Fenistil® (Fenistil®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDimethindenDimethinden
Dosage form: & nbsp

drops for oral administration.

Composition:

Active substance: dimethindene maleate.

1 ml of drops for oral administration contains 1 mg of dimethindene maleate

Excipients:

Sodium hydrophosphate dodecahydrate, citric acid monohydrate, benzoic acid, disodium edetate, sodium saccharinate, propylene glycol, purified water.
Description:colorless, clear liquid with practically no odor.
Pharmacotherapeutic group:Antiallergic agent - H1-histamine receptor blocker.
ATX: & nbsp

R.06.A.B.03   Dimethinden

D.04.A.A.13   Dimethinden

D.04.A.A   Antihistamines for external use

R.06.A.B   Alkylamines substituted

Pharmacodynamics:

Antihistamine, anti-allergic and antipruritic. Block H1-gistaminovyh receptors, is a competitive antagonist of histamine.

The drug reduces the increased permeability of capillaries, associated with allergic reactions.

It also has an anti-bradykinin and a weak m-holin-blocking effect.When taking the drug during the day, there may be a minor sedative effect.

Pharmacokinetics:Quickly and fairly fully absorbed when taken orally. Bioavailability is about 70%. Antihistaminic affect begins to appear 30 minutes after ingestion, reaching a maximum expression within 5 hours. Time to achieve the maximum concentration of dimethinden in the blood plasma after oral administration of drops - 2 hours. The connection with plasma proteins is 90%. Well penetrates into the tissue. Metabolised in the liver by hydroxylation and methoxylation. Half-life is 6 hours. It is excreted with bile and urine (90% in the form of metabolite and 10% in unchanged form).
Indications:

Allergic diseases: urticaria, hay fever, year-round allergic rhinitis, angioedema, food and drug allergy.

Itching of various origin (eczema, itching dermatoses: including atopic dermatitis, measles, rubella, chicken pox, insect bites).

Prevention of allergic reactions during hyposensitizing therapy.

Contraindications:Hypersensitivity to dimstindene and other components that make up the drug,closed angle glaucoma, bronchial asthma, prostatic hyperplasia, children under 1 month, pregnancy I trimester, the period of breastfeeding.
Carefully:

With chronic obstructive pulmonary disease, epilepsy. In children aged 1 month to 1 year, since sedation can be accompanied by episodes of nocturnal apnea.

Pregnancy and lactation:

The use of Fenistil® during pregnancy (II-III trimester) is possible under the supervision of a doctor, only if the expected benefit to the mother exceeds the potential risk to the fetus. The use of the drug Fenistil® during breastfeeding is contraindicated.

Dosing and Administration:

Inside.

Children from 1 month to 12 years of age: a daily dose of 0.1 mg / kg body weight is recommended, which is equivalent to 2 drops per kg of body weight. The daily dose should be divided into 3 divided doses. Children aged 1 month to 1 year should take the drug only as prescribed by the doctor and if there are indications for the use of H1-histamine receptor blockers.

Children over 12 years and adults: the recommended daily dose is 3-6 mg dimethindene (60 - 120 drops), divided into 3 doses, that is, 20-40 drops 3 times a day. 20 drops = 1 ml = 1 mg dimethindsen.

For older patients (over 65 years), dose adjustment is not required. Patients prone to drowsiness, it is recommended to use 40 drops before bedtime and 20 drops in the morning.

Side effects:

Classification of incidence of adverse reactions: very frequent (≥1 / 10), frequent (≥1 / 100 to <1/10), infrequent (≥1 / 1,000 to <1/100), rare (≥1 / 10,000 to <1 / 1,000), very rare (<1 / 10,000), including individual messages and reactions with an unknown frequency.

Immune system disorders:

Very rarely: anaphylactoid reactions, including facial edema, pharyngeal edema, rash, muscle spasms and shortness of breath.

Disorders of the psyche:

Rarely: anxiety.

Impaired nervous system:

Very often: fatigue.

Often: drowsiness, nervousness.

Rarely: headache, dizziness.

Disorders from the gastrointestinal tract:

Rarely: gastrointestinal disorders, nausea, dry mouth, dryness in the larynx.
If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.
Interaction:Strengthens the action of anxiolytics, hypnotics and other drugs that depress the function of the central nervous system (opioid analgesics, anticonvulsants drugs, tricyclic antidepressants, MAO inhibitors, antihistamines, antiemetics, neuroleptics, scopolamine, ethanol). Tricyclic antidepressants and m-cholinoblockers (bronchodilators, gastrointestinal antispasmodics, etc.) increase the risk of increased intraocular pressure or urinary retention. It is also necessary to avoid the joint use of antihistamines and procarbazine.
Special instructions:

In young children, in particular, before the age of 6, antihistamines can cause increased excitability.

Drops Fenistil® Do not expose to high temperatures; when administered to infants, they should be added to a bottle of warm baby food just before feeding. If the child is already fed from a spoon, the drops can be given undiluted. Drops have a pleasant taste. Do not exceed the recommended dose. Ineffective in itching associated with cholestasis.
Effect on the ability to drive transp. cf. and fur:Like other antihistamines, the drug Fenistil® can weaken attention, so it should be taken with caution when driving, working with machinery, or in other types of work that require increased attention.
Form release / dosage:Drops for ingestion 1 mg / ml.
Packaging:

For 20 ml in a bottle of dark glass, equipped with a dropper dispenser made of low density polyethylene and a polypropylene lid. The bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:At a temperature of no higher than 25 ° C.
Store the vial in its own carton. In a place inaccessible to children.
Shelf life:3 years. The drug should not be used after the expiration date.
Terms of leave from pharmacies:Without recipe
Registration number:П N011663 / 01
Date of registration:01.04.2011
The owner of the registration certificate:Новартис Консьюмер Хелс САНовартис Консьюмер Хелс СА Switzerland
Manufacturer: & nbsp
Representation: & nbspNOVARTIS CONSUMER HELS S.A. (part of Novartis groups) NOVARTIS CONSUMER HELS S.A. (part of Novartis groups) Switzerland
Information update date: & nbsp06.01.16
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