Progesterone Micronized

Progesterone Micronized is a prescription medicine used to prevent the symptoms of endometrial hyperplasia and to treat the symptoms of secondary amenorrhea (absence of menses or periods).

• Progesterone Micronized is available under the following different brand names: Prometrium

Adult dosage

Capsule

• 100mg
• 200mg

Prevention of Endometrial Hyperplasia

Adult dosage

• 200 mg orally every night at bedtime for 12 days sequentially per 28-day cycle

Secondary Amenorrhea

Adult dosage

• 400 mg orally every night at bedtime x10 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Progesterone Micronized include:

• drowsiness,
• dizziness,
• breast pain,
• mood changes,
• headache,
• constipation,
• diarrhea,
• heartburn,
• bloating,
• swelling in the hands or feet,
• joint pain,
• hot flashes, and
• vaginal discharge.

Serious side effects of Progesterone Micronized include:

• unusual vaginal bleeding,
• pain or burning when urinating,
• breast lump,
• sudden vision problems,
• pain behind the eyes,
• depression,
• sleep problems,
• weakness,
• mood changes,
• severe dizziness,
• drowsiness,
• spinning sensation,
• confusion,
• shortness of breath,
• chest pain or pressure,
• pain spreading to the jaw or shoulder,
• nausea,
• sweating,
• upper stomach pain,
• itching,
• tiredness,
• loss of appetite,
• dark-colored urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• sudden numbness or weakness,
• sudden severe headache,
• slurred speech,
• difficulty talking or balancing,
• sudden cough,
• wheezing,
• rapid breathing,
• coughing up blood,
• leg pain,
• swelling in the leg, and
• warmth or redness in one or both legs.

Rare side effects of Progesterone Micronized include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Progesterone Micronized has severe interactions with no other drugs.
• Progesterone Micronized has serious interactions with at least 26 other drugs.
• Progesterone Micronized has moderate interactions with at least 60 other drugs.
• Progesterone Micronized has minor interactions with the following drugs:
  • amitriptyline
  • amoxapine
  • clomipramine
  • desipramine
  • dosulepin
  • doxepin
  • imipramine
  • lofepramine
  • maprotiline
  • nortriptyline
  • protriptyline
  • ribociclib
  • ruxolitinib
  • ruxolitinib topical
  • trazodone
  • trimipramine

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

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

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Progesterone Micronized?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Progesterone Micronized?”

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 (e.g., migraine, asthma, epilepsy).
• 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 an increased risk of breast cancer, whereas other studies have not shown a change in risk.
• A woman’s risk depends on conditions where naturally high hormone levels persist for long periods 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 the 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 above 65 years of age reported
• Use with caution in patients with a 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 papilledema or retinal vascular lesions are observed upon examination

Pregnancy and Lactation

• May be acceptable during pregnancy.
• Lactation
  • Possibly safe; use caution