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Primulot N

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PRIMOLUT N

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PRIMOLUT N

for oral progestogen therapy (tablets)

COMPOSITION
1 tablet contains norethisterone (17-hydroxy-19-nor-17alpha-pregn-4-en-20-yn-3-one) 5,0 mg.

PHARMACOLOGICAL CLASSIFICATION
A. 21.8.2 Progesterones without estrogens.

PHARMACOLOGICAL ACTION
Primolut N is an orally active progestogen. A total dose of about 80-150 mg Primolut N, 10-15 mg on each of 8-10 consecutive days, will produce complete secretory transformation of an endometrium which has been adequately pre-treated with estrogens.
A particular advantage is that the menstruation-like withdrawal bleeding occurs very regularly 2-4 days after stopping the Primolut N treatment.
During treatment with Primolut N, the basal body temperature rises, as it does under the influence of endogenous progesterone in the second phase of the menstrual cycle.
In addition to the transformatory action norethisterone also has a styptic effect. A local influence on the endometrium leads to the cessation of dysfunctional bleeding.

INDICATIONS
Dysfunctional uterine bleeding, primary and secondary amenorrhoea, premenstrual syndrome, mastopathy, uterine hypoplasia, timing of menstruation, endometriosis.

CONTRA-INDICATIONS
Pregnancy, severe disturbance of liver function, Dubin-Johnson syndrome, Rotor syndrome, a history of jaundice or severe pruritus during pregnancy, a history of herpes of pregnancy.

DOSAGE AND DIRECTIONS FOR USE
Before starting Primolut N a thorough general medical and gynaecological examination (including the breasts) should be carried out and pregnancy must be excluded.
Unless otherwise prescribed by the doctor, the following dosages are recommended.

        Dysfunctional uterine bleeding
The administration of 1 tablet Primolut N 3 times daily over 10 days leads to the arrest of uterine bleeding not associated with organic lesions within 1-3 days. In individual cases, bleeding diminishes during the first few days after the commencement of tablet-taking and does not stop until about five days later. For the treatment to be successful Primolut N administration should be continued regularly even after arrest of bleeding (up to a total of 30 tablets).
About 2-4 days after discontinuation of treatment a withdrawal bleeding will occur resembling a normal menstruation in intensity and duration.
O        Slight bleeding during tablet-taking
Occasionally, slight bleeding may occur after initial arrest of bleeding. In these cases tablet-taking must not be interrupted.
O        Missing arrest of haemorrhage, heavy breakthrough bleeding
Primolut N can give valuable hints concerning differential diagnosis of uterine bleeding. If the bleeding does not stop in spite of regular tablet-taking, an organic cause must be considered. The attending physician must be informed immediately, because further measures are then mostly required. This applies also in cases where after initial arrest of haemorrhage, heavier bleedings still occur during tablet-taking.
O        Prevention of recurrence
To prevent recurrence of dysfunctional bleeding, it is recommended to administer Primolut N prophylactically during the next three cycles, ie 1 tablet Primolut N 2-3 times daily from the 19th to the 26th day of the cycle (1st day of the cycle = 1st day of the last bleeding). The withdrawal bleeding occurs some days after administration of the last tablet.
Only the physician can decide whether this measure is necessary. His decision is then based on the course of the basal body temperature, which must be measured daily.

        Primary and secondary amenorrhoea
In the case of secondary amenorrhoea hormone treatment is to be given at the earliest 8 weeks after the last menstrual period.
In order to induce a menstruation-like bleeding, an estrogen (eg estradiol valerate 10 mg) is to be given before the administration of Primolut N.
O        Commencement of treatment
2 ampoules estradiol valerate 10 mg im on the 1st day of treatment and 1 ampoule of estradiol valerate 10 mg im on the 14th day of treatment, followed by 1 tablet Primolut N 2-3 times daily from the 19th to the 26th day of treatment. Withdrawal bleeding starts about the 28th day.
O        Continuation of treatment (over at least 2-3 cycles)
1 ampoule estradiol valerate 10 mg im on the 6th and 16th days of the artificial cycle, followed by 1 tablet Primolut N twice daily from the 19th to the 26th day of the cycle (1st day of bleeding = 1st day of the cycle).
O        An attempt can then be made to stop the estrogen treatment and to induce a cyclical bleeding by the administration of 1 tablet Primolut N twice daily from the 19th to the 26th day of the cycle.
Exception: Patients of whom it can be safely assumed that endogenous estrogen production is insufficient (primary amenorrhoea in gonadal dysgenesia; secondary amenorrhoea in climacterium praecox).
O        Please note
During treatment pregnancy must not occur. Contraception should be practised with non-hormonal methods (with the exception of the rhythm method according to Knaus-Ogino and the temperature method). If withdrawal bleeding at regular intervals of about 28 days fails to occur under the therapeutic scheme (see above), pregnancy must be considered despite the protective measures. The treatment must then be interrupted until the situation has been clarified by differential diagnosis.

        Premenstrual syndrome, mastopathy
Premenstrual symptoms such as headaches, depressive moods, water retention, a feeling of tension in the breasts, may be relieved or palliated by 1 tablet Primolut N 2-3 times daily from the 19th to the 26th day of the cycle.
The remarks under "Please note" for the indication "Primary and secondary amenorrhoea" apply to this indication.

        Uterine hypoplasia
Treatment should commence directly after menstruation on the 5th day of the cycle.
1st and 2nd weeks: 1-2 ampoules estradiol valerate 10 mg im per week and 1 tablet Primolut N twice daily.
3rd to 7th week: 1-2 ampoules estradiol valerate 10 mg im per week and 2 tablets Primolut N twice daily.
8th week: 2 tablets Primolut N twice daily.
After the 8-week therapy a withdrawal bleeding will occur.

        Timing of menstruation
The monthly bleeding can be advanced or postponed if particular circumstances require this. However, advancement with progestogen-estrogen combinations is definitely to be preferred, because the occurrence of a pregnancy is virtually ruled out by the inhibition of ovulation. As opposed to this, the postponement of menstruation calls for the use of Primolut N at a time when the necessary exclusion of pregnancy can be problematical since Primolut N must be given at a time when pregnancy cannot be excluded using the currently available examination methods. Therefore, this method remains restricted to those cases in which there is no possibility of early pregnancy in the cycle concerned.
Dosage: 1 tablet Primolut N 3 times daily for not longer than 10-14 days, beginning about 3 days before the expected menstruation. Bleeding will occur 2-3 days after having stopped medication. If it does not, the doctor must be consulted.

        Endometriosis
Treatment is commenced on the 5th day of the cycle with 1 tablet Primolut N twice daily, increasing to 2 tablets twice daily in the event of spotting. When the bleeding ceases, the initial dose can be resumed. Duration of treatment at least 4-6 months. During treatment, ovulation and menstruation do not occur. After discontinuation of hormone treatment a withdrawal bleeding will occur.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
In rare cases nausea may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Unknown till now. Symptomatic treatment according to conventional methods.

IDENTIFICATION
White, round tablet, biconvex, imprinted with "AN" in a regular hexagon on one side.

PRESENTATION
30 tablets of 5 mg
150 tablets of 5 mg

STORAGE INSTRUCTIONS
Store below 30C. For shelf-life, please refer to the imprint on the pack. Keep out of reach of children.

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