What is Aerinaze?
Aerinaze is a drug containing the active substances desloratadine (2.5 mg) and pseudoephedrine (120 mg). it is available as blue and white modified release tablets. The term "modified release" means that the tablets are made in such a way that one of the active ingredients is released immediately and the other over a few hours.
What is Aerinaze used for?
Aerinaze is indicated for the treatment of symptoms of seasonal allergic rhinitis (hay fever, which is an "inflammation of the sinuses caused by a" pollen allergy) in patients with nasal congestion (stuffy nose).
The medicine can only be obtained with a prescription.
How is Aerinaze used?
In adults and adolescents over 12 years of age, the recommended dose of Aerinaze is one tablet twice a day, swallowed whole with a full glass of water. The tablet can be taken with or without food. Duration of treatment it should be as short as possible and the drug should be stopped after the symptoms, especially congestion (stuffy nose) have disappeared. Treatment for more than 10 days is not recommended, as the drug's effectiveness on nasal congestion may decrease. After congestion improves, patients can use desloratadine alone (alone).
How does Aerinaze work?
Aerinaze contains two active ingredients: desloratadine, an antihistamine, and pseudoephedrine, a nasal decongestant. Desloratadine blocks the receptors on which histamine, a substance in the body that causes allergic symptoms, usually attaches itself. Once the receptors are blocked, histamine cannot produce its effects and therefore a decrease in allergy symptoms is observed. Pseudoephedrine works by stimulating nerve endings to release the chemical norepinephrine, which causes blood vessels to constrict (narrow). In this way, the amount of fluid released by the vessels is reduced and, consequently, the swelling and there is less production of mucus in the nose. In Aerinaze, the two active ingredients are used together, because an antihistamine alone may not provide adequate relief for patients with nasal congestion.
Aerinaze tablets have two layers: the first containing desloratadine, the second containing pseudoephedrine. Desloratadine is released from its layer immediately after taking it while
pseudoephedrine is released slowly over the course of 12 hours. This way patients only need to take the tablet twice a day.
Desloratadine has been available in the European Union (EU) since 2001, while pseudoephedrine has been widely used in over-the-counter medicines for many years.
How has Aerinaze been studied?
The efficacy of Aerinaze was investigated in two main studies involving a total of 1,248 adult and adolescent patients. In both studies, Aerinaze was compared with desloratadine alone and with pseudoephedrine alone. The main indicators of efficacy were. the change in the severity of hay fever symptoms reported by patients prior to initiation of treatment and during the 15 days of treatment. During the study, patients recorded symptoms in a diary every 12 hours, attributing to the severity of symptoms that emerged in the over the previous 12 hours a score based on a standard scale.
What benefit has Aerinaze shown during the studies?
Aerinaze was more effective in reducing symptoms than either active substance taken alone. For all hay fever symptoms except nasal congestion, patients taking Aerinaze reported a reduction in symptoms of 46.0%, compared with 35.9% of patients treated with pseudoephedrine alone. Regarding nasal congestion, patients taking Aerinaze reported a reduction in symptoms of 37.4%, compared with 26.7% of patients treated with desloratadine alone. Similar results were seen in the second study.
What is the risk associated with Aerinaze?
The most common side effects with Aerinaze (seen between 1 and 10 patients in 100) are tachycardia (increased heart rate), dry mouth, dizziness, psychomotor hyperactivity (restlessness), pharyngitis (sore throat), anorexia (loss of d "appetite), constipation, headache, fatigue, insomnia, drowsiness, sleep disturbances and nervousness. For the full list of side effects reported with Aerinaze, see the package leaflet.
Aerinaze must not be used in people who may be hypersensitive (allergic) to desloratadine, pseudoephedrine or other ingredients, to adrenergic agents or to loratadine (another medicine used in the treatment of allergies). It must not be used in patients who are being treated with monoamine oxidase inhibitors (such as some medicines used to treat depression) or who have stopped treatment for less than two weeks. Aerinaze should also not be taken by people with narrow-angle glaucoma (increased pressure in the eye), urinary retention (difficulty urinating), cardiovascular disease including hypertension (increased blood pressure), hyperthyroidism (excessive activity thyroid gland) or a history or risk factors for hemorrhagic stroke (stroke caused by a 'brain hemorrhage).
Why has Aerinaze been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Aerinaze's benefits are greater than its risks in the symptomatic treatment of seasonal allergic rhinitis accompanied by nasal congestion and therefore recommended that the product be granted "Marketing Authorization". .
Other information about Aerinaze:
On July 30, 2007, the European Commission granted SP Europe a "Marketing Authorization" for Aerinaze, valid throughout the European Union.
For the full version of the Aerinaze EPAR click here.
Last update of this summary: 06-2007.
Aerinaze information published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
