Progesterone Micronized (Vaginal Gel)

Progesterone Micronized is indicated in-

• Maintenance of pregnancy in case of Threatened/Recurrent abortion.
• Luteal support during IVF and ART.
• Luteal support in case of proven luteal phase insufficiency.
• Secondary Amenorrhea.
• Dysfunctional Uterine Bleeding (DUB).

This preparation contains micronized Progesterone which is structurally and biologically identical to natural endogenous progesterone. Progesterone 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 necessary to increase endometrial receptivity for implantation of an embryo. Once an embryo is implanted, progesterone acts to maintain the pregnancy. Progesterone administration decreases the circulatory levels of gonadotropins.

Route of administration: Vaginal application

Maintenance of pregnancy in case of Threatened/Recurrent abortion: Use Progesterone Micronized vaginally once daily (90 mg of 8% gel).

Reproductive failure and in vitro fertilization treatment: Progesterone Micronized is given at a dose of 90 mg. Treatment is started within 4 days, preferably 2 days, after hCG (human chorionic gonadotropin) administration. One application of Progel 90 mg (8% gel) should be given vaginally daily or twice daily. Most women will respond to 90 mg given daily. However, some women may need 90 mg twice daily. If pregnancy occurs treatment may continue for up to 10 to 12 weeks.

Secondary Amenorrhea: Use Progesterone Micronized once a day (90 mg of 8% gel) for every alternative day for 6 days.

Use in children and adolescents: Progesterone Micronized is not indicated for use in children.

One application (applicator used to the ring mark) contains 1.125 gm of Progesterone Micronized, which contains 90 mg progesterone.

• Remove cap from the tube, invert it, and use the sharp point to open the tube.
• Pull the plunger up to the ring. Now attach it to the opening of the tube.
• Squeeze the tube slowly to the applicator up to the ring-mark (where the plunger stops).
• Remove the tube.
• To apply the Gel, lie down; insert the applicator deep into the vagina.
• Slowly push the plunger all the way in until the applicator is empty.
• After use, pull the plunger out of the barrel beyond the point of resistance and wash both parts in warm, soapy water. Do not use detergents. Rinse well and dry afterwards. Do not put the applicator in hot or boiling water.

Although no interactions with other drugs have been reported, Progel is not recommended for use concurrently with other vaginal preparations.

Known or suspected malignancy of the breast or genital organs, Missed abortion. Undiagnosed uterine bleeding, Liver dysfunction or disease, Known hypersensitivity to any of the components of the formulation, Known or suspected progesterone-dependent neoplasia, Active thrombophlebitis or thromboembolic disorders, cerebral apoplexy, or a history of hormone associated thrombophlebitis or thromboembolic disorders, Acute porphyria.

Common side effects: Abdominal pain, perineal pain, constipation, nausea, Diarrhea, vomiting, breast enlargement, dyspareunia, depression, decreased libido, nervousness, and somnolence, intermenstrual bleeding (spotting), vaginal irritation.

Rare side effects: cerebrovascular disorders, pulmonary embolism.

Pregnancy category A. It has been used to successfully support embryo implantation and maintain pregnancies. Do not use during lactation. Detectable amounts of progestogens have been identified in the milk of mothers receiving them. The effect of this on the nursing infant has not been determined.

If cerebrovascular disorders, pulmonary embolism, and retinal thrombosis occurs, the drug should be discontinued immediately. Treatment should be discontinued if the results of liver function tests become abnormal or if cholestatic jaundice appears. Patients with a history of depression should be carefully observed and discontinue the drug if the depression recurs to a serious degree. Progel should not be used concurrently with other vaginal therapy.

Acute over dosage is unlikely with this product due to the concentration-dependent, rate-limited absorption of progesterone by the vaginal epithelium and the prolonged release characteristics of the formulation. However, in case of over dosage, discontinue Progel and treat the patient symptomatically.

Drugs for Infertility

Store below 25°C temperature & dry place, protected from light. Keep all medicines out of reach of children.