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International generic name
Etamsylate
Drug form and composition
Solution for injection. One ampoule of 2 ml contains 250 mg Etamsylate (125 mg/ml).
Tablets. One tablet contains 250 or 500 mg Etamsylate.
Indications
The preparation is used for prevention and control of small vessel hemorrhage
in well-perfused tissues during surgery, including: obstetrics and gynecology, urology,
ophtalmology, stomatology and esthetic operations. In capillary bleeding of different
etiology, including: menorrhagia and metrorrhagia without organic pathology, hematemesis,
melena, hematuria, epistaxis. In prevention of periventricular hemorrhages in prematurely
born children.
Dosage and administration
Preventively Pharmacynon is applied 1-2 hours before surgery intervention in
dose 250-500 mg, intramuscularly or intravenously. It could be administered orally
in dose 500-750 mg (2-3 tablets) also. In the treatment of hemorrhages the preparation
is used as follows: the initial dose of 250-500 mg Pharmacynon is applied intramuscularly
or intravenously; after that the treatment is continued with 250-500 mg given orally
every 4-6 hours. The maintaining parenteral daily dose of Pharmacynon is 500-1000
mg (2-4 ampoules), whereas the oral maintaining dose is 500-2000 mg (2-8 tablets).
In neonatology the preparation is used in prematurely born and newborn children
in dose 12.5 mg per kg body weight, intramuscularly, till 2 hours after the birth.
After that the treatment continues with the same dose, given every 6 hours, within
4 days. The preparation could be used and locally as follows: the ampoule content
is poured-out on the dressing cloth and after that is applied on the bleeding surface.
After the teeth extraction a tampon moistened with the solution could be placed
in the bleeding alveolus. If necessary, the manipulation could be repeated, or Pharmacynon
orally or parenterally is administered.
Contraindications
Hypersensitivity to etamsylate; bronchial asthma; acute porphyria. The preparation
should not be used during the first trimester of the pregnancy and during lactation.
Special warnings and precautions
In case the patient’s condition requires infusion of Dextran solution, Pharmacynon
should be applied before the infusion. In intravenous infusion is possibly transitory
hypotension to appear. After the opening the ampoule should be used immediately
and should not be mixed with other preparation in one syringe.
Drug interactions
In concomitant application of nonsteroidal anti-inflammatory medicines (indomethacin,
feloran, etc.) a beneficial influence of the pain is seen, without adverse reactions
potentiation. Pharmacynon could be used simultaneously with other hemostatic preparations,
including anticoagulants.
Adverse reactions
In predisposed patients following adverse reactions may appear: headache; nausea;
skin rash; bronchospasm; anaphylactic shock.
Pharmacological mechanisms
Pharmacynon is a synthetic antihemorrhagic and angioprotective medicine, acting
on the first phase of hemostasis (interaction between endothelium of the small vessels
and platelets). Administration of the preparation does not increase the risk of
intravasal blood coagulation and does not change pathologically the prothrombine
index. Pharmacynon is characterized by selective action on the vessel wall; it normalizes
the increased permeability of the latter and increases its resistance to harmful
agents, disturbing vessel wall integrity. The lack of vasoconstictive effect is
an advantage of the preparation in patients with unstable hemodynamic.
Supplied
10 or 100 ampoules of 2 ml (250 mg). 100 tablets of 250 mg. 50 tablets of 500
mg.
Expiry
Solution for injection - 3 years. Tablets - 5 years
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