Siro Destacure 2.5mg/5ml Gracure treatment of seasonal and long -term allergic rhinitis, spontaneous urticaria (60ml)

Dosage form Bottle x 60ml
Specifications Desloratadine
Ingredient Rhinitis, allergic rhinitis, urticaria, itching, urticaria

Ingredient

Thành phần cho 5ml

Composition information	Content
Desloratadine	2.5mg

Uses

Indications

Seasonal allergic rhinitis

Destacure is expected to quickly reduce the symptoms of seasonal allergic rhinitis in patients 2 years of age or older.

Perennial allergic rhinitis

Destacure is indicated to quickly reduce the symptoms of perennial allergic rhinitis in patients from 6 months of age.

Chronic spontaneous urticaria

Destacure is indicated to quickly reduce the symptoms of itching, reduce the number and size of the rash in patients with chronic spontaneous urticaria from 6 months of age.

Metabolism

Desloratadin, (Loratadine's main metabolites) is strongly converted into 3 - hydroxydesloratadine, is an active metabolite, then it will match with glucuronic acid. Participating enzymes form 3 - Hydroxydesloratadine has not been determined. Data from clinical trials shows that a small part of the patient population has a reduction in the ability to form 3 - hydroxydesloratadine, and slow down the metabolism of desloratadine. In pharmacokinetic studies (n = 3748), about 6% of subjects have slow metabolism of desloratadin (identified as objects with the ratio of the area under the curve (AUC) of 3 - hydroxydesloratadin compared to the desloratadin below 0.1, or the object with the semi -destructoring time of Desloratadin over 50 hours). These pharmacokinetic studies include subjects aged 2 to 70 years old, of which 977 subjects aged 2 to 5 years old, 1575 subjects aged 6 to 11 years old, and 1196 subjects aged 12 to 70 years old. The slow metabolic rate between objects does not depend on the age group. The frequency of objects with slow metabolic in blacks is higher (17%, n = 988) compared to white people (2%, n = 1462) and the Greek origin (2%, n = 1063). Deslpratadin's AUC in those who metabolize is about 6 times larger than those who are not slow. It is impossible to identify people with slow metabolism for desloratadin and will have auc desloratadine in plasma higher after taking desloratadine at the right dose. In clinical studies, where the metabolism is determined, there are 94 slow metabolic objects and 123 normal metabolic objects have been detected and treated with desloratadin for 15 to 35 days. In these studies, there is no overall difference in safety that has been observed between those who have slow metabolism and those who have normal metabolism. Although there are no pharmacokinetic studies on this issue, patients with slow metabolism for desloratadin will be more sensitive to adultery effects related to dosage.

Elimination

Desloratadin's average selling time is 27 hours. CMAX and AUC peak concentration values increase the proportion of the one -time dose only between 5 and 20mg. The level of accumulation after 14 days of using the drug is suitable for the half -life and the frequency of dosage. A study on human excretion balance shows that approximately 87% of 14C - Desloratadin is distributed equally in urine and feces. Analysis 3 - Hydroxydesloratadine in plasma shows the same values of Tmax and the semi -cancellation time compared to the desloratadin.

Pharmacokic

Desloratadin is a selective antagonist with histamine in the peripheral H1 receptor, prolonged, unsafe effect. After drinking, desloratamine selectively inhibits H1 histamine receptors on the periphery, because the drug does not enter the central nervous system. In In vitro studies, desloratadin has been shown to have an anti -allergic effect including inhibiting the release of inflammatory cytokines such as IL - 4, IL - 6, IL - 8 and IL - 13 from mast/baSophil cells, as well as inhibiting the expression of adhesive molecules such as P - Selectin on endothicium cells. Clinical treatment effects are still being monitored.

pharmacokinetic

absorption

Can find desloratadin concentration in plasma after drinking 30 minutes in adults and adolescents. Desloratadin is well absorbed to reach the maximum concentration in plasma about 3 hours after drinking, the final waste time after about 27 hours. The accumulation of desioratadin is suitable for the sale time (about 27 hours) and used once a day. The bioavailability of desloratadin is proportional to the dose of 5 - 20mg.

Distribution

about 82% to 87% desloratadin and 85% to 89% 3 - hydroxydesloratadine attached to plasma proteins. The attachment to the protein of desloratadine and 3 - hydroxydesloratadine is unchanged in kidney failures.

Before taking Siro Destacure 2.5mg/5ml Gracure treatment of seasonal and long -term allergic rhinitis, spontaneous urticaria (60ml)

How to use

Should use Destacure suitable for age by measuring with a drip or cylinder to get from 2ml to 2.5ml (1/2 teaspoon).

Dosage

Adults and children over 12 years old: The recommended dose of Destacure is 2 tablespoons of full tea (5mg in 10ml) once a day.

Children from 6 to 11 years old: The recommended dose of Destacure is a full teaspoon of tea (2.5mg in 5ml) once a day.

Children from 12 months to 5 years: The recommended dose of Destacure is ½ teaspoon of tea (1.25mg in 2.5ml) once a day.

Children from 6 months to 11 months of age: The recommended dose of Destacure is 2ml (1.0mg) once a day.

What to do when overdose?

It is necessary to take symptomatic and supportive treatment.

Based on clinical trials with various doses in adults and adolescents with recommended doses of up to 45mg of desloratadin (9 times the usual dosage), there is no clinical effects related to the clinical effects.

Do not eliminate desloratadine by hemolysis, whether it is unclear whether or not the abdominal split.

What to do when you forget the dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

In clinical trials at a total of 246 children from 6 months to 11 years old, they are given Desloratadin. The incidence of unwanted effects in children 2 to 11 years old is the same between the group of Desloratadin and the placebo group. In infants and children from 6 to 23 months of age, most cases after taking desloratadin have some side effects such as diarrhea (3.7%), fever (2.3%) and insomnia (2.3%).

With recommended dose, in clinical trials related to adults and adolescents in indications including allergic rhinitis and chronic spontaneous urticaria, unwanted effects with desloratadin are recorded in 3% of patients compared to placebo. The same ratio of side effects between patients using desloratadine and placebo patients such as fatigue (1.2%), dry mouth (0.8%) and headache (0.6%). The other unwanted effect report is very rare in the after -sales tracking process listed in the following table:

Mental disorders The illusion breasts digestive disorders abdominal pain, nausea, vomiting, indigestion, diarrhea Mechanical

Warnings

Contraindicated

Do not use for patients with hypersensitivity to Destacure or any component of the drug or hypersensitivity to Loratadin.

Caution when taking drugs

When there are reactions due to sensitivity to the composition of the drug such as rash, itching, urticaria, edema, shortness of breath, it stops desloratadin and replaced by other treatment methods.

The ability to drive and operate machinery

Caution for drivers and operating machinery.

Pregnancy and lactation

Pregnancy

pregnancy during the FDA: type c.

Desloratadin does not cause teratogenic rats at a dose of 48mg/kg/day (estimated treatment of desloratadin and desloratadine metabolites about 210 AUC times in people based on the recommended daily oral dose) or in rabbits at a dose of 60mg/kg/day (estimate the treatment value of Desloratadin is about 230 times AUC in people based on daily oral doses that are recommended daily). Using desloratadine at a dose of 9mg/kg/day or more will reduce body weight and slowly reflect light in dogs during pregnancy (estimated the value of desloratadine treatment and the metabolite of desloratadin about 50 times AUC in humans based on the recommended daily oral dose). Desloratadin does not affect the fetal development in dogs at a dose of 3mg/kg/day (estimated the value of the treatment of desloratadin and the metabolites of the desloratadine about 7 times AUC in people based on the recommended daily oral dose). However, there is no appropriate and controlled research in pregnant women. Because animal reproductive studies do not always give the same results as in humans, desloratadin is only used during pregnancy if necessary.

Breastfeeding period

Desloratadin is excreted in breast milk; Therefore, it is necessary to decide to stop breastfeeding or stop taking desloratadin based on the importance of the mother.

Special subjects (elderly, children, allergies)

No report.

Drug interaction

Cytochrome P450 3A4 inhibitors

In control clinical studies shows that the oral desloratadin is in conjunction with ketoconazole, erythromycin, or azithromycin, resulting in increased plasma concentrations of desloratadin and 3 - hydroxydesloratadin, but there is no clinical manifestation related to interactive with desloratadin in clinical studies.

fluoxetine

In control clinical studies show that the oral desloratadin is in combination with fluoxetine, a selective recovery inhibitor Serotonin (SSRI), resulting in increased plasma concentrations of desloratadin and 3 - hydroxydesloratadin, but there is no clinical manifestation related to interactive with desloratadin in clinical studies.

cimetidine

In control clinical studies show that the oral desloratadin is in combination with cimetidin, a antagonist with histamine H2 receptor, resulting in increased plasma concentrations of desloratadin and 3 - hydroxydesloratadin, but there is no clinical manifestation related to interactive with desloratadine in clinical studies.

Storage

You should store at room temperature, avoid moisture and avoid light. No storage in the bathroom or in the freezer.

You should remember that each drug may have different storage methods. Therefore, you should read carefully storage instructions on the packaging or ask the pharmacist.

Keep pills out of reach of children and pets.

Expiry date: 36 months from the date of manufacture.

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