PROGESTERONE 50 mg/mL
PROGESTERONE · INJECTION, SOLUTION · XIROMED, LLC
PROGESTERONE is a injection, solution containing progesterone at 50 mg/mL, taken intramuscular. Manufactured by XIROMED, LLC.
Key Facts
- Brand Name
- PROGESTERONE
- Generic Name
- PROGESTERONE
- NDC Code (Product)
70700-286- Manufacturer
- XIROMED, LLC
- Strength
- 50 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- ANDA215634
- Drug Class
- Progesterone [EPC]
- Marketing Start
- 03/29/2022
Recall History
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Clinical Specialties Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
the Compounder
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
the Compounder
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
the Compounder
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
The Medicine Shoppe Pharmacy
Lack of Processing Control
JD & SN Inc., dba Moses Lake Professional Pharmacy
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
MPRX, Inc. dba Medical Park Pharmacy
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Eugia US LLC
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Progesterone 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 & Administration
DOSAGE AND ADMINISTRATION Prevention of Endometrial Hyperplasia Progesterone capsules should be given as a single daily dose at bedtime, 200 mg orally for 12 days sequentially per 28-day cycle, to postmenopausal women with a uterus who are receiving daily conjugated estrogens tablets. Treatment of Secondary Amenorrhea Progesterone capsules may be given as a single daily dose of 400 mg at bedtime for 10 days. Some women may experience difficulty swallowing progesterone capsules. For these women, progesterone capsules should be taken with a glass of water while in the standing position.
Warnings
WARNINGS See BOXED WARNING . 1. Cardiovascular disorders An increased risk of pulmonary embolism, deep vein thrombosis (DVT), stroke, and myocardial infarction has been reported with estrogen plus progestin therapy. Should any of these occur or be suspected, estrogen with progestin therapy should be discontinued immediately. Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (for example, personal history or family history of venous thromboembolism [VTE], obesity, and systemic lupus erythematosus) should be managed appropriately. a. Stroke In the Women’s Health Initiative (WHI) estrogen plus progestin substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women in the same age group receiving placebo (33 versus 25 per 10,000 women-years). The increase in risk was demonstrated after the first year and persisted. (See CLINICAL STUDIES .) Should a stroke occur or be suspected, estrogen plus progestin therapy should be discontinued immediately. b. Coronary Hear…
Contraindications
CONTRAINDICATIONS Progesterone capsules should not be used in women with any of the following conditions: Progesterone capsules should not be used in patients with known hypersensitivity to its ingredients. Progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts. Undiagnosed abnormal genital bleeding. Known, suspected, or history of breast cancer. Active deep vein thrombosis, pulmonary embolism or history of these conditions. Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. Known liver dysfunction or disease. Known or suspected pregnancy.
Adverse Reactions
ADVERSE REACTIONS See BOXED WARNING , 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 progesterone capsules on the endometrium was studied in a total of 875 postmenopausal women. Table 6 lists adverse experiences greater than or equal to 2 percent of women who received cyclic progesterone capsules, 200 mg daily (12 days per calendar month cycle) with 0.625 mg conjugated estrogens or placebo. Table 6. Adverse Experiences (≥2%) Reported in an 875 Patient Placebo-Controlled Trial in Postmenopausal Women Over a 3-Year Period [Percentage (%) of Patients Reporting] Progesterone capsules 200 mg with Congugated 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 / Vomiti…
Frequently Asked Questions
What is PROGESTERONE used for?
PROGESTERONE contains PROGESTERONE. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is PROGESTERONE a controlled substance?
PROGESTERONE is not classified as a controlled substance by the DEA.
What is the generic name for PROGESTERONE?
The generic name for PROGESTERONE is PROGESTERONE. There are 8 other brand versions of PROGESTERONE.
What is the NDC code for PROGESTERONE 50 mg/mL?
The NDC (National Drug Code) for PROGESTERONE 50 mg/mL is 70700-286, listed by XIROMED, LLC.