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Logo PRIMOGYN DEPOT 10 mg

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PRIMOGYN DEPOT 10 mg

For intramuscular estrogen therapy
(oily solution)

COMPOSITION
1 mL contains
estradiol valerate (estra-1,3,5(10)-triene-3,17beta-diol 17-valerate) 10,0 mg in an oily solution.

PHARMACOLOGICAL CLASSIFICATION
A. 21.8.1 Estrogens.

PHARMACOLOGICAL ACTION
Primogyn Depot 10 mg is an estrogen preparation which contains the n-valeric-acid ester of the naturally occurring estrogen, estradiol. Following intramuscular injection estradiol valerate provides a depot effect of about two weeks. With suitable dosage it is possible to induce proliferative changes in the endometrium and, in combination with progestogens, to imitate a physiological course of the menstrual cycle. Estradiol valerate is suitable for replacement therapy in all pathological conditions caused by estrogen deficiency.

INDICATIONS
Primary and secondary amenorrhoea, uterine hypoplasia, deficiency symptoms in young women after oophorectomy or radiological castration for non-carcinomatous diseases, gynaecological operations, dysfunctional bleeding.

CONTRA-INDICATIONS
Pregnancy; existing or suspected hormone-dependent tumours of the uterus or mammae, endometriosis.

DOSAGE AND DIRECTIONS FOR USE
Before starting the use of Primogyn Depot 10 mg a thorough general medical and gynaecological examination (including the breasts) should be carried out and pregnancy must be excluded.
Like all oily solutions Primogyn Depot 10 mg must be injected intramuscularly
•        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 addition to Primogyn Depot 10 mg, the administration of a progestogen (hydroxyprogesterone hexanoate injections or norethisterone tablets) is necessary to induce a menstruation-like bleeding.
O        Commencement of treatment
On the first day of treatment 2 ampoules Primogyn Depot 10 mg intramuscularly, followed 14 days later by 1 ampoule Primogyn Depot 10 mg together with 250 mg hydroxyprogesterone hexanoate intramuscularly. Instead of hydroxyprogesterone hexanoate injections, 1 tablet containing 5 mg norethisterone can be administered 2-3 times daily from the 19th to the 26th day of treatment. Withdrawal bleeding starts about the 28th day of treatment.
O        Continuation of treatment (over at least 2-3 cycles)
On the 6th day of the following artificial cycle, 1 ampoule Primogyn Depot 10 mg intramuscularly and on the 16th day another ampoule Primogyn Depot 10 mg together with 250 mg hydroxyprogesterone hexanoate intramuscularly.
Instead of hydroxyprogesterone hexanoate injections, 1 tablet containing 5 mg norethisterone twice daily from the 19th to the 26th day of the cycle can be given (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 one intramuscular injection of 250 mg hydroxyprogesterone hexanoate between the 18th and 20th day of the cycle or by the administration of 1 tablet containing 5 mg norethisterone 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).
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.

•        Uterine hypoplasia
O        Cyclical treatment
1 ampoule Primogyn Depot 10 mg intramuscularly immediately after menstruation on the 6th day of the cycle; on the 16th day of the cycle another ampoule Primogyn Depot 10 mg together with 250 mg hydroxyprogesterone hexanoate intramuscularly. This treatment has to be repeated for several cycles.
The remarks under "Please note" for the indication "Primary and secondary amenorrhoea" apply also to the administration of hormones according to this scheme.
O        Induction of a state of pseudo-pregnancy
Treatment is started following a menstruation, on the 5th day of the cycle.
  Primogyn Depot 10 mg Hydroxyprogesterone hexanoate
1st and 2nd weeks 1-2 ampoules im weekly 250 mg im weekly
3rd to 6th week 1-2 ampoules im weekly 250 mg im weekly
7th week 1-2 ampoules im 500 mg im
8th week         - 500 mg im
Alternative treatment started also on the 5th day of the cycle:
  Primogyn Depot 10 mg Norethisterone
(5 mg tablets)
1st and 2nd weeks 1-2 ampoules im weekly 1 tablet twice daily
3rd to 6th week 1-2 ampoules im weekly 2 tablets twice daily
7th week 1-2 ampoules im 2 tablets twice daily
8th week         - 2 tablets twice daily
After the 8-week therapy a withdrawal bleeding will occur.

•        Deficiency symptoms in young women after oophorectomy or radiological castration for non-carcinomatous diseases
In non-hysterectomised women a cyclical therapy is indicated: 1 ampoule Primogyn Depot 10 mg intramuscularly on the first day of treatment and 14 days later another ampoule Primogyn Depot 10 mg together with 250 mg hydroxyprogesterone hexanoate intramuscularly. Instead of hydroxyprogesterone hexanoate injections, 1 tablet containing 5 mg norethisterone can be given twice daily from the 19th to the 26th day of treatment. The treatment is repeated after each withdrawal bleeding.
If the patient had a hysterectomy as well as an oophorectomy the dosage of Primogyn Depot 10 mg can be adjusted entirely to the individual deficiency symptoms.
1 ampoule Primogyn Depot 10 mg intramuscularly. The next intramuscular injection of Primogyn Depot 10 mg is given after recurrence of symptoms, at the earliest, however, 2 weeks after the first one.

•        Gynaecological operations
2 ampoules Primogyn Depot 10 mg intramuscularly 2 weeks before the planned operation.

•        Dysfunctional bleeding
Bleeding of more than 3 weeks' duration (necrotic stage) can be more readily stopped if, for the proliferation of the necrotic mucosa, 1 ampoule Primogyn Depot 10 mg is injected intramuscularly at the beginning of treatment with oral progestogens (norethisterone) or progestogen/estrogen combinations.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
In rare cases a feeling of tension in the breasts can occur.
Not for use during pregnancy. Vaginal adenosis and vaginal and cervical adenocarcinoma has been noted in post pubertal girls whose mothers had been treated for threatened abortion with large doses of stilboestrol or related estrogenic substances during their pregnancies.
An increased incidence of endometrial uterine carcinoma, related to the continuous use of estrogens in the postmenopausal period has been reported.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
None. Symptomatic treatment according to conventional methods.

IDENTIFICATION
Clear, pale yellowish, oily solution.

PRESENTATION
3 ampoules of 1 mL each.

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

REFERENCE NUMBER
G.3120 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/009072/07)
106 Sixteenth Road
Randjespark
Midrand        1685
P O Box 5278
Halfway House        1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
6 February 1979

SCHERING (PTY) LTD
(Reg No: 1964/009072/07)
Subsidiary of
Schering AG        Germany

Updated on this site: April 2003
Current: January 2005
Source: Pharmaceutical Industry

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