Progesterone Soft Gelatin Capsules

(Progesterone Soft Gelatin Capsules)

COMPOSITION:

ZYSOL – 100		ZYSOL – 200
Each soft gelatin capsule contains		Each soft gelatin capsule contains
Progesterone (Natural, Miconized) BP 100 mg		Progesterone (Natural, Miconized) BP 200 mg
Excipients q.s		Excipients q.s

DESCRIPTION:

Progesterone is the main hormone secreted by corpus luteum. Large quantities are produced by placenta during pregnancy. It acts on the endometrium by converting the proliferative phase induced estrogen to a secretory phase and preparing the uterus to receive the fertilized ovum. It also suppresses uterine motility and is responsible for further development of the breasts.Progesterone is necessary to increase endometrial receptivity for implantation of an embryo. Once the embryo is implanted, progesterone acts to maintain the pregnancy.

Pure Progesterone has immense therapeutic potential in the management of gynecologic disorders, including menopausal symptoms, dysfunctional uterine bleeding amenorrhea, luteal phase inadequacy and premenstrual syndrome. Pure progesterone is being introduced into the market as soft gelatin capsule. The formulation contains pure progesterone in micronised form. The advantages of mocronized progesterone are rapid absorption increase dissolution and increase bioavailability. It can be administered either by oral, rectal or vaginal route.

MECHANISM OF ACTION:

Progesterone acts via specific receptors in target cells. The steroid receptor complex binds to DNA in the nucleus, thereby inducing the synthesis of specific proteins. Progesterone receptor concentrations are low in the absence of estrogens, and increase following estrogen administration. The progestational actions of progesterone include the development of a glandular endometriun in an estrogen primed uterus and the postponement of menstruation,

The maintenance of pregnancy, inhibition of uterine motility and delay in parturition. Progesterone administration decreases the circulatory levels of gonadotropins.

INDICATIONS:

·         Dysfunctional Uterine Bleeding

·         Premenstrual Syndrome

·         Prophylaxis of postnatal depression

·         Maintenance of pregnancy in cases of habitual or threatened abortion

·         Secondary amenorrhea

·         Prevention of endometrial hyperplasia in non hysterectomized postmenopausal women who are receiving conjugated estrogens

·         Supplementation of the luteal phase in case of sterility due to luteal deficiency.

·         Benign mastopathies.

DOSAGE AND ADMINISTRATION:

·         Maintenance of pregnancy in cases of habitual or threatened abortion.

            200 to 400 mg per day in divided doses

·         For premenstrua’ syndrome

            200-400 mg once or twice daily from the 12th to 14’ day of the cycle until onset of  

            menstruation.

·         For puerperal depression

400 mg twice daily in divided doses

Supplementation of the luteal phase in case of sterility due to luteal deficiency

400 to 600 mg per day upto the 12th week of pregnancy.

·         Neonates/children/elderly

            There are no indications for the use of progesterone.

Route of administration:

·         Vaginal, rectal or oral

·         Vaginal / rectal- each capsule should be deeply inserted.

ADVERSE REACTIONS:

Acute overdose reactions include euphoria, faintness and uterine cramps. Symptomatic reactions include weight gain or loss and various skin reactions such as acne, anal soreness, diarrhoea and flatulence may occur after rectal administration.

COMPETITIVE BRANDS:

Puregest                      (Sun)

Dubagest                     (Glenmark)

Naturogest                  (German Remedies)

PRESCRIBING DOCTORS:

Gynaecologist