Дицинон®
Producer: Sandoz Gmbh (Sandoz Gmbh) Germany
Code of automatic telephone exchange: B02BX01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
1 ampoule from 2 ml of solution for injections contains etamsylate 250 mg; in a box of 50 pieces.
1 tablet — 250 mg; in the blister of 10 pieces, in a box of 10 blisters.
Pharmacological properties:
Pharmacodynamics. Dicynonum is means for prevention and a stop of bleeding. It influences the first stage of the mechanism of a hemostasis (interaction between an endothelium and thrombocytes). Dicynonum raises a platelet stickness, normalizes stability of walls of capillaries, reducing thus their permeability, inhibits biosynthesis of prostaglandins which cause disaggregation of thrombocytes, a vazodilatation and a hyperpermeability of capillaries. As a result of it the bleeding time considerably decreases, blood loss decreases.
Pharmacokinetics. Etamsylate is almost completely absorbed in a GIT, reaching Cmax in a blood plasma in 4 h after reception.
Later in/in administrations of drug the haemo static effect is noted in 5–15 min., maximum is reached during 1 h. Drug is effective during 4–6 h then the effect gradually disappears. Later in/in introductions of Dicynonum in a dose of 500 mg the maximum level in a blood plasma is reached in 10 min. and makes 50 mkg/ml.
About 72% of the entered dose are removed during the first 24 h with urine in not changed look. Etamsylate gets through a placental barrier and gets into breast milk.
Indications to use:
Dicynonum is appointed for prevention and control of hemorrhages in superficial and internal capillaries of various etiology, especially if bleeding is caused by defeat of an endothelium:
• prevention and treatment of bleedings in time and after surgeries in otolaryngology, gynecology, obstetrics, urology, stomatology, ophthalmology and plastic surgery;
• prevention and treatment of capillary bleeding of various etiology and localization: a hamaturia, a metrorrhagia, primary hypermenorrhea, a hypermenorrhea at women with intrauterine contraceptives, nasal bleeding, bleeding of gums.
Besides solution for injections:
• neonatology: prevention of periventrikulyarny bleeding at premature babies.
Route of administration and doses:
Tablets
Apply inside. A pill is taken in time or after food.
The daily dose for adults makes 1–2 tablets 3–4 times a day. In hard cases the dose makes 3 tablets 3–4 times a day.
At a menorrhagia appoint 3–4 tablets a day, since 5th day from the expected beginning of periods till 5th day of the following menstrual cycle.
After operation each 6 h before disappearance of risk of bleeding apply 1–2 tablets.
The daily dose for children makes a half of a dose for adults.
Solution for injections
Apply in/in (slowly) or in oil. The optimum dose for adults makes 10–20 mg/kg of etamsylate and is entered into 3–4 receptions. In most cases the daily dose makes 1–2 ampoules 3–4 times a day. The daily dose for children makes a half of a dose for adults.
Before an operative measure enter in/in or 1–2 ampoules in oil. During operation enter into 1–2 ampoules; introduction in the same dose can be repeated. After operation each 6 h before disappearance of risk of bleeding enter 1–2 ampoules.
In a neonatology Dicynonum is entered in oil or in/in in doses of 12,5 mg/kg (0,1 ml =12, 5 mg). Treatment needs to be begun during the first 2 h after the birth. Administration of drug is carried out by each 6 h for 4 days to the general dose of 200 mg/kg.
It is possible to apply Dicynonum locally (a skin transplant, an odontectomy) by means of the sterile gauze napkin moistened with drug.
Features of use:
With care apply at patients with thrombosis or a thrombembolia in the anamnesis. Drug is inefficient at thrombocytopenia.
Before an initiation of treatment it is necessary to exclude other reasons of bleeding.
Each tablet of Dicynonum contains 60,5 mg of lactose therefore to patients with hereditary intolerance of a galactose, deficit of lactase, a sprue of a glucose/galactose it is not necessary to appoint this drug.
It is forbidden to use drug in case of discoloration of injection solution.
Incompatibility
Solution of Dicynonum is incompatible with solution of Natrii hydrocarbonas and powder of sodium of a lactate.
Use during pregnancy and feeding by a breast
Safety of use of etamsylate during pregnancy is not established. Therefore drug is appointed only if the expected advantage for mother exceeds potential risk for a fruit.
During treatment by drug it is necessary to stop feeding by a breast.
Children. Drug is contraindicated to children with a hemoblastosis (lymphatic and myeloid leukemia, an osteosarcoma).
Ability to influence speed of response at control of vehicles or work with other mechanisms. Does not influence.
Side effects:
From a nervous system: seldom — a headache, dizziness, inflows to the person, paresthesia in the lower extremities.
From cardiovascular system: very seldom — a thrombembolia, arterial hypotension.
From a GIT: nausea, pain in the field of an epigastrium.
From immune system: seldom — allergic reactions, rash on skin, the case of a Quincke's disease is described.
From endocrine system: very seldom — an acute porphyria.
From a musculoskeletal system: seldom — a dorsodynia.
All side effects weak and tranzitorny.
At children who were treated by etamsylate for prevention of bleeding at acute lymphatic and myeloid leukemia to a thicket noted a heavy leukopenia.
Interaction with other medicines:
Tablets: interactions with other medicines are not established.
Solution for injections: contents of an ampoule should not be mixed with other drugs in one syringe. If Dicynonum is mixed with physiological solution, it needs to be used immediately.
Contraindications:
Hypersensitivity to etamsylate or to any other ingredient of drug. An acute porphyria, the increased coagulability of blood. A hemoblastosis (lymphatic and myeloid leukemia, an osteosarcoma) at children; solution for injections also: hypersensitivity to sodium to sulfite; OH.
Overdose:
There are no data.
Storage conditions:
In the dry, protected from light place at a temperature not above 25 °C.
Issue conditions:
According to the recipe
Packaging:
Tablets of 250 mg blister, No. 100
Solution for infection. 250 mg of amp. 2 ml, No. 50