TAVEGIL

Active material: Clemastine
When ATH: R06AA04
CCF: Gistaminovыh blocker H₁-receptors. Allergy medication
ICD-10 codes (testimony): H10.1, J30.1, J30.3, L20.8, L23, L24, L28.0, L29, L30.0, L50, T78.2, T78.3, T88.7
When CSF: 13.01.01.01
Manufacturer: NOVARTIS CONSUMER HEALTH S.A. (Switzerland)

Pharmaceutical form, composition and packaging

Excipients: lactose monohydrate, povidone, corn starch, magnesium stearate, talc.

10 PC. – packings Valium planimetric (2) – packs cardboard.

Solution for in / and the / m clear, colourless or very pale yellow, or very pale greenish-yellow.

Excipients: sorbitol, ethanol, propylene glycol, sodium citrate, water d / and.

2 ml – glass ampoule (5) – trays, plastic (1) – cardboard boxes.

Pharmacological action

Gistaminovыh blocker H₁-receptors. Refers to an antihistamine funds from group benzgidril'nyh esters. Tavegil^® Yes ingibiruet gistaminove (H)₁-receptors and reduces the permeability of capillaries. It has anti-allergic and antipruritic effect, characterized by rapid onset and significant duration.

Antigistaminnaya activity of the drug ingestion reaches through 5-7 no, It persists for 10-12 no, and in some cases – to 24 no.

Pharmacokinetics

Absorption

After intake of clemastine is almost completely absorbed from the digestive tract. C_max plasma levels achieved after 2-4 no.

Distribution

Linking plasma protein is clemastina 95%. Is the breast milk in small quantities.

Metabolism and excretion

Inferring from the plasma is two-phase nature, T_1/2 is in the α-phase 3.6 ± 0.9 no, in the β-phase – 37 ± 16 no. Clemastine is exposed to significant metabolism in liver. Metabolites are mostly (45-65%) excreted in the urine; the unchanged active substance found in the urine only in trace quantities.

Testimony

For the application of tablets:

— hay fever and other allergic rinopatii;

— urticaria different Genesis;

-itching, pruritic dermatoses;

- Acute and chronic eczema, Contact Dermatitis and rash (as an additional means);

-insect bites.

For the application of Injection Solution:

-anaphylactic or anafilaktoidnyj shock and angioedema (as an additional means);

prevention or treatment of allergic and psevdoallergicheskih reactions (incl. with the introduction of contrast, blood transfusion, the diagnostic application of histamine).

Dosage regimen

Inside adults and children over 12 years appoint 1 tab. (1 mg) in the morning and in the evening. In cases, difficult to treat, daily dose of up to 6 tab. (6 mg).

For children 6-12 years appoint 1/2-1 tab. before breakfast and at night.

Tablets should be taken before meals, drinking water.

V / m or / adult appoint 2 mg (2 ml, ie. the contents of one ampoule).

With the aim of Prevention of possible immediately before occurrence of anaphylactic reaction or reactions in response to the use of histamine the drug is injected in/in struino dose 2 mg (2 ml). Injection in ampoule can be further diluted with izotoniceski solution of sodium chloride or 5% glucose solution in the ratio 1:5. In/in the injection Tavegila^® should be carried out slowly, over a 2-3 m.

Babies administered at a dose of 25 mcg/kg/day 2 introduction.

Side effect

CNS: perhaps – drowsiness, fatigue, headache, dizziness, tremor, sedation, weakness, feeling tired, lethargy, dystaxia; rarely, especially in children, noted the stimulating effect on the central nervous system, reflected concern, increased irritability, excitation, nervoznostью, insomnia, hysteria, euphoria, cramps, paresteziej.

From the digestive system: perhaps – dyspepsia, nausea, epigastric pain, constipation, vomiting; rarely – dry mouth; in some cases – decreased appetite, diarrhea.

From the urinary system: rarely – frequent urination, strangury.

The respiratory system: rarely – thickening bronchus secret and the difficulty of separating the phlegm, sense of pressure in the chest and difficulty breathing, nasal congestion.

Cardio-vascular system: rarely – low blood pressure (more frequently in elderly patients), heartbeat, arrythmia.

Allergic reactions: rarely – hives, skin rash; in some cases the on/in the introduction – anaphylactic shock.

Dermatological reactions: rarely – photosensitivity.

From the senses: violation of the definition of visual perception, diplopia, Acute labyrinthitis, noise in ears.

From the side of hematopoiesis: gemoliticheskaya anemia, thrombocytopenia, agranulocytosis.

Contraindications

-diseases of the lower respiratory tract infection (incl. bronchial asthma);

- Children up to age 1 year;

- Lactation (breast-feeding);

- Simultaneous use of MAO inhibitors;

-hypersensitivity to Tavegilu^® or another antihistamine drugs of similar chemical structure.

Pregnancy and lactation

When pregnancy Tavegil^® apply only, If the expected benefits of therapy to the mother outweighs the potential risk to the fetus.

Tavegil^® should not be used during lactation, tk. clemastine is allocated in small quantities in breast milk.

Cautions

With the utmost care use Tavegil^® in patients with stenosis privratnika stomach, stenoziruta stomach ulcer, with obstructive phenomena in piloroduodenal'noj field, with bladder neck obstruction, as well as the prostate hypertrophy, with the delay of urine, with zakratougolna glaucoma, hyperthyroidism, diseases of the cardiovascular system (incl. with hypertension).

The intraarterial administration of uterotonic Tavegil^® not allowed.

Use in Pediatrics

Tavegil^® in pill form is not recommended in children aged 1 Year to 6 years.

Effects on ability to drive vehicles and management mechanisms

Patients, host Tavegil^®, It is recommended that you refrain from driving motor vehicles, using machinery, as well as from other activities, requiring attention.

Overdose

Symptoms. An overdose can cause antigistaminnah funds how to ugnetajushhemu, and the stimulating effect on the CENTRAL NERVOUS SYSTEM. Stimulation of the CENTRAL NERVOUS SYSTEM is most commonly seen in children. Also can develop manifestations antiholinergicski actions: dry mouth, mydriasis, blood surges to the top half of the torso, disorders of the gastrointestinal tract (nausea, epigastric pain, vomiting).

Treatment. If the patient is vomiting does not arise spontaneously, You must call the (only, If the patient's consciousness is retained). If the drug passed 3 h or more, You can spend your gastric lavage using izotoniceski solution of sodium chloride. You can also assign a salt slabitelnoe. Also shown symptomatic therapy.

Drug Interactions

Tavegil^® potenziruet the medicines, CNS depressants (hypnotics, sedativnyh, trankvilizatorov), Mr. holinoblokatorov, and ethanol.

Conditions of supply of pharmacies

The drug is in the form of tablets is approved for use as a means of non-prescription.

A preparation in the form of solution for injection by prescription.

Conditions and terms

The drug should be stored out of reach of children at temperature from 15 ° to 30 ° C. Shelf life – 5 years.