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AERIUS SINUS + ALLERGY is a brand name for Desloratadine, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AERIUS® SINUS + ALLERGY (Desloratadine and Pseudoephedrine Sulfate Extended-Release Tablets) is indicated for: • Fast, long-acting and effective relief from multiple nasal and non-nasal symptoms associated with seasonal allergic rhinitis including nasal discharge/rhinorrhea, sinus pressure, nasal…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • The duration of the treatment should be kept as short as possible and should not be continued after the symptoms have disappeared. It is advisable to limit treatment to about 14 days, as during chronic administration the activity of pseudoephedrine diminishes with time.
• AERIUS® SINUS + ALLERGY is not recommended for use in patients with severe hepatic or renal impairment. • Do not exceed the recommended dosage and the duration of treatment. • Do not use concurrently with other over-the counter antihistamines and decongestants.
• AERIUS® SINUS + ALLERGY is not recommended for use in pregnant or lactating women. • AERIUS® SINUS + ALLERGY should be administered when the antihistaminic, anti-allergic and anti-inflammatory properties of desloratadine and the nasal and sinus decongestant activity of pseudoephedrine are desired.
2 Recommended Dose and Dosage Adjustment • Adults and children 12 years of age and over: The recommended dose of AERIUS® SINUS + ALLERGY is one tablet twice a day, administered approximately 12 hours apart. • After improvement of the congestive condition of the mucosae of the upper airway, treatment may be maintained with desloratadine alone, if necessary.
4 Administration The tablet may be taken with a full glass of water but must be swallowed whole (without crushing, breaking or chewing it). The tablet may be taken with or without a meal. 5 Missed Dose If dose was missed and not taken on time, dose can be taken when patient remembers.
Do not exceed more than one dose in 12 hours. 5 mg & Pseudoephedrine sulfate 120 mg> Page 6 of 36
1 Adverse Reaction Overview Very rare cases of hypersensitivity reactions including anaphylaxis and rash have been reported during the marketing of desloratadine. In addition, cases of tachycardia, palpitations, psychomotor hyperactivity, seizures, elevations of liver enzymes, hepatitis, increased bilirubin, and increased appetite have been reported very rarely.
As with other sympathomimetic amines, central nervous system stimulation, muscular weakness, tightness in the chest and syncope may also be encountered with the use of pseudoephedrine sulfate. 5 mg & Pseudoephedrine sulfate 120 mg> Page 10 of 36 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. A total of 1248 subjects, 12 years of age and older were randomized in two Phase-3 studies and received at least one dose of study drug.
All subjects were included in the safety evaluation presented in Table 2, demonstrating adverse events ≥ 1%. 5mg / PSE 120 mg QD n= 414 (%) DL, 5mg QD n= 412 (%) PSE, 120mg BID n= 422 (%) Urinary Tract Infection 0 2 1 Vision Dry eyes 1 1 0 DL = desloratadine; PSE = pseudoephedrine sulfate In all clinical studies conducted, AERIUS® SINUS + ALLERGY was safe and well tolerated.
In Phase-3 studies, the overall incidence of adverse events was similar in AERIUS® SINUS + ALLERGY and pseudoephedrine treatment groups, but was lower in the desloratadine group. The most common treatment-emergent adverse events of AERIUS® SINUS + ALLERGY were insomnia, headache and dry mouth.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings None to report. Post-Market Findings None to report. 5 Post-Market Adverse Reactions Very rare cases of hypersensitivity reactions (including anaphylaxis and rash), tachycardia, palpitations, psychomotor hyperactivity, seizures, elevation of liver enzymes, hepatitis, increased bilirubin, and increased appetite have been reported during the marketing of desloratadine.
Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General Do not exceed the recommended dosage and the duration of treatment. Do not use concurrently with other over-the counter antihistamines and decongestants. Cardiovascular Use with caution in patients with cardiovascular disease and hypertension.
Treatment should be discontinued in case of hypertension, tachycardia, palpitations or cardiac arrhythmias. Dependence/Tolerance As with other CNS stimulants, pseudoephedrine sulfate carries the risk of abuse. Increased doses may ultimately produce toxicity.
Continuous use can lead to tolerance and an increased risk of overdosing. Depression may follow rapid withdrawal. Endocrine and Metabolism Use with caution in patients with diabetes mellitus. Gastrointestinal Use with caution in patients with stenosing peptic ulcer and pyloroduodenal obstruction.
5 mg & Pseudoephedrine sulfate 120 mg> Page 8 of 36 Genitourinary Use with caution in patients with hypertrophy of the prostate or bladder neck obstruction. Hepatic/Biliary/Pancreatic The safety and efficacy of AERIUS® SINUS + ALLERGY has not been established in patients with impaired hepatic function, and there are insufficient data to give adequate dose recommendations.
The combination product is not recommended for use in patients with impaired hepatic function (see 10 CLINICAL PHARMACOLOGY). 4 times higher than healthy subjects. Desloratadine 5mg was administered for 10 days to subjects with normal hepatic function or moderate dysfunction.
Subjects with hepatic dysfunction could experience a 3-fold increase in exposure (AUC) to desloratadine. These findings are not considered to be clinically relevant. Neurologic Desloratadine should be administered with caution in patients with a medical or family history of seizures.
In particular, young children may be more susceptible to developing new seizures under desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment. Treatment should be discontinued in case of nausea or any other neurologic sign (such as headache or increased headache).
• Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING • Patients who are hypersensitive to adrenergic agents or to loratadine.
• Due to its pseudoephedrine content, it is also contraindicated in patient: o who are receiving irreversible monoamine oxidase (MAO) inhibitor therapy or during the 2 weeks following the stopping of such treatment o with narrow-angle glaucoma o with urinary retention o with cardiovascular diseases such as severe coronary artery disease, tachyarrhythmia and severe hypertension o with hyperthyroidism o with a history of haemorrhagic stroke or with risk factors which could increase the risk of haemorrhagic stroke.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Ophthalmologic Use with caution in patients with glaucoma and increased intraocular pressure. Peri-Operative Considerations If surgery is scheduled, discontinue treatment 24 hours before anaesthesia. Renal The safety and efficacy of AERIUS® SINUS + ALLERGY has not been established in patients with impaired renal function, and there are insufficient data to give adequate dose recommendations.
The combination product is not recommended for use in patients with impaired renal function (see 10 CLINICAL PHARMACOLOGY). 5-fold increases in desloratadine median AUC with minimal change in 3-hydroxy desloratadine concentrations. However, these findings are not considered to be clinically relevant.
Skin Acute generalized exanthematous pustulosis (AGEP), a form of severe skin reaction, may occur with pseudoephedrine-containing products in isolated cases. 5 mg & Pseudoephedrine sulfate 120 mg> Page 9 of 36 the sudden occurrence of small (generalized) pustules, erythema or fever are observed, patients should discontinue using the drug.
1 Pregnant Women The safe use of AERIUS® SINUS + ALLERGY during pregnancy has not been established. The use of pseudoephedrine decreases maternal blood flow. The use of AERIUS® SINUS + ALLERGY is not recommended for pregnant women. 2 Breast-feeding Desloratadine and pseudoephedrine are both excreted in breast milk; therefore the use of AERIUS® SINUS + ALLERGY is not recommended for women who are breast-feeding.
3 Pediatrics Pediatrics (< 12 years of age): AERIUS® SINUS + ALLERGY is not recommended for use in children below the age of 12 years due to lack of data on safety and efficacy. 4 Geriatrics Geriatrics (≥ 65 years of age): The number of patients 65 years of age and above treated with AERIUS® SINUS + ALLERGY were too limited to make any clinically relevant judgement regarding efficacy or safety of this drug product in this age group.
Patients of 65 years or older are more likely to experience adverse reactions from sympathomimetic medicinal products. Therefore, the combination product should be used with caution in patients above 65 years of age (see 10 CLINICAL PHARMACOLOGY).
CNS stimulations with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines. These effects may be more likely to occur in children or elderly patients Athletes: Athletes should be informed that treatment with pseudoephedrine could lead to positive doping tests.