Composition, form of production and packaging
? Drops for oral administration as a clear, colorless liquid, practically odorless.
1 ml (20 drops)
dimethindene maleate 1 mg
Excipients: 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.
20 ml - bottles of dark glass (1) with a dropper dispenser - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
The blocker of histamine H 1 -receptors is a competitive histamine antagonist. Has antiallergic and antipruritic effect. 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.
The antihistaminic effect begins to appear 30 minutes after ingestion, reaching a maximum expression within 5 hours.
PHARMACOKINETICS
Suction
After intake, absorbed quickly and fairly fully. C max in blood plasma is achieved within 2 hours. Bioavailability is about 70%.
Distribution
Binding to plasma proteins is 90%. Well penetrates into the tissue.
Metabolism
Metabolised in the liver by hydroxylation and methoxylation.
Excretion
T 1/2 is 6 hours. It is excreted with bile and urine (90% in the form of metabolite, 10% in unchanged form).
INDICATIONS
- allergic diseases (hives, hay fever, allergic rhinitis all year round, food and drug allergies, angioedema);
- skin itch of different origin (eczema, other itching dermatoses / including atopic dermatitis /, itching with measles, rubella, chickenpox, insect bites);
- prevention of allergic reactions during hyposensitizing therapy.
DOSING MODE
The drug is taken orally.
Children aged 1 month to 12 years are recommended a daily dose of 100 Ојg / kg body weight, equivalent to 2 drops per kg of body weight. The daily dose should be divided into 3 divided doses.
In children aged 1 month to 1 year, the drug should be used only as directed by a doctor and if there are indications for the use of histamine H 1 -receptor blockers.
For children over 12 years and adults, the recommended daily dose is 3-6 mg (60-120 drops) divided into 3 doses, i.e. 20-40 drops 3 times / day.
Patients prone to drowsiness, it is recommended that 40 drops be prescribed at bedtime and 20 drops in the morning.
20 drops = 1 ml = 1 mg dimethindene.
For patients of advanced age (over 65 years), dose adjustment is not required.
SIDE EFFECT
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 part of the immune system: very rarely - anaphylactoid reactions, including facial edema, pharyngeal edema, rash, muscle spasms and shortness of breath.
Disorders of the psyche: 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 are aggravated, or any other side effects occur, the patient should notify the doctor.
CONTRAINDICATIONS
- hypersensitivity to the components of the drug;
- an angle-closure glaucoma;
- bronchial asthma;
- hyperplasia of the prostate;
- Children's age up to 1 month;
- I trimester of pregnancy;
lactation period (breastfeeding).
Caution should be given to FenistilВ® in patients with chronic obstructive pulmonary diseases, epilepsy, children aged 1 month to 1 year (because they have a sedative effect may be accompanied by episodes of nocturnal apnea).
PREGNANCY AND LACTATION
Fenistil В® is contraindicated in the first trimester of pregnancy and during lactation (breastfeeding).
The use of Fenistil in the II and III trimesters of pregnancy is possible under the supervision of a doctor, only if the expected benefit for the mother exceeds the potential risk to the fetus.
APPLICATION FOR CHILDREN
Contraindicated: children under 1 month (especially premature). With caution should appoint Fenistil В® to children under the age of 1 year, t. they have a sedative effect can be accompanied by episodes of nocturnal apnea.
SPECIAL INSTRUCTIONS
In children under 6 years of age, antihistamines may cause increased excitability.
Do not expose the drops to high temperatures.
When given 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.
The drug is not effective for itching associated with cholestasis.
Impact on the ability to drive vehicles and manage mechanisms
Fenistil В® can weaken attention, so it should be taken with caution when driving, working with machinery, or in other types of work requiring increased attention.
OVERDOSE
Symptoms: CNS depression and drowsiness (mainly in adults), CNS stimulation and m-cholinoblocking effects (especially in children), incl. excitation, ataxia, tachycardia, hallucinations, tonic or clonic convulsions, mydriasis, dry mouth, flush of the face, urinary retention, fever, lowering of blood pressure, collapse.
Treatment: should be assigned activated charcoal, saline laxative; carry out activities to maintain the function of the cardiovascular and respiratory systems (do not apply analeptics).
DRUG INTERACTION
Fenistil В® enhances the action of anxiolytics, hypnotics and other drugs that have a depressing effect on the central nervous system (opioid analgesics, anticonvulsant drugs, tricyclic antidepressants, MAO inhibitors, antihistamines, antiemetics, neuroleptics, scopolamine, ethanol).
Tricyclic antidepressants and m-holinoblokatory (including bronchodilators, antispasmodics) increase the risk of increased intraocular pressure or urinary retention.
It is necessary to avoid the joint use of antihistamines and procarbazine.
TERMS OF RELEASE FROM PHARMACY
The drug is dispensed without a prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children, in the original package, at a temperature of no higher than 25 В° C. Shelf life - 2 years.
