Precautions: Oral Tablets and Sterile Aqueous Suspension
      The pretreatment physical examination should include special reference to breast and  pelvic organs, as well as Papanicolaou smear. 

               Because progestogens 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. 

               In cases of breakthrough bleeding, as in all cases of irregular bleeding per vaginum,  nonfunctional causes should be borne in mind. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures are indicated. 

               Patients who have a history of psychic depression should be carefully observed and  the drug discontinued if the depression recurs to a serious degree. 

               Any possible influence of prolonged progestin therapy on pituitary, ovarian, adrenal,  hepatic or uterine functions awaits further study. 

               A decrease in glucose tolerance has been observed in a small percentage of  patients on estrogen-progestin combination drugs. The mechanism of this decrease is obscure. For this reason, diabetic patients should be carefully observed while receiving progestin therapy. 

               The age of the patient constitutes no absolute limiting factor although treatment with 
 progestins may mask the onset of the climacteric. 

               The pathologist should be advised of progestin therapy when relevant specimens are  submitted. 

               Because of the occasional occurrence of thrombotic disorders, (thrombophlebitis,  pulmonary embolism, retinal thrombosis, and cerebrovascular disorders) in patients taking estrogen-progestin combinations  and since the mechanism is obscure, the physician should be alert to the earliest manifestation of these disorders. 

Studies of the addition of a progestin product to an estrogen replacement regimen for seven or more days of a cycle of estrogen administration have reported a lowered incidence of endometrial  hyperplasia. Morphological and biochemical studies of endometrium suggest that 10-13 days of a progestin are needed to provide maximal maturation of the endometrium and to eliminate any hyperplastic changes. Whether this will provide protection from endometrial carcinoma has not been clearly established. There are possible additional risks which may be associated with the inclusion of progestin in estrogen replacement regimen. The potential risks include adverse effects on carbohydrate  and lipid metabolism. The dosage used may be important in minimizing these adverse effects. 

          Pregnancy: See BOXED WARNINGfor possible adverse effects on the fetus. 

          Breast: Breast tenderness or galactorrhea has been reported rarely. 

          Skin: Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash  have occurred in an occasional patient.  Acne, alopecia and hirsutism have been reported in a few cases. 

          Thromboembolic Phenomena: Thromboembolic phenomena including thrombophlebitis  and pulmonary embolism have been  reported. 

          The following adverse reactions have been observed in women taking progestins  including medroxyprogesterone acetate tablets: 

 breakthrough bleeding, spotting, change in menstrual flow, amenorrhea, edema, change 
 in weight (increase or decrease), changes in  cervical erosion and cervical secretions, cholestatic jaundice, anaphylactoid reactions  and anaphylaxis, rash (allergic) with and without pruritus, mental depression, pyrexia, insomnia, nausea, somnolence. 

          A statistically significant association has been demonstrated between use of  estrogen-progestin combination drugs and the following  serious adverse reactions: thrombophlebitis; pulmonary embolism and cerebral  thrombosis and embolism. For this reason patients on progestin therapy should be carefully observed. 

          Although available evidence is suggestive of an association, such a relationship has been neither confirmed nor refuted for the following serious adverse reactions: 

          neuro-ocular lesions, e.g., retinal thrombosis and optic neuritis. 

The following adverse reactions have been observed in patients receiving estrogen  progestin combination drugs: 

rise in blood pressure in susceptible individuals; premenstrual-like syndrome; changes in libido; changes in appetite; cystitis-like  syndrome, headache, nervousness; fatigue; backache; hirsutism; loss of scalp hair;  erythema multiforme; erythema nodosum;  hemorrhagic eruption; itching; dizziness 

          USES: 
               This medication is a female hormone. It is used to treat amenorrhea (lack of  menstrual flow), abnormal bleeding from the uterus, or endometriosis (a painful condition where the lining of the uterus is abnormal). It is also used to treat certain types of cancer and menopausal symptoms. 

          HOW TO TAKE THIS MEDICATION: 
               May be taken with food or immediately after a meal to prevent stomach upset. Take this medication as prescribed. It is usually taken for 5 to 13 days during the later end of the menstrual cycle. A menstrual period should begin within 3 to 10 days of stopping the medication. For treatment of cancer, the medication is usually taken more often. Follow the dosing schedule carefully. Be sure to ask your doctor if you have any questions. 

          SIDE EFFECTS: 
               This medication may cause nausea, vomiting, headache, dizziness, depression, sleeplessness, or irritability. These effects should disappear as your body adjusts to the medication. If they persist or become severe, inform your doctor. Notify your doctor if you experience any of the following while taking this medication: dizziness or fainting, sudden severe headache, changes in vision, numbness or tingling in the arms or legs, swelling of the hands or feet, acute chest pain, shortness of breath; pain in the calves accompanied by swelling, warmth or redness; changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or complete stoppage of bleeding). 

          PRECAUTIONS: 
               Before you take this medication, tell your doctor your medical history, including high blood pressure, seizures, migraine headaches, diabetes, asthma; heart, liver or kidney disease; strokes, blood clots, heart attacks, cancer of the breast or genitals, high blood level of cholesterol or fats, depression, excessive weight gain or fluid retention during menstrual cycle and jaundice (yellowing of skin or eyes). Before having surgery, including dental surgery, tell the doctor that you take medroxyprogesterone. Because this drug can interfere with laboratory tests, tell the doctor and laboratory personnel that you take medroxyprogesterone. Medroxyprogesterone may slightly increase your risk of strokes, blood clots, high blood pressure, heart attacks, gallbladder disease, vision problems, and liver tumors. Cigarette smoking further increases these risks. Therefore, cigarette smoking should be avoided while taking this medication. This drug is not recommended for use during pregnancy, especially during the first four months of pregnancy. Consult your your doctor before using this drug. This drug is excreted into breast milk. To date, in usual dosing, no problems have been noted in nursing infants. Breast-feeding while using very high doses is not recommended. Consult your doctor before breast-feeding. 

          DRUG INTERACTIONS: Tell your doctor what prescription and nonprescription drugs you are taking. 

          NOTES: 
               It is important to have an annual physical exam and do regular self breast examinations while taking this medication. Patient information should be included with the medication. Read it carefully and ask your doctor or pharmacist about any questions you may have. Do not allow anyone else to take this medication. 

          MISSED DOSE: 
               If you miss a dose, take as soon as remembered; do not take if it is almost time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up. 

          STORAGE: 
               Store at room temperature between 59 and 86 degrees F (between 15 and 30 degrees C) away from moisture and sunlight. Do not store in the bathroom. 

Please! Allow me the opportunity to stand up and be counted (yet again for the doubters): I take Provera. I think it's super. I thought it was super when I was taking 20mg/day and my bleeding slowed from a flood to a flow; I still thought it was super when the dose dropped from 20 to 10 mg and the flow slowed to a trickle. I thought it most super of all when the trickle finally stopped. I've been on continuous Provera for almost a year and am completely happy with it. No headaches, no PMS from hell, and I post this message about three times a week and have been for months. 

I can assure you that I'm quite real. If my name is unfamiliar to you, I suspect that you haven't been reading alt.support.menopause very long. 

Regards, lblanch000

Hah! I just thought of something. I take my Provera pill at night just before I go to bed -- mostly because that's a routine that works for me. But, hey, guess what? I sleep like a baby and don't have weird mood swings. Maybe some of you HRT folks out there might want to switch to taking your pills right before you go to bed and see what that does to your side-effects..... 

I saw my doctor last Wednesday, and she changed my 10 mgs a day for 1-13 days of the month to 2.5 mgs every day; but my chief difficulty with Provera has been weepy mood swings that "feel" distinctly hormonal, as opposed to real depression--that is, they come on suddenly, almost "kick in," and then depart. 

By taking Provera at night, I found (though I haven't tested this very long, certainly) immediate relief from at least that main problem--my feelings of "well-being" are back.  I intend--and my doctor agreed--to continue taking Provera at night.  When it hits my system, I guess I'll have nightmares, instead of weeping furtively in my office corner during  the morning. 

Jackie
 

 I don't actually do what you are referring to, but I do know that a study was done here at Washington University which indicated that having a bleed every three months (which is what this regimen does) is as effective (against uterine cancer, etc.) as having a bleed every month. This HRT regimen is of course, taking estrogen alone for a certain period and then adding the progesterone.  I did a two month regimen for a while, and it worked fine for me.  I changed to the prempro however, because I wanted to see how things went with that (no bleed with this regimen). 

Note: the "effectiveness" of a bleed every month is also not foolproof. 

Quarterly progestin challenge, the "long cycle", has not been as fully investigated as the monthly challenge.  The advantage is to be exposed only 4x a year to a bleed and the other unwanted effects of provera/cycrin. 

From a cardiovascular risk perspective, progestins appear to attenuate the putative beneficial vascular effects of estrogen.  So a 4x a year exposure to progestin may be desirable  in this regard as well. 

The downside is that some work has suggested that this regime may not be as endometrial-protective as monthly. As well, you might predict that the quarterly flow will be heavier. Because the dose of progestin given will be higher, there is also a greater chance of experiencing unwanted effects. 

If a woman is having trouble with medroxyprogesterone acetate (Provera, Cycrin, Prempro), there are other progestins to consider, including progesterone and norethindrone. 

[email protected] (Mark Rogers)