Prometrium Progesterone 100 mg Capsule, 30-count
Other active recalls for Progesterone (different manufacturers) — 2 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Progesterone class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Progesterone is used along with estrogen therapy to manage symptoms of menopause. Combination of estrogen and progesterone used during menopause is called menopausal hormone therapy (MHT). Progesterone is also used to produce a period in women who have amenorrhea (absence of periods). Progesterone is in a class of medications called progestins (female hormones). It works as part of hormone replacement therapy by decreasing the amount of estrogen in the uterus. It works to bring on menstruation by replacing the natural progesterone that some women are lacking.
Read the full MedlinePlus article ↗- When you still have your uterus and you're taking estrogen, estrogen can cause the lining of your uterus to grow too thick — a condition called endometrial hyperplasia, which can i...
- Why do I need to take progesterone if I'm already on estrogen?
- Yes, and it's important to be honest about this. Large studies have shown that taking estrogen combined with progestin — including progesterone — is associated with a higher risk o...
- Is it true that taking progesterone with estrogen can raise my risk of breast cancer or stroke?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Progesterone — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
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UNII 5TL50QU0W4
Peanut oil is a plant-based oil extracted from peanuts. It's used in medicines as a solvent and carrier to dissolve or suspend active ingredients, making them easier to deliver and absorb in the body.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $15.921 | $477.62 / 30 capsules |
| Medicaid paysCMS SDUD · 12 mo | $15.05 | $451.58 / 30 capsules |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Progesterone 100 mg 00054-0829-25 | Hikma | 100 capsules | $0.231 | AB | Availability likely | save 99% |
| Progesterone 100 mg 16714-0157-01 | Northstar | 100 capsules | $0.231 | AB | Availability likely | save 99% |
| Progesterone 100 mg 43598-0349-01 | Dr. | 100 capsules | $0.231 | AB | Availability likely | save 99% |
| Progesterone 100 mg 59651-0152-01 | Aurobindo | 100 capsules | $0.231 | AB | Availability likely | save 99% |
| Progesterone 100 mg 65162-0807-10 | Amneal | 100 capsules | $0.231 | AB | Availability likely | save 99% |
| Progesterone 100 mg 69452-0233-20 | Bionpharma | 100 capsules | $0.231 | AB | Availability likely | save 99% |
| Progesterone 100 mg 70700-0162-01 | Xiromed, | 100 capsules | $0.231 | AB | Availability likely | save 99% |
| Prometrium 100 mgthis 72989-0372-30 | Acertis | 30 capsules | $15.921 | AB | Availability likely | — |
| Progesterone 100 mg 42291-0784-01 | AvKARE | 100 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 50090-5928-00 | A-S | 10 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 50090-6475-00 | A-S | 10 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 50090-6771-00 | A-S | 10 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 50090-6835-00 | A-S | 10 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 51407-0980-01 | Golden | 100 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 51655-0542-26 | Northwind | 90 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 68071-3557-08 | NuCare | 180 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 68071-3952-03 | NuCare | 30 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 68788-4068-03 | Preferred | 30 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 68788-8296-03 | Preferred | 30 capsules | — | AB | Discontinued | — |
| Progesterone 100 mg 68788-8709-03 | Preferred | 30 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 69452-0148-20 | Bionpharma | 100 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 70518-2560-01 | REMEDYREPACK | 100 capsules | — | AB | Discontinued | — |
| Progesterone 100 mg 70518-4166-00 | REMEDYREPACK | 90 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 70518-4552-00 | REMEDYREPACK | 90 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 71205-0684-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 71205-0902-11 | Proficient | 1000 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 71335-1443-01 | Bryant | 30 capsules | — | AB | Discontinued | — |
| Progesterone 100 mg 71335-1913-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 71335-9739-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 72189-0204-90 | direct | 90 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 72189-0654-90 | Direct_Rx | 90 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 73190-0064-01 | AvKARE | 100 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 76420-0058-10 | Asclemed | 100 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 76420-0072-10 | Asclemed | 100 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 76420-0267-01 | Asclemed | 100 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 76420-0281-01 | Asclemed | 100 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 76420-0582-10 | Asclemed | 100 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 67296-2283-09 | Redpharm | 90 capsules | — | AB | FDA listed | — |
| Progesterone 100 mg 72603-0974-01 | NorthStar | 100 capsules | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72989-0372-30 You're viewing this | 30 CAPSULE in 1 BOTTLE (72989-372-30) | 2022-11-01 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE PROMETRIUM ® (progesterone, USP) Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Prevention of Endometrial Hyperplasia PROMETRIUM Capsules should be given as a single daily dose at bedtime, 200 mg orally for 12 days sequentially per 28-day cycle, to a postmenopausal woman with a uterus who is receiving daily conjugated estrogens tablets. Treatment of Secondary Amenorrhea PROMETRIUM Capsules may be given as a single daily dose of 400 mg at bedtime for 10 days. Some women may experience difficulty swallowing PROMETRIUM Capsules.
For these women, PROMETRIUM Capsules should be taken with a glass of water while in the standing position.
⛔ Contraindications ▾
CONTRAINDICATIONS PROMETRIUM is contraindicated in women with any of the following conditions: 1. Hypersensitivity to its ingredients. PROMETRIUM Capsules contain peanut oil and is contraindicated in patients allergic to peanuts.
2. Abnormal genital bleeding of unknown etiology. 3.
Known, suspected, or history of breast cancer. 4. Active deep vein thrombosis, pulmonary embolism or history of these conditions.
5. Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. 6.
Known liver dysfunction or disease.
⚠️ Warnings ▾
WARNINGS 1. Cardiovascular disorders PROMETRIUM is contraindicated in females with active DVT, PE, arterial thromboembolic disease (e.g., stroke, MI) disease, or a history of these conditions (See CONTRAINDICATIONS ). Immediately discontinue PROMETRIUM if a PE, DVT, stroke, or MI occurs or is suspected.
If feasible, discontinue PROMETRIUM at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. The safety and efficacy of estrogen plus progestogen for the prevention of cardiovascular disorders has not been established. (See CLINICAL STUDIES ) The Women’s Health Initiative (WHI) estrogen plus progestin trial reported increased risks of PE, DVT, stroke, and MI in postmenopausal women (50 to 79 years of age, average age 63.4 years) 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.
Analyses were also conducted in women aged 50-59 years, a group of women more likely to present with new onset of moderate to severe VMS compared to women in other age groups in the trial. (See CLINICAL STUDIES .) Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin trial of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known.
Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. a. Venous Thromboembolism In women aged 50 to 59 years, the WHI estrogen plus progestin trial reported a relative risk for PE of 2.05 (95% confidence interval [CI], 0.89, 4.71) for CE/MPA compared to placebo, with a risk difference of 6 per 10,000 women-years (WYs; 11 versus 5). The relative risk for DVT was 3.01 (95% CI, 1.36, 6.66) in those receiving CE/MPA compared to placebo, with a risk difference of 10 per 10,000 WYs (15 versus 5).
(See CLINICAL STUDIES ). In the overall study population of women aged 50 to 79 years (average 63.4 years), the trial reported a relative risk for PE of 1.98 (95% CI, 1.36, 2.87) for CE/MPA compared to placebo, with a risk difference of 9 per 10,000 WYs (18 versus 9). The relative risk for DVT was 1.87 (95% CI, 1.37, 2.54) for CE/MPA compared to placebo, with a risk difference of 12 per 10,000 WYs (25 versus 14).
(See CLINICAL STUDIES ). b. Stroke In women aged 50 to 59 years, the WHI estrogen plus progestin trial reported a relative risk for stroke of 1.51 (95% CI, 0.81, 2.82) for CE/MPA compared to placebo, with a risk difference of 5 per 10,000 WYs (15 versus 10). (See CLINICAL STUDIES ).
In the overall study population of women aged 50 to 79 years (average 63.4 years), the WHI estrogen plus progestin trial reported relative risk for stroke of 1.37 (95% CI, 1.07, 1.76) for CE/MPA compared to placebo, with a risk difference of 9 per 10,000 WYs (33 versus 24). (See CLINICAL STUDIES ). c. Coronary Heart Disease In women 50 to 59 years of age,the WHI estrogen plus progestin trial reported a relative risk for coronary heart disease (CHD) events (defined as nonfatal MI, silent MI, or CHD death) of 1.34 (95% CI, 0.82, 2.19) for CE/MPA compared placebo, with a risk difference of 5 per 10,000 WYs (23 versus 17).
In the overall study population of women aged 50 to 79 years (average 63.4 years), the trial reported a relative risk of CHD of 1.18 (95% CI, 0.95, 1.45) for CE/MPA compared to placebo, with a risk difference of 6 per 10,000 WYs (41 versus 35). (See CLINICAL STUDIES ). In the Heart and Estrogen/Progestin Replacement Study (HERS) and open label extension (HERS II), postmenopausal women with documented heart disease (n = 2,763, average age 66.7 years) received daily CE (0.625 mg) plus MPA or placebo.
In Year 1, there were more CHD events in the CE plus MPA-treated group t…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS See WARNINGS and PRECAUTIONS . Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a multicenter, randomized, double-blind, placebo-controlled clinical trial, the effects of PROMETRIUM Capsules on the endometrium was studied in a total of 875 postmenopausal women.
Table 7 lists adverse reactions greater than or equal to 2 percent of women who received cyclic PROMETRIUM Capsules 200 mg daily (12 days per calendar month cycle) with 0.625 mg conjugated estrogens or placebo. TABLE 7. Adverse Reactions (≥ 2%) Reported in an 875 Patient Placebo-Controlled Trial in Postmenopausal Women Over a 3-Year Period [Percentage (%) of Patients Reporting] PROMETRIUM Capsules 200 mg with Conjugated Estrogens 0.625 mg Placebo (n=178) (n=174) Headache 31 27 Breast Tenderness 27 6 Joint Pain 20 29 Depression 19 12 Dizziness 15 9 Abdominal Bloating 12 5 Hot Flashes 11 35 Urinary Problems 11 9 Abdominal Pain 10 10 Vaginal Discharge 10 3 Nausea / Vomiting 8 7 Worry 8 4 Chest Pain 7 5 Diarrhea 7 4 Night Sweats 7 17 Breast Pain 6 2 Swelling of Hands and Feet 6 9 Vaginal Dryness 6 10 Constipation 3 2 Breast Carcinoma 2 <1 Breast Excisional Biopsy 2 <1 Cholecystectomy 2 <1 Effects on Secondary Amenorrhea In a multicenter, randomized, double-blind, placebo-controlled clinical trial, the effects of PROMETRIUM ® (progesterone, USP) Capsules on secondary amenorrhea was studied in 49 estrogen-primed postmenopausal women.
Table 8 lists adverse reactions greater than or equal to 5 percent of women who received PROMETRIUM Capsules or placebo. TABLE 8. Adverse Reactions (≥ 5%) Reported in Patients Using 400 mg/day in a Placebo-Controlled Trial in Estrogen-Primed Postmenopausal Women Adverse Experience PROMETRIUM Capsules 400 mg Placebo n=25 n=24 Percentage (%) of Patients Fatigue 8 4 Headache 16 8 Dizziness 24 4 Abdominal Distention (Bloating) 8 8 Abdominal Pain (Cramping) 20 13 Diarrhea 8 4 Nausea 8 0 Back Pain 8 8 Musculoskeletal Pain 12 4 Irritability 8 4 Breast Pain 16 8 Infection Viral 12 0 Coughing 8 0 In a multicenter, parallel-group, open label postmarketing dosing study consisting of three consecutive 28-day treatment cycles, 220 premenopausal women with secondary amenorrhea were randomized to receive daily conjugated estrogens therapy (0.625 mg conjugated estrogens) and PROMETRIUM Capsules, 300 mg per day (n=113) or PROMETRIUM Capsules, 400 mg per /day (n=107) for 10 days of each treatment cycle.
Overall, the most frequently reported treatment-emergent adverse reactions, reported in greater than or equal to 5 percent of subjects, were nausea, fatigue, vaginal mycosis, nasopharyngitis, upper respiratory tract infection, headache, dizziness, breast tenderness, abdominal distension, acne, dysmenorrhea, mood swing, and urinary tract infection. Postmarketing Experience: The following additional adverse reactions have been reported with PROMETRIUM Capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Genitourinary System: endometrial carcinoma, hypospadia, intra-uterine death, menorrhagia, menstrual disorder, metrorrhagia, ovarian cyst, spontaneous abortion. Cardiovascular: circulatory collapse, congenital heart disease (including ventricular septal defect and patent ductus arteriosus), hypertension, hypotension, tachycardia. Gastrointestinal: acute pancreatitis, cholestasis, cholestatic hepatitis, dysphagia, hepatic failure, hepatic necrosis, hepatitis, increased liver function tests (including alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased), jaundice, swollen tongue.
Skin: alopecia, pruritus, urticaria. Eyes: blur…
🔄 Drug / Laboratory Test Interactions ▾
C. Drug-Laboratory Test Interactions The following laboratory results may be altered by the use of estrogen plus progestin therapy: • Increased sulfobromophthalein retention and other hepatic function tests. • Coagulation tests: increase in prothrombin factors VII, VIII, IX and X. • Pregnanediol determination. • Thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in T3 uptake values.
🤰 Pregnancy ▾
E. Pregnancy PROMETRIUM Capsules should not be used during pregnancy. Pregnancy Category B: Reproductive studies have been performed in mice at doses up to 9 times the human oral dose, in rats at doses up to 44 times the human oral dose, in rabbits at a dose of 10 mcg/day delivered locally within the uterus by an implanted device, in guinea pigs at doses of approximately one-half the human oral dose and in rhesus monkeys at doses approximately the human dose, all based on body surface area, and have revealed little or no evidence of impaired fertility or harm to the fetus due to progesterone.
🧒 Pediatric Use ▾
G. Pediatric Use PROMETRIUM Capsules are not indicated in children. Clinical studies have not been conducted in the pediatric population.
🧓 Geriatric Use ▾
H. Geriatric Use There have not been sufficient numbers of geriatric women involved in clinical studies utilizing PROMETRIUM Capsules to determine whether those over 65 years of age differ from younger subjects in their response to PROMETRIUM Capsules. The Women's Health Initiative Study In the Women's Health Initiative (WHI) estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age.
(See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Malignant neoplasms .) The Women's Health Initiative Memory Study In the Women's Health Initiative Memory Study (WHIMS) of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in the estrogen plus progestin ancillary study when compared to placebo. (See CLINICAL STUDIES .)
🆘 Overdosage ▾
OVERDOSAGE No studies on overdosage have been conducted in humans. In the case of overdosage, PROMETRIUM ® (progesterone, USP) Capsules should be discontinued and the patient should be treated symptomatically.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY PROMETRIUM Capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. The oral bioavailability of progesterone is increased through micronization. Pharmacokinetics A.
Absorption After oral administration of progesterone as a micronized soft-gelatin capsule formulation, maximum serum concentrations were attained within 3 hours. The absolute bioavailability of micronized progesterone is not known. Table 1 summarizes the mean pharmacokinetic parameters in postmenopausal women after five oral daily doses of PROMETRIUM Capsules 100 mg as a micronized soft-gelatin capsule formulation.
TABLE 1. Pharmacokinetic Parameters of PROMETRIUM Capsules Parameter PROMETRIUM Capsules Daily Dose 100 mg 200 mg 300 mg C max (ng/mL) 17.3 ±
21.9Mean ± S.D. 38.1 ± 37.8 60.6 ±
72.5T max (hr) 1.5 ± 0.8 2.3 ± 1.4 1.7 ±
0.6AUC (0-10) (ng × hr/mL) 43.3 ± 30.8 101.2 ± 66.0 175.7 ± 170.3 Serum progesterone concentrations appeared linear and dose proportional following multiple dose administration of PROMETRIUM ® (progesterone, USP) Capsules 100 mg over the dose range 100 mg per day to 300 mg per day in postmenopausal women. Although doses greater than 300 mg per day were not studied in females, serum concentrations from a study in male volunteers appeared linear and dose proportional between 100 mg per day and 400 mg per day. The pharmacokinetic parameters in male volunteers were generally consistent with those seen in postmenopausal women.
B. Distribution Progesterone is approximately 96 percent to 99 percent bound to serum proteins, primarily to serum albumin (50 to 54 percent) and transcortin (43 to 48 percent). C.
Metabolism Progesterone is metabolized primarily by the liver largely to pregnanediols and pregnanolones. Pregnanediols and pregnanolones are conjugated in the liver to glucuronide and sulfate metabolites. Progesterone metabolites which are excreted in the bile may be deconjugated and may be further metabolized in the intestine via reduction, dehydroxylation, and epimerization.
D. Excretion The glucuronide and sulfate conjugates of pregnanediol and pregnanolone are excreted in the bile and urine. Progesterone metabolites are eliminated mainly by the kidneys.
Progesterone metabolites which are excreted in the bile may undergo enterohepatic recycling or may be excreted in the feces. E. Special Populations The pharmacokinetics of PROMETRIUM Capsules have not been assessed in low body weight or obese patients.
Hepatic Insufficiency: The effect of hepatic impairment on the pharmacokinetics of PROMETRIUM Capsules has not been studied. Renal Insufficiency: The effect of renal impairment on the pharmacokinetics of PROMETRIUM Capsules has not been studied. F.
Food–Drug Interaction Concomitant food ingestion increased the bioavailability of PROMETRIUM Capsules relative to a fasting state when administered to postmenopausal women at a dose of 200 mg. G. Drug Interactions The metabolism of progesterone by human liver microsomes was inhibited by ketoconazole (IC 50 < 0.1 μM).
Ketoconazole is a known inhibitor of cytochrome P450 3A4, hence 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. Coadministration of conjugated estrogens and PROMETRIUM Capsules to 29 postmenopausal women over a 12-day period resulted in an increase in total estrone concentrations (C max 3.68 ng/mL to 4.93 ng/mL) and total equilin concentrations (C max 2.27 ng/mL to 3.22 ng/mL) and a decrease in circulating 17β estradiol concentrations (C max 0.037 ng/mL to 0.030 ng/mL).
The half-life of the conjugated estrogens was similar with coadministration of PROMETRIUM Capsules. Table 2 summarizes the pharmacokinetic parameters. TABLE 2.
Mean (± S.D.) Pharmacokinetic Parameters for Estradiol, Estrone, and Equilin Following Coadministration of Conjugated Estrogens 0.625…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED PROMETRIUM ® (progesterone, USP) Capsules 100 mg are round, peach-colored capsules branded with black imprint "SV." NDC 72989-372-30 (Bottle of 30) PROMETRIUM ® (progesterone, USP) Capsules 200 mg are oval, pale yellow-colored capsules branded with black imprint "SV2." NDC 72989-373-30 (Bottle of 30) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from excessive moisture. Dispense in tight, light-resistant container as defined in USP/NF, accompanied by a Patient Insert.
Keep out of reach of children.
📦 Storage and Handling ▾
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from excessive moisture. Dispense in tight, light-resistant container as defined in USP/NF, accompanied by a Patient Insert. Keep out of reach of children.
📋 Description ▾
DESCRIPTION PROMETRIUM ® (progesterone, USP) Capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C 21 H 30 O 2 . Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C.
The structural formula is: Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. PROMETRIUM Capsules are available in multiple strengths to afford dosage flexibility for optimum management. PROMETRIUM Capsules contain 100 mg or 200 mg micronized progesterone.
The inactive ingredients for PROMETRIUM Capsules 100 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, FD&C Red No. 40, and D&C Yellow No. 10.
The inactive ingredients for PROMETRIUM Capsules 200 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Yellow No. 6.
Chemical Structure
💬 Information for Patients ▾
B. Patient Information General: This product contains peanut oil and should not be used if you are allergic to peanuts. Physicians are advised to discuss the contents of the Patient Information leaflet with patients for whom they prescribe PROMETRIUM Capsules.