Clemastine-Eskom - instructions for use, dose, side effects, contraindications

Active substanceClemastineClemastine

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Clemastin-Eskom

solution w / m in / in

ESKOM NPK, OAO Russia

Tavegil®

pills inwards

Новартис Консьюмер Хелс СА Switzerland

Tavegil®

solution w / m in / in

Новартис Консьюмер Хелс СА Switzerland

Dosage form: & nbspsolution for intravenous and intramuscular administration

Composition:

1 ml of the solution contains:

active substance: Clemastine fumarate 1.34 mg (in terms of clemastine) 1 mg;

atExcipients: D-sorbitol 45 mg, ethanol (ethanol) 95% - 70 mg, propylene glycol - 300 mg, sodium citrate - up to pH 6.3, water for injection up to 1.0 ml.

Description:

Transparent, colorless or from light yellow to pale greenish-yellow liquid.

Pharmacotherapeutic group:Antiallergic agent - H1-histamine receptor blocker

ATX: & nbsp

A.06.A.A.04 Clemastine

Pharmacodynamics:

Clemastine is a blocker of H₁receptors. Refers to to antihistamines from benzhydryl esters, reduces the permeability of capillaries, has antiallergic and antipruritic effect, characterized by a rapid onset and a significant duration of action.

Pharmacokinetics:

The connection with plasma proteins is 95%. Clemastine is significantly metabolized in the liver.Metabolites in the main (45-65%) are excreted through the kidneys with urine; The unchanged active substance is found in urine only in trace amounts. During lactation, a small amount of klemastin can penetrate into breast milk.

Indications:

Prophylaxis or treatment of allergic and pseudoallergic reactions (including with the introduction of contrast agents, blood transfusion, diagnostic use of histamine).

Angioedema, anaphylactic or anaphylactoid shock (as an additional remedy).

Contraindications:

Hypersensitivity to klemastinu: simultaneous use of monoamine oxidase (MAO) inhibitors, bronchial asthma, children under 1 year.

Carefully:

Be particularly careful when using clemastine in patients with stenosing peptic ulcer, piloroduodenalnoy obstruction, obstruction of the bladder neck and prostatic hypertrophy, accompanied by urinary retention, with increased intraocular pressure, hyperthyroidism, cardiovascular system, including arterial hypertension.

Pregnancy and lactation:

During pregnancy Clemastine apply only if the expected benefit to the mother exceeds the potential risk to the fetus.

Clemastin should not be used in women during lactation.

Dosing and Administration:

Children from 12 years and adults: the average single dose is 2 mg, that is, the contents of 1 ampoule. The maximum dose is 3-4 mg / day. The drug is administered intravenously or intramuscularly. For prophylactic purposes, the drug is injected intravenously slowly in a dose of 2 mg immediately before the possible occurrence of an anaphylactic reaction or reaction in response to the use of histamine. The drug solution can be further diluted with 0.9% sodium chloride solution or 5% dextrose solution in a ratio of 1: 5.

Children from 1 to 12 years old: 0.025 mg / kg per day intramuscularly for 2 injections.

Side effects:

From the central nervous system (CNS): increased fatigue, drowsiness, headache, dizziness, tremor, sedative affect, weakness, fatigue, inhibition, impaired coordination of movements; in rare cases, especially in children, there is a stimulating effect on the central nervous system, anxiety, increased irritability, agitation, nervousness, insomnia, hysteria, euphoria, convulsions, paresthesia, neuritis.

From the gastrointestinal tract: dyspepsia, nausea, epigastric pain, constipation, vomiting, dry mouth, decreased appetite, diarrhea.

From the urinary system: rapid or difficult urination.

On the part of the respiratory system: condensation of bronchial secretion and difficulty in sputum discharge, sensation of pressure in the chest and difficulty breathing, nasal congestion.

From the side of the cardiovascular system: lowering blood pressure (more often in elderly patients), palpitation, extrasystole.

From the sense organs: violation of the clarity of visual perception, diplopia, acute labyrinthitis, tinnitus.

From the hematopoiesis: hemolytic anemia, thrombocytopenia, agranulocytosis.

Allergic reactions: urticaria, skin rashes, photosensitivity, bronchospasm, dyspnea, anaphylactic shock.

Overdose:

Symptoms. Overdose can lead to both depressing and stimulating effects on the central nervous system. Stimulation of the central nervous system is more common in children. Also, the phenomenon of anticholinergic action may develop: dry mouth, fixed dilated pupils, flushing of blood to the upper half of the body, disorders of the gastrointestinal tract (nausea, epigastric pain, vomiting).

Treatment. Symptomatic therapy.

Interaction:

Clemastin enhances the effect of drugs that depress the central nervous system (hypnotics, sedatives, anxiolytics), M-holinoblokatorov, as well as alcohol. It is not compatible with simultaneous administration of MAO inhibitors.

Special instructions:

Intraarterial administration of the drug is not permitted!

For the period of treatment should stop drinking alcohol.

Careful monitoring of children and elderly patients is necessary (sensitivity to antihistamines is increased: in children - stimulating effect of Clemastine on the central nervous system, elderly patients - dizziness, lowering blood pressure, increasing sedation).

To prevent distortion of skin scarification test results for allergens, the drug should be discontinued 72 hours before the allergy testing.

Effect on the ability to drive transp. cf. and fur:Patients receiving Clemastine. it is recommended to refrain from driving vehicles, working with mechanisms, as well as from other activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Solution for intravenous and intramuscular injection, 1 mg / ml.

Packaging:

2 ml of the drug in ampoules.

For 5 or 10 ampoules in contour cell packs from a polyvinyl chloride film.

For 1 or 2 outline carton packs along with instructions for use in a cardboard pack.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-007834/08

Date of registration:06.10.2008

Expiration Date:Unlimited

The owner of the registration certificate:ESKOM NPK, OAO ESKOM NPK, OAO Russia

Manufacturer: & nbsp

ESKOM NPK, OAO Russia

Representation: & nbspESKOM NPK, OAOESKOM NPK, OAO

Information update date: & nbsp25.01.2018

Illustrated instructions

Instructions

Clemastin-Eskom (Clemastine-Eskom)