Progesterone-deficiency related disorders. Oral: Menstrual irregularity due to dysovulation. Vag: In vitro fertilization (IVF) cycles; alternative to oral route if not tolerable.
Dosage/Direction for Use
Not >200 mg/intake. Progesterone insufficiencies 200-300 mg daily in 1 or 2 divided doses. May increase dose to 600 mg daily in 3 divided doses, in case of aiding pregnancy. Vag Insert 1 cap deeply in the vag. Duration of treatment may depend on indication & efficacy of treatment.
Administration
Should be taken on an empty stomach: Preferably taken at bedtime. Swallow whole w/ a glass of water.
Contraindications
Hypersensitivity. Allergy to sunflower, severe hepatic dysfunction, undiagnosed vag bleeding, mammary or genital tract carcinoma, thrombophlebitis, thromboembolic disorder, cerebral hemorrhage, porphyria.
Special Precautions
Not for premature labour; contraceptive. Discontinue if unexplained, sudden or gradual, partial or complete loss of vision, proptosis or diplopia, papilloedema, retinal vascular lesions or migraine occur. Intended to be co-prescribed w/ an estrogen product as HRT. Increased risk of developing DVT or pulmonary embolism. Assess women prior to taking HRT & at regular intervals thereafter. HTN, cardiac disease, renal disease, epilepsy, migraine, asthma. History of depression, diabetes, mild to moderate hepatic dysfunction, migraine or photosensitivity. Perform clinical exam of the breasts & pelvic exam. May affect ability to drive & use machines.
Adverse Reactions
Somnolence or transient dizziness. Acne, urticaria, rashes, fluid retention, wt changes, GI disturbances, changes in libido, breast discomfort, premenstrual symptoms, menstrual disturbances; chloasma, depression, pyrexia, insomnia, alopecia, hirsutism. VTE. Vag admnistration: Local irritation. PO: Altered menstrual cycles, amenorrhea, intermenstual bleeding, headache.
May interfere w/ bromocriptine effects & may raise plasma conc of cyclosporine. May affect the results of lab tests of hepatic &/or endocrine functions. Accelerated Utrogestan metabolism by rifamycin. Ketoconazole may increase bioavailability of progesterone.
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