Тавегил®
Producer: Novartis Pharma Production (Novartis) Germany
Code of automatic telephone exchange: R06AA04
Release form: Liquid dosage forms. Solution for injections.
General characteristics. Structure:
Active agent - 2,68 mg of Clemastinum of a gidrofumarat (2 mg of Clemastinum are equivalent),
excipients - sorbitol of 90 mg, ethanol of 140 mg, propylene glycol of 600 mg, citrate sodium a dihydrate to pH 6,3, water for injections to 2 ml.
Description: Transparent, colourless or from light yellow till pale chartreuse color liquid.
Pharmacological properties:
Pharmacodynamics. H1-of histamine receptors blocker, derivative ethanolamine. Has strong antihistaminic and antipruritic effect with quick start of action and lasting up to 12 watch, prevents development of a vazodilatation and reduction of the unstriated muscles induced by a histamine.
Possessing antiallergic action, reduces permeability of vessels, capillaries, brakes exudation and formation of hypostasis, reduces an itch, renders m-holinoblokiruyushchy effect.
Pharmacokinetics. Communication with proteins of plasma makes 95%. Removal from plasma dvukhfazno, the corresponding elimination half-lives make 3.6 ± 0.9 hours and 37 ± 16 hours. Clemastinum is exposed to considerable metabolism in a liver. Metabolites in the basic (45 - 65%) are removed through kidneys with urine; not changed Active agent is found in urine only in trace quantities. In the period of a lactation a small amount of Clemastinum can get into breast milk.
Indications to use:
- prevention or treatment of allergic and pseudo-allergic reactions (including at administration of contrast mediums, hemotransfusion, diagnostic use of a histamine);
- a Quincke's disease, acute or anaphylactoid anaphylaxis (as an additional tool).
Route of administration and doses:
Intravenously or intramusculary.
Adult: 2 mg (2 ml), that is contents 1 ampoules, 2 times a day (in the morning and in the evening). With the preventive purpose the drug is administered intravenously struyno slowly (within 2-3 min. and more) in a dose of 2 mg just before possible emergence of anaphylactic reaction or reaction in response to use of a histamine. Solution of drug can be in addition divorced with isotonic solution of sodium of chloride or 5% glucose solution in the ratio 1:5.
To children: 0,025 mg/kg a day intramusculary, dividing into 2 injections.
Features of use:
Clemastinum possesses insignificant sedation (from weak to moderated on intensity) therefore the persons accepting Tavegil® are recommended to abstain from driving of vehicles, work with mechanisms, and also from other types of activity demanding the increased concentration of attention and speed of psychomotor reactions.
Side effects:
Classification of frequency of emergence of side reactions:
very often (≥1/10); often (≥1/100, ≤1/10); infrequently (≥1/1000, ≤1/100); seldom (≥1/10 000, ≤1/1000); very seldom (≤1/10 000).
From a nervous system:
Often: increased fatigue, drowsiness, sedation, weakness, feeling of fatigue, block, lack of coordination of movements;
Infrequently: dizziness;
Seldom: headache, tremor, promoting effect.
From digestive tract:
Seldom: dyspepsia, nausea, vomiting, a gastralgia, dryness in a mouth;
Very seldom: lock.
From sense bodys:
Seldom: disturbance of clearness of visual perception, diplopia, acute labyrinthitis, sonitus.
From kidneys and urinary tract:
Very seldom: the speeded-up or complicated urination.
From respiratory system:
Seldom: a condensation of a bronchial secret and difficulty of an otkhozhdeniye of a phlegm, feeling of pressure in a thorax, breath disturbance, a nose congestion.
From cardiovascular system:
Seldom: a lowering of arterial pressure (is more often at elderly patients), premature ventricular contraction.
Very seldom: tachycardia.
From blood and hemopoietic bodies:
Seldom: hemolitic anemia, thrombocytopenia, agranulocytosis.
From skin and a hypodermic fatty tissue:
Seldom: skin rash.
From immune system:
Infrequently: photosensitization, asthma;
Seldom: acute anaphylaxis.
If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor.
Interaction with other medicines:
Тавегил® strengthens effect of the medicines oppressing the central nervous system (somnolent, sedative, anxiolytics), m-holinoblokatorov, and also alcohol. It is incompatible with a concomitant use of MAO inhibitors.
Contraindications:
Hypersensitivity, pregnancy, the lactation period, reception of monoamine oxidase inhibitors (MAO), diseases of the lower respiratory tracts (including bronchial asthma), intolerance of fructose, children's age till 1 year.
Intra arterial administration of drug is not allowed!
With care
At patients with the stenosing stomach ulcer, piloroduodenalny obstruction, with obstruction of a neck of a bladder, and also the prostatauxe which is followed by an ischuria with the increased intraocular pressure, a hyperthyroidism, diseases of cardiovascular system, including arterial hypertension.
Use at pregnancy and during breastfeeding
Use of drug at pregnancy and during breastfeeding is contraindicated.
Overdose:
Symptoms. The overdose of antihistamines can lead both to oppressing, and to the promoting effect on the central nervous system more often observed at children. Also the phenomena of anticholinergic action can develop: dryness in a mouth, the fixed expansion of pupils, rushes of blood to an upper half of a body, tachycardia, disturbances from digestive tract (nausea, pains in epigastriums, vomiting).
Treatment. Symptomatic therapy is shown.
Storage conditions:
At a temperature from 15 to 30 °C. To store in the place, unavailable to children. A period of validity - 5 years. Not to use after the term specified on packaging.
Issue conditions:
According to the recipe
Packaging:
Solution for intravenous and intramuscular administration of 1 mg/ml.
On 2 ml of solution in ampoules from glass type 1 (Evr. T.). On 5 ampoules in the plastic pallet. One plastic pallet together with the application instruction is placed in a cardboard box.