IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

 Active peptic ulcer, a history of recurrent ulceration or active inflammatory disease of the gastrointestinal system, such as ulcerative colitis and Crohn’s disease.  Known or suspected hypersensitivity to ibuprofen or other non-steroidal anti- inflammatory (NSAID) drugs.

Patients who are hypersensitive to this drug or any ingredient in the formulation or component of the container. For a complete listing, see Dosage Forms, Composition and Packaging section of the product monograph. The potential for cross-reactivity between different NSAIDs must be kept in mind.

 Ibuprofen and Pseudoephedrine Hydrochloride Capsules should not be used in patients with the complete or partial syndrome of nasal polyps, or in whom angioedema syndrome, asthma, anaphylaxis, bronchospastic reaction, urticaria, rhinitis or other allergic manifestations are precipitated by acetylsalicylic acid (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 (See Drug Interactions). 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 and Pseudoephedrine Hydrochloride Capsules should not be used by patients who have known or suspected hypersensitivity to pseudoephedrine or other sympathomimetic amines, are taking or have taken monoamine oxidase inhibitor (MAOI) drugs within the last 14 days, have been diagnosed with severe hypertension, or have severe coronary artery disease [62] (See Drug Interactions).

 Ibuprofen should not be used during pregnancy or by nursing mothers.  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) Page 5 of 52  Immediately before or following heart surgery.  In patients with thyroid disease.  In patients with Raynaud’s Syndrome. WARNINGS AND PRECAUTIONS Serious Warnings and Precautions  Patients with glaucoma or difficulty in urination due to enlargement of the prostate gland should not take this drug unless directed by a physician [63] (See WARNINGS AND PRECAUTIONS, General).

 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, 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). > General As with other anti-inflammatory drugs, ibuprofen may mask the usual signs of infection.

If nervousness, dizziness, or sleeplessness occurs, use of Ibuprofen and Pseudoephedrine Hydrochloride Capsules should be discontinued and a physician should be consulted. Ibuprofen and Pseudoephedrine Hydrochloride Capsules should not be used for more than 3 days for fever or 5 days for cold symptoms/pain.

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. Ibuprofen and Pseudoephedrine Hydrochloride Capsules should be used with caution in Page 6 of 52 hypertensive patients because of the possible pressor effect of pseudoephedrine.

Pseudoephedrine has been shown to increase blood pressure in normotensive adults and in patients with hypertension. Pseudoephedrine treatment may increase heart rate and can cause arrhythmia. Asymptomatic, multifocal premature ventricular contractions (PVCs) were reported with the use of Actifed® (a combination of pseudoephedrine with an antihistamine, triprolidine), two tablets every 4 hours around the clock, for several days to treat nasal congestion [66].

The PVCs disappeared within a few days after discontinuation of the medication. Dependence/Tolerance Pseudoephedrine has the potential to cause drug dependency and withdrawal effects. Reportedly, a woman with a history of depression experienced a stimulatory effect from the use of 50 to 300 mL of Actifed® (pseudoephedrine and triprolidine) daily (the recommended dose is 30 mL per day) [74].

A 37-year-old woman admitted to taking 100 to 150 30-mg pseudoephedrine tablets daily [75]. She had gradually increased the daily dose over the previous 5 years to counteract chronic fatigue, apathy, and depression. A previous attempt to discontinue use of the drug had produced visual hallucinations, severe fatigue, and depression.

Slow withdrawal by 200 to 300 […]