Loading…
SUDAFED SINUS ADVANCE 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: SUDAFED® SINUS ADVANCE (Ibuprofen/Pseudoephedrine Hydrochloride) is indicated: • for temporary relief of symptoms associated with the common cold, sinusitis or flu including nasal congestion, headache, fever, body aches and pains. 1.1 Pediatrics Pediatrics (< 12 years of age): Based on the data submitted, the safety…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations • Do not take for fever for more than 3 days or for more than 5 days for cold symptoms/pain. • Not recommended for patients over 65 years. o Do not give to children under 12 years of age. Recommended Dose and Dosage Adjustment • Adults and children 12 years to 65 years of age: Take 1 or 2 caplets every four to six hours as needed.
Do not exceed six caplets in 24 hours, unless directed by a physician Administration • The product is taken orally with water. SUDAFED® SINUS ADVANCE (Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg, 30 mg) Page 7 of 44 Missed Dose Continue to take 1 or 2 caplets every 4 to 6 hours as needed after a missed dose.
Do not take twice the recommended dose following a missed dose.
Adverse Reaction Overview Ibuprofen The adverse reactions most frequently seen with prescribed ibuprofen therapy involve the gastrointestinal system. The most commonly reported adverse events for ibuprofen (3 to 9%) are: nausea, epigastric pain, heartburn, dizziness, rash (including maculopapular type) and tinnitus.
Adverse reactions that occurred at lesser incidence are summarised below.
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.
SUDAFED® SINUS ADVANCE (Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg, 30 mg) Page 15 of 44 Allergic Incidence less than 1%: anaphylaxis (see Contraindications) Causal relationship unknown: fever, serum sickness, lupus erythematosus Cardiovascular Incidence less than 1%: congestive heart failure in patients with marginal cardiac function, elevated blood pressure Causal relationship unknown: arrhythmias (sinus tachycardia, sinus bradycardia, palpitations), Kounis syndrome CNS Incidence 3 to 9%: dizziness Incidence 1 to 3%: headache, nervousness Incidence less than 1%: depression, insomnia Causal relationship unknown:paresthesia, 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.
, for three days before menses. g. purpura, epistaxis, hematuria, menorrhagia) Metabolic Incidence 1 to 3%: decreased appetite, edema, fluid retention Fluid retention generally responds promptly to drug discontinuation (see Precautions).
Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General In common with other anti-inflammatory drugs, ibuprofen may mask the usual signs of infection. If the symptoms do not improve, or are accompanied by a high fever, or new symptoms occur, the patient should be advised to report to his physician.
NSAIDS should be used with caution in patients with asthma, gastrointestinal disease, renal disease, hepatic disease, hypertension, fluid retention, heart disease or in patients taking a diuretic. Patients with thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate should not take pseudoephedrine unless directed by a physician.
Adult and Pediatric Formulations Ibuprofen may cause a severe allergic reaction, especially in patients allergic to acetylsalicylic acid (ASA). Symptoms may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash or blisters with or without pyrexia or erythema.
If any of these symptoms occur, patients should stop use and seek medical help right away. For children 12 years and older, caregivers should ask a doctor before use if the child has not been drinking fluids or has lost a lot of fluid due to vomiting or diarrhea.
Carcinogenesis and Mutagenesis Ibuprofen and pseudoephedrine have been individually studied in animals with no significant effects. Cardiovascular Patients with high blood pressure, or heart disease or congestive heart failure should take SUDAFED® SINUS ADVANCE only under the advice and supervision of a physician.
NSAIDS may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke. This risk may increase with dose and duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Ibuprofen may decrease the cardioprotective and antiplatelet activity of acetylsalicylic acid (ASA). Dependence/Tolerance Pseudoephedrine has the potential to cause drug dependency and withdrawal effects. Ear/Nose/Throat Patients on SUDAFED® SINUS ADVANCE should be cautioned to report to their physician if any signs or symptoms of tinnitus occur.
• Should not be used in patients who have previously exhibited hypersensitivity to it, or its components ibuprofen or any other nonsteroidal anti-inflammatory drug (NSAID), including acetylsalicylic acid (ASA), pseudoephedrine, or to any of the ingredients in the formulation, including any non-medicinal ingredient or component of the container, or in individuals with the angioedema syndrome of nasal polyps.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Should not be used in individuals with the angioedema syndrome of nasal polyps, and bronchospastic reactivity to acetylsalicylic acid, or other nonsteroidal anti-inflammatory agents.
• Should not be used in patients with hypertension, coronary artery disease and in patients on monoamine oxidase (MAO) inhibitor therapy, or for 2 weeks after stopping MAO SUDAFED® SINUS ADVANCE (Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg, 30 mg) Page 5 of 44 inhibitor drug (see Drug Interactions).
The concomitant use of these medications may cause a rise in high blood pressure or hypertensive crisis. • The third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus, and prolonged parturition. • Should not be used in nursing mothers because its safety under these conditions has not been established.
• Should not be used in pediatric patients because safety under these conditions has not been established. • Should not be used by patients with systemic lupus erythematosus. Aseptic meningitis, fever, or rash has been reported in connection with ibuprofen therapy in patients with systemic lupus erythematosus.
• Should not be taken by patients with active peptic ulcer disease or gastrointestinal bleeding. • Should not be used right before or after heart surgery. • Should not be used if there is significant hepatic impairment or active liver disease • Should not be used if there is severely impaired or deteriorating renal function (creatinine clearance <30 ML/min).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ibuprofen in Canada.
Know a brand we are missing in Canada? Suggest a brand →
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.
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 Precautions).
1% of the placebo group. The analysis included data from trials which employed doses greater than 1200 mg, used for longer periods than OTC recommendations and by patients being treated for serious conditions. 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 SUDAFED® SINUS ADVANCE (Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg, 30 mg) Page 17 of 44 Pseudoephedrine Pseudoephedrine may cause mild CNS stimulation, especially in patients who are hypersensitive to the effects of sympathomimetic drugs.
Nervousness, excitability, restlessness, dizziness, weakness, and insomnia may occur. Headache and drowsiness have also been reported. Large doses may cause light-headedness, nausea, and/or vomiting. In addition, the possibility of other adverse effects associated with sympathomimetic drugs, including fear, anxiety, tenseness, tremor, hallucinations, seizures, pallor, respiratory difficulty, dysuria, and cardiovascular collapse should be considered.
Although oral administration of usual doses of pseudoephedrine to normotensive patients usually produced negligible pressor effects, the drug should be used with caution in hypertensive patients. Pseudoephedrine may increase the irritability of heart muscle and may alter the rhythmic function of the ventricles, especially in large doses or when administered to patients who are hypersensitive to the myocardial effects of sympathomimetic drugs.
Tachycardia or palpitation may occur. One patient who received 120 mg of pseudoephedrine hydrochloride every 4 hours developed multifocal premature ventricular contractions which disappeared a few days after the drug was discontinued.
In addition, pseudoephedrine may have precipitated an attack of atrial fibrillation in an infant. It was postulated that the patient my have had previously unsuspected idiopathic atrial fibrillation, and […]
Endocrine and Metabolism SUDAFED® SINUS ADVANCE (Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg, 30 mg) Page 9 of 44 Patients with diabetes, thyroid disease or enlargement of the prostate gland should take SUDAFED® SINUS ADVANCE only under the advice and supervision of a physician.
(see Serious Warnings and Precautions) Gastrointestinal Patients with active peptic ulcer disease or gastrointestinal bleeding should not take SUDAFED® SINUS ADVANCE (see Contraindications). NSAIDS, including Ibuprofen, may cause serious GI toxicity, such as peptic ulceration, perforation and gastrointestinal bleeding, sometimes severe and occasionally fatal, at any time, with or without symptoms.
The risk may increase with dose and duration of use and may be higher in the elderly patients with a history of gastric ulcers or bleeding disorders, patients taking anticoagulants, corticosteroids, or other NSAIDS, and with alcohol use.
There is no definitive evidence that the concomitant administration of histamine H2-receptor antagonists and/or antacids will either prevent the occurrence of gastrointestinal side effects or allow the continuation of SUDAFED® SINUS ADVANCE if GI side effects occur.
Patients on SUDAFED® SINUS ADVANCE should be cautioned to report to their physician any signs or symptoms of gastrointestinal ulceration or bleeding. Patients with a history of gastrointestinal tract disease should only use SUDAFED® SINUS ADVANCE under the advice and the supervision of a physician.
(see Serious Warnings and Precautions). Ischemic colitis has been reported in association with the use of pseudoephedrine. In reported cases the patient recovered without further incident or recurrence after pseudoephedrine was discontinued.
Genitourinary Some NSAIDS are known to cause persistent urinary symptoms (bladder pain, dysuria, urinary frequency) hematuria or cystitis. The onset of these symptoms may occur at any time after the initiation of therapy with an NSAID.
Some cases have become severe on continued treatment. Should urinary symptoms occur, treatment with SUDAFED® SINUS ADVANCE must be stopped immediately to obtain recovery. This should be done before any urological investigations or treatments are carried out.
Patients with pre-existing difficulty in urination due to enlargement of the prostate gland should take SUDAFED® SINUS ADVANCE only under the advice and supervision of a physician. Hematologic Like other nonsteroidal anti-inflammatory agents, ibuprofen can inhibit platelet aggregation.
However, compared to ASA, the effect is quantitatively less, of shorter duration, and reversible SUDAFED® SINUS ADVANCE (Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg, 30 mg) Page 10 of 44 upon discontinuation of ibuprofen.
Bleeding time has also been prolonged by ibuprofen though within the normal range in normal subjects. Because this effect on bleeding time may be exaggerated in patients with underlying hemostatic defects, SUDAFED® SINUS ADVANCE should be avoided by persons with intrinsic coagulation defects and those on anticoagulant therapy.
Blood dyscrasias (such as neutropenia, leukopenia, thrombocytopenia, aplastic anemia and agranulocytosis) associated with the use of non-steroidal anti-inflammatory drugs are rare, but could occur with severe consequences. Hepatic/Biliary/Pancreatic As with other nonsteroidal anti-inflammatory drugs, borderline elevations of one or more liver function tests (AST, ALT, alkaline phosphatase) may occur in up to 15% of patients.
These abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of more severe hepatic reaction […]
Individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored. • Ibuprofen should not be used in the presence of known hyperkalemia (also see Warnings and Precautions – Renal section).
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. • Should not be used in patients with thyroid disease