indications) IBUPROFEN CAPSULE,200 mg Product Monograph Page 5 of 37 WARNINGS AND PRECAUTIONS 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 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 Ibuprofen products 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 Breastfeeding). • 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).
General In common with other anti-inflammatory drugs, ibuprofen may mask the usual signs of infection. IBUPROFEN CAPSULES, 200 mg 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.
(See Drug Interactions, Drug/Drug Interactions, Acetylsalicylic acid (ASA) or other NSAIDs) 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.
Long term continuous use may increase the risk of heart attack or stroke. 130 Dependence/Tolerance Not applicable. Ear/Nose/Throat Patients with complete or partial syndrome of nasal polyps should not use IBUPROFEN CAPSULES, 200 mg (See CONTRAINDICATIONS).
IBUPROFEN CAPSULE,200 mg Product Monograph Page 6 of 37 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.
IBUPROFEN CAPSULES, 200 mg 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 […]