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PENDO-IBUPROFEN ES 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.............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Post-Market Adverse Drug Reactions The most common adverse reactions encountered with non-steroidal anti-inflammatory drugs are gastrointestinal, of which gastric or duodenal ulcer, with or without bleeding, is the most severe. Fatalities have occurred, particularly in the elderly.
Experience reported with prescription use of ibuprofen has included the following adverse reactions.
Note:
Reactions listed below under Causal Relationship Unknown are those where a causal relationship could not be established; however, in these rarely reported events, the possibility of a relationship to ibuprofen also cannot be excluded.
Common ( > 1 % but <10%) Adverse Effect Incidence 3-9% Incidence 1-3% Less Common (<1%) • anaphylaxis (See Contraindications) Allergic Also reported but with unknown causal relationship, rarely: • fever • serum sickness • lupus erythematosus syndrome • congestive heart failure in patients with marginal cardiac function • elevated blood pressure Conditions such as congestive heart failure and hypertension may be aggravated by sodium retention and edema caused by ibuprofen in such patients.
Cardiovascular Also reported but with unknown causal relationship, rare cases of: • arrhythmias (sinus tachycardia, sinus bradycardia, palpitations) • dizziness • headache • nervousness • depression • insomnia Central Nervous System • Also reported but with unknown causal relationship: • paresthesias • hallucinations • dream abnormalities • aseptic meningitis has been reported in patients with systemic lupus erythematosus or other connective tissue disease • aseptic meningitis and meningioencephalitis, in one case accompanied by eosinophilia in the cerebrospinal fluids, has been reported in patients who took 11 Common ( > 1 % but <10%) Adverse Effect Incidence 3-9% Incidence 1-3% Less Common (<1%) ibuprofen intermittently and did not have any connective tissue disease • cognitive dysfunction has been observed in elderly patients who took ibuprofen • rash • (including maculopapular type) • pruritis • vesiculobullous eruptions • urticaria • erythema multiforme Dermatologic • Also reported but with unknown causal relationship: • alopecia • Stevens-Johnson Syndrome Endocrine Also reported but with unknown causal relationship, rare cases of: • gynecomastia • hypoglycemic reaction • menstrual delays of up to two weeks and dysfunctional uterine bleeding occurred in nine patients taking ibuprofen 400 mg three times a day for three days before menses • nausea • epigastric pain • heartburn • diarrhea • abdominal distress • nausea and vomiting • indigestion • constipation • abdominal cramps and pain • gastrointestinal l tract fullness (bloating or flatulence) • gastric or duodenal ulcer with bleeding and/or perforation • gastrointestinal hemorrhage • melena • hepatitis • jaundice • abnormal liver function (SGOT, serum bilirubin and alkaline phosphatase) Gastrointestinal The generally modest elevations of serum transaminase activity that has been observed are usually without clinical sequelae but severe, potentially fatal toxic hepatitis can occur.
The following are contraindications to the use of Ibuprofen: • Patients who are hypersensitive to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or to any ingredient in the formulation. For a complete listing of ingredients, 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 should not be used in patients with the complete or partial syndrome of acetylsalicylic acid (ASA) intolerance (rhinosinusitis, urticaria/angioedema, nasal polyps, asthma) in whom asthma, anaphylaxis, urticaria/angioedema, rhinitis or other allergic manifestations are precipitated by ASA or other non-steroidal 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. • Active gastric or duodenal ulcer, a history of recurrent ulceration, gastrointestinal bleeding, or active inflammatory disease of the gastrointestinal system.
• Significant hepatic impairment or active liver disease. • Severely impaired or deteriorating renal function (creatinine clearance <30 ml/min). • Ibuprofen should not be used in the presence of known hyperkalemia (also see Warnings and Precautions – Renal section).
• Children with kidney disease and/or who have suffered significant fluid loss. • 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 should not be used during pregnancy. WARNINGS AND PRECAUTIONS • Patients with heart disease and high blood pressure should not take this drug unless directed by a physician • Caution in patients with heart failure, hypertension or other conditions predisposing to fluid retention.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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g. prupura, epistaxis, hematuria, menorrhagia) • auto-immune hematological anemia occurred in one patient taking 400 mg of ibuprofen three times a day for ten days • fatal aplastic anemia was reported in one patient who took 600 mg per day for eight months • decreased appetite • edema • fluid retention.
Metabolic Fluid retention generally responds promptly to drug discontinuation. Renal Also reported but with unknown causal relationship: • decreased creatinine clearance 12 Common ( > 1 % but <10%) Adverse Effect Incidence 3-9% Incidence 1-3% Less Common (<1%) • polyuria • azotemia Like other non-steroidal anti-inflammatory agents, ibuprofen inhibits renal prostaglandin synthesis that may decrease renal function and cause sodium retention.
Renal blood flow glomerular filtration rate decreased in patients with mild impairment of renal functions 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) • tinnitus • 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 Special Senses Also reported but with unknown causal relationship: • • conjunctivitis • • diplopia • • optic neuritis DRUG INTERACTIONS Serious Drug Interactions • Use with acetylsalicylic acid (ASA) or other NSAIDs, including ibuprofen, may result in possible additive adverse side effects.
• Use with acetaminophen, may increase the risk of adverse renal effect. , bleeding). • Use with hypoglycemic agents (oral agents and insulin) may increase the risk of hypoglycaemia. • Use with antihypertensives may interference with circulatory control.
• Use with diuretics may reduce the diuretic effect. • Use with methotrexate may increase the risk of methotrexate toxicity. • Use with lithium may increase the risk of lithium toxicity. Acetylsalicylic acid (ASA) or other NSAIDs The use of ibuprofen in addition to any other NSAID is not recommended because of the absence of any evidence demonstrating synergistic benefits and the potential for additive side effects.
13 Animal studies show that ASA given with NSAID agents, including ibuprofen, yield a net decrease in anti-inflammatory activity with lowered blood levels of the non-ASA drug. Single dose bioavailability studies in normal volunteers have failed to show an effect of ASA on ibuprofen blood levels.
Correlative clinical studies have not been done. Also, some NSAIDs may interfere with the anti-platelet […]
• Caution in patients prone to gastrointestinal tract irritation, particularly those with a 5 history of peptic ulcer, diverticulosis or other inflammatory disease of the gastrointestinal tract such as ulcerative colitis and Crohn’s disease.
• The elderly and patients with impaired renal function, heart failure, liver dysfunction, and those taking diuretics are at increased risk of renal toxicity. • If persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria and cystitis occur, the drug should be stopped immediately.
• Ibuprofen use during nursing should be avoided General Several medical conditions that can predispose patients to the adverse effects of non-steroidal anti-inflammatory drugs in general may be applicable to ibuprofen. Patients with any serious medical condition should consult a physician before using ibuprofen as an analgesic or antipyretic (1).
In common with other anti-inflammatory drugs, ibuprofen may suppress fever. Cardiovascular Some patients with pre-existing hypertension may develop worsening of blood pressure control when placed on an NSAID and regular monitoring of blood pressure should be performed under such circumstances.
NSAIDs may exacerbate congestive heart failure. Patients who are taking low-dose ASA as cardio protective therapy should consult with a health professional prior to taking ibuprofen (see also Drug Interactions - Acetylsalicylic Acid).
Gastrointestinal Serious GI toxicity, such as ulceration, perforation, obstruction and gastrointestinal bleeding, sometimes severe and occasionally fatal, can occur at any time, with or without symptoms in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) including ibuprofen.
GI symptoms, such as dyspepsia, are common, usually developing early in therapy. Health providers 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 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.
The incidence of these complications is related to dose, past history of known ulcer disease, and advanced age (see Special Populations). Studies have shown that the use of oral corticosteroids increases the risk of upper gastrointestinal complications associated with NSAIDs (2, 3, 4, 5 and 6) Ibuprofen should be given under close medical supervision to patients with a history of ulcer of the upper gastrointestinal tract or inflammatory disease of the gastrointestinal tract such as 6 ulcerative colitis and Crohn's disease.
In these cases the health provider must weigh the benefits of treatment against the possible hazards. Health providers should inform patients about the signs and symptoms of serious GI toxicity and instruct them to contact a health provider 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, health providers should follow chronically treated patients and watch 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 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 Helicobacter pylori infection, excess alcohol intake, smoking, and concomitant oral steroids, anti-coagulants, anti-platelet agents (including ASA), or selective serotonin reuptake […]