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Brand Names: Proluton Depot
Generic Name: Hydroxyprogesterone Caproate USP
Depot amp 250 mg/mL (only solution) x 1 mL x 20's.
In contrast to the short-acting compound, progesterone, hydroxyprogesterone caproate has a progestational depot effect in man. If an estrogen is administered at the same time, the effect of Proluton Depot at the level of the endometriurn lasts about 10 days.
The suppressive effect on the hypothalamo-pituitary system, which Is inherent In all sex hormones, is relatively weak in the case of Proluton Depot, as in the thermogenetic effect. 500 mg and more are required to induce an increase in the body temperature.
Hydroxyprogesterone caproate is completely bioavailable after IM administration. The substance is released slowly from the depot, the maximum blood levels of active ingredient and metabolites being reached 2-5 days after the injection. After reaching the maximum, the concentration decreases with a half-life of around 9 days. In keeping with this, emptying of the depot was observed 30 days after administration. The depot effect of hydroxyprogesterone caproate is based on the delayed release of the substance from the injected depot and not on the formation of a secondary depot (eg, adipose tissue) in the body. The greatest part of the dose of hydroxyprogesterone caproate does not appear to be hydrolysed. Biotransformation is effective at the steroid ester, and only very small fractions of the dose are converted to estradiol and its metabolites. Hydroxyprogesterone caproate and its metabolites are eliminated with the bile and urine in a ratio of 8:2. The rate of excretion is characterised by a half-life of approxematly 6 days, and is determined by the substance released from the depot. Virtuaty no unchanged substance is eliminated. If Proluton Depot is administered weekly or more frequency, accumulation of the active ingredient and its metabolism of >100% must be expected. The absolute bioavailability of hydroxyprogesterone caproate is 100%
Habitual and threatened abortion, infertility due to corpus luteum insufficiency, primary and secondary amenorrhoea.
DOSAGE & ADMINISTRATION
Like all oily solutions, Proluton Depot must be injected IM. Experience shows that the short-lasting reactions (urge to cough, coughing fits, respiratory distress) which occur in rare cases, during or immediately after the injection of oily solutions, can be avoided by injecting the solution extremely slowly.
According to the present state of scientific knowledge, medicinal therapy should be given in early pregnancy, only if it is absolutely essential. This is also valid for the use of hormone preparations e.g., Proluton Depot for the maintenance of pregnancy. Consequently, Proluton Depot should only be prescribed if there is an urgent desire for children, primarily in the presence of corpus luteum insufficiency or a case history of abortion. Proluton Depot is indicated for both prophylaxis and treatment of abortion because it compensates for the hormone defeat induces quiescence of the uterus and stimulates growth of an underdeveloped uterus. Prolonged treatment with an adequate dosage of Proluton Depot is necessary to achieve this objective and to maintain pregnancy. Because Proluton Depot places the uterus at rest, it is possible for an already dead embryo to be retained. In the case of protracted therapy, it is therefore necessary to check the continued existence of pregnancy by means of appropriate examinations and immunological tests.
As soon as pregnancy has been confirmed by diagnosis, 250-500 mg Proluton Depot are injected IM at weekly intervals during the initial months or in individual cases, for even longer.
The therapy is initiated with an IM I infection of 500 mg Proluton Depot 2-3 times weekly until the bleeding ceases, bed rest befog urgently recommended. The treatment must then be continued for several weeks with 250 mg Proluton Depot IM twice weekly until the patient remains free from complaints and bleeding despite mobilization Whether Proluton Depot should be given prophylactically even beyond this point will depend on the individual case. 8-14 days after unsuccessful treatment of threatened abortion and subsequent curettage, withdrawal bleeding may occur in isolated cases owing to the continuing effect of Proluton Depot I 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 too short-lived and increase in the basal body temperature in the second half of the cycle, Proluton Depot brings about secretory transformation of the inadequately transformed endo-metrium, thus improving; the chances of nidation.
IM injection of 250 mg Proluton Depot about 3 days after the rise in basal body temperature.
Since there is often a coexisting estrogen deficit, additional administration of an estrogen preparation may be employed. Thus, a physiological transformation of the endometrium can be achieved.
Primary and Secondary Amenorrhea
In the case of secondary amenorrhea, hormonial 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 preparation (eg. Progynon Depot 10 mg) is to be given before the administration of Proluton Depot However, before treatment is commenced, the presence of a prolactin-producing pituitary tumour should be excluded because, accordning to the present state of knowledge, the possibility cannot be ruled out that macro adenomas increasein size when exposed to higher doses of estrogen for prolonged periods of time.
Commencement of Treatment On the 1st day of treatment 2 amps Progynon Depot 10 mg IM, 14 days later, 1 amp Progynon Depot 10 mg together with 250 mg Proluton Depot IM. Withdrawal bleeding starts about the 28th day of treatment.
Continuation of Treatment (over at least 2-3 cycles): On the 6th day of the artificial cycle, 1 amp Progynon Depot 10 mg lM and on the 16th day, another ampoule Progynon Depot 10 mg together with 250 mg Proluton Depot IM (1st day of bleeding =1st day of the cycle).
An attempt can then be made to stop the estrogen-treatment, and to induce a cyclical bleeding by an IM injection of 250 mg Proluton Depot between the 18th and the 20th day of the cycle.
Patients in whom it can be safely assumed that endogenous estrogen production is insufficient (primary amenorrhea in gonadal dysgenesia).
Note: If there is no desire for children, contraception should be practiced with nonhormonal methods (with the exception of the rhythm method and temperature method). If withdrawal bleeding at regular intervals of about 28 days fails to occur under the therapeutic scheme, pregnancy must be considered despite the protective measures. The treatment must then be interrupted until the situation has been clarified by differential diagnosis. If, on the other hand, there is a desire for children and pregnancy has occurred, treatment with Proluton Depot should only be continued if there is reason to assume a risk of abortion.
A history of herpes of pregnancy, previous or existing liver tumours.
Before starting therapy, a thorough general medical and
gynaecological examination (including the breasts and a cytological smear of the cervix) should be carried out and pregnancy must be excluded in the appropriate indications. Patients suffering from diabetes should be closely supervised. In rare cases, benign and in even rarer cases, malignant liver tumours leading in isolated cases to life-threatening intra-abdominal haemorrhage have been observed after the use of hormonal substances eg, the one contained in Proluton Depot If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be included in the differential-diagnostic considerations. The Question of
Possible Teratogenic Effects
A possible association between the administration of female sex hormones in early pregnancy and the occurrence of malformations has been the subject of discussions in recent years. According to the present state of scientific knowledge, the assumption that there may be a causal association can be regarded as unfounded. However, it must be clearly understood that no drug, including sex hormones, can be claimed with absolute certainty to be free from teratogenic effects. This remaining uncertainty is the reason why, in certain indications, the exclusion of pregnancy is called for before the start of sex hormone therapy.
The requirement for oral antdiabetics or insulin can change.