aerius drug Uses, Dosage, Side Effects, Precautions & Warnings
what is aerius used for and indication?
Aerius is indicated in adults and adolescents 12 years of age and older for the symptomatic treatment of:
- allergic rhinitis (see section on Pharmacodynamic properties )
- urticaria (see section on Pharmacodynamic properties )
aerius 5mg dosage
aerius 5mg dosage for adults
- Adults and adolescents (12 years and older): one tablet once daily, at or outside of meals for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria ( see section on pharmacodynamic properties).
- In adolescents aged 12 to 17, the experience of using desloratadine in clinical efficacy studies is limited (see sections on adverse effects and pharmacodynamic properties).
- Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or less than 4 weeks) should be managed based on the patient’s history of to be interrupted after the disappearance of symptoms, and restored to their reappearance.
- In persistent allergic rhinitis (presence of symptoms over a period of 4 days or more per week and for more than 4 weeks), continuous treatment may be offered to patients during periods of allergen exposure.
- Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
- The efficacy and safety of Aerius orodispersible tablets have not been established in children under 12 years of age.
- This product contains 2.9 mg of phenylalanine per 5 mg orodispersible tablet of Aerius. Phenylalanine can have harmful consequences in people with phenylketonuria.
- Pregnancy: desloratadine has not shown a teratogenic effect in studies carried out in animals. The safety of the product during pregnancy has not been established. Therefore, the use of Aerius during pregnancy is not recommended.
- Breast-feeding: Desloratadine is excreted in breast milk, therefore the use of Aerius is not recommended in women who are breast-feeding.
how does aerius work
Pharmacotherapeutic group: antihistamines anti-H 1 , ATC code: R06A X27
- Desloratadine is a non-sedating, long-acting antihistamine that exerts a selective antagonist effect on peripheral Hi receptors. After oral administration, desloratadine selectively blocks peripheral histamine H 1receptors as it does not diffuse into the central nervous system.
- The antiallergic properties of desloratadine have been demonstrated from in vitro studies . Inhibition of the release of pro-inflammatory cytokines such as: IL-4, IL-6, IL-8, and IL-13 by human mast cells / basophils has been demonstrated, as well as inhibition of expression of the P-selectin adhesion molecule on endothelial cells. The clinical relevance of these observations remains to be confirmed.
Clinical efficacy and safety data
- In a repeat dose clinical trial in which up to 20 mg daily of desloratadine was administered for 14 days, no statistically or clinically significant cardiovascular effects were observed. In a clinical pharmacology trial, in which desloratadine was administered at a dose of 45 mg daily (nine times the therapeutic dose) for ten days, no QT prolongation was observed.
- Repeated dose interaction studies with ketoconazole and erythromycin did not show clinically significant changes in desloratadine plasma concentrations.
- Desloratadine does not diffuse easily in the central nervous system. In controlled clinical studies, at the recommended dose of 5 mg daily, there was no increase in the incidence of drowsiness compared with placebo. Aerius administered once a day at a single dose of 7.5 mg did not impair psychomotor performance in clinical trials. In a single dose study in adults, desloratadine 5 mg did not change the standard measurement parameters of flight performance, including subjective sleep exacerbation or piloting activities. a plane.
- In clinical pharmacology trials concomitant administration with alcohol did not increase drowsiness or impaired alcohol-induced performance. No significant difference was found between desloratadine and placebo groups in psychomotility tests, whether administered alone or in combination with alcohol.
- In patients with allergic rhinitis, Aerius relieved symptoms such as sneezing, runny nose, and pruritus, but also eye pruritus, tearing and redness, and pruritus of the palate. Aerius correctly controlled the symptoms throughout the nycthemeron.
- The effectiveness of Aerius tablets has not been clearly demonstrated in studies in adolescent patients aged 12 to 17 years.
- In addition to the established classifications of seasonal and perennial allergic rhinitis, allergic rhinitis may also be classified as intermittent allergic rhinitis and persistent allergic rhinitis depending on the duration of the symptoms. Intermittent allergic rhinitis is defined as the presence of symptoms over a period of less than 4 days per week or over a period of less than 4 weeks. Persistent allergic rhinitis is defined as the presence of symptoms over a period of 4 days or more per week and for more than 4 weeks.
- Aerius decreased the disabling character of seasonal allergic rhinitis, as shown by the total score of the rhino-conjunctivitis quality of life questionnaire. The most significant improvement was observed in the area of practical problems and daily activities limited by symptoms.
- Chronic idiopathic urticaria has been studied as a clinical model of urticarial manifestations, since the underlying pathophysiology is similar, regardless of etiology, and because chronic patients can be more easily recruited prospectively. As histamine release is a factor responsible for all urticarial pathologies, desloratadine is expected to be effective in relieving the symptoms of other urticarial manifestations, in addition to chronic idiopathic urticaria, as recommended in the literature. clinical guidelines.
- In two placebo-controlled six-week trials in patients with chronic idiopathic urticaria, Aerius was effective in relieving pruritus and decreasing the number and size of urticaria by the end of the first dose. In each trial, the effects were maintained throughout the nycthemeron. As in other trials of antihistamines in chronic idiopathic urticaria, the few patients identified as non-responders to antihistamines have been excluded. A decrease in pruritus of more than 50% was observed in 55% of patients treated with desloratadine compared to 19% of patients treated with placebo. Aerius treatment also significantly reduced sleep interference and daily activity,
What are the side effects of Aerius?
In clinical trials conducted in allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, adverse events were reported in 3% more patients than those treated with placebo.
The most commonly reported adverse events with an incidence greater than placebo were: asthenia (1.2%), dry mouth (0.8%) and headache (0.6%). In a clinical study in 578 adolescent patients aged 12 to 17, the most common adverse event was headache; it occurred in 5.9% of patients treated with desloratadine and in 6.9% of patients receiving placebo.
Other adverse effects that have been very rarely reported since marketing are listed in the following table:
- -Psychiatric disorders : Hallucinations.
- – Nervous system disorders : Dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions.
- – Cardiac disorders : Tachycardia, palpitations.
- – Gastrointestinal disorders : Abdominal pain, nausea, vomiting, dyspepsia, diarrhea.
- – Hepatobiliary disorders : Elevations of liver enzymes, increased bilirubin, hepatitis.
- – Musculoskeletal and systemic disorders : Myalgia.
- – General disorders : Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnea, pruritus, rash, and urticaria).
In clinical trials with desloratadine tablets in which patients received erythromycin or ketoconazole in combination, no clinically significant interactions were observed.
- Interaction studies have only been performed in adults.
- In a clinical pharmacology trial, there was no evidence of potentiation of the deleterious effects of alcohol on performance tests when used with Aerius tablets (see section 5.1 ). However, cases of intolerance and alcohol intoxication have been reported since marketing. Therefore, caution is advised in case of concomitant intake of alcohol.
AERIUS Warnings and Precautions
Aerius should be used with caution in patients with severe renal impairment (see section 5.2 Pharmacokinetic properties ).
Patients with rare hereditary conditions such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Drive and use machines
In view of the available clinical studies, Aerius has only a negligible or no effect on the ability to drive and use machines. Patients should be informed that, although most people do not feel drowsy, there is interindividual variability.
As a result, patients should be informed of the need to test their response to this medication before any activity requiring vigilance, such as driving vehicles or operating machinery.
AERIUS and PREGNANCY / BREAST FEEDING / FERTILITY
aerius during pregnancy
- On a large number of pregnancies (more than 1000 pregnancies), no malformative or toxic effects of desloratadine have been demonstrated for the fetus or the newborn.
- Studies in animals have not shown any direct or indirect harmful effects on reproduction ( see Preclinical safety ). As a precaution, it is best to avoid using Aerius during pregnancy.
aerius during Breastfeeding
- Desloratadine has been identified in neonates / infants breastfed by a treated woman.
- The effect of desloratadine on newborns / infants is unknown.
- A decision must be made either to discontinue breastfeeding or to discontinue / abstain from treatment with Aerius taking into account the benefit of breastfeeding for the child with regard to the benefit of treatment for the woman.
aerius during Fertility
- No data are available to document effects on human fertility.
aerius tablets overdose
The post-marketing adverse event profile of an overdose is similar to that observed at therapeutic doses, however, these effects may be greater.
- In case of overdose, elimination by usual methods of the unabsorbed active substance should be considered. Symptomatic treatment and appropriate therapeutic measures are recommended.
- Desloratadine is not removed by hemodialysis; it is not known if it is eliminated by peritoneal dialysis.
- In a repeat dose clinical trial, no clinically significant effect was observed when desloratadine was administered at a dose of up to 45 mg (nine times the therapeutic dose).
- The post-marketing adverse event profile of an overdose is similar to that observed at therapeutic doses, however, these effects may be greater.
What is Forms and Composition?
|FORMS and PRESENTATIONS|
- 5 mg film-coated tablet (light blue): Boxes of 15 and 30, in blister packs.
- Oral solution 0.5 mg / ml: 150 ml bottle (with child safety cap) + graduated syringe (2.5 ml and 5 ml).
|Compressed :||p cp|
|Desloratadine (DCI)||5 mg|
- Excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, corn starch, talc.
- Film coating : coating film (containing lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin E 132), clear coating (containing hypromellose, macrogol 400), wax carnauba, white wax.
- Excipient with known effect: lactose.
|Drinkable solution :||p ml|
|Desloratadine (DCI)||0.5 mg|
- Excipients: sorbitol, propylene glycol, sucralose E 955, hypromellose 2910, sodium citrate dihydrate, natural and artificial flavor (bubble gum), citric acid anhydrous, edetate disodium, purified water.
- Excipient with known effect: sorbitol (150 mg / ml).
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