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Aerinaze is a brand name for Desloratadine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Aerinaze is indicated in adults and adolescents 12 years and older for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.
Verbatim from this product's EMA label. Tap a section to expand.
Posology The recommended dose of Aerinaze is one tablet twice a day. The recommended dosage and the duration of treatment should not be exceeded. The duration of 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 10 days, as during chronic administration the activity of pseudoephedrine sulphate may diminish. After improvement of the congestive condition of the mucosae of the upper airway, treatment may be maintained with desloratadine alone, if necessary.
Elderly patients Patients of 60 years or older are more likely to experience adverse reactions to sympathomimetic medicinal products, such as pseudoephedrine sulphate. The safety and efficacy of Aerinaze have not been established in this population, and there are insufficient data to give adequate dose recommendations.
Therefore Aerinaze should be used with caution in patients above 60 years of age. Patients with renal or hepatic impairment The safety and efficacy of Aerinaze have not been established in patients with impaired renal or hepatic function, and there are insufficient data to give adequate dose recommendations.
Aerinaze is not recommended for use in patients with impaired renal or hepatic function. Paediatric population The safety and efficacy of Aerinaze in children below the age of 12 years have not been established. No data are available.
Aerinaze is not recommended for use in children below the age of 12 years. Method of administration Oral use. The tablet may be taken with a full glass of water but must be swallowed entirely (without crushing, breaking or chewing it).
The tablet may be taken with or without food. 3
1 %). Tabulated list of adverse reactions Adverse reactions considered by investigators to be causally related to Aerinaze are listed below by System Organ Class. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 7 System Organ Class Frequency Adverse reactions seen with Aerinaze Metabolism and nutrition disorders Common Uncommon Decreased appetite Thirst, glycosuria, hyperglycaemia Psychiatric disorders Common Uncommon Insomnia, somnolence, sleep disorder, nervousness Agitation, anxiety, irritability Nervous system disorders Common Uncommon Dizziness, psychomotor hyperactivity Hyperkinesia, confusional state Eye disorders Uncommon Vision blurred, dry eye Cardiac disorders Common Uncommon Tachycardia Palpitation, supraventricular extrasystoles Respiratory, thoracic and mediastinal disorders Common Uncommon Pharyngitis Rhinitis, sinusitis, epistaxis, nasal discomfort, rhinorrhea, dry throat, hyposmia Gastrointestinal disorders Common Uncommon Constipation Dyspepsia, nausea, abdominal pain, gastroenteritis, abnormal faeces Skin and subcutaneous tissue disorders Uncommon Pruritus Renal and urinary disorders Uncommon Dysuria, micturition disorder General disorders and administration site conditions Common Uncommon Headache, fatigue, dry mouth Chills, flushing, hot flush Investigations Uncommon Hepatic enzymes increased 8 Other adverse reactions reported for desloratadine during the post-marketing period are listed hereunder.
System Organ Class Frequency Adverse reactions Immune system disorders Very rare Hypersensitivity (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria) Metabolism and nutrition disorders Not known Increased appetite Psychiatric disorders Very rare Not known Hallucination Abnormal behaviour, aggression, depressed mood Nervous system disorders Very rare Convulsion Cardiac disorders Not known QT prolongation Gastrointestinal disorders Very rare Vomiting, diarrhoea Hepatobiliary disorders Very rare Hepatitis Musculoskeletal and connective tissue disorders Very rare Myalgia Investigations Very rare Not known Blood bilirubin increased Weight increased Other adverse reactions reported for pseudoephedrine-containing products during the post-marketing period are listed hereunder.
Cardiovascular and general effects Patients should be informed that the treatment should be discontinued in case of hypertension, tachycardia, palpitations or cardiac arrhythmias, nausea or any other neurological sign (such as headache or increased headache).
5) Gastrointestinal and genitourinary effects Use with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, and obstruction of the vesical cervix. 5). These include: • decongestants • anorexogenics or amphetamine-type psychostimulants • antihypertensive medicinal products • tricyclic antidepressants and other antihistamines.
5). 8). 3). Pseudoephedrine should be discontinued and immediate medical assistance sought if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances.
Most reported cases of PRES and RCVS resolved following discontinuation and appropriate treatment. Convulsions Desloratadine should be administered with caution in patients with medical or familial history of seizures, and mainly young children, being more susceptible to develop new seizures under desloratadine treatment.
Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment. Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines.
9). Risks of abuse Pseudoephedrine sulphate carries the risk of abuse. Increased doses may ultimately produce toxicity. Continuous use can lead to tolerance resulting in an increased risk of overdosing. Depression may follow rapid withdrawal.
Other Perioperative acute hypertension can occur if volatile halogenated anaesthetics are used during treatment with indirect sympathomimetic agents. Therefore, if surgery is scheduled, it is preferable to discontinue treatment 24 hours before anaesthesia.
1, or to adrenergic medicinal products or to loratadine. As Aerinaze contains pseudoephedrine sulphate, it is also contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitor therapy or during the 2 weeks following the stopping of such treatment.
Aerinaze is also contraindicated in patients with: • narrow-angle glaucoma, • urinary retention, • cardiovascular diseases such as ischaemic heart disease and tachyarrhythmia, • severe hypertension or uncontrolled hypertension, • hyperthyroidism, • a history of haemorrhagic stroke or with risk factors which could increase the risk of haemorrhagic stroke.
This is due to the alpha-mimetic activity of pseudoephedrine sulphate in combination with other vasoconstrictors such as bromocripitine, pergolide, lisuride, cabergoline, ergotamine, dihydroergotamine or any other decongestant medicinal product used as a nasal decongestant, either by oral route or by nasal route (phenylpropanolamine, phenylephrine, ephedrine, oxymetazoline, naphazoline…), • severe acute or chronic kidney disease/renal failure.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Desloratadine in European Union.
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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.
4) Eye disorders Not known Ischaemic optic neuropathy Gastrointestinal disorders Not known Ischaemic colitis Cases of severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) have been reported with pseudoephedrine-containing products.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
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Interference with serological testing Athletes should be informed that treatment with pseudoephedrine sulphate could lead to positive doping tests. The administration of Aerinaze should be discontinued at least 48 hours before skin tests since antihistamines maybe prevent or reduce otherwise positive reaction to dermal reactivity index.
Severe skin reactions Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema or many small pustules are observed, administration of Aerinaze should be discontinued and appropriate measures taken if needed.
Ischaemic optic neuropathy Cases of ischaemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued and medical advice sought if sudden loss of vision or decreased visual acuity such as scotoma occurs.
Ischaemic colitis Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.
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