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
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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 Warning

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

Active or history of breast cancer

Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease

Estrogen-dependent neoplasia

Liver disease, liver tumors

Undiagnosed abnormal vaginal bleeding

Uncontrolled hypertension

Diabetes mellitus with vascular involvement, jaundice with prior oral contraceptive use

Missed abortion or ectopic pregnancy

Pregnancy diagnostic tests

Cerebral apoplexy

Cautions

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.

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

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 pepilledema or retinal vascular lesions are observed upon examination

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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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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.

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.
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