INDICATION AND DOSAGE
PRIMOLUT DEPOT contains????? Hydroxyprogesterone caproate. It indicated for management of Habitual and imminent abortion, infertility due to corpus luteum insufficiency, primary and secondary amenorrhea.
RECOMMENDED DOSAGE
Habitual abortion
As soon as pregnancy has been confirmed by diagnosis, 250 - 500 mg Primolut Depot are injected i.m. at weekly intervals during the initial months or, in individual cases, for even longer.
Imminent abortion
The therapy is initiated with an i.m. injection of 500 mg Primolut Depot 2 - 3 times weekly until the bleeding ceases, bed rest being urgently recommended. The treatment must then be continued for several weeks with 250 mg Primolut Depot i.m. twice weekly until the patient remains free from complaints and bleeding despite mobilization. Whether Primolut Depot should be given prophylactically even beyond this point will depend on the individual case.
8 to 14 days after unsuccessful treatment of imminent abortion and subsequent curettage withdrawal bleeding may occur in isolated cases owing to the continuing effect of Primolut Depot which subsides only gradually. However, no further measures are necessary.
Infertility due to corpus luteum insufficiency
In cases in which the luteal phase is short - a situation characterized by a too short-lived increase in the basal body temperature in the second half of the cycle - Primolut Depot brings about secretory transformation of the inadequately transformed endometrium, thus improving the chances of nidation.
Intramuscular injection of 250 mg Primolut Depot should be given about 3 days after the rise in basal body temperature. Since there is often a coexisting estrogen deficit, endometrial priming with an estrogen should be carried out (e.g., for 14 days) before beginning treatment with Primolut Depot. Thus a physiological transformation of the endometrium can be achieved.
Primary and secondary amenorrhea
Hormone treatment of secondary amenorrhea can be carried out only after the exclusion of pregnancy. Before treatment of primary or secondary amenorrhea is commenced the presence of a prolactin-producing pituitary tumor should be excluded. The possibility cannot be ruled out that macroadenomas increase in size when exposed to high doses of estrogen for prolonged periods of time.
Endometrial priming with an estrogen should be carried out (e.g., for 14 days) before beginning treatment with Primolut Depot. Thereafter, treatment is commenced with 250 mg Primolut Depot intramuscularly.
In patients in whom sufficient endogenous estrogen levels have been achieved, an attempt can be made to stop the estrogen treatment and to induce cyclical bleeding by administering 250 mg Primolut Depot intramuscularly between the 18th and the 20th day of the cycle.
PREGNANCY AND LACTATION
Pregnancy should be ruled out unless Primolut Depot is being used for the treatment of habitual and threatened abortion.
A doctor's consultation is recommended in case of breastfeeding mothers.
SIDE EFFECTS
Allergic rash, Allergic urticaria, Allergic edema, Injection site redness, Injection site swelling, Injection site pain.
ACTIVE INGREDIENTS
Hydroxyprogesterone caproate