Fenistil, allergy drops for oral use 0.1%, 20ml

Product description

Fenistil drops for oral use is an oral antihistamine that eases the symptoms of skin rashes, reduces itching and irritation from insect bites and skin-allergic reactions. * After ingestion, the drops begin to work within 30 minutes after application. *Benefits of * Fenistil Drops: – suitable for adults and children from 1 month of life, – do not contain alcohol and dyes-provide easy dosing. * Instructions for medical use, RU No. P-011663/01 of 13.05.2019

Composition

Active ingredient:

Dimethindenee Maleate 1 mg in 1 ml (20 drops)

Auxiliary substances:

Methyl parahydroxybenzoate (preservative E 218).

Ethanol is 96%.

Sodium dihydrogen phosphate dihydrate.

Sorbitol is liquid (non-crystallizing).

Purified water.

Pharmacological action

A histamine H1-receptor blocker, it is a competitive histamine antagonist. It has an anti-allergic and antipruritic effect. Reduces the increased capillary permeability associated with allergic reactions. It also has an anti-radikinin and weak m-holinoblokiruyushchy effect. When taking the drug during the day, there may be a slight sedative effect. The antihistamine effect begins to manifest itself 30 minutes after ingestion, reaching maximum severity within 5 hours.

Clinical pharmacology

Absorption After oral use, it is absorbed quickly and fairly completely. Cmax in blood plasma is reached within 2 hours. Bioavailability is about 70%. Distribution Binding to plasma proteins is 90%. Penetrates well into tissues. Metabolismmetabolized in the liver by hydroxylation and methoxylation. Excretion1 / 2 is 6 hours. It is excreted in bile and urine (90% – as a metabolite,10% – unchanged).

Indications

-allergic diseases (urticaria, hay fever, year-round allergic rhinitis, food and drug allergies, angioedema);- skin pruritus of various origins (eczema, other itchy dermatoses (including atopic dermatitis), itching in measles, rubella, chickenpox, insect bites);- prevention of allergic reactions during hyposensitizing therapy.

Use during pregnancy and lactation

Fenistil® is contraindicated in the first trimester of pregnancy and during lactation (breastfeeding). The use of Fenistil in the second and third trimesters of pregnancy is possible under the supervision of a doctor, only if the expected benefit to the mother exceeds the potential risk to the fetus.

Contraindications

-hypersensitivity to the components of the drug;— angle-closure glaucoma— – bronchial asthma;— prostatic hyperplasia— – children under 1 month of age; – I trimester of pregnancy; – lactation (breastfeeding). “Fenistil® should be used with caution in patients with chronic obstructive pulmonary diseases, epilepsy, and children aged from 1 month to 1 year (since their sedative effect may be accompanied by episodes of nocturnal apnea).

Side effects

Determining the frequency of side effects: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10 000 and <1/1000), very rare (Immune system disorders: Very rare-anaphylactoid reactions, including facial edema, 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, dry larynx. If any of the above side effects get worse, or any other side effects occur, the patient should inform the doctor.

Interaction

Fenistil ® enhances the effect of anxiolytics, hypnotics and other drugs that have a depressing effect on the central nervous system (opioid analgesics, anticonvulsants, tricyclic antidepressants, MAO inhibitors, antihistamines, antiemetics, neuroleptics, scopolamine, ethanol). Tricyclic antidepressants and m-holinoblockers (including bronchodilators, antispasmodics) increase the risk of increased intraocular pressure or urinary retention. It is necessary to avoid the combined use of antihistamines and procarbazine.

How to take, course of use and dosage

The drug is taken orally. Children aged 1 month to 12 years are recommended to take a daily dose of 100 mcg/kg of body weight, which is equivalent to 2 drops per kg of body weight. The daily dose should be divided into 3 doses. In children aged from 1 month to 1 year, the drug should be used only as prescribed by a doctor and if there are indications for the use of histamine H1 receptor blockers. For children over 12 years of age and adults, the recommended daily dose is 3-6 mg (60-120 drops), divided into 3 doses, i. e. 20-40 drops 3 times a day. Patients who are prone to drowsiness are recommended to take 40 drops before bedtime and 20 drops in the morning. 20 drops = 1 ml = 1 mg of Dimethindenee. For elderly patients (over 65 years of age), no dose adjustment is required.

Overdose

Symptoms: CNS depression and drowsiness (mainly in adults), CNS stimulation and m-holinoblocking effects (especially in children), including agitation, ataxia, tachycardia, hallucinations, tonic or clonic seizures, mydriasis, dry mouth, flushes of blood to the face, urinary retention, fever, decreased blood pressure, collapse. Treatment: you should prescribe activated charcoal, saline laxative; take measures to maintain the function of the cardiovascular and respiratory systems (do not use analeptics).

Description

Drops for oral use in the form of a clear, colorless liquid, almost odorless.

Special instructions

In children under 6 years of age, antihistamines can cause increased excitability. Drops should not be exposed to high temperatures. When prescribed to infants, they should be added to a bottle of warm baby food immediately before feeding. If the child is already being spoon-fed, drops can be given undiluted. Drops have a pleasant taste. Do not exceed the recommended dose. The drug is not effective for itching associated with cholestasis. Effects on the ability to drive vehicles and operate mechanicsmiphenistil® can weaken attention, so it should be taken with caution when driving a car, working with mechanisms, or in other types of work that require increased attention.

Form of production

Drops for oral use

Storage conditions

The drug should be stored out of the reach of children, in its original packaging, at a temperature not exceeding 25°C.

Shelf

life is 2 years.

Active ingredient

Dimethindenee

Dosage form

Drops for oral use

Description

Children older than 1 month, Pregnant women in the second and third trimester as prescribed by a doctor, For adults

Indications

Allergic Rhinitis, Dermatitis, Allergy, Dermatosis, Insect Bites, Pollinosis, Eczema, Urticaria, Allergic Conjunctivitis