Dicynone __________دايسينون
Etamsylate _________ المادة الفعالة
________________________________
Antihemorrhagic مضاد للنزيف
الاشكال الدوائية المختلفة و التركيزات و الاسعار موضحة فى الصورة
Dicynone
® contains etamsylate as active principle. This anti-haemorrhagic
medication is able to reduce the bleeding time and blood loss after
systemic and/or local administration.
Dicynone ® prevents and
treats capillary haemorrhages of whatever origin and localisation. It
normalises too heavy or too long-lasting menses.
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Properties/Effects
Etamsylate
is a synthetic antihaemorrhagic and angioprotective drug acting on the
first step of haemostasis (endothelium-platelet interaction).
By improving platelet adhesiveness and restoring capillary resistance, it is able to reduce bleeding time and blood losses.
Etamsylate has no vasoconstrictor action, it does not influence fibrinolysis nor modify the plasma coagulation factors
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Composition
Active principle: etamsylate
Tablet: etamsylate 500 mg. Antiox. (E 221), excipients for tablet.
Tablet: etamsylate 250 mg. Antiox. (E 221), excipients for tablet.
Ampoule: etamsylate 250 mg. Antiox. (E 223) 0.8 mg, water for injection q.s.p 2 ml.
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Pharmacokinetics
When
given p.o., 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 h, but bioavailability is not
known. The binding rate to plasma proteins is about 95%. Plasma
half-life is about 3.7 h.
About 72% of the administered dose are excreted in the first 24 h-urine; the molecule is excreted unchanged.
After
i.v. administration of 500 mg etamsylate, the maximum plasma level,
i.e. 50 µg/ml, is reached after 10 minutes; plasma half-life is about
1.9 h. About 85% of the administered dose are excreted in the first 24
h-urine.
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.
Kinetics in particular situations
It
is not known if the pharmacokinetic properties of etamsylate are
modified in patients suffering from renal and/or hepatic function
disorders.
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Indications
In surgery:
Prevention
and treatment of pre-, per-, or postsurgical capillary haemorrhages in
all delicate operations and in those affecting highly vascularised
tissues : E.N.T., gynaecology, obstetrics, urology, odontostomatology,
ophthalmology, plastic and reconstructive surgery.
In internal medicine:
Prevention
and treatment of capillary haemorrhages of whatever origin or
localisation: haematuria, haematemesis, melaena, epistaxis,
gingivorrhagia.
In gynaecology:
Metrorrhagia, primary or IUD-related menorrhagia in the absence of organic pathology.
In pediatrics:
Prevention of periventricular haemorrhages in premature babies.
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Dosage and administration
Adults
Presurgical: 1 or 2 tablets (250-500 mg) or 1-2 ampoules i.v. or i.m. 1 hour before surgery.
Presurgical: 1-2 ampoules i.v. Repeat the dosage if necessary.
Postsurgical:
1 or 2 tablets (250-500 mg) or 1-2 ampoules i.v. or i.m. every 4 - 6
hours as long as the risk of bleeding persists.
Internal medicine:
generally 1 or 2 tablets 2 - 3 times a day (1000 - 1500 mg) to be taken
with meals with a little water; treatment duration depends on the
results obtained.
Gynaecology, meno-metrorrhagia: 1 or 2 tablets 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.
Emergency cases: according to the severity of the case: 1-2
ampoules i.v. or i.m. every 4 - 6 hours as long as the bleeding risks
persists.
Local treatment: soak a swab with the contents of one
ampoule and apply to haemorrhagic area, or in the tooth socket after
dental extraction. The application may be repeated if necessary; it may
be associated with oral or parenteral administration.
Children
Half the adult dose of 250 mg ampoule or tablet.
Because of its high concentration of active principle, Dicynone 500 is not appropriate for children.
For the prevention of periventricular haemorrhages in premature infants, Dicynone 250 in ampoules for injection is recommended.
Neonates:
10 mg per kg body-weight (0.1 ml=12.5 mg) injected intramusculary
within 2 hours of birth, then every 6 hours for 4 days.
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Limitations for use
Contraindications
Acute porphyria.
Dicynone 250 ampoules: bronchial asthma, proven hypersensibility to sulphites.
Precautions
As
parenteral administration of Dicynone may induce a drop in blood
pressure it is advised to carefully monitor patients suffering from
blood pressure instability or hypotension (see Adverse reactions), but
no data have been reported on such a risk during oral administration.
If
Dicynone is administered for a reduction of excessive and/or prolonged
menstrual haemorrhages, and no improvement is observed, possible
pathological causes should be looked for and excluded.
Pregnancy and 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,
it should be administered only if the expected therapeutic benefit is
judged as superior to the potential risk for the foetus.
In the
absence of data regarding passage into maternal milk, lactation during
treatment is not advisable or, if lactation is to continue, the
treatment must be stopped.
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Adverse reactions
In
certain cases, parenteral administration can produce a drop in blood
pressure. Pressure returns to normal values within the next hours.
Dicynone
250 ampoule contains sodium ersulphite as antioxidant that may cause
allergic reactions, nausea and diarrhea in susceptible patients.
The
allergic reactions may leadd to anaphylactic shock and cause
life-threatening asthma attacks. The incidence in the population is not
known but is probably low. However, hypersensitivity toward sulphites is
observed more frequetly in asthmatics than in non-asthmatics (see
limitations for use). In case of hypersensitivity reactions, the
administration of Dicynone 250 ampoules must be immediately stopped.
Rare: gastralgia, nausea, headache, skin rash.
In most cases, these symptoms disappear spontaneously.
If they persist, the dosage should be reduced or the treatment withdrawn.
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Interactions
For the oral form of Dicynone, no interaction is known up to now.
Thiamine
(vitamin B1) is inactived by the sulphite contained in Dicynone 250 for
injection. If a perfusion with Dextran is necessary, Dicynone 250 must
be injected first.
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