Sunday, February 12, 2017

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DICYNONE AMPOULES
Antihemorrhagic
Composition
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Each 2 m; arnpoule contains: diethylammonium I .4 dihydroxybenzenesuifonate (INN, etamsylate) 250 mg,
antiox. (E 223) 08 mg.
Each tablet contains: diethylammonium I ,4 dihydroxybenzenesulfonate (INN, etamsylate) 250 mg.
DICYNONE 500
Each tablet contains: diethylammonium I dihydroxybenzenesulfonate (INN, etamsylate) 500 mg.
antiox. (E 221).
Properties / Mode of action
Etamsy!3te is a synthetic antihernorrhagjc and angioprotective drug acting on the first step of hemostasis
(endothelium - platelet interaction). BV improving platelet adhesiveness and restonng capillary resistance, it
reduces (he bleedinq time and blood fosses. Etamsylate has no vasoconstrictor action , it does not influence
tibrinotysis nor modify the plasma coagulation factors.
Pharmacokinetics
After i.v. administration of 500 mg etamsylate, the maximum plasma level, i.e. 50 pg / ml, is reached at
10 minutes. The plasma half-life is around 1 ,9 h. About 85% oi the administered dose are excreted in the first
24 h -urine.
When given po . etamsylate is resorbed through the gastrointestinal tract. After oral administration of
500 mg etarnsvtate, maximum plasma level, i.e. 15 ug/rnl, is reached at 4 h. The plasma half-life IS around
3,7 h. About 720/0 of the administered dose are excreted in the first 24 h-urine; the molecule is excreted
unchanged.
Etamsylate crosses the placentai barrier. Materna! and cord blood contains similar concentrations of
etamsyiate.
Indications
In surgery: Prevention and treatment of per- or postsurgical oozing in all delicate operations and in those
affecting highly vascularized tissues: E.N.T, gynecology, obstetrics, urology, odontostomatology, ophthal-
mology, plastic and reconstructive surgery.
In intemal medicine: Prevention and treatment of capillary hemorrhages of whatever origin or localization;
hematuria, hematemesis, melena, metrorrhagia, primary or IUD-related menorrhagia , epistaxis, gingivorr-
hagia.
in pediatrics: Prevention of periventricular hemorrhages in premature babies.
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Adults:
Presurgical: 1-2 ampoules i.v. or i.m. 1 hour before surgery.
Persurgical: 1-2 ampoules i.v. Repeat the dosage if necessary.
Postsurgtcal: 1-2 ampoules (1-2 tablets). Repeat every 4-6 hours as long as the bleeding risk persists.
Emergency cases, according to the severity of the case:l -2 ampoules i.v. or i.m. Repeat every 4-6 hours as
long as the risk of bleeding persists.
Local treatment: soak a swab with the content of an ampoule and apply to hemorrhagic area, or in the tooth
socket after dental extraction. The application may be repeated when necessary; it may be associated with
oral or parenterai administration.
Children: halt the adult dose.
Pediatrics: 10 mg per kg body weight (0.1 ml-12.5 mg) injected intramuscularly wtthin 2 hours atter birth
then every 6 hours for 4 days.
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Adults:
Postsurgjcal: I tablet, repeat every 4-6 hours as long as the bleeding risk persists,
Internal medicine generally, 2-3 tablets daily; the duration of treatment depends on the results.
Gynecology, in meno-metrorrhagia: from the fifth day before the expected onset of the menstrua' period
3 tablets da.ly for 10 days.
Children: half the adult dose.
umitations for use - As for most drugs, Dicynone!Dicynone 500 Should not be taken during the first
trimester of pregnancy.
Adverse effects - Etamsyiate does not induce serological or allergic side-effects.
Interactidt* - Dicynone/Dicynone 500 may be given In association with any other drug (for example anti-
coagulants). When a perfusion with dextran is necessary. Dicynone has to be administered first.
Stability - Protect the ampoules from light. Discard Dicynone ampoules if the solution is coloured.
Dtcynone/Dlcynone 500 may be administered until the expiration date indicated on the package (EXP).
Presentations
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Ampoules (250 mg/2 ml): 3 , 100
0M 0M Laboratories Ltd, Meyrin-Geneva (Switzerland)