progesterone micronized (Rx)

Brand and Other Names:Prometrium
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 100mg
  • 200mg
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Prevention of Endometrial Hyperplasia

200 mg PO qHS for 12 days sequentially per 28-day cycle

Secondary Amenorrhea

400 mg PO qHS x10 days

Not recommended

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Interactions

Interaction Checker

and progesterone micronized

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse 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

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            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

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            Pregnancy & 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.

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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 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%)

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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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