Klemastin-Borimed
Producer: JSC Borisovsky Plant of Medical Supplies Republic of Belarus
Code of automatic telephone exchange: R06AA04
Release form: Liquid dosage forms. Solution for injections.
General characteristics. Structure:
Active ingredient: 0? 001 g of Clemastinum (in the form of a fumarat) in 1 ml of solution.
Excipients: sodium citrate for injections, propylene glycol, sorbite food, the alcohol rectified from food raw materials of 96,3%, water for injections.
Pharmacological properties:
Pharmacodynamics. Blakator histamine H1 receptors. Treats antihistamines from group of benzgidrilny ethers. Possesses antiallergic action, reduces permeability of vessels, renders sedative and m-holinoblokiruyushchy effect, has no somnolent activity. Prevents development of a vazodilatation and reduction of the unstriated muscles induced by a histamine. Reduces permeability of capillaries, brakes exudation and formation of hypostasis, reduces an itch, shows mestnoanesteziruyushchy activity.
Pharmacokinetics. Linkng with proteins of plasma makes 90-95%. Passes through a blood-brain barrier. In the period of a lactation in a small amount gets into breast milk. It is metabolized in a liver.
Removal from plasma - two-phase, T1/2 of the first phase – 2,7-4,5 h, the second – 21-53 h. Metabolites (45-65%) are allocated with kidneys, not changed drug is found in urine in trace quantities.
Indications to use:
Acute or anaphylactoid anaphylaxis and Quincke's disease (as an additional tool).
Prevention or treatment of allergic and pseudo-allergic reactions (including at administration of contrast mediums, hemotransfusion, diagnostic use of a histamine).
Route of administration and doses:
Intramusculary and intravenously appoint 2 mg 2 times a day (in the morning and in the evening).
Intravenous administration of injections should be carried out slowly, within more than 2 - 3 min.
To children - intramusculary on 25 mkg/kg/days, dividing into 2 injections.
For prevention of allergic reactions enter intravenously 2 mg slowly (within 2 - 3 min. and more). Just before an injection contents of an ampoule are parted by 0,9% with sodium solution chloride or 5% dextrose solution in the ratio 1: 5.
Features of use:
For treatment it is necessary to refuse the ethanol use.
Careful observation of children and patients of advanced age is necessary (hypersensitivity to antihistaminic medicines).
It is necessary to exclude a possibility of intra arterial introduction. Solution for injections contains ethanol.
For prevention of distortion of results of skin scarifying tests on allergens medicine needs to be cancelled for 72 h before conducting allergological testing.
During treatment it is necessary to be careful during the driving of motor transport and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.
Pregnancy and lactation. Appointment only is possible if the expected advantage for mother surpasses potential risk for the child.
Side effects:
From a nervous system: increased fatigue, drowsiness, a headache, dizziness, a tremor, sedation, weakness, feeling of fatigue, block, lacks of coordination of movements, it is rare - a promoting effect (usually at children): concern, acrimony, excitement, nervousness, sleeplessness, hysteria, euphoria, tremor, spasms; paresthesias, neuritis.
From sense bodys: disturbance of clearness of visual perception, diplopia, acute labyrinthitis, sonitus.
From the alimentary system: dryness in a mouth, a loss of appetite, nausea, vomiting, diarrhea or locks, a gastralgia.
From an urinary system: the speeded-up or complicated urination.
From respiratory system: a condensation of a bronchial secret and difficulty of department of a phlegm, feeling of pressure in a thorax, breath disturbance, a nose congestion.
From cardiovascular system: a lowering of arterial pressure (is more often at elderly), heartbeat, premature ventricular contraction.
From bodies of a hemopoiesis: hemolitic anemia, thrombocytopenia, agranulocytosis.
Allergic reactions: skin reactions, bronchospasm, asthma (parenteral administration), photosensitization, acute anaphylaxis.
Interaction with other medicines:
Strengthens effect of sedative, somnolent, antipsychotic medicines (neuroleptics), medicines for the general anesthesia and other medicines oppressing the central nervous system.
Strengthens effect of m-holinoblokatorov.
It is incompatible with a concomitant use of monoamine oxidase inhibitors and ethanol.
Contraindications:
Hypersensitivity, pregnancy, the lactation period, children's age (till 1 year), a concomitant use of monoamine oxidase inhibitors, diseases of the lower respiratory tracts (including bronchial asthma).
With care. It is necessary to observe extra care at use of medicine for 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 care appoint medicine sick with the increased intraocular pressure, a hyperthyroidism, diseases of cardiovascular system, including an arterial hypertension.
Overdose:
Symptoms: the overdose of anti-histamine means can lead both to oppressing, and to a promoting effect on the central nervous system, manifestations of anticholinergic action can develop: dryness in a mouth, the fixed expansion of pupils, disturbances from digestive tract.
Treatment: performing symptomatic therapy.
Storage conditions:
List B. In the place protected from light, at a temperature not over 25 ºС. To store in the place, unavailable to children. A period of validity - 2 years. Not to use medicine after the termination of a period of validity.
Issue conditions:
According to the recipe
Packaging:
Solution for injections of 0,1% on 2 ml in ampoules. On 10 ampoules together with a knife for opening of ampoules in a box from a cardboard. On 10 ampoules in the blister packaging from a film polyvinyl chloride. On 1 or 2 blister packagings together with a knife for opening of ampoules and a leaf insert in a pack from a cardboard.