Mesocept
Ampoule
Depot progetogen-estrogen for hormonal contraception Composition :
1 ml Mesocept contains 50 mg norethisterone enanthate and 5 mg estradiol
valerate in oily solution. Properties
Mesocept is a depot preparation.
The contraceptive effect of Mesocept is based on an interaction of central
and peripheral mechanisms , primarily on ovulation inhibition and alteration
of the cervical mucus. In addition, Mesocept causes morphological and enzymatic changes in the endometrium, which have the effect of rendering nidation difficult.
The contraceptive reliability of the depot injection of Mesocept is similar to
that achieved by daily ingestion of progestogen - estrogen combine preparations. Indication & usage :
Hormonal contraception. Contra-indications :
Pregnancy , severe disturbances of liver function , jaundice or persistent
itching during a previous pregnancy, dubin – johnson syndrome, rotor
syndrome, previous or existing liver tumors, existing or previous
thromboembolic processes in arteries or veins and conditions which
predispose to such diseases (e.g. disturbances of the clotting system with
a tendency towards thrombosis, certain heart diseases ), sickle-cell anaemia,
existing or treated cancer of the breast or the endometrium, severe diabetes
with vascular changes, disturbances of lipometabolism, a history of herpes
of pregnancy, otosclerosis with deterioration during pregnancy.
Reasons for immediate discontinuation of Mesocept
No further injections should be given in case of :
Occurrence for the first time of migrainous headaches or more
frequent occurrence of unusually severe headaches sudden perceptual
disorders (e.g. disturbances of vision or hearing), first signs of
thrombophlebitis or thromboembolic symptoms (for example, unusual
pains in or swelling of the legs, stabbing pains on breathing or coughing
for no apparent reason ) a feeling of pain and tightness in the chest,
pending operations ( six weeks beforehand ), immobilization ( for
instance, following accidents). In all these cases there may be an
increased risk of thrombosis. Further reasons for discontinuation are:
Onset of jaundice, onset of hepatitis, itching of the whole body, increase in
epileptic seizures, significant rise in blood pressure, pregnancy. Special notes :
According to the present state of knowledge, an association between the
use of hormonal contraceptives and an increased risk of venous and
arterial thromboembolic diseases cannot be ruled out.
The relative risk of arterial thromboses (e.g. stroke, myocardial
infarction) appears to increase further when heavy smoking ,increasing
age and the use of combined hormonal contraceptives coincide.
In rare cases benign and in even rarer cases malignant liver tumours
leading in isolated cases to life-threatening intraabdominal haemorrhage
have been observed after the use of hormonal substances such as those
contained in Mesocept. The doctor must therefore be informed of the
occurrence of unusual upper abdominal complaints which do not disappear
spontaneously within a short time.
The following conditions require strict medical supervision:-
diabetes mellitus, tendency towards diabetes mellitus, hypertension,
varicose veins, a history of phlebitis, otosclerosis, multiple sclerosis,
epilepsy, porphyria, tetany, chorea minor.
Mesocept has no inhibiting influence on lactation. Unfavourable effects
on breast-fed babies have not been reported.
However, small quantities of the steroid may be eliminated with the
milk. As with other steroids it is therefore theoretically possible that the
degradation of bilirubin in neonates is impaired particularly during the
first week of life. If the new-born is suffering from severe or persistent
jaundice which requires medical treatment, breast-feeding must be
interrupted for the time of treatment. Side effects :
In rare cases, headache, gastric upsets, nausea, a feeling of tension in
the breasts, changes in body weight and libido, or depressive moods
can occur.
Break-through bleedings and amenorrhea are rarely encountered.
With persistent and recurrent heavy break-through bleedings which do
not disappear spontaneously, the medication must be discontinued to
exclude an organic cause.
In predisposed women, long-term use of the injection can sometimes
cause chloasma which is made worse by long exposure to the sun. Women who have this tendency should therefore avoid excessive exposure to sunlight. Individual cases of poor tolerance of contact lenses have been reported. Drug interactions :
The doctor should be informed if other medicines are being taken
regularly (e. g. barbiturates, phenylbutazone, hydantoins, rifampicin,
ampicillin), since these may impair the action of Mesocept . The requirement for oral antidiabetics or insulin can chang |
