|Cidolut Nor |
Oral progestogen preparation
Each tablet contains norethisterone acetate 5 mg
Cidolut Nor is a progestogen derived from nor-testosterone which has weak estrogenic and androgenic properties used commonly as hormonal contraceptive and in menopausal HRT to oppose the effect of estrogens on the endometrium .
Indications & usage :-
Dysfunctional bleeding, primary and secondary amenorrhea, premenstrual syndrome, mastopathy, uterine hypoplasia, timing of menstruation, endometriosis and progressive carcinoma of the breast.
Pregnancy , severe disturbances of liver function , Dubin -Johnson
syndrome , Rotor syndrome , previous or existing liver tumors
( in progressive carcinoma of the breast only if these are not due to
metastases), a history of jaundice or severe pruritus during pregnancy,
a history of herpes of pregnancy and thromboembolic processes .
Side effects :-
In rare cases nausea may occur .
In some cases when given larger doses as in breast cancer may rarely occur
impaired liver function .
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 steroid hormones like norethisterone.
- Insulin and antidiabetic requirements may change.
Warnings & precautions :
Before starting the treatment with the drug, be sure that the pregnancy has been excluded and the pregnant mother must be warned about the risk of effect of the drug on her fetus .
This drug is not used as a pregnancy test .
This drug should not be given in missed or incomplete abortion .
The doctor must be informed if the patient suffers from diabetes , since this disease requires careful supervision.
It has been concluded from epidemiological surveys that the use of oral estrogen /progestogen containing ovulation inhibitors is attended by an increased incidence of thromboembolic diseases .
Although Cidolut Nor does not contain estrogen , one should keep the possibility of an increased thromboembolic risk in mind , particularly where there is a history of thromboembolic diseases or in the presence of severe diabetes with vascular changes or sickle- cell anemia .
In rare cases benign and in even rare cases malignant liver tumors leading in isolated cases to life threatening intra-abdominal hemorrhage have been observed after the use of hormonal substances such as the one contained in Cidolut Nor. The doctor must therefore be informed of the occurrence
of unusual upper abdominal complaints which do not disappear spontaneously within a short time as it may then be necessary to withdraw the preparation.
Reasons for immediate discontinuation of the tablets:-
Occurrence of the first time of migrainous headaches or more frequent occurrence usually severe headache , sudden perceptual disorders (e.g. disturbances of vision or hearing ) first signs of thrombophlebitis or thromboembolic symptoms ( for example ,unusual pain in or swelling of the leg , stabbing pains on breathing or coughing for no apparent reason ). A feeling of pain and tightness in the chest , pending operations ( six weeks before hand) and immobilization (for instance , following accidents ) , onset of jaundice , onset of hepatitis , itching of the whole body , significant rise in blood pressure , pregnancy , hypercalcaemia ( in women with carcinoma of the breast )
Dosage & administration:-
Before starting Cidolut Nor a thorough general medical and gynaecological examination (including the breasts) should be carried out and pregnancy must be excluded .
As precaution, control examinations should be conducted at intervals of
about 6 months during long-term treatment with Cidolut Nor .
The tablets are to be swallowed as whole with some liquid .
Unless otherwise prescribed by the doctor the following dosage schemes are
The administration of 1 tablet Cidolut-Nor twice daily over 10 days
leads to arrest of uterine bleeding that not associated with organic lesions
within 1 – 4 days. In individual cases, bleeding diminishes during the first
few days after the commencement of tablet – taking and does not stop until
about 5 – 7 days later. For the treatment to be successful, Cidolut Nor
administration must be continued regularly even after arrest of bleeding
(up to a total of 20 tablets Cidolut-Nor).
About 2 – 4 days after discontinuation of treatment a withdrawal bleeding
will occur resembling a normal menstruation in intensity and duration.
Slight bleeding during tablet – taking:-
Occasionally slight bleeding may occur after initial arrest of bleeding. In these cases tablet – taking must not be interrupted .
Missing arrest of hemorrhage, heavy breakthrough bleeding :-
Cidolut Nor can give valuable hints concerning differential diagnosis