progesterone intravaginal gel (Rx)

Brand and Other Names:Crinone, Endometrin, more...Prochieve, Progesterone, Vaginal
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravaginal gel

  • 4%
  • 8%

vaginal insert

  • 100mg

Assisted Reproductive Technology (ART)

90 mg (8% gel) intravaginal qDay

Women with partial or complete ovarian failure: 90 mg twice daily intravaginal

May continue 10-12 weeks postconception until placental autonomy

Secondary Amenorrhea

45 mg (4% gel) intravaginal every other day x 6 doses

If no response, try 90 mg (8% gel) every other day x 6 doses

Not recommended

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Adverse Effects

>10%

Breast enlargement (40%)

Breast tenderness (27%)

Somnolence (27%)

Cramps (15-26%)

Mood swings (22-23%)

Nausea (6-22%)

Depression (11-19%)

Dizziness (15-24%)

Sleep disorder (18%)

Perineal pain (17%)

Nervousness (16%)

Urinary difficulties (11%)

Musculoskeletal pain (12%)

Headache (13%)

Breast pain (13%)

Abdominal pain (5-12%)

1-10%

Dizziness (5%)

Constipation (2-3%)

Cough (8%)

Vaginal discharge (10%)

Chest pain (7%)

Fatigue (8%)

Irritability (8%)

Worry (8%)

Diarrhea (7-8%)

Constipation (<5%)

Cholecystectomy (<5%)

Frequency Not Defined

Arthralgia

Bloating

Vaginal candidiasis

General pruritus

Ectopic pregnancy

Dysarthria

Drunk feeling

Jaundice

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Warnings

Black Box Warnings

An increased risk of invasive cancer has been reported in postmenopausal women using conjugated estrogens in combination with medroxyprogesterone acetate

Not for prevention of dementian in older women in combination with estrogens as it may actually increase risk of dementian

Not for the prevention of vascular disease in combination with estrogens

Therapy with estrogen should be given for shortest duration possible

Contraindications

Documented hypersensitivity to drug or excipients

Known or suspected malignancy of the breast or genital organ

Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events

Liver disease, liver tumors

Undiagnosed abnormal vaginal bleeding

Known missed abortion or ectopic pregnancy

Cautions

Progesterone and progestins have been used to prevent miscarriage in women with a history of recurrent spontaneous pregnancy losses; no adequate evidence is available to show that they are effective for this purpose

Caution in patients with 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).

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

The pretreatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear

Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significant blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery.

Discontinue 4 weeks 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.

Do not use other intravaginal meds 6 hr before or after progesterone vaginal

Vaginal insert not recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert

In cases of breakthrough bleeding, as in all cases of irregular vaginal bleeding, nonfunctional causes should be considered; in cases of undiagnosed vaginal bleeding, adequate diagnostic measures should be undertaken

Patients who have a history of psychic depression should be carefully observed

The pathologist should be advised of progesterone therapy when relevant specimens are submitted

Use with caution in patients with diseases that could become exacerbated by fluid retention including epilepsy, migraine, renal dysfunction, or asthma

In cases of partial or complete vision loss, diplopia, sudden onset of proptosis, discontinue permanently if pepilledema or retinal vascular lesions are observed upon examination

A decrease in glucose tolerance has been observed in a small percentage of patients on estrogen­ progestin combination drugs; the mechanism of this decrease is not known; for this reason, diabetic patients should be carefully observed while receiving progestin therapy

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Pregnancy & Lactation

Pregnancy Category: achieved through ART: 3% teratology; 17% spontaneous abortion

Lactation: Possibly safe; use caution

Pregnancy Categories

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.

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Pharmacology

Mechanism of Action

Natural progestin hormone; promotes mammary gland development, induces change in endometrium, relaxes uterine smooth muscles, blocks follicular ovulation, maintains pregnancy

Pharmacokinetics

Half-Life: 5-20 min

Excretion: Urine (50-60%); feces, including bile (10%)

Protein bound: 96-99%

Peak serum time: 8 hr

Metabolism: Primarily by hepatic CYP3A3/4

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Endometrin vaginal
-
100 mg insert
progesterone micronized oral
-
100 mg capsule
progesterone micronized oral
-
200 mg capsule
progesterone micronized oral
-
200 mg capsule
progesterone micronized oral
-
100 mg capsule
progesterone micronized oral
-
200 mg capsule
progesterone micronized oral
-
200 mg capsule
progesterone micronized oral
-
100 mg capsule
progesterone micronized oral
-
200 mg capsule
progesterone micronized oral
-
100 mg capsule
progesterone micronized oral
-
100 mg capsule
progesterone micronized oral
-
200 mg capsule
progesterone micronized oral
-
200 mg capsule
progesterone micronized oral
-
100 mg capsule
progesterone micronized oral
-
100 mg capsule
progesterone micronized oral
-
100 mg capsule
progesterone micronized oral
-
200 mg capsule
progesterone micronized oral
-
200 mg capsule
Prometrium oral
-
100 mg capsule
Prometrium oral
-
200 mg capsule
Crinone vaginal
-
4 % gel
Crinone vaginal
-
4 % gel
Crinone vaginal
-
8 % gel
Crinone vaginal
-
8 % gel
Crinone vaginal
-
4 % gel

Copyright © 2010 First DataBank, Inc.

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Patient Handout

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Patient Education
progesterone micronized oral

PROGESTERONE - ORAL

(pro-JESS-ter-own)

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 Notes section.

USES: Progesterone is a type of female 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 provided by your pharmacist before you start using this drug and each time you get a refill. If you have any questions, consult 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 therapy.Inform your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: 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 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 any of these very serious side effects occur: 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: 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, 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).Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (such as on a long plane flight). You may need to stop the medication for a time or take special precautions because of the increased risk for blood clots. Ask your doctor for more details.Do not smoke. Smoking combined with this medication further increases your risk for strokes, blood clots, high blood pressure, and heart attacks.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 breast-feeding.

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 can affect the results of certain lab tests. Make sure laboratory personnel and all your doctors know you use this medication.

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe nausea and vomiting.

NOTES: Do not share this medication with others.Keep all appointments with your doctor and the laboratory. You should have a complete physical examination that includes blood pressure measurements and breast/pelvic examinations at regular intervals (such as once a year) or as directed by your doctor. Follow your doctor's instructions on how to examine your own breasts and report any lumps right away. You should also be regularly screened for cervical cancer (for example, by having a Pap test) and have periodic mammograms as determined by your doctor. 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 April 2022. Copyright(c) 2022 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.

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Formulary

FormularyPatient Discounts

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
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Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.