Fenistil drops for oral administration: instructions for using the medicine, structure, Contraindications
Active material: Dimethindene
When ATH: R06AB03
CCF: Gistaminovыh blocker H1-receptors. Allergy medication
ICD-10 codes (testimony): J30.1, J30.3, L20.8, L23, L24, L28.0, L29, L30.0, L50, T14.0, T78.3
When CSF: 13.01.01.02
Manufacturer: NOVARTIS CONSUMER HEALTH S.A. (Switzerland)
Fenistil drops: dosage form, composition and packaging
◊ Drops for intake clear, Colorless, practically odorless.
| 1 ml (20 drops) | |
| dimethindene maleate | 1 mg |
Excipients: Sorbitol liquid (noncrystallizing), sodium dihydrogen phosphate dihydrate, metilparagidroksiʙenzoat, ethanol 96%, Purified water.
20 ml – vials of dark glass (1) with dropper-dispenser – packs cardboard.
Fenistil drops: pharmachologic effect
Gistaminovыh blocker H1-receptors. It has anti-allergic and antipruritic effect. Reduces the increased capillary permeability, associated with allergic reactions.
Blocks the action of kinins, It has a weak anticholinergic action, It may cause a slight sedative effect.
Fenistil drops: pharmacokinetics
Absorption
After intake of rapidly absorbed. Cmax plasma levels reached within 2 no. Bioavailability is about 70%.
Distribution
Protein binding is about 90%. It penetrates the tissues.
Metabolism
It is metabolized in the liver by hydroxylation and methoxylation.
Deduction
T1/2 is 6 no. Excreted in the bile and urine (90% – It saw in the metabolite, 10% – in unchanged form).
Fenistil drops: testimony
- allergic diseases (hives, hay fever, perennial allergic rhinitis, food and drug allergy, angioedema);
- itching of various origins (eczema, other itchy dermatoses, itching varicella, peel, Rubella, insect bites);
- prevention of allergic reactions during hyposensitizing therapy.
Fenistil drops: dosing regimen
When administered to adults and children over 12 years daily dose is normally 3-6 mg, divided by 3 admission (ie. by 20-40 drops 3 times / day).
Patients, prone to sleepiness, It is encouraged to nominate 40 drops before bedtime and 20 drops in the morning, during breakfast.
To children aged 1 months before 12 years daily doses given in the table. The daily dose should be divided into 3 admission.
| Patients | Single dose (drop *) | Daily dose (drop *) |
| Children 1 Months before 1 year | 3-10 | 10-30 |
| Children 1 Year to 3 years | 10-15 | 30-45 |
| Children 3 to 12 years | 15-20 | 45-60 |
* 20 drops = 1 ml = 1 mg dimethindene maleate.
Fenistil Drops® not be exposed to high temperatures; they should be added to the bottle to warm baby food immediately before feeding. If a child is already being fed with a spoon, Drops may be given undiluted, teaspoon. The drops have a pleasant taste.
Fenistil drops: side effects
CNS: drowsiness (at the beginning of treatment), dizziness, excitation, headache.
From the digestive system: nausea, dry mouth.
The respiratory system: dryness in the throat, respiratory disorders.
Other: swelling, skin rash, muscle spasm.
Fenistil drops: Contraindications
- zakrыtougolynaya glaucoma;
- prostatic hyperplasia;
- Children up to age 1 Months (especially premature);
- pregnancy (I trimester);
- lactation (breast-feeding);
- hypersensitivity to dimethindene and other components, part of the drug.
FROM caution Fenistil should be administered® patients with bronchial asthma and chronic obstructive pulmonary disease, as well as children under the age of 1 year, tk. their sedation may be accompanied by episodes of sleep apnea.
Fenistil drops: Pregnancy and lactation
Fenistil® contraindicated in pregnancy (I trimester) and lactation.
Application fenistil® Pregnancy (in II and III trimesters) possible only for health and under medical supervision.
Fenistil drops: Special instructions
Drops should not be exposed to high temperatures. In the appointment of infants should be added to the bottle to warm baby food immediately before feeding. If a child is already being fed with a spoon, Drops may be given undiluted. The drops have a pleasant taste.
The drug is not effective for itching, associated with cholestasis.
Effects on ability to drive vehicles and management mechanisms
Patients, activities which require high concentration and rapid psychomotor reactions (driving, using machinery), it is not recommended to take the drug.
Fenistil drops: overdose
Symptoms: CNS depression and lethargy (mainly in adults), CNS stimulation and anticholinergic effects (especially in children), incl. excitation, ataxia, tachycardia, hallucinations, tonic or clonic seizures, midriaz, dry mouth, redness of the face, urinary retention, fever, decrease in blood pressure, collapse.
Treatment: should appoint the activated carbon, saline laxative; to take measures to maintain the function of the cardiovascular and respiratory systems (analeptics should not apply).
Fenistil drops: drug interaction
Fenistil® enhances the effect of anxiolytics and hypnotics.
When concomitant administration with Fenistilom® ethanol marked slowdown in the rate of reaction.
MAO inhibitors enhance the anticholinergic and a depressing effect on the central nervous system.
In an application with Fenistilom® tricyclic antidepressants, and anticholinergics may increase the risk of elevated intraocular pressure.
Fenistil drops: terms of dispensing from pharmacies
The drug is resolved to application as an agent Valium holidays.
Fenistil drops: terms and conditions of storage
The drug should be stored out of reach of children at or above 30 ° C. The bottle should be stored in their original carton.
