Storage:
active substance: mebhydrolin;
1 dragee contains 50 mg (0.05 g) or 100 mg (0.1 g) of mebhydrolin based on 100% dry matter;
excipients: sucrose, starch molasses, talc, yellow wax, sunflower oil.
Medicinal form. Dragee.
Main physicochemical properties: white or almost white dragees. In a cross section, two layers are visible. Dragees should have a spherical shape.
Pharmacotherapeutic group.
Antihistamines for systemic use.
ATX code R06A X15.
Pharmacological properties.
Pharmacodynamics.
Mebhydrolin belongs to antihistamine drugs, is a blocker of H1 histamine receptors. Mebhydrolin weakens the spasmogenic effect of histamine on the smooth muscles of the bronchi and intestines, as well as its effect on vascular permeability. Unlike antihistamines of the first generation (diphenhydramine, suprastin), it has a less pronounced sedative and hypnotic effect. It has weak m-choline blocking and anesthetic properties.
Pharmacokinetics.
It is quickly absorbed from the digestive tract. Bioavailability ranges from 40 to 60%. The therapeutic effect develops after 15 – 30 minutes, the maximum effect is observed after 1 – 2 hours. The duration of the effect can reach 2 days. The drug practically does not penetrate the blood-brain barrier, is metabolized in the liver by methylation, induces liver enzymes, and is excreted by the kidneys.
Clinical characteristics.
Indication.
Prevention and treatment of seasonal and allergic rhinitis, pollinosis, urticaria, food and drug allergies, dermatoses accompanied by skin itching (eczema, neurodermatitis).
Contraindication.
Hypersensitivity to the components of the drug. Peptic ulcer disease of the stomach and duodenum in the period of exacerbation, inflammatory diseases of the digestive tract, pylorostenosis, hyperplasia of the prostate gland, angle-closure glaucoma, epilepsy, heart rhythm disorders.
Interaction with other medicinal products and other types of interactions.
Diazolin® potentiates the effect of sleeping pills, sedatives and other drugs that suppress the central nervous system, as well as alcohol.
Features of application.
Diazolin® is prescribed with caution in severe liver and/or kidney failure (possible dose adjustment and increased intervals between doses). During treatment with Diazolin®, drinking alcoholic beverages and taking drugs containing ethanol are not recommended.
If you have an intolerance to some sugars, consult your doctor before taking this medicine.
Use during pregnancy or breastfeeding.
It is contraindicated to use the drug during pregnancy or breastfeeding.
The ability to influence the speed of reaction when driving vehicles or other mechanisms. When using the drug, it is not recommended to drive vehicles and engage in other potentially dangerous activities that require concentration.
Method of application and dosage.
Diazolin® should be prescribed internally, after meals, to adults and children over 12 years of age at 100 – 200 mg 1 – 2 times a day. Maximum doses for adults: single – 300 mg, daily – 600 mg.
Children aged 5 – 12 years should be prescribed 50 mg 1 – 3 times a day; children aged 3-5 years – 50 mg 1-2 times a day.
The duration of treatment is determined by the doctor depending on the nature of the disease, clinical effect and tolerability of the drug.
Children. Use the drug for children over 3 years of age.
Overdose.
With an overdose of the drug, the risk of adverse reactions, which are described in the corresponding section, increases. In this case, the drug is canceled, if necessary, measures of general detoxification (gastric lavage, forced diuresis), symptomatic therapy are carried out.
Adverse reactions.
From the side of the digestive system: irritation of the mucous membranes of the gastrointestinal tract, which is sometimes manifested by dyspeptic phenomena (heartburn, nausea, pain in the epigastric region).
From the side of the central nervous system: dizziness, paresthesias, increased fatigue, drowsiness, blurred visual perception, slowing of the speed of reactions, tremors, anxiety (at night).
Others: dry mouth, urination disorders, allergic reactions. Granulocytopenia and agranulocytosis are extremely rare.
Paradoxical reactions are sometimes observed in children: increased excitement, tremors, sleep disturbances, irritability.
In isolated cases, the following adverse reactions were noted in the post-registration period: headache, itching, rash, urticaria, Quincke’s edema.
Expiration date.
3 years and 6 months.
Do not use the drug after the expiration date indicated on the package.
Storage conditions.
Store in a place protected from light at a temperature not higher than 25 °C.
Keep out of the reach of children.
Packaging. 10 dragees in a blister without putting in a pack.
10 dragees in a blister. 2 blisters in a pack.
Release category. Without a prescription.
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