Progesterone
50 mg/mL · Injection, Solution
- Prescription only
- Progesterone
- Active substance
- Progesterone
- Made by
- Eugia US LLC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2023-09-12
- Class II Ongoing · 2024-12-27 — Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.Using the product could cause temporary or medically reversible harm.
- Class II Ongoing · 2024-07-26 — Presence of Particulate Matter: Complaint received of a glass particle in the vial.Using the product could cause temporary or medically reversible harm.
A recall usually covers specific lots. Check the lot number on your pack against the notice, and ask your pharmacist before you stop a medicine. FDA recalls
Progesterone
- 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.
Amenorrhea: Five to 10 mg are given for six to eight consecutive days.
Full directions ↓Current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy.
All warnings ↓- Prescription only
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- 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.
From the official label · 2023-09-12 · DailyMed
How it works
From this product’s own US prescribing label.
Transforms proliferative endometrium into secretory endometrium.
Inhibits (at the usual dose range) the secretion of pituitary gonadotropins, which in turn prevents follicular maturation and ovulation.
Progesterone is metabolized primarily in the liver by reduction to pregnanediol, pregnanetriol, and pregnanolone.
The glucuronide and sulfate conjugates of pregnanediol and pregnanolone are excreted in the urine and bile.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-09-12
Do not take it if
- Current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy.
- Liver dysfunction or disease.
- Known or suspected malignancy of breast or genital organs.
- Undiagnosed vaginal bleeding.
- Missed abortion.
- Known sensitivity to progesterone injection.
- Known sensitivity to sesame oil/seeds.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- Progesterone is administered by intramuscular injection.
- It differs from other commonly used steroids in that it is irritating at the place of injection.
- Amenorrhea: Five to 10 mg are given for six to eight consecutive days.
- If there has been sufficient ovarian activity to produce a proliferative endometrium, one can expect withdrawal bleeding forty-eight to seventy-two hours after the last injection.
- This may be followed by spontaneous normal cycles.
- Functional Uterine Bleeding: Five to 10 mg are given daily for six doses.
- Bleeding may be expected to cease within six days.
- When estrogen is given as well, the administration of progesterone is begun after two weeks of estrogen therapy.
- If menstrual flow begins during the course of injections of progesterone, they are discontinued.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis).
- Should any of these occur or be suspected, the drug should be discontinued immediately.
- Medication should be discontinued pending examination if there is a sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia or migraine.
- If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn.
- Acute eosinophilic pneumonia has been reported in patients receiving progesterone in sesame oil.
- In reported cases associated with progesterone in sesame oil, patients developed fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates.
- In general, patients developed eosinophilic pneumonia 2 to 4 weeks after starting progesterone in sesame oil and improved when progesterone in sesame oil was discontinued and a different formulation of progesterone and/or steroid therapy was initiated.
- Patients who develop these signs and symptoms while receiving progesterone in sesame oil should undergo prompt medical evaluation, and progesterone in sesame oil should be discontinued immediately.
- 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.
- In cases of breakthrough bleeding, as in all cases of irregular bleeding per vaginum, nonfunctional causes should be borne in mind, and adequate diagnostic measures undertaken.
- Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
- The age of the patient constitutes no absolute limiting factor although treatment with progestin may mask the onset of the climacteric.
- The pathologist should be advised of progestin therapy when relevant specimens are submitted.
- There are possible risks which may be associated with the use of progestin treatment, including adverse effects on carbohydrate and lipid metabolism.
- The dosage used may be important in minimizing these adverse effects.
- A decrease in glucose tolerance has been observed in a small percentage of patients on estrogen- progestin combination treatment.
- The mechanism of this decrease is obscure.
- For this reason, diabetic patients should be carefully observed while receiving such therapy.
- Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term intramuscular administration of Medroxyprogesterone acetate (MPA) has been shown to produce mammary tumors in beagle dogs.
- There is no evidence of a carcinogenic effect associated with the oral administration of MPA to rats and mice.
- Medroxyprogesterone acetate was not mutagenic in a battery of in vitro or in vivo genetic toxicity assays.
- Progesterone at high doses is an antifertility drug and high doses would be expected to impair fertility until the cessation of treatment.
- Geriatric Use:
- Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
- Nursing Mothers:
- 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.
- In cases of breakthrough bleeding, as in all cases of irregular bleeding per vaginum, nonfunctional causes should be borne in mind, and adequate diagnostic measures undertaken.
- Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
- The age of the patient constitutes no absolute limiting factor although treatment with progestin may mask the onset of the climacteric.
- The pathologist should be advised of progestin therapy when relevant specimens are submitted.
- There are possible risks which may be associated with the use of progestin treatment, including adverse effects on carbohydrate and lipid metabolism.
- The dosage used may be important in minimizing these adverse effects.
- A decrease in glucose tolerance has been observed in a small percentage of patients on estrogen- progestin combination treatment.
- The mechanism of this decrease is obscure.
- For this reason, diabetic patients should be carefully observed while receiving such therapy.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
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.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Use in children
Safety and effectiveness in pediatric patients have not been established.
Quoted from the official label, section “Pediatric Use”.
Use in older people
The safety and effectiveness in geriatric patients (over age 65) have not been established.
Quoted from the official label, section “Geriatric Use”.
Side effects
- 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 (including eosinophilic pneumonia); 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 T 3 uptake values.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
- Progesterone injection USP, 500 mg per 10 mL (50 mg/mL) is a sterile, clear, colorless to yellowish oily solution and is supplied as follows:
- 10 mL Multiple-Dose Vial packaged individually NDC 55150-306-10
- Store at 20° to 25°C (68° to 77°F) [see USP controlled room temperature].
- The vial stopper is not made with natural rubber latex.
- For all medical inquiries contact: Eugia US LLC 279 Princeton-Hightstown Rd.
- E.
- Windsor, NJ 08520 1-866-850-2876 Distributed by:
- Eugia US LLC 279 Princeton-Hightstown Rd.
- E.Windsor, NJ 08520 Manufactured by:
- Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised:
- June 2023
Quoted from the official label, section “How Supplied”.
What is in it
- Progesterone injection USP, a progestin, is a sterile solution of progesterone in a suitable vegetable oil available for intramuscular use.
- Progesterone occurs as a white or creamy white, crystalline powder or colourless crystals.
- It is soluble in alcohol, in acetone, and in dioxane; sparingly soluble in vegetable oils; practically insoluble in water.
- It has the following structural formula:
- Pregn-4-ene-3, 20-dione Each mL contains:
- Progesterone 50 mg, Benzyl Alcohol 10% as preservative in Sesame Oil q.s. chemical-structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (5)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 5 of 5
- ProgesteroneThis onePrescription onlyEugia US LLCNo ingredient list on the stored label
- ProgesteronePrescription onlyActavis Pharma, Inc.No ingredient list on the stored label
- ProgesteronePrescription onlyFresenius Kabi USA, LLCNo ingredient list on the stored label
- ProgesteronePrescription onlyHikma Pharmaceuticals USA Inc.No ingredient list on the stored label
- ProgesteronePrescription onlyXIROMED, LLCNo ingredient list on the stored label
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
Details
| Made by | Eugia US LLC |
|---|---|
| Active substance | Progesterone |
| Strength | 50 mg/mL |
| Form | Injection, Solution |
| Route | Intramuscular |
| Packs | 10 mL in 1 VIAL, MULTI-DOSE |
| NDC | 55150-306 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
45 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Capsule36 products
- Injection, Solution4 products
50 mg/mL4
50 mg/mL · 4 companies
- Actavis Pharma, Inc.
- Eugia US LLC · this page
- Fresenius Kabi USA, LLC
- XIROMED, LLC
- Liquid3 products
6X/mL2
6X/mL · 2 companies
- 15X/mL
- Injection1 products
Show all forms · 5 forms
- Insert1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.