Tradename
Dicynone
Generic Name
Etamsylate
Category
Cardiovascular System
Form
Various
Composition
Tablets
Etamsylate................250, 500 mg
Ampoules (2 ml)
Etamsylate.......................250 mg
Description
Antihemorrhagic
Properties/Actions
Pharmacodynamics
Etamsylate is a synthetic antihemorrhagic and angioprotective drug acting on the first step of hemostasis (endothelium - platelet interaction). By improving platelet adhesiveness and restoring capillary resistance. It reduces the bleeding time and blood losses.
Etamsylate has no vasoconstrictor action, it does not influence fibrinolysis nor modify the plasma coagulation factors.

Pharmacokinetics
When given post-operatively, etamsylate is slowly absorbed from the gastrointestinal tract. After oral administration of 500 mg etamsylate maximum plasma level, i.e. 15 µg/ml, is reached at 4 hours, but bioavailability is unknown. The binding rate to plasma proteins is about 95%. Plasma half-life is about 3.7 hours. About 72% of the administered dose is excreted in the first 24 hours in urine, the molecule is excreted unchanged.
Etamsylate crosses the placental barrier. Maternal and cord blood contains similar concentrations of etamsylate. It is not known if etamsylate is excreted in the maternal milk.
It is not known if the pharmacokinetic properties of etamsylate are modified in patients suffering from renal and/or hepatic function disorders.
After IV administration of 500 mg etamsylate (2 ampoules), the maximum plasma level, i.e. 50 µg/ml, is reached at 10 minuts. The plasma half-life is around 1.9 hours. About 85% of the administered dose are excrete in the first 24 hours urine.
Indications
Dicynone is indicated:
1. In Surgery:
Prevention and treatment of pre- or postsurgical capillary hemorrhages in all delicate operations and in those affecting highly vascularised tissues: E.N.T., gynecology, obsterics, urology, odontostomatology, ophthalmology, plastic and reconstructive surgery.
2. In Internal Medicine:
Prevention and treatment of capillary hemorrhages of whatever origin or localization: hematuria, hematemesis, melena, epistaxis, gingivorrhagia.
3. In Gynecology:
Metrorrhagia, primary or IUD-related menorrhagia in the absence of organic pathology.
Contraindications
Acute porphyria.
Drug Interactions
The following is noted:
  • Dicynone may be given is association with any other drug (e.g. anticoagulants).
  • When a perfusion with dextran is necessary, Dicynone should be administered first.
Side Effects/Adverse Effects
Rarely:
  • Gastralgia
  • Nausea
  • Headache
  • Skin rash
In mosts cases, these symptoms disappear spontaneously. If they persist, the dosage should be reduced or the treatmend withdrawn.
Pregnancy & Lactation
Pregnancy
Category C
: Studies in pregnant women or animals are not available.
As a precaution, Dicynone should not be administered during the first trimester of pregnancy, whereas during the second and third trimesters, if should be administered only if the expected therapeutic benefit is judged as superior to the potential risk for the foetus.

Lactation
In the absense of data regarding passage into maternal milk, lactations during trreatment is not advisable, or if lactation is to be continued, the treatment must be stopped.
Dosage & Administration
1. Tablets:
a) Adults:
  • Pre-surgical: 1 tablet (500 mg) 1 hour before surgery.
  • Post-surgical: 1 tablet (500 mg) every 4-6 hours as long as the risk of bleeding persists.
  • Internal Medicine: Generally, 1 tablet 2-3 times a day (1000-1500 mg) to be taken with meals with a little water; treatment duration depends on the results obtained.
  • Gynecology, meno-metrorrhagia: 1 tablet 3 times a day (1500 mg) to be taken with meals with a little water. Treatment lasts 10 days and starts 5 days before the expected onset of menses.
b) Children:
  • Because of its high concentration of active principle, Dicynone is not appropriate for children.

2. Ampoules: 
a) Adults:

  • Presurgical: 1-2 ampoules IV or IM 1 hour before surgery.
  • Persurgical: 1-2 ampoules IV. Repeat dosage if necessary.
  • Postsurgical: 1-2 ampoules. To be repeated every 4-6 hours as longa s the bleeding risk persists.
  • Emergency cases: 1-2 ampoules IV or IM to be repeated every 4-6 hours as long as the risk of bleeding persists.
  • Local treatment: A cotton swab is to be soaked with the content of an ampoule and applied to the hemorrhagic area, or in tooth socket after dental extraction. The application may be repeated when necessary, and it may be associate with oral or parenteral administration.

b) Children:

  • Half the adult dose.
c) Infants:
  • Generally, 10 mg/kg injected intramuscularly within 2 hours after birth then every 6 hours for 4 days.
Overdosage
Signs of overdosage are unknown. In case of overdosage, smyptomatic treatment should be initiated.
Warnings
Parenteral administration of Dicynone may induce a drop in blood pressure, but no data has been reported on such a risk during oral administration. If Dicynone is administered for a reduction excessive and/or prolonged menstrual hemorrhages, and no improvement is observed, possible pathological caues should be looked for and excluded.
Notes
Storage
Store at room temperature, protected from light and humidity.
Packaging
Strips of 10 tablets each.
Box of 3 ampoules of 2 ml each.
Manufacturer
MINAPHARM
Date Added/Updated
10th January 2010 12:19 pm
//date_format

Miscellaneous

Share This!

Respected Sites

drugs.com

rxlist.com

rxwiki.com

Need Help?

on-call support