| The mood enhancing/sedating effects of progesterone are of course perfectly obvious to most women. Remember how wonderful you always feel/felt in the last week before your period started? Remember how terrible you felt when your period started and how you felt worse and worse until the middle of your cycle when you began a slow improvement in mood gradually getting better and better until a couple of daysjust before your period? Oh, I'm sorry. You remember horrible pms in that week? You remember your period starting as a relief from that pms? Then progesterone is obviously not what you need since in the normal cycle it is only produced for the last two weeks. The level falls abruptly over the last 2 days thereby triggering menstruation. The serious and immediate side effects of progesterone are hardly limited to depression and sedation. From rxlist using prometrium/progesterone as the search term Side effects: (There are also two tables which I cannot reproduce here) "The most common adverse experiences reported in ?5% of patients in all PROMETRIUM Capsules dosage groups studied in this trial (100 mg/day to 400 mg/day) were: dizziness (16%), breast pain (11%), headache (10%), abdominal pain (10%), fatigue (9%), viral infection (7%), abdominal distention (6%), musculoskeletal pain (6%), emotional lability (6%), irritability (5%), and upper respiratory tract infection (5%). Other adverse events reported in <5% of patients taking PROMETRIUM Capsules include: Autonomic Nervous System Disorders: dry mouth Body As A Whole: accidental injury, chest pain, fever Cardiovascular System Disorders: hypertension Central and Peripheral Nervous System Disorders: confusion, somnolence, speech disorder Gastrointestinal System Disorders: constipation, dyspepsia, gastroenteritis, hemorrhagic rectum, hiatus hernia, vomiting Hearing and Vestibular Disorders: earache Heart Rate and Rhythm Disorders: palpitation Metabolic and Nutritional Disorders: edema, edema peripheral Musculoskeletal System Disorders: arthritis, leg cramps, hypertonia, muscle disorder, myalgia Myo/Endo/Pericardial and Valve Disorders: angina pectoris Psychiatric Disorders: anxiety, impaired concentration, insomnia, personality disorder Reproductive System Disorders: leukorrhea, uterine fibroid, vaginal dryness, fungal vaginitis, vaginitis Resistance Mechanism Disorders: abscess, herpes simplex Respiratory System Disorders: bronchitis, nasal congestion, pharyngitis, pneumonitis, sinusitis Skin and Appendages Disorders: acne, verruca, wound debridement Urinary System Disorders: urinary tract infection Vision Disorders: abnormal vision White Cell and Resistance Disorders: lymphadenopathy The following adverse experiences have been reported with PROMETRIUM Capsules in other U.S. clinical trials: increased sweating, asthenia, tooth disorder, anorexia, increased appetite, nervousness, and breast enlargement. The following spontaneous adverse events have been reported during the foreign marketing of PROMETRIUM Capsules: reversible cases of hepatitis and elevated transaminases. These events occurred mainly in patients receiving high doses of up to 1200 mg. The following additional adverse experiences have been observed in women taking progestins in general: breakthrough bleeding, spotting, change in menstrual flow, amenorrhea, changes in weight (increase or decrease), changes in the cervical squamo-columnar junction and cervical secretions, cholestatic jaundice, anaphylactoid reactions and anaphylaxis, rash (allergic) with and without pruritus, melasma or chloasma, pyrexia, and insomnia. DRUG INTERACTIONS Drug Lab Test Interactions The following laboratory results may be altered by the use of estrogen-progestin combination drugs: Increased sulfobromophthalein retention and other hepatic function tests. Coagulation tests: increase in prothrombin factors VII, VIII, IX and X. Metyrapone test. Pregnanediol determination. Thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in T3 uptake values. Food-Drug Interaction: Concomitant food ingestion increased the bioavailability of PROMETRIUM Capsules relative to a fasting state when administered to postmenopausal women at a dose of 200 mg. Drug-Drug Interaction: The metabolism of progesterone by human liver microsomes was inhibited by ketoconazole (IC50 <0.1 µM). Ketoconazole is a known inhibitor of cytochrome P450 3A4, hence these data suggest that ketoconazole or other known inhibitors of this enzyme may increase the bioavailability of progesterone. The clinical relevance of the in vitro findings is unknown. Coadministration of conjugated estrogens and PROMETRIUM Capsules to 29 postmenopausal women over a 12 day period resulted in an increase in total estrone concentrations (Cmax 3.68 ng/ml to 4.93 ng/ml) and total equilin concentrations (Cmax 2.27 ng/ml to 3.22 ng/ml) and a decrease in circulating 17b estradiol concentrations (Cmax 0.037 ng/ml to 0.030 ng/ml). The half-life of the conjugated estrogens was similar with coadministration of PROMETRIUM Capsules." " PRECAUTIONS General 1.The pretreatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear. 2.Because progesterone may cause some degree of fluid retention, conditions which might be influenced by this factor, such as epilepsy, migraine, asthma, cardiac or renal dysfunction, require careful observation. 3.In cases of breakthrough bleeding, as in any cases of irregular bleeding per vaginum, nonfunctional causes should be borne in mind. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures are indicated. 4.Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree. 5.Any possible influence of prolonged progestin therapy on pituitary, ovarian, adrenal, hepatic or uterine functions awaits further study. 6.Although concomitant use of conjugated estrogens and PROMETRIUM Capsules did not result in a decrease in glucose tolerance, diabetic patients should be carefully observed while receiving estrogen-progestin therapy. 7.The pathologist should be advised of progestin therapy when relevant specimens are submitted. 8.Because of the occurrence of thrombotic disorders (thrombophlebitis, pulmonary embolism, retinal thrombosis, and cerebrovascular disorders) in patients taking estrogen-progestin combinations, the physician should be alert to the earliest manifestation of these disorders. 9.Transient dizziness may occur in some patients. Use caution when driving a motor vehicle or operating machinery. A small percentage of women may experience extreme dizziness and/or drowsiness during initial therapy. For these women, bedtime dosing is advised." So much for the virtual guarantees of safety proponents of natural progesterone offer so glibly. |