Siro Desbebe 2.5mg/5ml Gracure treatment of allergic rhinitis, urticaria (60ml)

Dosage form Box of 1 bottle x 60ml
Specifications Desloratadina
Ingredient Gracure Pharmaceuticals

Ingredient

Thành phần cho 5ml

Composition information	Content
Desloratadina	2.5mg

Uses

indications

Desbebe 2.5mg/5ml drug is indicated in the following cases:

Seasonal allergic rhinitis: Desbebe is indicated to quickly reduce the symptoms of seasonal allergic rhinitis in patients 2 years and older. Reduce the number and size of the rash in patients with chronic spontaneous urticaria 2 years and older. 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, Desloratadine has been shown to have an allergen -resistant effect.

Inhibits the release of inflammatory cytokines such as IL-4, IL-6, IL-8 and IL-13 from BaSophil cells/cells, as well as inhibiting the exposure of adhesive molecules such as p-selectin on endothelial cells. Clinical appropriate for these studies is still being confirmed.

Pharmacokinetics

absorption

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

Distribution

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

Metabolism

Desloratadine (Loratadine's main metabolites) are strongly converted into 3-hydroxydesloratadine, which is an active metabolite, then glucuronicization will be. Participating enzymes form 3-hydroxydesloratadine. 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 desloratadine (identified as objects with AUC ratio of 3-hydroxydesloratadine compared to desloratadine below 0.1 or the object of semi-cancellation Desloratadine exceeds 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. There is no difference in slow metabolism between age groups. 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). The average plasma concentration (AUC) of desloratadine in people metabolic is about 6 times larger than those who are not slow metabolites. It is impossible to identify people with slow metabolism for desloratadine and there will be auc desloratadine in plasma higher after taking desloratadine at the right dose.

In safe clinical doses, where the metabolism has been determined, there are 94 slow metabolic objects and 123 normal metabolic subjects have been detected and treated with Desloratadine 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 desloratadine will be more sensitive to adultery effects related to dosage.

Elimination

Desloratadine average half -life is 27 hours. CMAX and AUC peak concentration values increase the proportion of the one -time dose only between 5 and 20 mg. The level of accumulation after drinking 14 days goes hand in hand with a semi -cancellation time and the frequency of dosage. A study of mass balance in humans shows that there is a restoration of about 87% of the 14C-Desloratadine dose, found in urine and feces as metabolites. 3-Hydroxydesloratadine analysis in plasma shows the same values of Tmax and the semi-cancellation time compared to the desloratadine.

Before taking Siro Desbebe 2.5mg/5ml Gracure treatment of allergic rhinitis, urticaria (60ml)

How to use

use oral, should use Desbebe suitable for the age by the form of drip or cylinder tube to get from 2 to 2.5 ml (1/2 teaspoon of tea).

Dosage

recommended dose:

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

It is necessary to take symptomatic treatment and support treatment.

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

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

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.

Side Effects

In clinical trials at a total of 246 children from 6 months to 11 years old, they are given syrup Desloratadine, the incidence of unwanted effects in children 2 to 11 years old is similar between the Desloratadine group and the placebo group, in newborns and children aged 6 to 23 months old, most cases after drinking clear number Desloratadine have some irregular effects (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 desloratadine are recorded in 3 % of patients compared to placebo.

Most cases have unwanted effects when compared to placebo is tired (1.2 %), dry mouth (0.8 %) and headache (0.6 %). The other unwanted effect report is very rare in the after -sales tracking process:

Liver disorders: Increased liver enzymes, increased bilirubin, hepatitis Drugs.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Desbebe 2.5mg/5ml contraindicated in the following cases:

Do not use for patients with hypersensitivity to desloratadine or any ingredients of the drug or hypersensitivity to desloratadine.

Be cautious when using

Precautions when using desloratadine for patients with a history of epilepsy.

Be careful when taking desloratadine because there will be reactions due to sensitivity to the composition of the drug such as rash, itching, urticaria, edema, shortness of breath. If these reactions occur, it is advisable to stop treating with desloratadine and replaced by other treatments.

Due to the ingredients with sucrose, no drugs when free-intolerance, Glucose-Galactose or Sucrose-Isomaltase deficiency.

Due to the Color Sunset Yellow Supra, it can cause an allergic reaction, so it is necessary to be cautious.

The effect of the drug on the ability to drive and operate machinery

Caution when driving and operating machinery because the drug can cause unwanted effects such as dizziness, drowsiness.

Use drugs for women during pregnancy and lactation

pregnancy

Desloratadine does not cause teratogenic rats in a dose of 48 mg/kg/day (estimated treatment value of desloratadine and Desloratadine metabolites about 210 AUC times in humans based on the recommended daily oral dose) or rabbit with a dose of 60 mg/kg/day (estimate the treatment value of Desloratadine is about 230 times AUC in humans based on daily oral doses that are recommended daily). Using desloratadine at a dose of 9mg/kg/day or more will reduce the body weight and slowly reflect the light in the dog during pregnancy (estimated the value of the treatment of desloratadine and the metabolite of the desloratadine about 50 times AUC in humans based on the recommended daily oral dose). Desloratadine does not affect the fetal development in dogs at a dose of 3mg/kg/day (estimated treatment of desloratadine and desloratadine metabolites 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, desloratadine should be used during pregnancy if necessary.

Breastfeeding period

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

Medicinal interaction

Desloratadine increases the concentration and effects of alcohol, anti -cholin drugs, central neurological inhibitors, selective inhibitors with Serotonin recovery.

Desloratadine concentration and effects may be increased by droperidol, hydroxyzin, P.Glycoprotein inhibitors, pramintid.

Desloratadine reduces concentration and reduces the effects of acetylcholininininthines inhibitors, benzylpeniciloyl polylysin, betahistin, amphetamine, p-glycoprotein induction drugs.

Food does not affect the bioavailability of desloratadine.

Has potential for pharmacokinetic interaction of Destoratine with drugs that affect metabolic enzymes in the liver microsom such as azithromycin, cimetidin, erythromycin, fluoxetin, ketoconazole.

However, there is no important change in ECG as well as clinical symptoms, changing living functions, or any side effects recorded.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

To be out of reach of children, read the user manual carefully before use.

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