Indications

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

Usage:I.M.

1. Threatened abortion: Generally 10-20 mg, used until pain and bleeding stop.

2. History of recurrent miscarriage: 10-20 mg once a week, 2-3 times a week, starting from the beginning of pregnancy.

3. Functional uterine bleeding: For withdrawal bleeding with hemoglobin below 7 mg, 10 mg daily for 5 days, or 20 mg daily for 3-4 days.

4. Amenorrhea: 10 mg intramuscularly daily for 5 days, 8-10 days before the expected menstruation; or 20 mg intramuscularly daily for 3-4 days.

5. Premenstrual syndrome: 10-20 mg injected 12 days before the expected menstruation for 10 days.

Please consult your doctor for detailed usage instructions.

Precautions & Warning:

1.General: The pretreatment physical examination should include special reference to breast and pelvic organs, as well as a Papanicolaou smear. Because progestational drugs may cause some degree of fluid retention, conditions which might be influenced by this condition, such as epilepsy, migraine, asthma, cardiac, or renal dysfunction, require careful observation.

2.Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term intramuscular administration of Medroxyprogesterone acetate (MPA) has been shown to produce mammary tumors in beagle dogs.

3.Geriatric Use: The safety and effectiveness in geriatric patients (over age 65) have not been established.

4.Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

5.Nursing Mothers: Detectable amounts of drug have been identified in the milk of mothers receiving progestational drugs. The effect of this on the nursing infant has not been determined.

6.The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis).

Contraindications:

1. Current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy.

2. Liver dysfunction or disease.

3. Known or suspected malignancy of breast or genital organs.

4. Undiagnosed vaginal bleeding.

5. Missed abortion.

6. Known sensitivity to progesterone injection.

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; 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 T3 uptake values.

Drug interactions:

The metabolism of progesterone by human liver microsomes was inhibited by ketoconazole (IC50 < 01 µM). Ketoconazole is a known inhibitor of cytochrome P450 3A4 and these data suggest that ketoconazole or other known inhibitors of this enzyme may increase the bioavailability of progesterone. The clinical relevance of the in vitro findings is unknown.

Storage instructions:

Store at 15°-30°C in original packaging.