PROGESTERONE

INDICATIONS AND USAGE: This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.

DOSAGE AND ADMINISTRATION: Progesterone is administered by intramuscular injection. It differs from other commonly used steroids in that it is irritating at the place of injection. Amenorrhea Five to 10 mg are given for six to eight consecutive days. If there has been sufficient ovarian activity to produce a proliferative endometrium, one can expect withdrawal bleeding 48 to 72 hours after the last injection. This may be followed by spontaneous normal cycles. Functional Uterine Bleeding Five to 10 mg are given daily for six doses. Bleeding may be expected to cease within six days. When estrogen is given as well, the administration of progesterone is begun after two weeks of estrogen therapy. If menstrual flow begins during the course of injections of progesterone, they are discontinued. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.

Amenorrhea Five to 10 mg are given for six to eight consecutive days. If there has been sufficient ovarian activity to produce a proliferative endometrium, one can expect withdrawal bleeding 48 to 72 hours after the last injection. This may be followed by spontaneous normal cycles.

Functional Uterine Bleeding Five to 10 mg are given daily for six doses. Bleeding may be expected to cease within six days. When estrogen is given as well, the administration of progesterone is begun after two weeks of estrogen therapy. If menstrual flow begins during the course of injections of progesterone, they are discontinued. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.

CONTRAINDICATIONS Current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy. Liver dysfunction or disease. Known or suspected malignancy of breast or genital organs. Undiagnosed vaginal bleeding. Missed abortion. Known sensitivity to progesterone injection. Known sensitivity to sesame oil/seeds.

ADVERSE REACTIONS Breakthrough bleeding; spotting; change in menstrual flow; amenorrhea; edema; change in weight (increase or decrease); changes in cervical erosion and cervical secretions; cholestatic jaundice; breast tenderness and galactorrhea; pain, irritation, and/or redness at the injection area; skin sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash; acne, alopecia and hirsutism; rash (allergic) with and without pruritus; anaphylactoid reactions (including eosinophilic pneumonia); mental depression; pyrexia; insomnia; nausea; and somnolence. A statistically significant association has been demonstrated between use of estrogen-progestin combination drugs and pulmonary embolism and cerebral thrombosis and embolism. For this reason patients on progestin therapy should be carefully observed. There is also evidence suggestive of an association with neuro-ocular lesions, e.g., retinal thrombosis and optic neuritis. The following adverse reactions have been observed in patients receiving estrogen-progestin combination drugs: rise in blood pressure in susceptible individual, premenstrual syndrome, changes in libido, changes in appetite, cystitis-like syndrome, headache, nervousness, fatigue, backache, hirsutism, loss of scalp hair, erythema multiforme, erythema nodosum, hemorrhagic eruption, itching, and dizziness. The following laboratory results may be altered by the use of estrogen-progestin combination drugs: increased sulfobromophthalein retention and other hepatic function tests; coagulation tests: increase in prothrombin factors VII, VIII, IX, and X; metyrapone test; pregnanediol determinations; thyroid function: increase in PBI and butanol extractable protein bound iodine, and decrease in T 3 uptake values.

DESCRIPTION Progesterone injection, a progestin, is a sterile solution of progesterone in a suitable vegetable oil available for intramuscular use. Progesterone occurs as a white or creamy white, crystalline powder. It is odorless and is stable in air. Practically insoluble in water, it is soluble in alcohol, acetone, and dioxane and sparingly soluble in vegetable oils. It has the following structural formula: C 21 H 30 O 2 M.W. 314.47 Pregn-4-ene-3, 20-dione Each mL contains: Progesterone 50 mg, Benzyl Alcohol 10% as preservative in Sesame Oil q.s. Progesterone structural

HOW SUPPLIED Progesterone injection USP, 500 mg per 10 mL (50 mg/mL) is a sterile, clear, colorless to yellowish oily solution and is supplied as follows: 10 mL Multiple-Dose Vial packaged individually NDC 55150-306-10 Store at 20° to 25°C (68° to 77°F) [see USP controlled room temperature]. The vial stopper is not made with natural rubber latex. For all medical inquiries contact: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 1-866-850-2876 Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E.Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: June 2023