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Composition

active ingredient: dimethindene maleate;


1 ml (20 drops) of the drug contains dimethindene maleate 1 mg;


excipients: sodium hydrophosphate, citric acid, sodium saccharin, propylene glycol, disodium edetate, benzoic acid (E 210), purified water.


Dosage form

Oral Drops, solution.


Basic physical and chemical properties: colorless transparent solution.


Pharmacotherapeutic group

Antihistamines for systemic use.


ATX code R06A B03.


Pharmacological properties

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 shows a high affinity for H1 receptors and is a stabilizer of mast cells. Dimethindene maleate does not affect H2 receptors. It also has local anesthetic properties.


Dimethindene maleate is an antagonist of bradykinin, serotonin, and acetylcholine. It exists as a racemic mixture with R-(-)-dimethindene, which has a more pronounced H1-antihistamine activity.


Dimethindene maleate significantly reduces capillary hyperpermeability, which is associated with immediate hypersensitivity reactions.


In combination with histamine H2 receptor antagonists, it inhibits almost all types of histamine action on blood circulation.


Studies have shown that the effect of 1 dose of 4 mg dimethindene 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 – within 5 hours. After taking the drops, the maximum concentration of dimethindene in the blood plasma is reached within 2 hours.


At concentrations from 0.09 to 2 micrograms/ML, The Binding of dimethindene to plasma proteins is approximately 90 %. Metabolic reactions of dimethindene include hydroxylation and methoxylation.


Its elimination Half-Life is almost 6 hours. Dimethindene and its metabolites are excreted by the liver and kidneys.


Preclinical studies on safety, toxicity and genotoxicity have not revealed any risk when using the drug in humans. Studies in rats and rabbits did not reveal a teratogenic effect of the drug. Also, in the course of studies on rats, no effect of the drug on the ability to fertilize, as well as on the development of the fetus and newborns, was found when used in doses that are 250 times higher than the dosage for humans.


Indications

Symptomatic treatment of allergic diseases: urticaria, seasonal (hay fever) and year-round allergic rhinitis, allergies to medicines and food.


Pruritus of various origins, except for those associated with cholestasis. Itching in diseases with skin rashes, such as chickenpox. Insect bites.


Auxiliary agent for eczema and other itchy dermatoses of allergic origin.


Contraindications

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


Interactions with other drugs and other types of interactions

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, sleeping pills, scopolamine and ethyl alcohol, it is possible to increase CNS depression, which can lead to undesirable consequences or even life-threatening.


Tricyclic antidepressants and anticholinergic drugs, such as bronchodilators, gastrointestinal antispasmodics, mydriatics, urological antimuscarinic agents, can cause an additional antimuscarinic effect when taken together with antihistamines, which increases 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.


Application features

As with other antihistamines, caution should be exercised when using Dimethindene-zdorovye in patients with glaucoma, urinary disorders, including prostatic hypertrophy, as well as with chronic lung diseases. 


As with all H1-receptor antagonists and partially H2-receptor antagonists, this drug should be used with caution in patients with epilepsy. Antihistamines can cause agitation in children.


Use during pregnancy or lactation.


Animal studies have not revealed any teratogenic effects of dimethindene and any direct or indirect harmful effects on pregnancy, embryonic development, and/or postnatal development. However, since there is currently no information on the use of the drug during pregnancy, the drug Dimethindene-zdorovye can only be prescribed when it is extremely necessary. It is not recommended to take the drug during breast-feeding. If necessary, breast-feeding should be discontinued for the duration of treatment.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


When taking the drug, it is possible to slow down the speed of psychomotor reactions, drowsiness, dizziness, so you should refrain from driving a car or working with mechanical means.


Dosage and administration

Adults, children over 12 years of age, and elderly patients.


The recommended daily dose is 3-6 mg, divided into 3 doses – 20-40 drops 3 times a day. Patients who are prone to drowsiness are recommended to prescribe 40 drops before bedtime and 20 drops in the morning, during breakfast.


Children.


Taking the drug is recommended after prior consultation with a doctor, children aged 1 month to 1 year can only be used after consultation with a doctor. The recommended daily dose is 0.1 mg (i.e. 2 drops) per kg of body weight per day, divided into 3 doses.


20 drops = 1 ml = 1 mg of dimethindene maleate.


The drug should not be exposed to high temperatures. In a bottle of warm baby food, it should be added Immediately before feeding. If the child is fed from a spoon, the drug can be used undiluted, in a teaspoon. The drug has a pleasant taste.


The duration of the course of treatment is determined by the doctor individually.


Children. Do not prescribe to children under 1 month of age, especially premature babies. Caution should be exercised when prescribing the drug in the form of drops to children under 1 year of age: sedation may be accompanied by episodes of nocturnal apnea. In young children, antihistamines can cause arousal.


Dimethindene-zdorovye can be used in children aged 1 month to 1 year only after consulting a doctor and if there are clear indications for treatment with antihistamines. Do not exceed the recommended dose.


Overdose

Overdose of Dimethindene-zdorovye, like other antihistamines, may cause the following symptoms: central nervous system (CNS) depression, drowsiness (mainly in adults), CNS stimulation, and anticholinergic effects (especially in children), including agitation, ataxia, tachycardia, hallucinations, seizures, tremor, urinary retention, and fever. Hypotension, coma, and cardiorespiratory collapse may also occur after this.


There is no specific antidote for an overdose of antihistamines. Standard measures should be taken, which include taking activated charcoal, a saline laxative, and taking measures to maintain the functions of the cardiovascular and respiratory systems. The use of stimulants is not recommended. Vasoconstrictors can be used to treat hypotension.


Side effects

The main side effect of using the drug is drowsiness, especially at the beginning of treatment. In very rare cases, allergic reactions may occur.


Possible side effects.


From the immune system.


Rare: anaphylactic reactions, including facial edema, pharyngeal edema, rash; muscle spasms and shortness of breath.


Mental disorders.


Isolated: arousal.


From the nervous system.


Very common: increased fatigue.


Often drowsiness, nervousness.


Isolated cases: headache, dizziness.


From the digestive tract.


Isolated: gastrointestinal disorders, nausea, dry mouth and throat.

Tags: Dimetinden