Each vaginal tablet contains micronized progesterone and excipients.
Pharmacology: The pharmacological particulars of Endometrin are those of the naturally occuring progesterone, which is secreted by the ovary, placenta and adrenal gland. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium.
Progesterone is essential for the development of decidual tissue and the effect of progesterone on the differentiation of glandular epithelia and stroma has been extensively studied. Progesterone is necessary to increase endometrial receptivity for implantation of an embryo. Once an embryo is implanted, progesterone acts to maintain the pregnancy.
Progesterone supplementation or replacement in cases eg, treatment of infertile women and in vitro fertilization.
Dosage is according to physician's instructions.
The dosage and the number of days during the month the tablets should be administered will be decided on an individual basis by the doctor according to the purpose of use. Do not exceed the recommended dosage.
This medication is to be administered at specific time intervals as determined by the attending doctor.
If the patient forgets to administer Endometrin at its fixed time, she should skip the missed dose and continue administering the medicine for an extra day until the treatment is completed.
In general, the following dosage is recommended: Endometrin is inserted twice daily intravaginally, initiated within several days of ovulation. Treatment is usually continued for 10-12 weeks of gestation from which time natural secretion of progesterone from the placenta is established.
Instructions for Use/Handling: Take the tablet out of the package and place it on the applicator at the designated area. The applicator may be inserted into the vagina in a sitting or lying position with the knees bent. Gently insert the applicator deeply into the vagina and push the plunger in order to release the tablet. Remove the applicator and wash it with warm water and soap.
Endometrin is unlikely and is not expected to produce any side effects. Treatment is by observation and if necessary, symptomatic and supportive measures should be provided.
Patients with known sensitivity to progesterone, undiagnosed vaginal bleeding, liver dysfunction or disease. Known or suspected malignancy of the breast or genital organs. Active thrombophlebitis or thromboembolic disorders, or a history of hormone associated thrombophlebitis or thromboembolic disorders.
Endometrin should not be used with other local intravaginal therapy. In case of use with other intravaginal therapy, a 6-hr interval should be observed between the 2 medicaments.
The patient should undergo physical examination with special reference to breast and pelvic organs.
Since progesterone may cause some degree of fluid retention, conditions which might be influenced by this factor (eg, epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation.
The pathologist should be advised of progesterone therapy when relevant specimens are submitted.
Patients with a history of psychic depression should be carefully observed and Endometrin should be discontinued if the depression recurs to a serious degree.
A decrease in glucose tolerance has been observed in a small percentage of patients on estrogen-progestin combination medicaments. The mechanism of this decrease is unknown. For this reason, diabetic patients should be carefully monitored while receiving progestin therapy.
In case of recurring sunspots, use with caution.
Effects on the Ability to Drive or Operate Machinery: Drivers and users of machines should be warned that risk of somnolence may occur.
Use in Pregnancy: Endometrin is used to maintain pregnancy where there is a deficient production of endogenous progesterone from the corpus luteum. It is not necessary to administer Endometrin once there is an adequate secretion of placental progesterone.
Use in Lactation: Detectable amounts of progesterone were found in breast milk. As the effect on the suckling infant with the use of Endometrin has not been determined, it is not recommended for use during lactation.
Use in Pregnancy: Endometrin is used to maintain pregnancy where there is a deficient production of endogenous progesterone from the corpus luteum. It is not necessary to administer Endometrin once there is an adequate secretion of placental progesterone.
Use in Lactation: Detectable amounts of progesterone were found in breast milk. As the effect on the suckling infant with the use of Endometrin has not been determined, it is not recommended for use during lactation.
Changes in vaginal discharge, mild vaginitis, breast sensitivity, fluid retention, swelling of feet, weight changes, allergic reactions, itching, acne, skin spots, sleep disturbance, swelling of eyes, headaches, yellowing of skin or eyes, vaginal pain, groin pain, pain in the calves or chest, sudden shortness of breath, coughing up blood, vomiting, dizziness, faintness, changes in vision or speech, weakness or numbness, breast lumps.
No drug interactions have been assessed with Endometrin.
Store at room temperature below 25°C and in a dry place.
Close bottle cap firmly to prevent penetration of air and humidity.
Shelf-Life: 5 years.
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
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