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Active ingredients
Dimetinden
Release form
Drops
Composition
Dimetindena maleate 1 mg. Auxiliary substances: sodium hydrogen phosphate dodecahydrate - 16 mg, citric acid monohydrate - 5 mg, benzoic acid - 1 mg, disodium edetate - 1 mg, sodium saccharinate - 0.5 mg, propylene glycol - 100 mg, purified water - 888.5 mg .
Pharmacological effect
Histamine H1 receptor blocker, is a competitive histamine antagonist. It has anti-allergic and antipruritic effect. Reduces the increased capillary permeability associated with allergic reactions. It also has an anti-bradykinin and weak m-anticholinergic blocking effect. When taking the drug during the day may have a slight sedative effect. The antihistamine effect begins to appear 30 minutes after ingestion, reaching maximum severity within 5 hours.
Pharmacokinetics
AbsorptionAfter ingestion is absorbed quickly and completely. Cmax in plasma is achieved within 2 hours. Bioavailability is about 70%. Distribution: Plasma protein binding is 90%. It penetrates tissues well. Metabolism Metabolizes in the liver by hydroxylation and methoxylation. Output T1 / 2 is 6 hours. It is excreted in bile and urine (90% in the form of a metabolite, 10% in an unchanged form).
Indications
- allergic diseases (urticaria, hay fever, perennial allergic rhinitis, food and drug allergies, angioedema); - pruritus of various origins (eczema, other itchy dermatosis / including atopic dermatitis /, itching for measles, rubella, varicella smallpox, insect bites); - prevention of allergic reactions during hyposensitization therapy.
Contraindications
- hypersensitivity to the components of the drug; - angle-closure glaucoma; - bronchial asthma; - prostatic hyperplasia; - children up to 1 month; - I trimester of pregnancy; - lactation (breastfeeding) .With caution, Fenistil should be prescribed; patients with chronic obstructive pulmonary diseases, epilepsy, children aged 1 month to 1 year (because they may have a sedative effect accompanied by episodes of sleep apnea).
Precautionary measures
Use in childrenIt is contraindicated: children up to 1 month (especially premature). Fenistil should be prescribed with caution; children under the age of 1 year, because they have a sedative effect may be accompanied by episodes of sleep apnea.
Use during pregnancy and lactation
Fenistil; contraindicated in the first trimester of pregnancy and lactation (breastfeeding). The use of Fenistil in the second and third trimesters of pregnancy is possible under the supervision of a physician, only if the expected benefit to the mother outweighs the potential risk to the fetus.
Dosage and administration
The drug is taken orally. For children aged 1 month to 12 years, a daily dose is recommended at the rate of 100 mcg / kg body weight, which is equivalent to 2 drops per kg body weight. The daily dose should be divided into 3 doses. In children aged 1 month to 1 year, the drug should be used only as prescribed by a doctor and, if indicated, histamine H1 receptor blockers are indicated. The recommended daily dose for children over 12 years old and adults is 3-6 mg (60-120 drops) divided into 3 doses, i.e. 20-40 drops 3 times / day. For patients prone to drowsiness, it is recommended to prescribe 40 drops at bedtime and 20 drops in the morning. 20 drops = 1 ml = 1 mg of dimetinden. For elderly patients (over 65), dose adjustment is not required .
Side effects
Determination of the frequency of side effects: very often (≥1 / 10), often (≥1 / 100 and <1/10), infrequently (≥1 / 1000 and <1/100), rarely (≥1 / 10 000 and <1 / 1000), very rarely (<1/10 000), including individual messages and reactions with an unknown frequency. On the immune system: very rarely - anaphylactoid reactions, including facial swelling, pharyngeal edema, rash, muscle spasms and shortness of breath. Mental disorders : rarely - anxiety. From the nervous system: very often - fatigue; often - drowsiness, nervousness; rarely - headache, dizziness. From the digestive system: rarely - gastrointestinal disorders, nausea, dry mouth, dryness in the larynx. If any of the above side effects worsen, or any other side effects occur, the patient should report this to the doctor.