Eden

On the shelves of modern pharmacies you can find a wide selection of products of the pharmaceutical plant Farmak (Ukraine), which is distinguished by a relatively low cost, while the quality of its goods is not inferior in its effectiveness to foreign analogues. Edam is one of such products.

Indications Eden

The active chemical compound of the drug is desloratadine. Possessing high antihistamine characteristics of systemic action, it dictates the indications for the use of Edem:

• The medicine is prescribed in case of diagnosis of seasonal rhinitis of allergic nature.
• A therapy that acts as a supportive treatment in case of chronic rhinitis caused by allergies, which does not go away all year round and is not dependent on seasonality.
• Conjunctivitis caused by allergic irritants.
• Elimination of such symptoms:
  • Regular discharge of watery mucus from the nasal passages, similar to that seen with a cold (rhinorrhea).
  • Irritating itching in the palate and eyes.
  • Decreased capillary permeability.
  • Sneezing.
  • Swelling of the mucous membrane, causing nasal congestion and difficulty swallowing.
  • Lacrimation.
  • Nasal congestion.
  • Smooth muscle spasm.
  • Redness of the conjunctiva.
• Relief of urticaria in the chronic stage of unknown genesis.

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Release form

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

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

This drug is presented on the pharmacological market:

1. The standard and most commonly used form of release is tablets, each containing 5 mg of desloratadine. A unit of the drug has a round, slightly convex outline. The active substance of the drug is protected by a hard shell, which has a bluish tint. Ten tablets are placed on one blaster. The manufacturer offers packages with one or three blasters inside and instructions for use of the drug attached to the drug.
2. Release form - solution in the form of syrup. 1 ml of liquid substance of the medicine contains 0.5 mg of active basic compound, which is desloratadine. It is a transparent viscous liquid of orange color. The syrup is poured into bottles of 60 ml or 100 ml. The bottle, together with a measuring spoon and instructions for use, is placed in a classic cardboard box.

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Pharmacodynamics

The pharmacodynamics of Edem are mainly determined by the physicochemical characteristics of desloratadine. This chemical compound has virtually no sedative effect and does not affect the psychomotor reactions of the patient's body. Taking desloratadine does not provoke an extension of the QT interval on the electrocardiogram, does not show a systemic effect on the receptors of the central nervous and cardiovascular systems as a whole.

The active ingredient of Edem is a selective, sequentially acting blocker of peripheral H1-histamine prolonged receptors. Desloratadine effectively suppresses or completely stops various types 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 Edem, the release of superoxide anion product is observed - this occurs under the influence of polymorphonuclear neutrophils. There is also a release of such biochemical processes as chemotaxis (directed movement of cells along the concentration gradient under the influence of chemical reagents), IgE-mediated release of histamine, D2-prostaglandin. Under the influence of desloratadine, the isolation of the molecular component of adhesion (adhesion of the surfaces of two dissimilar solid and/or liquid bodies) from the adhesion of eosinophils is observed. As a result of this reaction - the production of molecules of C4-leukotriene and P-selectin.

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

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Pharmacokinetics

After the drug enters the patient's body, its active chemical compound is absorbed by the gastrointestinal mucosa in a short period of time. The time and amount of food taken, as well as the patient's age factor, do not affect the absorption parameters. Pharmacokinetics Edem shows the maximum concentration of desloratadine in the blood plasma three hours after administration, and its minor doses can be found half an hour after administration. The half-life (T½) is approximately 27 hours. The level of accumulation of drug molecules in the body (cumulation) corresponds to its half-life, i.e. 27 hours. The drug is administered to the patient once a day. If during two-week therapy, when the drug is administered once a day, the patient received a clinically justified dose of 5 to 20 mg, therapeutically manifested cumulation of desloratadine in the body is not determined.

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

Desloratadine is metabolized in the liver. The result of extensive biotransformation is 3-OH-desloratadine, which is bound to a glucuronic acid compound (glucuronide).

Only a small proportion of the administered amount of the drug is excreted unchanged from the patient's body in urine (about two percent) and feces (less than seven percent), the rest is converted into metabolites.

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Dosing and administration

Depending on the overall clinical picture of the disease, the patient's age and health condition at the time of therapy with Edem, only the attending physician can correctly prescribe the form, method of administration and dosage of the drug. The drug is intended for oral administration. To obtain the maximum therapeutic effect, it is advisable to administer it to the body at a certain, strictly fixed time. The use of the drug does not depend on the time of food intake.

If the medicine is prescribed in the form of a syrup, it is easy to dose it using the measuring spoon supplied with the bottle, which has volume markings of 1.25 ml, 2.5 ml and 5 ml.

The usual starting dose of desloratadine for children aged two to five years is one dose per day of 2.5 ml, which is equal to half a measuring spoon.

For children between the ages of six and eleven, Eden is prescribed in the amount of 5 ml (one dosing spoon) once daily.

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

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Use Eden during pregnancy

The pharmacodynamics of desloratadine limit the ability of this compound to penetrate the blood-brain barrier. However, due to the lack of sufficient clinical data, the use of Edem during pregnancy is not recommended. The only exception may be a doctor's decision on the need for this therapy, while its results greatly exceed the potential threat to fetal development.

If treatment with an antihistamine is prescribed during lactation, it is better to stop breastfeeding the newborn during this time.

Contraindications

Almost every pharmacological agent has its limitations in use. There are also contraindications to the use of Edem:

• The medicine is not used to treat children under two years of age.
• Increased individual intolerance to the active substance desloratadine or other components of the drug.
• The tablet form is not prescribed to patients with a history of hypersensitivity to galactose, glucose-galactose malabsorption, or lactase deficiency. This is due to the fact that the protective coating of the tablet contains lactose.
• The tablet form is not prescribed for the treatment of patients under 12 years of age.
• The period of pregnancy and breastfeeding.
• The drug and its dosage should be prescribed with particular caution if the patient suffers from renal dysfunction with creatinine clearance below 30 ml per minute.
• The syrup should be prescribed with caution to patients with a history of diabetes mellitus, since the liquid contains sucrose.

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Side effects Eden

The human body is individual. Therefore, it can react differently to the introduction of the same drug. Desloratadine is generally well tolerated by patients, but cases of side effects have been observed. Side effects of Edem usually manifest themselves in the following symptoms:

• The patient may feel dryness of the oral mucosa.
• Tachycardia.
• The occurrence of pain in the head and in the abdominal area.
• Hepatitis.
• High transient activity of liver enzymes may occur.
• Rapid fatigue is observed.
• Itching and hives.
• Studies show an increase in bilirubin levels in the blood.
• Increased heart rate.
• Frequent bowel movements with watery discharge.
• Nausea, an intense process that can lead to vomiting.
• Digestive upset.
• Psychomotor hyperactivity.
• Dizziness.
• Decreased overall tone of the body.
• Cramps.
• In isolated cases, swelling of a neurotic nature can be observed, including anaphylactic shock and Quincke's edema.

If one or more of these phenomena occur, you should inform your doctor as soon as possible. Only a specialist can correctly assess the situation and take adequate measures: cancel the drug or adjust its dosage, prescribe symptomatic treatment.

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Overdose

If all the recommendations for administering the drug were followed during monotherapy and the required dosage was maintained, it is quite problematic to exceed the norm of the active component in the blood. When administering a fivefold recommended dosage, the patient did not experience any occurrence or progression of severe complications.
But if, due to the individual characteristics of the patient's body or due to an incorrectly prescribed dose, an overdose of the drug was received, then the first thing to do is to wash the victim's stomach with an enema. After this, any enterosorbent should be administered, for example, activated carbon. And then symptomatic treatment is practiced.

An overdose of desloratadine cannot be corrected by hemodialysis. It is also impossible to remove excess medication using peritoneal dialysis. There is currently no specific antidote for this situation.

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Interactions with other drugs

There have been no sufficiently serious studies in the field of interaction of Edem with other drugs. But referring to the data of monitoring clinical complex therapy, for example, with tandem administration 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 administered together, have been identified.

However, due to the fact that at the moment the liver enzyme that is directly involved in the biotransformation of desloratadine into its metabolites has not been identified, the complete absence of mutual influence of concomitantly administered drugs should not be completely ruled out.

Some recommendations:

1. If the patient suffers from liver dysfunction, which shows creatinine clearance below 30 ml per minute, the drug should be administered with particular caution, constantly monitoring renal function.
2. For safety and maximum effectiveness, the drug in tablet form should only be prescribed to patients aged twelve years or older.

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Storage conditions

The long-term effectiveness of the pharmacological characteristics of the drug mainly depends on how correctly the storage conditions of Edem are maintained.

• The room should have low humidity.
• The drug must be stored in a room where the temperature does not exceed 30°C.
• The storage location must not be accessible to children.

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Shelf life

If all recommendations for storage conditions of the drug have been followed, its shelf life is two years (or 24 months). After this period, it is not advisable to use Edem. The time frame for the effective and safe use of the drug is necessarily reflected on the cardboard packaging and on each blister of the drug.