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Progesterone

Pronunciation

Pronunciation

(proe JES ter one)

Index Terms

  • Pregnenedione
  • Prochieve
  • Progestin

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Prometrium: 100 mg, 200 mg [contains peanut oil]

Generic: 100 mg, 200 mg

Cream, Transdermal:

Generic: 10% (60 g)

Gel, Vaginal:

Crinone: 4% (1.125 g); 8% (1.125 g)

Insert, Vaginal:

Endometrin: 100 mg (21 ea)

Oil, Intramuscular:

Generic: 50 mg/mL (10 mL)

Suppository, Vaginal:

First-Progesterone VGS 25: 25 mg (30 ea)

First-Progesterone VGS 50: 50 mg (30 ea)

First-Progesterone VGS 100: 100 mg (30 ea)

First-Progesterone VGS 200: 200 mg (30 ea)

First-Progesterone VGS 400: 400 mg (30 ea)

Brand Names: U.S.

  • Crinone
  • Endometrin
  • First-Progesterone VGS 100
  • First-Progesterone VGS 200
  • First-Progesterone VGS 25
  • First-Progesterone VGS 400
  • First-Progesterone VGS 50
  • Prometrium

Pharmacologic Category

  • Progestin

Pharmacology

Natural steroid hormone that induces secretory changes in the endometrium, promotes mammary gland development, relaxes uterine smooth muscle, blocks follicular maturation and ovulation, and maintains pregnancy. When used as part of an ART program in the luteal phase, progesterone supports embryo implantation.

Absorption

Vaginal gel: Prolonged; Absorption half-life: 25 to 50 hours

Metabolism

Hepatic

Excretion

Urine, bile, feces

Time to Peak

Oral: Within 3 hours; IM: ~8 hours; Vaginal insert: ~17 to 24 hours

Half-Life Elimination

Vaginal gel: 5 to 20 minutes

Protein Binding

Albumin (50% to 54%) and cortisol-binding protein (43% to 48%)

Use: Labeled Indications

Oral: Prevention of endometrial hyperplasia in nonhysterectomized, postmenopausal women who are receiving conjugated estrogen tablets; secondary amenorrhea

IM: Amenorrhea; abnormal uterine bleeding due to hormonal imbalance

Intravaginal gel: Part of assisted reproductive technology (ART) for infertile women with progesterone deficiency; secondary amenorrhea

Vaginal insert: Part of ART for infertile women with progesterone deficiency

Use: Unlabeled

Reduce the risk of spontaneous preterm birth in women with singleton pregnancies who have either had a prior spontaneous preterm birth or who have a cervix <20 mm before or at 24 weeks gestation (ACOG, 2012).

Contraindications

Hypersensitivity to progesterone or any component of the formulation; undiagnosed abnormal vaginal bleeding; history of or current thrombophlebitis or venous thromboembolic disorders (including DVT, PE); active or history of arterial thromboembolic disease (eg, stroke, MI); history of or known or suspected carcinoma of the breast or genital organs; hepatic dysfunction or disease; missed abortion or ectopic pregnancy; diagnostic test for pregnancy; capsules are also contraindicated for use during pregnancy

Dosing: Adult

Females:

Amenorrhea: IM: 5 to 10 mg/day for 6 to 8 consecutive days

Amenorrhea, secondary:

Intravaginal gel: 45 mg (4% gel) every other day for 6 doses; if response is inadequate, may increase to 90 mg (8% gel) at same schedule

Oral: 400 mg every evening for 10 days

ART in patients who require progesterone supplementation:

Intravaginal gel: 90 mg (8% gel) once daily. If pregnancy occurs, may continue treatment for 10 to 12 weeks.

Intravaginal insert: 100 mg 2 to 3 times daily starting at oocyte retrieval and continuing for up to 10 weeks.

ART in patients with partial or complete ovarian failure:

Intravaginal gel: 90 mg (8% gel) twice daily. If pregnancy occurs, continue treatment for 10 to 12 weeks.

Endometrial hyperplasia prevention (in postmenopausal women with a uterus who are receiving daily conjugated estrogen tablets): Oral: 200 mg as a single daily dose every evening for 12 days sequentially per 28-day cycle

Functional uterine bleeding: IM: 5 to 10 mg/day for 6 doses

Prevention of spontaneous preterm delivery (singleton pregnancy and prior preterm birth or short cervix) (off-label use): Intravaginal gel: 90 mg (8% gel) once daily (Hassan, 2011; O’Brien, 2009). Treatment initiation is recommended before or at gestational week 24 (ACOG, 2012).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

Injection, oral: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). Use with caution.

Intravaginal gel, insert: There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

Use is contraindicated in liver dysfunction or disease.

Administration

IM: Administer deep IM only

Intravaginal:

Vaginal gel: (A small amount of gel will remain in the applicator following insertion): Administer into the vagina directly from sealed applicator. Remove applicator from wrapper; holding applicator by thickest end, shake down to move contents to thin end; while holding applicator by flat section of thick end, twist off tab; gently insert into vagina and squeeze thick end of applicator.

For use at altitudes above 2500 feet: Remove applicator from wrapper; hold applicator on both sides of bubble in the thick end; using a lancet, make a single puncture in the bubble to relieve air pressure; holding applicator by thickest end, shake down to move contents to thin end; while holding applicator by flat section of thick end, twist off tab; gently insert into vagina and squeeze thick end of applicator.

Vaginal insert: Insert tablet in vagina using disposable applicator provided.

Oral capsule: For patients who experience difficulty swallowing the capsules, taking with a full glass of water in the standing position may be beneficial.

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).

Storage

Store at controlled room temperature. Protect capsules from excessive moisture.

Drug Interactions

Afatinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Afatinib. Management: Per US labeling: reduce afatinib by 10mg if not tolerated. Per Canadian labeling: avoid combination if possible; if used, administer the P-gp inhibitor simultaneously with or after the dose of afatinib. Consider therapy modification

Anticoagulants: Progestins may diminish the therapeutic effect of Anticoagulants. More specifically, the potential prothrombotic effects of some progestins and progestin-estrogen combinations may counteract anticoagulant effects. Management: Carefully weigh the prospective benefits of progestins against the potential increased risk of procoagulant effects and thromboembolism. Use is considered contraindicated under some circumstances. Refer to related guidelines for specific recommendations. Consider therapy modification

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Antifungal Agents (Vaginal): May diminish the therapeutic effect of Progesterone. Avoid combination

Bosentan: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Bosutinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Bosutinib. Avoid combination

Brentuximab Vedotin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Brentuximab Vedotin. Specifically, concentrations of the active monomethyl auristatin E (MMAE) component may be increased. Monitor therapy

C1 inhibitors: Progestins may enhance the thrombogenic effect of C1 inhibitors. Monitor therapy

Colchicine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Colchicine. Colchicine distribution into certain tissues (e.g., brain) may also be increased. Management: Colchicine is contraindicated in patients with impaired renal or hepatic function who are also receiving a p-glycoprotein inhibitor. In those with normal renal and hepatic function, reduce colchicine dose as directed. Consider therapy modification

CYP2C19 Inducers (Strong): May increase the metabolism of CYP2C19 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Dabigatran Etexilate: P-glycoprotein/ABCB1 Inhibitors may increase serum concentrations of the active metabolite(s) of Dabigatran Etexilate. Management: Dabigatran dose reductions may be needed. Specific recommendations vary considerably according to US vs Canadian labeling, specific P-gp inhibitor, renal function, and indication for dabigatran treatment. Refer to full monograph or dabigatran labeling. Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates. Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP2C19 Substrates. Management: Seek alternatives to the CYP2C19 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

DOXOrubicin (Conventional): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of DOXOrubicin (Conventional). Management: Seek alternatives to P-glycoprotein inhibitors in patients treated with doxorubicin whenever possible. One U.S. manufacturer (Pfizer Inc.) recommends that these combinations be avoided. Consider therapy modification

Edoxaban: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Edoxaban. Management: See full monograph for details. Reduced doses are recommended for patients receiving edoxaban for venous thromboembolism in combination with certain inhibitors. Similar dose adjustment is not recommended for edoxaban use in atrial fibrillation. Consider therapy modification

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates. Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification

Enzalutamide: May decrease the serum concentration of CYP2C19 Substrates. Conversely, concentrations of active metabolites may be increased for those drugs activated by CYP2C19. Management: Concurrent use of enzalutamide with CYP2C19 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP2C19 substrate should be performed with caution and close monitoring. Consider therapy modification

Everolimus: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Everolimus. Management: Everolimus dose reductions are required for patients being treated for subependymal giant cell astrocytoma or renal cell carcinoma. See prescribing information for specific dose adjustment and monitoring recommendations. Consider therapy modification

Herbs (Progestogenic Properties) (eg, Bloodroot, Yucca): May enhance the adverse/toxic effect of Progestins. Monitor therapy

Ledipasvir: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Ledipasvir. Monitor therapy

Mitotane: May decrease the serum concentration of CYP3A4 Substrates. Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

Naloxegol: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Naloxegol. Monitor therapy

Osimertinib: May increase the serum concentration of CYP3A4 Substrates. Osimertinib may decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

PAZOPanib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of PAZOPanib. Avoid combination

P-glycoprotein/ABCB1 Substrates: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy

Prucalopride: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Prucalopride. Monitor therapy

Ranolazine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Ranolazine. Monitor therapy

Rifaximin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Rifaximin. Monitor therapy

Silodosin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Silodosin. Avoid combination

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

St John's Wort: May decrease the serum concentration of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Topotecan: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Topotecan. Avoid combination

Ulipristal: May diminish the therapeutic effect of Progestins. Progestins may diminish the therapeutic effect of Ulipristal. Management: Ulipristal for uterine fibroids (Canadian indication): avoid progestins within 12 days of stopping ulipristal; as emergency contraceptive (U.S. indication): avoid progestins within 5 days of stopping ulipristal. Avoid combination

Venetoclax: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Venetoclax. Management: Reduce the venetoclax dose by at least 50% in patients requiring these combinations. Consider therapy modification

VinCRIStine (Liposomal): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of VinCRIStine (Liposomal). Avoid combination

Test Interactions

Thyroid function, metyrapone, liver function, coagulation tests, endocrine function tests

Adverse Reactions

Injection (IM):

Cardiovascular: Cerebral edema, cerebral thrombosis, edema

Central nervous system: Depression, fever, insomnia, somnolence

Dermatologic: Acne, allergic rash (rare), alopecia, hirsutism, pruritus, rash, urticaria

Endocrine & metabolic: Amenorrhea, breakthrough bleeding, breast tenderness, galactorrhea, menstrual flow changes, spotting

Gastrointestinal: Nausea, weight gain/loss

Genitourinary: Cervical erosion changes, cervical secretion changes

Hepatic: Cholestatic jaundice

Local: Injection site: Irritation, pain, redness

Ocular: Optic neuritis, retinal thrombosis

Respiratory: Pulmonary embolism

Miscellaneous: Anaphylactoid reactions

Oral capsule (percentages reported when used in combination with or cycled with conjugated estrogens):

>10%:

Central nervous system: Headache (16% to 31%), dizziness (15% to 24%), depression (19%)

Endocrine & metabolic: Breast tenderness (27%), breast pain (6% to 16%)

Gastrointestinal: Abdominal pain (10% to 20%), abdominal bloating (8% to 12%)

Genitourinary: Urinary problems (11%)

Neuromuscular & skeletal: Joint pain (20%), musculoskeletal pain (12%)

Miscellaneous: Viral infection (12%)

5% to 10%:

Cardiovascular: Chest pain (7%)

Central nervous system: Fatigue (8%), irritability (8%), worry (8%)

Gastrointestinal: Nausea/vomiting (8%), diarrhea (7% to 8%)

Genitourinary: Vaginal discharge (10%)

Respiratory: Cough (8%)

<5%: Breast biopsy, breast cancer, cholecystectomy, constipation

Postmarketing and/or case reports: Aggression, alopecia, anaphylactic reaction, arthralgia, asthma, blurred vision, choking, cholestasis, cholestatic hepatitis, circulatory collapse, confusion, consciousness depressed/loss, convulsion, depersonalization, diplopia, disorientation, drunk feeling, dysarthria, dysphagia, dyspnea, endometrial carcinoma, facial edema, feeling abnormal, gait abnormal, hepatic enzymes increased, hepatic failure, hepatic necrosis, hepatitis, hyperglycemia, hyper-/hypotension, hypersensitivity, jaundice, liver function tests increased, menorrhagia, menstrual disorder, metrorrhagia, muscle cramps, ovarian cyst, pancreatitis (acute), paresthesia, pruritus, sedation, slurred speech, stupor, suicidal ideation, syncope, tachycardia, throat tightness, TIA, tinnitus, tongue swelling, urticaria, vertigo, visual disturbance, walking difficulty, weight gain/loss

Vaginal gel (percentages reported with ART); also refer to oral capsule reactions listing for additional effects noted with progesterone:

>10%:

Central nervous system: Somnolence (27%), headache (13% to 17%), nervousness (16%), depression (11%)

Endocrine & metabolic: Breast enlargement (40%), breast pain (13%), libido decreased (11%)

Gastrointestinal: Constipation (27%), nausea (7% to 22%), cramps (15%), abdominal pain (12%)

Genitourinary: Perineal pain (17%), nocturia (13%)

5% to 10%:

Central nervous system: Pain (8%), dizziness (5%)

Gastrointestinal: Diarrhea (8%), bloating (7%), vomiting (5%)

Genitourinary: Vaginal discharge (7%), dyspareunia (6%), genital moniliasis (5%), genital pruritus (5%)

Neuromuscular & skeletal: Arthralgia (8%)

Vaginal insert (percentages reported with ART); also refer to oral capsule reactions listing for additional effects noted with progesterone:

>10%:

Gastrointestinal: Abdominal pain (12%)

Miscellaneous: Post-oocyte retrieval pain (25% to 28%)

1% to 10%:

Central nervous system: Headache (3% to 4%), fatigue (2% to 3%)

Endocrine & metabolic: Ovarian hyperstimulation syndrome (7%)

Gastrointestinal: Nausea (7% to 8%), abdominal distension (4%), constipation (2% to 3%), vomiting (2% to 3%)

Genitourinary: Uterine spasm (3% to 4%), vaginal bleeding (3%), urinary tract infection (1% to 2%)

<1%: Burning, discomfort, itching, peripheral edema, urticaria, vaginal irritation

ALERT: U.S. Boxed Warning

Cardiovascular disease (capsule):

Do not use progestins plus estrogens for the prevention of cardiovascular disease.

The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of myocardial infarction (MI), stroke, pulmonary embolism (PE), and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens 0.625 mg combined with medroxyprogesterone acetate 2.5 mg relative to placebo.

Dementia (capsules):

Do not use progestins plus estrogens for the prevention of dementia.

The Women's Health Initiative Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years and older during 4 years of treatment with daily conjugated estrogens 0.625 mg combined with medroxyprogesterone acetate 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Breast cancer (capsule):

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.

In the absence of comparable data, assume these risks to be similar for other doses of conjugated estrogens and medroxyprogesterone acetate and other combinations and dosage forms of estrogens and progestins.

Risks vs benefits (capsule):

Prescribe progestins with estrogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Warnings/Precautions

Concerns related to adverse effects:

• Breast cancer: [US Boxed Warning]: Based on data from the Women’s Health Initiative (WHI) studies, an increased risk of invasive breast cancer was observed in postmenopausal women using conjugated estrogens (CE) in combination with medroxyprogesterone acetate (MPA). This risk may be associated with duration of use and declines once combined therapy is discontinued (Chlebowski, 2009). The risk of invasive breast cancer was decreased in postmenopausal women with a hysterectomy using CE only, regardless of weight. However, the risk was not significantly decreased in women at high risk for breast cancer (family history of breast cancer, personal history of benign breast disease) (Anderson, 2012). An increase in abnormal mammogram findings has also been reported with estrogen alone or in combination with progestin therapy. Use is contraindicated in patients with known or suspected breast cancer.

• CNS effects: Patients should be warned that progesterone might cause transient dizziness or drowsiness during initial therapy.

• Dementia: [US Boxed Warning]: Estrogens with or without progestin should not be used to prevent dementia. In the Women’s Health Initiative Memory Study (WHIMS), an increased incidence of dementia was observed in women ≥65 years of age taking CE alone or in combination with MPA .

• Endometrial cancer: Progesterone is used to reduce the risk of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving conjugated estrogens. The use of unopposed estrogen in women with an intact uterus is associated with an increased risk of endometrial cancer. The addition of a progestin to estrogen therapy may decrease the risk of endometrial hyperplasia, a precursor to endometrial cancer. Adequate diagnostic measures, including endometrial sampling if indicated, should be performed to rule out malignancy in postmenopausal women with undiagnosed abnormal vaginal bleeding. Estrogens may exacerbate endometriosis. Malignant transformation of residual endometrial implants has been reported posthysterectomy with unopposed estrogen therapy. Consider adding a progestin in women with residual endometriosis posthysterectomy.

• Ovarian cancer: Postmenopausal estrogen therapy and combined estrogen/progesterone therapy may increase the risk of ovarian cancer; however, the absolute risk to an individual woman is small. Although results from various studies are not consistent, risk does not appear to be significantly associated with the duration, route, or dose of therapy. In one study, the risk decreased after 2 years following discontinuation of therapy (Mørch, 2009). Although the risk of ovarian cancer is rare, women who are at an increased risk (eg, family history) should be counseled about the association (NAMS, 2012).

• Retinal vascular thrombosis: Discontinue pending examination in cases of sudden partial or complete vision loss, sudden onset of proptosis, diplopia, or migraine; discontinue permanently if papilledema or retinal vascular lesions are observed on examination.

Disease-related concerns:

• Cardiovascular disease: [US Boxed Warning]: Estrogens with or without progestin should not be used to prevent cardiovascular disease. Using data from the Women’s Health Initiative (WHI) studies, an increased risk of deep vein thrombosis (DVT) and stroke has been reported with CE and an increased risk of DVT, stroke, pulmonary emboli (PE) and myocardial infarction (MI) has been reported with CE with MPA in postmenopausal women. Additional risk factors include diabetes mellitus, hypercholesterolemia, hypertension, SLE, obesity, tobacco use, and/or history of venous thromboembolism (VTE). Risk factors should be managed appropriately; discontinue use if adverse cardiovascular events occur or are suspected.

• Depression: Use with caution in patients with a history of depression.

• Diseases exacerbated by fluid retention: Use with caution in patients with diseases which may be exacerbated by fluid retention, including asthma, epilepsy, migraine, diabetes, or renal dysfunction.

Special populations:

• Pediatric: Not for use prior to menarche.

• Surgical patients: Whenever possible, progestins in combination with estrogens should be discontinued at least 4 to 6 weeks prior to and for 2 weeks following elective surgery associated with an increased risk of thromboembolism or during periods of prolonged immobilization.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

• Palm oil: Some products may contain palm oil.

• Peanut oil: Some products may contain peanut oil.

• Sesame oil: Some products may contain sesame oil.

Special handling:

• Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH, 2014 [group 2]).

Other warnings/precautions:

• Risks vs benefits: [US Boxed Warning]: Estrogens with or without progestin should be used for the shortest duration possible at the lowest effective dose consistent with treatment goals. Before prescribing estrogen therapy to postmenopausal women, the risks and benefits must be weighed for each patient. Women should be informed of these risks and benefits, as well as possible effects of progestin when added to estrogen therapy. Patients should be reevaluated as clinically appropriate to determine if treatment is still necessary. Available data related to treatment risks are from Women’s Health Initiative (WHI) studies, which evaluated oral CE 0.625 mg with or without MPA 2.5 mg relative to placebo in postmenopausal women. Other combinations and dosage forms of estrogens and progestins were not studied. Outcomes reported from clinical trials using CE with or without MPA should be assumed to be similar for other doses and other dosage forms of estrogens and progestins until comparable data becomes available.

Monitoring Parameters

Routine physical examination that includes blood pressure and Papanicolaou smear, breast exam, mammogram. Adequate diagnostic measures, including endometrial sampling, if indicated, should be performed to rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding. Signs and symptoms of thromboembolic disorders, vision changes

Pregnancy Risk Factor

B (oral)

Pregnancy Considerations

The oral capsules are contraindicated for use during pregnancy.

Adverse events were not observed following oral administration in animal reproduction studies. Adverse events following maternal use in pregnancy (eg, hypospadias, congenital heart disease, cleft lip/palate) have been noted in postmarketing data, however a causal relationship has not been clearly established. Use of vaginal progesterone may be considered to decrease the risk of recurrent spontaneous preterm birth in women with a singleton pregnancy and prior spontaneous preterm singleton birth (therapy may begin at 16 to 24 weeks, regardless of cervical length). It may also be used to prevent spontaneous preterm birth in women with a singleton pregnancy who have a cervix <20 mm before or at 24 weeks gestation. Use is not recommended as an intervention for women with multiple gestations (ACOG, 2012). The vaginal gel and insert are indicated for use in ART.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience fatigue, insomnia, more hungry, constipation, hair loss, abdominal pain, cramps, bloating, diarrhea, enlarged breasts, muscle pain, back pain, loss of strength and energy, decreased libido, or injection site irritation. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), angina, shortness of breath, coughing up blood, abnormal gait, severe headache, severe nausea, vomiting, severe dizziness, passing out, bulging eyes, vision changes, lump in breast, breast soreness or pain, nipple discharge, vaginitis, vaginal bleeding, pain with urination, polyuria, depression, mood changes, memory impairment, seizures, swelling of hands or feet, signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), or pelvic pain (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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