Crinone, Prochieve (progesterone intravaginal gel) dosing, indications, interactions, adverse effects, and more

Sections

Sections progesterone intravaginal gel
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravaginal gel

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

>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

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

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.

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

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

Patient Handout

Select a drug:

PROGESTERONE SUPPOSITORY - VAGINAL

(pro-JESS-ter-own)

COMMON BRAND NAME(S): Endometrin

USES: This medication contains a hormone called progesterone. Progesterone and other hormones help you become and stay pregnant. This medication is used to increase the level of progesterone in women taking fertility treatments because these treatments tend to decrease progesterone levels.

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.This medication is for vaginal use only. Unwrap the suppository. Following the instructions, use the applicator to insert this medication into the vagina as directed by your doctor, usually 2 or 3 times a day. If you become pregnant, continue to use this medication for up to a total of 10 weeks or as directed by your doctor.Dosage is based on your medical condition and response to treatment.To get the most benefit from this medication, use it regularly at evenly spaced intervals. To help you remember, use it at the same times each day.

SIDE EFFECTS: Bloating, stomach/abdominal pain, nausea, breast tenderness, headache, drowsiness, mood swings, irritability, or vaginal discomfort may occur. If any of these effects last or get worse, tell 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: unusual vaginal bleeding, severe mental/mood changes (such as depression), swelling ankles/feet, yellowing eyes/skin, breast lumps.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/eye 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 using 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, 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, liver disease, cancer (especially of the breast or other female organs), vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion"), an abnormal pregnancy where the fertilized egg is outside of the uterus (ectopic pregnancy), kidney disease, heart disease (such as past heart attacks, heart failure), high blood pressure, seizures, migraine headaches, asthma, depression, diabetes, strokes, high level of fats in the blood (high cholesterol/triglycerides).This drug may make you drowsy. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). In general, alcohol is not recommended for pregnant or possibly pregnant women due to increased risk of harm to the baby.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 be used during pregnancy, but 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.Do not use other vaginal products during treatment with this medication unless otherwise directed by your doctor. Doing so may affect how well the drug is absorbed by your body.

OVERDOSE: This medicine may be harmful if swallowed. 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.

NOTES: Do not share this medication with others.Keep all medical and lab appointments.

MISSED DOSE: If you miss a dose, use it as soon as you remember. However, do not use more doses in a day than prescribed. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature. 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.

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.

Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

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
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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