Instructions for use Edermic oral drops solution 1 mg/ml bottle 25 ml
Composition
active ingredient: dimethindene maleate;
1 ml of drops (20 drops) contains dimethindene maleate (calculated on 100% dry matter) – 1 mg;
Excipients: sodium hydrogen phosphate dodecahydrate; citric acid monohydrate; benzoic acid (E 210); disodium edetate; sodium saccharin; propylene glycol; purified water.
Dosage form
Oral drops, solution.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group
Antihistamines for systemic use. ATX code R06A B03.
Pharmacological properties
Pharmacodynamics. Dimethindene maleate is a histamine antagonist at the level of H1 receptors. At low concentrations, it has a stimulating effect on histamine methyltransferase, which leads to the inactivation of histamine. It exhibits high affinity for H1 receptors and is a mast cell stabilizer. Dimethindene maleate does not affect H2 receptors, and 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-type hypersensitivity reactions.
In combination with histamine H2 receptor antagonists, it inhibits almost all types of histamine effects on the bloodstream.
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 - 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 μg/ml, the binding of dimethindene to plasma proteins is approximately 90%. The metabolic reactions of dimethindene include hydroxylation and methoxylation.
Its half-life is almost 6 hours. Dimethindene and its metabolites are excreted by the liver and kidneys.
Preclinical safety, toxicity and genotoxicity studies did not reveal any risk to humans. Studies in rats and rabbits did not reveal any teratogenic effects of the drug. Studies in rats also did not reveal any effects on fertility or on fetal and neonatal development at doses 250 times the human dose.
Indication
Symptomatic treatment of allergic diseases: urticaria, seasonal (hay fever) and perennial allergic rhinitis, allergies to medicines and foods.
Itching of various origins, except that associated with cholestasis. Itching in diseases with skin rashes, such as chickenpox. Insect bites.
An auxiliary remedy for eczema and other itchy dermatoses of allergic origin.
Contraindication
Hypersensitivity to dimethindene maleate or any other component of the drug. Presence of duodenal/pyloric stenosis in the patient.
Interaction with other medicinal products 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, hypnotics, scopolamine and ethyl alcohol, increased CNS depression is possible, which can lead to undesirable effects or even life-threatening consequences.
Tricyclic antidepressants and anticholinergic drugs, such as bronchodilators, gastrointestinal antispasmodics, mydriatics, urological antimuscarinics may cause an additive antimuscarinic effect when taken concomitantly 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 concomitant use of procarbazine and antihistamines should be carried out with caution.
Application features
As with other antihistamines, caution should be exercised when using Edermic oral drops in patients with glaucoma, urinary disorders, including prostatic hypertrophy, and chronic lung diseases.
As with all H1-receptor antagonists and some H2-receptor antagonists, this drug should be used with caution in patients with epilepsy. Antihistamines may cause agitation in children.
Use during pregnancy or breastfeeding
Animal studies have not revealed 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, Edermic oral drops should be prescribed only if absolutely necessary. It is not recommended to take the drug during breastfeeding. If necessary, breastfeeding should be discontinued for the period of treatment.
Ability to influence reaction speed when driving vehicles or other mechanisms
When taking the drug Edermic, a slowdown in the speed of psychomotor reactions, drowsiness, dizziness may occur, so you should refrain from driving a car or working with mechanisms.
Method of administration and doses
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 prone to drowsiness are recommended to be prescribed 40 drops before bedtime and 20 drops in the morning, during breakfast.
For children.
It is recommended to take the drug after prior consultation with a doctor, children aged 1 month to 1 year can be used only 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.
Edermic, oral drops, should not be exposed to high temperatures. They should be added to a bottle of warm baby food immediately before feeding. If the child is fed from a spoon, the drops can be used undiluted, in a teaspoon. The drops have a pleasant taste.
The duration of the course of treatment is determined by the doctor individually.
Children
Do not administer to children under 1 month of age, especially premature infants. Use drops with caution in children under 1 year of age: sedation may be associated with episodes of sleep apnea. Antihistamines may cause agitation in younger children.
Edermic oral drops can be used in children aged 1 month to 1 year only after consultation with a doctor and in case of clear indications for treatment with antihistamines. Do not exceed the recommended dose.
Overdose
In case of overdose with Edermic oral drops, as with other antihistamines, the following symptoms may occur: central nervous system (CNS) depression, drowsiness (mainly in adults), CNS stimulation and anticholinergic effects (especially in children), including agitation, ataxia, tachycardia, hallucinations, convulsions, tremor, urinary retention and fever. Hypotension, coma and cardiorespiratory collapse may also develop.
There is no specific antidote for antihistamine overdose. Standard measures should be taken, including administration of activated charcoal, saline laxatives, and measures to support cardiovascular and respiratory function. Stimulants are not recommended. Vasoconstrictors may be used to treat hypotension.
Adverse reactions
The main side effect of 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: agitation.
From the nervous system.
Very common: increased fatigue.
Common: drowsiness, nervousness.
Rare: headache, dizziness.
From the digestive tract.
Rare: gastrointestinal disorders, nausea, dry mouth and throat.
Expiration date
2 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
20 ml or 25 ml in a bottle.
Vacation category
Without a prescription.
Producer
JSC "Farmak".
Location of the manufacturer and its business address.
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
