progesterone intravaginal gel (Crinone, Endometrin, Prochieve, Progesterone, Vaginal)
Classes: Progestins; Vaginal Preparations, Other
Dosing and uses of Crinone, Prochieve (progesterone intravaginal gel)
Adult dosage forms and 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
Pediatric dosage forms and strengths
Not recommended
Crinone, Prochieve (progesterone intravaginal gel) adverse (side) 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
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
Pregnancy and 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.
Pharmacology of Crinone, Prochieve (progesterone intravaginal gel)
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