Dosing and uses of Prometrium (progesterone micronized)
Adult dosage forms and strengths
capsule
- 100mg
- 200mg
Prevention of Endometrial Hyperplasia
200 mg PO qHS for 12 days sequentially per 28-day cycle
Secondary Amenorrhea
400 mg PO qHS x10 days
Pediatric dosage forms and strengths
Not recommended
Prometrium (progesterone micronized) adverse (side) effects
>10%
Headache (10-31%)
Breast tenderness (16-27%)
Dizziness (15-24%)
Abdominal pain (10-20%)
Depression (19%)
Breast pain (6-16%)
Viral disease (7-12%)
1-10%
Fatigue (8-9%)
Nausea (8%)
Mood swings (6%)
Frequency not defined
Dementia, probable(postmenopausal women >65 years of age, possible association)
Anorexia
Weakness
Weight change (less common than with synthetic progestins)
Vomiting
Edema
DVT (postmenopausal women 50-79 years of age)
Thrombophlebitis
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)
Cholestatic jaundice
Warnings
Contraindications
Hypersensitivity to progesterone products
History of: acute thrombophlebitis, thromboembolic disorders
Breast/genital cancer
Liver disease
Missed abortion or ectopic pregnancy
Pregnancy diagnostic tests
Undiagnosed abnormal vaginal bleeding
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.
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 pepilledema or retinal vascular lesions are observed upon examination
Pregnancy and lactation
Pregnancy category: B
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 Prometrium (progesterone micronized)
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 min
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%)
