Endometrin (progesterone, micronized)
Progestins Vaginal Insert
Last reviewed · Source: First Databank (FDB) drug data
Overview
Progesterone is a naturally occurring progestin secreted by the corpus luteum and is the prototype of the progestins.
Progesterone is used orally to reduce the incidence of endometrial hyperplasia in postmenopausal women receiving estrogen replacement therapy.
Generic name: progesterone, micronized
Pronunciation: (pro-JESS-ter-own)
Drug class: Progestins
Therapeutic class: Endocrine
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Endometrin
Indications
The following indications are listed for Endometrin:
- Corpus Luteum Insufficiency Syndrome
Dosing
No dosing information is available for this tab.
Progesterone is administered by orally, intravaginally, and by IM injection.
Progesterone capsules are administered orally once daily at bedtime. Women who have difficulty swallowing the capsules should be advised to swallow progesterone capsules while in an upright position and with adequate amounts of fluid (e.g., a glass of water). Administration at bedtime may alleviate some of the adverse effects (e.g., dizziness, blurred vision) associated with the drug.
Progesterone vaginal gel should not be administered concurrently with other intravaginal preparations. If therapy with another agent administered intravaginally is needed, such therapy should be administered 6 hours before or 6 hours after progesterone vaginal gel.
Concomitant use of progesterone vaginal inserts with other preparations that are administered intravaginally is not recommended. Although specific studies have not been undertaken, the possibility exists that concomitant administration of a progesterone vaginal insert with another preparation administered intravaginally may alter the release and absorption of progesterone from the vaginal insert.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Endometrin 100 Mg Vag Insert | Maintenance | Insert 1 vaginal insert (100 mg) by vaginal route 2 times per day. |
| Drug label | Dosing type | Instructions |
|---|---|---|
| Progesterone 100 Mg Vag Insert | Maintenance | Insert 1 vaginal insert (100 mg) by vaginal route 2 times per day. |
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Progestin Replacement Therapy/Ulipristal
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Ulipristal is a progesterone receptor modulator and binds to the progesterone receptor with high affinity.(1)(2)
CLINICAL EFFECTS: Concurrent use of ulipristal may make progesterone products ineffective.(1,2) These agents may also make ulipristal ineffective.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Products containing progestin should not be used within 12 days of ulipristal discontinuation.(3)
DISCUSSION: Ulipristal is a progesterone receptor modulator and binds to the progesterone receptor with high affinity, thus it may interfere with the efficacy of progestin products.(1-3) These products may also make ulipristal ineffective.(3)
There are no moderate interactions for this drug.
Contraindications
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- Carcinoma of breast
- Cerebrovascular accident
- Disease of liver
- Malignant neoplasm of liver
- Porphyria
- Pulmonary thromboembolism
- Thromboembolic disorder
- Acute myocardial infarction
- Asthma
- Chronic heart failure
- Depression
- Diabetes mellitus
- Kidney disease with reduction in glomerular filtration rate (GFr)
- Migraine
- Seizure disorder
Adverse reactions
There is no enhanced messaging for this drug.
More Frequent
- Abdominal distension
- Abnormal vaginal bleeding
- Irregular menstrual periods
Less Frequent
- Endometrial hyperplasia
Rare or Very Rare
- Abnormal hepatic function tests
- Acute myocardial infarction
- Anaphylaxis
- Angioedema
- Depression
- Ectopic pregnancy
- Erythema multiforme
- Erythema nodosum
- Galactorrhea not associated with childbirth
- Hypersensitivity drug reaction
- Hypertension
- Malignant neoplasm of the ovary
- Menorrhagia
- Obstructive hyperbilirubinemia
- Optic neuritis
- Ovarian cyst
- Pancreatitis
- Pruritus of skin
- Pulmonary thromboembolism
- Retinal thrombosis
- Thromboembolic disorder
- Thrombophlebitis
More Frequent
- Back pain
- Edema
- Fatigue
- Headache disorder
- Myalgia
- Vaginitis
- Weight loss
Less Frequent
- Dizziness
- Dyspepsia
- Ectropion of cervix
- Hypertonia
- Palpitations
- Vaginal discharge
Rare or Very Rare
- Acne vulgaris
- Alopecia
- Amenorrhea
- Body fluid retention
- Cervical discharge
- Chloasma
- Constipation
- Cystitis
- Drowsy
- Fever
- Fibrocystic breast disease
- Hirsutism
- Hyperglycemia
- Insomnia
- Irritability
- Mastalgia
- Migraine
- Nausea
- Nervousness
- Pain in extremities
- Skin rash
- Urinary incontinence
- Urticaria
- Weight gain
Precautions
No enhanced messaging available.
No enhanced messaging available.
Progesterone is used to support embryo implantation and maintain pregnancy as a component of assisted reproductive technology (ART) treatment in infertile women. Such use is associated with increased ongoing pregnancy rates.
Although progestins have been used beginning in the first trimester of pregnancy to prevent habitual abortion or to treat threatened abortion, there is no adequate evidence from well-controlled studies to substantiate the efficacy of progestins for these uses; however, there is evidence of potential adverse effects on the fetus when these drugs are administered during the first 4 months of pregnancy. In addition, in most women, the cause of abortion is a defective ovum, which progestins could not be expected to influence. Because of their uterine-relaxant effects, progestins may delay spontaneous abortion of fertilized defective ova. Masculinization of the female fetus has reportedly occurred when progestins were used during pregnancy. Clitoral hypertrophy has been reported in a few female neonates born to women who had received medroxyprogesterone during pregnancy. An association between intrauterine exposure to female sex hormones and congenital anomalies, including cardiovascular and limb defects, has been suggested. (See Cautions: Pregnancy, Fertility, and Lactation, in Estrogen-Progestin Combinations 68:12.) Use of progestins generally is not recommended during the first 4 months of pregnancy.
Progesterone should not be used to induce withdrawal bleeding as a test for pregnancy.
Progestins are reportedly distributed into milk. The manufacturers warn that the possible effects of progestins in milk on nursing infants have not been determined.
No enhanced messaging available.
ICD codes
| Code | Type | Description |
|---|---|---|
| Corpus luteum insufficiency syndrome | ||
| E28.39 | ICD10CM | Other primary ovarian failure |
| E28.8 | ICD10CM | Other ovarian dysfunction |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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