Breast tenderness (16-27%)
Abdominal pain (10-20%)
Breast pain (6-16%)
Viral disease (7-12%)
Dementia, probable(postmenopausal women >65 years of age, possible association)
Weight change (less common than with synthetic progestins)
DVT (postmenopausal women 50-79 years of age)
Myocardial infarction (postmenopausal women 50-79 years of age)
Stroke (postmenopausal women 50-79 years of age)
Pulmonary emboli (postmenopausal women 50-79 years of age)
Amenorrhea (less common than with synthetic progestins)
Breakthrough bleeding (less common than with synthetic progestins)
Change in menstrual flow(less common than with synthetic progestins)
Spotting (less common than with synthetic progestins)
Breast changes (less common than with synthetic progestins)
Invasive breast cancer(postmenopausal women 50-79 years of age)
Hypersensitivity to progesterone products
History of: acute thrombophlebitis, thromboembolic disorders
Missed abortion or ectopic pregnancy
Pregnancy diagnostic tests
Undiagnosed abnormal vaginal bleeding
Family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy).
Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significang blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery.
Discontinue 4 week before major surgery or prolonged immobilization. Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted). Some studies link OCP use with increased risk of breast cancer, whereas other studies have not shown a change in risk.
Woman's risk depends on conditions where naturally high hormone levels persist for long periods of time including early onset menstruation before age 12, late onset menopause, after age 55, first child after age 30, nulliparity.
Increased risk of cervical cancer with OCP use, however HPV remains as main risk factor for this cancer. Evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk. Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use.
May cause dizziness; use caution when driving a motor vehicle or operating machinery
Increased risk of developing probable dementia in postmenopausal women >65 years of age reported
Use with caution in patients with history of depression
Use with caution in patients with diseases that could become exacerbated by fluid retention including epilepsy, migraine, renal dysfunction, diabetes, or asthma
In cases of partial or complete vision loss, diplopia, sudden onset of proptosis, discontinue permanently if papilledema or retinal vascular lesions are observed upon examination
Observational studies have reported an increased risk of breast cancer with estrogen plus progestin therapy, and a smaller increase in risk for breast cancer with estrogen-alone therapy, after several years of use; one large meta-analysis of prospective cohort studies reported increased risks that were dependent upon duration of use and could last up to >10 years after discontinuation of estrogen plus progestin therapy and estrogen-alone therapy; extension of WHI Trials also demonstrated increased breast cancer risk associated with estrogen plus progestin therapy
Not for use during pregnancy (contraindicated)
Not for use during lactation; estrogen administration to nursing mothers has been shown to decrease quantity and quality of milk; detectable amounts of estrogens and progestins have been identified in milk of mothers receiving this drug; exercise caution when administering this drug to a nursing mother
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Natural progestin hormone; promotes mammary gland development, induces change in endometrium, relaxes uterine smooth muscles, blocks follicular ovulation, maintains pregnancy
Peak serum time: 3 hr
Protein Bound: 96-99%
Metabolism: Liver to metabolites
Enzyme induced: CYP3A3/4
Excretion: Urine (50-60%); feces, including bile (10%)
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Prometrium oral |
Copyright © 2010 First DataBank, Inc.
COMMON BRAND NAME(S): Prometrium
WARNING: Progesterone is sometimes used with another medication (a type of estrogen) as combination hormone replacement therapy (HRT) in women after menopause. Combination HRT can rarely cause very serious side effects such as heart disease (such as heart attacks), stroke, serious blood clots (such as in the lungs and legs), dementia, and breast cancer. Some of these risks appear to depend on the length of treatment and other factors. Combination HRT should be used for the shortest possible length of time at the lowest effective dose so you can obtain the benefits and minimize the chance of serious side effects from long-term treatment. Combination HRT should not be used to prevent heart disease or dementia. Discuss the risks and benefits of treatment and your personal health history with your doctor. If you take combination HRT, check with your doctor regularly (such as every 3-6 months) to see if you still need to take it.If you use this medication for an extended period, you should have a complete physical exam at regular intervals (such as once a year) or as directed by your doctor. See also Notes section.
USES: Progesterone is a type of hormone (progestin). This medication is similar to the progesterone that your body naturally makes and is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and not going through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea).Progesterone is also used as part of combination hormone replacement therapy with estrogens to reduce menopause symptoms (such as hot flashes). Progesterone is added to estrogen replacement therapy to reduce the risk of cancer of the uterus.This medication is not for use in children.Progesterone must not be used to test for pregnancy.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this drug and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually once a day at bedtime. If you have trouble swallowing the pills, take with a full glass of water while standing up. Follow the dosing schedule carefully. Ask your doctor if you have any questions. The dosage is based on your medical condition and response to treatment.Inform your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: See also Warning section.Nausea, bloating, breast tenderness, headache, change in vaginal discharge, mood swings, blurred vision, dizziness, or drowsiness may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: nausea/vomiting that doesn't stop, unusual vaginal bleeding (such as spotting, breakthrough bleeding), mental/mood changes (such as depression, memory loss), swelling of the hands/feet, frequent/burning/painful urination, breast lumps, dark patches on the skin or face (melasma), yellowing eyes/skin, stomach/abdominal pain, dark urine, unusual tiredness.This medication, especially if used along with an estrogen product, may rarely cause very serious (possibly fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs, blindness). Get medical help right away if you have: chest/jaw/left arm pain, weakness on one side of the body, trouble speaking, difficulty walking, sudden vision changes (such as blurred/double vision, loss of vision, bulging eyes), confusion, sudden severe headache, severe dizziness, fainting, trouble breathing, coughing up blood, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: See also Warning section.Before taking progesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as peanut oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots, history of bleeding in the brain, liver disease, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion"), personal or family history of cancer (especially breast or other female organs), kidney disease, obesity, heart disease (such as past heart attacks, coronary artery disease, heart failure), high blood pressure, seizures, migraine headaches, asthma, high blood levels of cholesterol/fats, depression, diabetes, strokes, smoking, lupus.This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.This medication may be used during pregnancy only as directed by your doctor. Discuss the risks and benefits with your doctor.This drug passes into breast milk. Consult your doctor before breastfeeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include severe nausea and vomiting.
NOTES: Do not share this medication with others.Regular complete physical exams which include lab and/or medical tests (such as blood pressure, breast exam/mammogram, pelvic exam, Pap smear) should be done while you are taking this medication. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised June 2024. Copyright(c) 2024 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.