Hydroxyprogesterone caproate

Composition

17-alpha hydroxyl-progesterone-17-caproate

Properties

Hydroxyprogesterone caproate contains 17-alpha hydroxyl-progesterone-17-caproate in an oily solution. Cidolut depot is a clear solution and maybe injected through needles of the usual bore. The preparation does not give rise to any inflammation at the site of injection. The duration of action of hydroxyprogesterone caproate is one week.

Indications and Usage:

  • Habitual abortion
  • Primary and secondary amenorrhoea
  • Functional uterine bleeding (Puberty and preclimacteric bleeding)
  • Polymenorrhoea

Contra-indications

  • Undiagnosed vaginal bleeding
  • Patients with a history of a recurrent high risk of arterial disease
  • Breast or genital carcinoma
  • Hepatic impairment, especially if severe.
  • Diagnostically for a pregnancy test.
  • Missed or incomplete abortion.

Drug Interactions

  • Enzyme inducing drugs such as carbamazepine, griseofulvin, phenobarbital, phenytoin and rifampicin may enhance the metabolism and clearance of progesterone.
  • Since hydroxyprogesterone caproate can influence diabetic control, an adjustment in antidiabetic dosage should be required.
  • Progesterone may inhibit ciclosporin concentration and risk of toxicity.

Warnings and Precautions:

  • Hydroxyprogesterone caproate should be used with caution in patients with cardiovascular diseases or renal impairment, diabetes mellitus, asthma, epilepsy and migraine.
  • High doses of hydroxyprogesterone caproate depot should be used with caution in patients susceptible to thromboembolism.
  • Sometimes a local reaction may occur at the site of injection.
  • Rarely occurring: coughing, dyspnoea and circulatory disturbance during or immediately after injection, but that can be avoided by injecting the drug very slowly.

Dosage and Administration

The high concentration contained in hydroxyprogesterone caproate takes into account the latest scientific discoveries about corpus luteum therapy. These have shown that it is often only possible to obtain a successful result using large doses. Over dosage of progesterone and its derivatives is practically speaking is not possible.
The administration of hydroxyprogesterone caproate is always indicated if it is desired to obtain a corpus luteum effect extending over at least one week or longer. This is especially the case in the second half of the menstrual cycle and during pregnancy.

  1. Habitual AbortionIn cases of the tendency to habitual abortion, it is often advisable to administer larger doses of progesterone over a longer time than has been usual in order to preserve the pregnancy.

    In the tendency of habitual abortion – 125 to 250 mg of hydroxyprogesterone caproate.
    Should be injected at weekly intervals for at least the first half of pregnancy.

  2. Amenorrhoea:Primary amenorrhoea and secondary amenorrhoea of relatively long duration:
    It is recommended that a cyclical treatment as described by Kaufmann be carried out over several months. Frequently a spontaneous cycle occurs subsequently. If this does not take place the treatment must be repeated over a few months. Using Estradiol valerate and hydroxyprogesterone caproate it is found possible to carry out a cyclically correct treatment in a simple manner.

    At the beginning of treatment 10 mg estradiol valerate are injected intramuscularly. Next either 10 mg estradiol valerate is injected on the 14th day as well as 125mg. hydroxyprogesterone caproate intramuscularly on the 14th and 22nd days or alternatively 10mg estradiol valerate together with 250 mg hydroxyprogesterone caproate intramuscularly on the 18th day of treatment.

    Following the bleeding which resembles menstruation and occurs approximately on the 28th day 10mg estradiol valerate intramuscularly.

  3. Functional bleeding (Cyclical glandular hyperplasia)Especially puberty bleeding and pre-climacteric bleeding.
    Progesterone has a haemostatic action on the endometrium. The duration of the bleeding and the condition of the endometrium are of great
    significance in the mechanism of this action.

    Estrogen should be injected simultaneously with 125 mg hydroxyprogesterone caproate 10 mg Estradiol valerate. A few days later menstruation like bleeding of limited bleeding duration may occur (medical curettage). When the bleeding is of long duration the desquamated endometrium should first of all be built up to the stage of proliferation by means of estrogen and then transformed by means of hydroxyprogesterone caproate.

  4. In shortening of the phase of secretion, the time of ovulation may be easily determined by regular measurement of the morning temperature.
    65 to 125 mg of hydroxyprogesterone caproate should be injected intramuscularly between 20th and 22nd days.