Usual Adult Dose for Amenorrhea

Oral capsules and tablets:
400 mg orally once a day (at bedtime) for 10 days

4% vaginal gel:
Administer 45 mg vaginally every other day, up to a total of 6 doses

• If no response, may try 90 mg of the 8% gel vaginally every other day, up to a total of 6 doses
• Dosage increase may only be accomplished using the 8% gel; increasing the volume of the 4% gel does not increase the amount of progesterone absorbed.

Intramuscular injection:
5 to 10 mg intramuscularly once a day for 6 to 8 consecutive days

• If ovarian activity is sufficient to produce a proliferative endometrium, withdrawal bleeding is expected 48 to 72 hours after the last injection.
• Spontaneous normal cycles may follow withdrawal bleeding.

Use: Treatment of secondary amenorrhea

Usual Adult Dose for Uterine Bleeding

5 to 10 mg intramuscularly once a day for 6 doses

Comments:

• Bleeding may be expected to cease within 6 days.
• If estrogen is also given, start progesterone 2 weeks after starting estrogen.
• Discontinue if menstrual flow begins during the injections.

Use: Abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer

Usual Adult Dose for Endometrial Hyperplasia - Prophylaxis

200 mg orally once a day (at bedtime) for 12 consecutive days per 28 day cycle

Use: Prevention of endometrial hyperplasia in postmenopausal women with uteruses who are receiving daily conjugated estrogens

Usual Adult Dose for Fetal Maturation

Vaginal insert:
Initial dose: 100 mg vaginally 2 to 3 times a day, starting the day after oocyte retrieval
Duration of therapy: Up to 10 weeks total.

8% vaginal gel:
90 mg vaginally once a day for progesterone supplementation
or
90 mg vaginally twice a day with partial or complete ovarian failure requiring progesterone supplementation
Duration of therapy: Up to 10 to 12 weeks, until placental autonomy is achieved

Comments:

• Efficacy and dosing in women over 35 has not been clearly established.

Use: To support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an assisted reproductive technology (ART) treatment program for infertile women.

Usual Adult Dose for Progesterone Insufficiency

Vaginal insert:
Initial dose: 100 mg vaginally 2 to 3 times a day, starting the day after oocyte retrieval
Duration of therapy: Up to 10 weeks total.

8% vaginal gel:
90 mg vaginally once a day for progesterone supplementation
or
90 mg vaginally twice a day with partial or complete ovarian failure requiring progesterone supplementation
Duration of therapy: Up to 10 to 12 weeks, until placental autonomy is achieved

Comments:

• Efficacy and dosing in women over 35 has not been clearly established.

Use: To support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an assisted reproductive technology (ART) treatment program for infertile women.

Usual Adult Dose for Female Infertility

Vaginal insert:
Initial dose: 100 mg vaginally 2 to 3 times a day, starting the day after oocyte retrieval
Duration of therapy: Up to 10 weeks total.

8% vaginal gel:
90 mg vaginally once a day for progesterone supplementation
or
90 mg vaginally twice a day with partial or complete ovarian failure requiring progesterone supplementation
Duration of therapy: Up to 10 to 12 weeks, until placental autonomy is achieved

Comments:

• Efficacy and dosing in women over 35 has not been clearly established.

Use: To support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an assisted reproductive technology (ART) treatment program for infertile women.

Renal Dose Adjustments

Data not available.

Liver Dose Adjustments

Contraindicated

Precautions

ORAL Tablets:
US BOXED WARNING(S): CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY.

Cardiovascular Disorders and Probable Dementia:

• Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.
• The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis, pulmonary embolism, stroke and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.
• The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Breast Cancer

• The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.
• In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins.
• Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Safety and efficacy have not been established in pediatric and geriatric patients (over 65 years old).

Consult WARNINGS section for additional precautions.

Dialysis

Data not available.

Other Comments

Administration advice:

• Patients having difficulty swallowing the capsules should take them with water while in the standing position.
• Do not coadminister vaginal progesterone with other vaginal products; the release and absorption may be altered. Separate vaginal medications by at least 6 hours.