Eden

On the shelves of modern pharmacies you can find a wide selection of products pharmacological factory Farmak (Ukraine), which is relatively low-cost, while the quality of its goods is not inferior in performance to foreign counterparts. Edam is one of these products.

Indications Eden

The active chemical compound of the drug is desloratadine (desloratadine). Possessing high antihistaminic characteristics of systemic exposure, he dictates the indications for the use of Eden:

• The medicine is prescribed in case of diagnosing seasonal rhinitis of an allergic nature.
• Therapy, which works as a supportive in the case of chronic rhinitis caused by an allergy, which does not pass the whole year and does not depend on seasonality.
• Conjunctivitis caused by allergic irritants.
• Elimination of such symptoms:
  • Regular discharge of watery mucus from the nasal passages, similar to catarrhal discharge (rhinorrhea).
  • Irritating itching in the area of the sky, in the eyes.
  • Reducing the permeability of capillaries.
  • Sneezing.
  • Swelling of the mucous, causing nasal congestion and problems with swallowing.
  • Tear.
  • Nasal congestion.
  • Spasmodic smooth muscles.
  • Redness of the conjunctiva.
• Cessation of urticaria in the stage of chronic course, unknown genesis.

[1], [2], [3], [4], [5], [6], [7]

Release form

The basic active substance of the Eden drug is the chemical compound desloratadine (desloratadine). Its content in a unit of the drug is 5 mg, when converted to an anhydrous substance.

Additional chemical compounds included in the preparation: a glaver containing glucose and fructose, disodium dodecahydrate phosphate, disodium ethylenediaminetetraacetic acid, sorbitol, 1,2-propylene glycol, citric acid, a food coloring that gives a yellowish tinge, a sodium salt of benzoic acid , pure water.

On the pharmacological market this preparation is presented:

1. The standard and predominantly used form of release is tablets, each of which has 5 mg desloratadine in its composition. The unit of medicine has a round, slightly convex contour. The active substance of the preparation is protected by a rigid coating, which has a bluish tinge. Ten blisters are placed on one blaster. The manufacturer offers packages with one or three blasters inside and an instruction on the use of the medication attached to the medicine.
2. Form release - a solution in the form of syrup. 1 ml of the drug's liquid substance contains 0.5 mg of the active base compound, which is desloratadine. It is a transparent, viscous orange-colored liquid. The syrup is poured over vials of 60 ml or 100 ml. A bottle, together with a measuring spoon and instructions for use, is placed in a classic cardboard box.

[8], [9], [10], [11], [12]

Pharmacodynamics

Mainly, the pharmacodynamics of Eden is conditioned by the physico-chemical characteristics of desloratadine. This chemical compound has practically no sedative effect, does not affect the psychomotor reactions of the patient's body. Reception desloratadine does not provoke prolongation of the QT interval on the electrocardiogram, does not show systemic effects on the receptors of the central nervous and cardiovascular system as a whole.

Active active substance Edema is a selective, sequentially acting blocker of peripheral H1-histamine prolonged receptors. Desloratadine effectively inhibits or completely removes various kinds of allergic reactions that provoke the development and progression of inflammatory processes. This property of the drug allows the release of cytokines (peptide information molecules), including interleukins such as IL-4, IL-6, IL-8, IL-13. A similar process occurs with inflammatory chemokines (secreted proteins) or chemokine receptors, which include RANTES.

Due to the action of Eden, the release of the product of superoxide anions is observed - this occurs under the influence of polymorphonuclear neutrophils. There is an extension of biochemical processes such as chemotaxis (directed movement of cells along the concentration gradient under the influence of chemical reagents), mediated IgE-release of histamine, D2-prostaglandin. Under the influence of desloratadine, the molecular component of adhesion (adhesion of the surfaces of two dissimilar solid and / or liquid bodies) is isolated from the adhesion of eosinophils. As a result of this reaction - the production of molecules of C4-leukotriene and P-selectin.  

The primary active metabolite of desloratadine is loratadine. Receiving Eden has an anti-inflammatory, anti-exudative, antihistamine, antipruritic and anti-allergic effect on the patient's body. Pharmacodynamics Eden does not show characteristics that allow desloratadine to penetrate the blood-brain barrier.

[13], [14], [15], [16]

Pharmacokinetics

After the receipt of the drug in the patient's body, its active chemical compound is absorbed into the mucosa of the gastrointestinal tract in a small amount of time. The time and amount of food taken, as well as the age factor of the patient does not affect the absorption parameters. Pharmacokinetics Eden shows the maximum concentration of desloratadine in the blood plasma just three hours after admission, and its minor doses can be found only half an hour after injection. The half-life (T1) is approximately 27 hours. The level of accumulation in the body of molecules of the drug substance (cumulation) corresponds to its half-life, that is, 27 hours. The drug is administered to the patient once a day. If during the two-week therapy, once the drug was administered once a day, the patient received a clinically valid dose of 5 to 20 mg, the therapeutically manifested cumulation of desloratadine in the body is not determined.

Desloratadine shows a rather insignificant level of communication with serum proteins. This indicator is characterized by approximately 83-87% of the compounds. The therapeutically substantiated bioavailability of the active chemical compound Eden, confirmed by the clinic, is determined by the limits from 5 to 20 mg.

The metabolism of desloratadine occurs in the liver. The result of intensive biotransformation is 3-OH-desloratadine, which binds to a glucuronic acid compound (glucuronide).

Only a small fraction of the amount administered is unchanged from the patient's body with urine (about two percent) and calories (less than seven percent), the rest teaches metabolites.

[17], [18], [19], [20], [21], [22], [23], [24], [25]

Dosing and administration

Depending on the overall clinical picture of the disease, the age of the patient and the state of his health at the time of Eden therapy, only the attending physician is able to correctly formulate the form, the method of administration and the dose of the drug. The drug is intended for oral administration. To get the maximum therapeutic effect, it is desirable to introduce it into the body at a certain strictly fixed time. The use of the drug does not depend on the time of taking food.

If the medicine is prescribed in the form of a syrup, it can be easily dispensed with a dosage spoon attached to the vial, which contains volume marks in 1.25 ml, 2.5 ml and 5 ml.

Mostly, the starting dosage of desloratadine for babies, whose age falls within the limits of two to five years, is one dose per day in a dose of 2.5 ml, which corresponds to half a measuring spoon.

Children, whose age falls within the limits of six to eleven years, Eden is assigned at a rate of 5 ml (one metering spoon) one daily reception. 

Adult patients and adolescents over 12 years of age are prescribed a single dose per day at a dose of 10 ml, which corresponds to two measuring spoons, or the dosage corresponds to a given amount of active substance, but in the form of a tablet. The duration of therapy is individual and directly depends on the susceptibility of the organism to the active compound of the drug, the severity of the course of the disease.

[41], [42], [43], [44], [45]

Use Eden during pregnancy

Pharmacodynamics of desloratadine limits the possibility of penetration of this compound through the blood-brain barrier. But due to the lack of sufficient clinical data, the use of Eden during pregnancy is not recommended. The only exception may be the doctor's decision about the need for this therapy, while her results far exceed the potential threat to the development of the fetus.

If treatment with an antihistamine drug is prescribed during lactation, it is better at this time to stop feeding the newborn with breastmilk.

Contraindications

Virtually every pharmacological agent has its limitations in use. There are contraindications to the use of Eden:

• The drug is not used in the treatment of children who are not yet two years old.
• Increased individual intolerance of the active substance desloratadine or other constituent components of the drug.
• The tableted form of release is not assigned to patients with a history of hypersensitivity to galactose, malabsorption of glucose-galactose, as well as lactase deficiency. This is due to the fact that the composition of the protective coating of the tablet includes lactose.
• The tablet form of release is not prescribed in the therapy of patients who have not yet turned 12 years old.
• The period of pregnancy and feeding the baby with breast milk.
• With extreme caution, prescribe the drug and its dosage if the patient suffers from renal dysfunction with a creatinine clearance lower than 30 mL per minute.
• It is worthwhile to prescribe the syrup to patients with a history of diabetes mellitus, as the composition of the liquid includes sucrose.

[26], [27], [28], [29], [30], [31], [32]

Side effects Eden

The human body is individual. Therefore, the introduction of the same drug is able to respond in different ways. Mostly, desloratadine is tolerated well, but there have been cases of adverse symptoms. Side effects of Eden, usually, are manifested by such symptoms:

• The patient can feel the dryness of the oral mucosa.
• Tachycardia.
• The onset of pain in the head and in the abdomen.
• Hepatitis.
• A high transient activity of liver enzymes may appear.
• There is rapid fatigue.
• Itching and hives.
• Studies show an increase in the bilirubin level in the blood.
• Cardiopalmus.
• Increased defecation with watery discharge.
• A nausea, an intense process that can lead to vomiting.
• Indigestion disorder.
• Psychomotor hyperactivity.
• Dizziness.
• Decrease in the general tone of the body.
• Convulsions.
• In single cases it is possible to observe puffiness of a neurotic character, up to anaphylactic shock and Quincke's edema.

In case of manifestations of one or several similar phenomena, it is necessary to inform the doctor in charge as soon as possible about it. Only a specialist is able to correctly assess the situation and take adequate measures: cancel the drug or adjust its dosage, prescribe symptomatic treatment.

[33], [34], [35], [36], [37], [38], [39], [40]

Overdose

If all recommendations for the administration of the drug have been met with monotherapy and the necessary dosage is maintained, it is problematic to exceed the active component level in the blood. With the introduction of a five-fold recommended dosage, the patient did not notice the onset and progression of severe complications.
But if in connection with the individual characteristics of the patient's body or because of an incorrectly prescribed dose, an overdose of the drug has been obtained, then it is necessary to rinse the stomach of the affected person first of all with the enema. After that, enter any enterosorbent, for example, activated carbon. And then symptomatic treatment is practiced.

Overdosage desloratadine by hemodialysis can not be corrected. To deduce an excess of a medical preparation, using peritoneal dialysis, as it does not turn out. There is no specific antidote to this situation for today.

[46], [47], [48], [49]

Interactions with other drugs

Not enough serious research has been conducted in the field of interaction of Eden with other drugs. But referring to the monitoring data of clinical complex therapy, for example, with tandem entry with such drugs as erythromycin, azithromycin, ketoconazole, cimetidine, fluoxetine, it can be noted that no significant significant changes in the effect of desloratadine on other drugs, when combined, have been identified .

But, due to the fact that the hepatic enzyme, which directly participates in the biotransformation of desloratadine in its metabolites, is not currently defined, one should not completely exclude the complete absence of mutual influence of concurrently administered drugs.

Some recommendations:

1. If the patient suffers a liver dysfunction that shows creatinine clearance below the figure of 30 ml per minute, the drug should be injected with particular caution, by constantly monitoring the kidney function.
2. For safety and to achieve the greatest effectiveness, a drug in the form of tablets should be administered only after the patient reaches the age of twelve.

[50], [51], [52], [53], [54], [55], [56], [57], [58]

Storage conditions

The long-term indicator of the effective pharmacological characteristics of the medicament depends mainly on how well the conditions of storage of Eden are maintained.

• The room should be low in humidity.
• The drug should be stored in a room where temperature values do not cross the 30 ° C mark.
• The storage location should not be accessible to children.

[59], [60]

Shelf life

If all the recommendations on storage conditions have been met, its shelf life is two years (or 24 months). After the expiry of this period, it is undesirable to apply Edem. The timeframe for the effective and safe use of the drug is necessarily reflected on the carton and on each blister of the drug.