Progesterone Dosage

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Usual Adult Dose for Amenorrhea

5 to 10 mg IM for six to eight consecutive days.

400 mg orally for 10 days. Give dose in the evening.

Secondary Amenorrhea:
90 mg intravaginally, 4% gel, every other day for a total of six doses. If no response observed, the administration of the 8% gel every other day for a total of six doses may be used.

Usual Adult Dose for Uterine Bleeding

5 to 10 mg IM daily for 6 doses.

Usual Adult Dose for Endometrial Hyperplasia - Prophylaxis

200 mg orally for 12 consecutive days, per 28 day cycle. Give dose in the evening.

Usual Adult Dose for Progesterone Insufficiency

Assisted Reproductive Technology (ART) - Gel:
90 mg of the 8% gel, once daily intravaginally, in women who require supplementation.
90 mg of the 8% gel, twice daily intravaginally, in women with partial or complete ovarian failure who require replacement.
If pregnancy occurs, therapy with the intravaginal gel may be continued until placental autonomy is achieved, up to 10 to 12 weeks.

Assisted Reproductive Technology (ART) - Vaginal Insert
100 mg administered vaginally two or three times daily starting at oocyte retrieval and continuing for up to 10 weeks total duration. Efficacy in women 35 years of age and older has not been clearly established. The appropriate dose in this age group has not been determined.

Progesterone deficiency associated with menopause and perimenopause:
progesterone 1.7% topical cream: rub 1/4 to 1/2 teaspoon into the palms of the hands, soles of the feet, or other soft areas of skin once or twice daily.

Usual Adult Dose for Premature Labor

Study (n=459) - National Institute of Child Health and Human Development (NICHD) - Prevention of Recurrent Preterm Delivery in Women at High Risk: 17-alpha-hydroxyprogesterone caproate (17P) 250 mg IM once weekly starting on the 21st week of gestation through time of delivery or week 36 of gestation.

Study (n=142) - Reduce Incidence of Spontaneous Preterm Birth in Women at Increased Risk: 100 mg vaginal suppository daily, between 24 and 34 weeks of gestation.

Usual Adult Dose for Seizures

(Study=25) - Catamenial epilepsy [complex partial or secondary generalized motor seizures]:
200 mg lozenge three times daily administered in relation to pattern of seizure exacerbation during luteal phase of menstrual cycle. For patients with perimenstrual exacerbation, dose was provided on day 23 through day 25 of menstrual cycle. For patients with seizure exacerbation during entire luteal phase, dose was provided on day 15 through day 25 of each menstrual cycle. The desired progesterone serum level was between 5 and 25 ng/mL 4 hours after taking the lozenge. All patients continued taking their best antiseizure medication.

Usual Adult Dose for Perimenopausal Symptoms

Progesterone deficiency associated with menopause and perimenopause:
progesterone 1.7% topical cream: Rub 1/4 to 1/2 teaspoonful into the palms of the hands, soles of feet, or other soft area once or twice daily.

Renal Dose Adjustments

Data not available.

Liver Dose Adjustments

Progesterone is contraindicated in severe liver disease or dysfunction.

Dose Adjustments

If menses starts during the course of progesterone injections, the drug should be discontinued.

Precautions

Progesterone is contraindicated in patients allergic to peanuts (as the capsules contain peanut oil).

Progesterone is contraindicated for use in known or suspected pregnancy, as a diagnostic test for pregnancy, missed abortion, undiagnosed vaginal bleeding, and in severe liver dysfunction or disease.

Progesterone is also contraindicated in patients with thrombophlebitis, thromboembolic disorders, cerebral apoplexy or patients with a past history of these conditions. If early manifestations of these disorders occur, progesterone should be discontinued immediately.

Progesterone should be discontinued if there is sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia or migraine, or if examination reveals papilledema or retinal vascular lesions. Patients should report immediately to their doctors any changes in vision.

Since transient dizziness can develop in some patients, caution is advised when driving a motor vehicle or operating machinery. In severe cases of dizziness and/or drowsiness, bedtime dosing is advised.

Several laboratory tests may be altered as a result of estrogen-progestin combination drugs including hepatic function tests, coagulation tests (increase in prothrombin factors VII, VIII, IX and X), metyrapone test, pregnanediol determination, and thyroid function (increase in PBI, and butanol extractable protein bound iodine and decrease in T3. The pathologist should be informed of progestin therapy when relevant specimens are submitted.

Patients with a history of psychiatric depression should be closely observed and the drug discontinued if the depression recurs or worsens.

Because progestational drugs may cause some degree of fluid retention, patients with the following conditions may be affected and should be closely monitored: epilepsy, migraines, asthma, and cardiac, or renal dysfunction.

Prior to treatment, patients should undergo a physical examination with special reference to the breast and pelvic organs, as well as Papanicolaou smear. and adequate diagnostic measures taken in cases of breakthrough bleeding, or irregular bleeding to determine any nonfunctional cause.

Reports of adverse effects on carbohydrate and lipid metabolisms associated with the use of progesterone may be minimized by reduction in dose.

A decrease in glucose tolerance has been observed in a small percentage of patients taking estrogen-progestin combination treatment. Diabetic patients should be carefully monitored while receiving progesterone therapy in combination with estrogen.

Progesterone gel should not be used concurrently with other local intravaginal therapy. There should be a time interval of at least 6 hours before or after the use of the gel.

Dialysis

Data not available.

Other Comments

When given in combination with estrogen, the administration of progesterone is started after 2 weeks of estrogen therapy.

Recent published studies support the hypothesis that progesterone supplementation reduces preterm birth in women at high-risk. The American College of Obstetricians and Gynecologists Committee on Obstetric Practice has issued an opinion on the use of progesterone to reduce preterm birth. The committee believes that further studies are needed to evaluate the use of progesterone in patients with other high-risk obstetric factors. Progesterone, if used, should be restricted to only women with a documented history of a previous spontaneous birth at less than 37 weeks of gestation, because optimal route of administration and long-term safety of the drug remain to be resolved.

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