Edermik (dimetindene maleatee) oral drops solution 1 mg/ml. 25 ml. vial

Description

Edermik Composition
active substance: dimethindene maleate;
1 ml of drops (20 drops) contains dimethindene maleate (calculated as 100% dry matter) – 1 mg;

Edermik excipients:

sodium hydrogen phosphate, dodecahydrate; citric acid, monohydrate; benzoic acid (E 210); disodium edetate; saccharin sodium; propylene glycol; purified water.

Edermik Dosage form
Oral drops, solution.
Basic physical and chemical properties: clear, colorless liquid.

Pharmacotherapeutic group
Antihistamines for systemic use. ATX code R06A B03.

Pharmacodynamics
Dimethindene maleate is a histamine antagonist at the H1 receptor level. In low concentrations, it has a stimulating effect on histamine methyltransferase, which leads to inactivation of histamine. It exhibits high affinity for H1 receptors and is a mast cell stabilizer. Maleate does not affect the H2-receptors of dimethindene, it has local anesthetic properties. Dimethindene maleate is an antagonist of bradykinin, serotonin and acetylcholine. It exists in the form of a racemic mixture with R – (-) – dimethindene, which has a more pronounced H1-antihistamine activity. Dimethindene maleate significantly reduces capillary hyperpermeability associated with immediate hypersensitivity reactions. In combination with antagonists of histamine H2-receptors, it inhibits almost all types of histamine action on blood circulation. According to research data, the effect of a single dose of 4 mg of dimethindene maleate in the form of drops on skin reactions is determined up to 24 hours after administration of the drug.

Pharmacokinetics
The systemic bioavailability of dimethindene in the form of drops is approximately 70%. The initial response of the body to the drug is expected within 30 minutes after administration, the maximum response is expected within 5 hours. After taking the drops, the maximum concentration of dimetindene in the blood plasma is reached within 2 hours. At concentrations from 0.09 to 2 μg / ml, the binding of dimethindene to blood plasma proteins is approximately 90%. Metabolic reactions of dimethindene include hydroxylation and methoxylation. Its half-life is about 6 hours. Dimethindene and its metabolites are excreted by the liver and kidneys. Preclinical studies on safety, toxicity and genotoxicity did not reveal any risks when using the drug in humans. Studies in rats and rabbits did not reveal a teratogenic effect of the drug. Also, studies on rats did not reveal the effect of the drug on the ability to fertilize, as well as on the development of the fetus and newborns when used in doses 250 times higher than the dose for humans.

Indications
Symptomatic treatment of allergic diseases: urticaria, seasonal (hay fever) and perennial allergic rhinitis, drug and food allergies. Itching of various origins, except associated with cholestasis. Itching in conditions with skin rashes such as chickenpox. Insect bites. Adjuvant for eczema and other itchy dermatoses of allergic genesis.

Contraindications
Hypersensitivity to dimethindene maleate or to any other component of the drug. The patient has duodenal / pyloric stenosis.

Interaction with other medicinal products and other forms of interaction
With the simultaneous use of drugs that depress the central nervous system (CNS), for example, opioid analgesics, anticonvulsants, antidepressants (tricyclic antidepressants and monoamine oxidase inhibitors), other antihistamines, antiemetics, antipsychotics, anxiolytics, hypnotics, and possibly these drugs, scabies Central nervous system, which can lead to undesirable consequences or even to a threat to life. Tricyclic antidepressants and anticholinergic drugs, for example, bronchodilators, gastrointestinal antispasmodics, mydriatics, urological antimuscarinic drugs can cause an additional antimuscarinic effect when taken simultaneously with antihistamines, thereby increasing the risk of worsening glaucoma and urinary retention. In order to minimize the risk of CNS depression or possible potentiation, the combined use of procarbazine and antihistamines should be carried out with caution.