PROLUTON DEPOT INJECTION 250MG/ML [SIN14879P]

Product Info

PROLUTON DEPOT INJECTION 250MG/ML

[SIN14879P]

Therapeutic indications

Habitual and imminent abortion

Dosage and method of administration

• How to use Proluton Depot

  Proluton Depot must be administered always as a deep intramuscular injection, preferably intragluteal, alternatively into the upper arm. The injection must be administered extremely slowly (see section “Undesirable effects” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Abortion

  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 such as 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 deficit, 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.

• Habitual abortion

  As soon as pregnancy has been confirmed by diagnosis, 250 – 500 mg Proluton 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 Proluton 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 Proluton Depot i.m. 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 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 Proluton Depot which subsides only gradually. However, no further measures are necessary.

Contraindications

Proluton Depot should not be used in the presence of any of the conditions listed below. Should any of the conditions appear during the use of Proluton Depot, the use of the preparation must be discontinued immediately.

• Active venous thromboembolic disorders.

• Arterial and cardiovascular disease present or in history (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease).

• Diabetes mellitus with vascular involvement.

• Presence or history of severe hepatic disease as long as liver function values have not returned to normal.

• Presence or history of liver tumors (benign or malignant).

• Known or suspected sex hormone-dependent malignancies.

• Hypersensitivity to hydroxyprogesterone caproate or to any of the excipients.