- Heavy period after Provera is a normal response to medication
- Indication: What Provera is used for
- Action: How Provera works
- Dose advice: How to use Provera
- Before you take Provera
- How to take Provera
- While you are taking Provera
- After taking Provera
- Schedule of Provera
- Side effects of Provera
- Incidence of endometrial hyperplasia in postmenopausal women taking conjugated estrogens (Premarin) with medroxyprogesterone acetate or conjugated estrogens alone
- Provera and Ovulation
- Provera and Ovulation Stimulation
- Provera and Pregnancy
- PROVERA® (medroxyprogesterone acetate) tablets Information for Patients
Heavy period after Provera is a normal response to medication
If there is no period after stopping the Provera, it suggests there may be a blockage in the uterus. It’s also possible the lining of the uterus (which requires estrogen) never built up in the first place, so further evaluation would be required.
Dear Dr. Roach: I am a 55-year-old woman. I have a leg with atrophied muscles due to having meningitis as a child. Consequently, I fall a lot. I fell and broke my wrist recently, and last year I broke my foot. I had a scan done for osteoporosis, and my T-score was -2.5. The doctor suggested I start medication for osteoporosis. I am hesitant to take such medication due to side effects. Does the number warrant taking medication? Is osteoporosis a condition that worsens over time, or will it stay at -2.5, which appears to be not too egregious, without the medication? Are there lifestyle changes that help this condition? — T.C.
Dear T.C.: The T-score is a statistical measure of how a person’s bone density compares with a normal, healthy young person of peak bone mass. Someone with higher-than-average bone density will have a positive score: A score of less bone density will be negative. A T-score below -2.5 is defined as osteoporosis, so you are just at the border. However, that still puts you at greater risk for fractures, and a history of wrist fracture (even with a fall) means more risk of future fracture than someone with the same T-score and no previous fracture. Treatment is appropriate for a score this low, but that does not necessarily mean medication is the starting point for all people.
Initial treatment should include adequate calcium and vitamin D intake. Most people in North America have a hard time getting adequate vitamin D in the winter. There are few good food sources (swordfish is one); vitamin D is mostly made in the skin, and only with adequate sunlight. I often test vitamin D levels for my patients. Another reasonable approach is to give supplemental vitamin D-3 (cholecalciferol), such as 1,000 IU daily.
Exercise is another important treatment, and having balance problems is a challenge. However, any kind of exercise can be helpful, and some, such as tai chi, have been shown to improve both balance and bone density. If these are not enough, I do recommend treatment with an anti-resorptive agent, such as risedronate (Actonel) for most women in your situation. There are side effects, but these are outweighed by the benefits of reducing fracture risk. A three- to five-year course is appropriate for most women before re-evaluation.
Readers may email questions to [email protected]
SIDE EFFECTS: Nausea, bloating, breast tenderness, headache, change in vaginal discharge, mood swings, blurred vision, dizziness, drowsiness, or weight gain/loss may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these serious side effects occur: unusual vaginal bleeding (e.g., spotting, breakthrough bleeding), mental/mood changes (e.g., depression, memory loss), swelling of the hands/feet, frequent/burning/painful urination, breast lumps, dark patches on the skin or face (melasma), yellowing eyes/skin, unusual tiredness.This medication may rarely cause very serious (possibly fatal) problems from blood clots (e.g., heart attack, stroke, blood clots in the lungs or legs, blindness). Seek immediate medical attention if you experience any of the following: chest/jaw/left arm pain, weakness on one side of the body, slurred speech, sudden vision changes (e.g., blurred/double vision, loss of vision, bulging eyes), confusion, sudden severe headache, severe dizziness, fainting, trouble breathing, coughing up blood, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking medroxyprogesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Some Canadian brands of this product may contain inactive ingredients (such as soybean), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of blood clots, history of bleeding in the brain, liver disease, cancer of the breast or other female organs, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus (“missed abortion”), recent stroke or heart attack (within 1 year).Before using this medication, tell your doctor or pharmacist your medical history, especially of: family medical history (especially breast lumps and cancer), kidney disease, obesity, heart disease (e.g., past heart attacks, coronary artery disease, congestive heart failure), high blood pressure, seizures, migraine headaches, asthma, high blood levels of cholesterol/fats, depression, diabetes, strokes.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to stop the medication for a time or take special precautions because of the increased risk for blood clots. Ask your doctor for more details.Do not smoke. Smoking combined with this medication further increases your risk for strokes, blood clots, high blood pressure, and heart attacks.This medication may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen, and wear protective clothing when outdoors.This medication must not be used during pregnancy because it may harm an unborn baby, especially during the first 4 months of pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately.This drug passes into breast milk. Consult your doctor before breast-feeding.
Endometriosis occurs deep inside the uterus. See Answer
Generic Name: medroxyprogesterone acetate
Product Name: Provera
Indication: What Provera is used for
Provera is used to treat:
- Endometriosis – a condition in which tissue similar to the lining of the uterus (womb) grows outside the uterus, causing pain and bleeding. Provera helps to stop the growth of this tissue;
- Secondary amenorrhoea (a lack of menstrual periods not due to pregnancy); Provera, with or without an estrogen, helps to re-establish a regular menstrual cycle;
- Abnormal bleeding from the uterus, when the lining of the uterus breaks down during the menstrual cycle rather than at the end, resulting in vaginal spotting or bleeding. Provera helps to re-establish a regular menstrual cycle;
- Certain types of cancer including cancer of the breast, kidney and endometrium;
- Provera, in combination with an estrogen-containing medicine, is used to relieve symptoms of menopause in women with an intact uterus. This is called hormone replacement therapy (HRT). Provera is used to protect the lining of the uterus while the estrogens relieve the symptoms of menopause. Provera is not suitable as an HRT treatment in women who have undergone a hysterectomy.
Ask your doctor if you have any questions about why Provera has been prescribed for you. Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor’s prescription.
Action: How Provera works
Provera is a progestogen that comes from progesterone, a natural sex hormone. Provera works in a similar way to progesterone.
Medroxyprogesterone acetate (MPA) is a progestational agent. When administered in recommended doses to women with adequate endogenous estrogen, it transforms proliferative into secretory endometrium. MPA may inhibit gonadotrophin production, which in turn prevents follicular maturation and ovulation.
Like progesterone, MPA is thermogenic. At the very high dosage levels used in the treatment of certain cancers (500 mg daily or more), a corticoid-like activity may be manifest.
The active ingredient in Provera tablets is medroxyprogesterone acetate.
Provera 2.5 mg, 5 mg, 10 mg tablets also contain the inactive ingredients lactose monohydrate, sucrose, maize starch, liquid paraffin, purified talc, calcium stearate, sunset yellow FCF (5mg ), and indigo carmine (5 mg).
Provera 10 mg tablets do not contain colouring agents.
Provera 100 mg, 200 mg, 250 mg, 500 mg tablets also contain the inactive ingredients sodium starch glycollate, microcrystalline cellulose, maize starch, gelatin, docusate sodium, macrogol 400, sodium benzoate, isopropyl alcohol, and magnesium stearate.
Provera 100 mg, 200 mg, 250 mg, 500 mg tablets do not contain colouring agents.
Dose advice: How to use Provera
Before you take Provera
When you must not take it
Do not take Provera if you have an allergy to medroxyprogesterone acetate or any of the ingredients in Provera listed here.
Do not take Provera if you have or have had any of the following medical conditions:
- A stroke, blood clots or pulmonary embolism;
- Severe liver disease;
- Unusual or irregular vaginal bleeding or blood in your urine that has not been diagnosed by your doctor;
- Bleeding or discharge from your nipples;
- Breast cancer or breast lumps not diagnosed by your doctor;
- Uncontrolled high blood pressure.
Do not take Provera if you are pregnant or suspect you may be pregnant. Provera may affect your developing baby if you take it during pregnancy.
Do not take Provera after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking Provera, contact your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Before prescribing Provera for you, your doctor may conduct a physical examination which may include breast examinations or a mammogram and a PAP smear.
Tell your doctor if you have or have had any of the following medical conditions:
- Heart problems;
- Kidney problems;
- Unusual or irregular vaginal bleeding;
- Genital or breast cancer;
If you have not told your doctor about any of the above, tell them before you start taking Provera.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may interfere with Provera. This includes aminoglutethimide, a medicine used to treat breast cancer. This medicine may affect how well Provera works. You may need different amounts of your medicine or you may need to take different medicines. Your doctor will advise you.
Your doctor or pharmacist may have more information on medicines to be careful with or avoid while taking Provera.
How to take Provera
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained here.
If you do not understand the instructions on the label or here, ask your doctor or pharmacist for help.
How much to take
Your doctor will tell you how much Provera to take. This will vary depending on the condition for which you are being treated. Provera should be used at the lowest effective dose to treat your condition.
Your doctor may tell you to take Provera every day or in repeating cycles with a break in between.
Swallow the tablets whole with a full glass of water.
When to take Provera
Take Provera at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
How long to take it
Continue taking your medicine for as long as your doctor tells you. Your doctor will prescribe Provera for the shortest duration necessary to effectively treat your condition.
If you forget to take Provera
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking Provera as you would normally.
Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist. If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital if you think you or anyone else may have taken too much Provera. Do this even if there are no signs of discomfort or poisoning. You may need medical attention.
While you are taking Provera
Things you must do
Take Provera exactly as your doctor has prescribed.
Tell your doctor if you think you may have become pregnant during treatment. Provera should not be used during pregnancy.
Tell your doctor immediately if you have sudden partial or complete loss of vision or sudden onset of double vision or migraine. You will need to be examined and may need to stop taking your medicine.
Tell all doctors and pharmacists who are treating you that you are taking Provera.
If you are about to start taking any new medicines, tell your doctor and pharmacist that you are taking Provera.
If you are going to have any laboratory tests, tell your doctor that you are taking Provera. Provera may interfere with the results of some tests.
Tell your doctor if you feel that Provera is not helping your condition.
Visit your doctor regularly. Your doctor needs to check your progress and see whether you need to keep taking Provera.
Regularly check your breasts for any lumps and have regular professional breast examinations and mammograms, as recommended by your doctor.
If you use Provera as hormone replacement therapy (HRT) for 5 or more years, your doctor will need to physically check your pelvic organs and conduct blood tests, to rule out the risk of developing ovarian cancer.
The use of Provera may result in a decrease in the amount of calcium in your bones. This could increase your risk of developing brittle bones (osteoporosis), which can lead to bone breakages in later life. This effect can increase with long-term use of Provera. The amount of calcium in your bones will start to increase again once you stop treatment with Provera. The time to recovery depends on the duration of use. Some women may only partially recover the amount of calcium in their bone.
If you are taking Provera for prolonged periods, your doctor may also need to evaluate your bone mineral density (BMD).
Tell your doctor if, for any reason, you have not taken Provera exactly as prescribed.
Always discuss with your doctor any problems or difficulties during or after taking Provera.
Things you must not do
Do not change your dose or stop taking Provera without first checking with your doctor.
Do not take Provera to treat other complaints unless your doctor tells you to.
Do not give Provera to anyone else, even if they have the same condition as you.
Things to be careful of
Provera generally does not cause any problems with your ability to drive a car or operate machinery. However, Provera may cause dizziness, drowsiness or fatigue in some people. Make sure you know how you react to Provera before driving a car or operating machinery.
After taking Provera
Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.
Keep Provera in a cool, dry place where the temperature stays below 30°C. Do not store Provera or any other medicine in a bathroom or near a sink. Do not leave it in the car or on windowsills. Heat and dampness can destroy some medicines.
Keep your Provera tablets where children cannot reach them. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking Provera, or it has passed its expiry date, ask your pharmacist what to do with any tablets left over.
Schedule of Provera
Provera is an S4 (prescription only) medicine.
Side effects of Provera
Tell your doctor or pharmacist as soon as possible if you do not feel well while taking or soon after you are finished taking Provera. Provera helps most people for whom it is prescribed but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
If you are over 65 years of age you may have an increased chance of getting some side effects.
The use of an estrogen at the same time as Provera may also increase the risk of side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and it worries you:
- Nervousness or difficulty concentrating;
- Difficulty sleeping or increased sleepiness, drowsiness or fatigue;
- Depression or excitation;
- Skin conditions, such as hives, itching, rash or acne;
- Unusual hair loss or hair thinning or increased hairiness;
- Irregular vaginal bleeding or spotting or unusual changes in vaginal secretions;
- Lack of menstrual periods;
- Nausea or vomiting;
- Constipation or diarrhoea;
- Dry mouth;
- Breast tenderness;
- Unusual secretion of breast milk;
- Changes in sexual drive;
- Weight increases or decreases;
- Leg cramps;
- Muscle spasms;
- Fluid retention;
- Impotence (mainly in cancer treated patients).
Tell your doctor as soon as possible if you notice the following:
- Confusion or memory loss;
- Lumps or change in your breasts;
- Yellowing of the skin or eyes.
Although these side effects are not common, they may require further medical assessment for serious conditions, such as dementia or breast cancer.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen:
- Painful swelling in the arms or legs;
- Swollen or tender veins;
- Chest pain or shortness of breath;
- Severe headaches or changes in speech or vision;
- Swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing;
- Changes in metabolism resulting in the loss of body fat in certain areas of your body such as your face;
- Hand tremors, swelling, cramps in calves at night;
- Yellowing of the skin and/or eyes.
The above list includes side effects that may indicate serious conditions that require urgent medical attention or hospitalisation, such as blood clots, heart attack, stroke or severe allergic reactions. Such side effects are not common.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.
Some side effects (such as changes in blood pressure) can only be found when your doctor does tests from time to time to check your progress.
For further information talk to your doctor.
Incidence of endometrial hyperplasia in postmenopausal women taking conjugated estrogens (Premarin) with medroxyprogesterone acetate or conjugated estrogens alone
OBJECTIVE: We evaluated four oral combinations of conjugated estrogens (Premarin) and medroxyprogesterone acetate in preventing endometrial hyperplasia, which can occur with conjugated estrogens alone. STUDY DESIGN: This was a 1-year prospective, double-blind, randomized, multicenter study in 1724 postmenopausal women. All five groups took conjugated estrogens (0.625 mg) daily. The respective medroxyprogesterone acetate dosages were 2.5 and 5.0 mg daily (groups A and B) and 5.0 and 10.0 mg for 14 days per 28-day cycle (groups C and D). RESULTS: Among the 1385 patients with valid biopsy data, endometrial hyperplasia developed in 20% in the conjugated estrogens–treated group and ≤1% in each of the four conjugated estrogens/medroxyprogesterone acetate–treated groups. The incidence of endometrial hyperplasia did not differ significantly between any of the conjugated estrogens/medroxyprogesterone acetate regimens. However, none of the patients receiving the two higher medroxyprogesterone acetate dosages (groups B and D) had endometrial hyperplasia. CONCLUSION: The endometrial hyperplasia incidence was significantly lower in women treated with conjugated estrogens and medroxyprogesterone acetate than in women treated with conjugated estrogens alone. (AM J OBSTET GYNECOL 1994;170:1213-23.)
Provera and Ovulation
Provera is a prescription drug containing medroxyprogesterone acetate, a type of synthetic progesterone. Progesterone is one of the hormones that controls the menstrual cycle and ovulation, the monthly release of an egg from the ovaries. Progesterone also helps to prepare the womb lining for pregnancy and shed the lining each month when pregnancy does not occur (a process you know as your monthly period).
Why is Provera Prescribed?
Provera is most commonly used to treat various disorders related to the menstrual cycle, which are often the result of a hormonal imbalance. These disorders include irregular or abnormal uterine bleeding, amenorrhea (lack of periods), excessive bleeding and endometriosis, a condition in which cells that normally line the uterus grow outside the womb or in other parts of the body.
“Provera is most often used to induce a withdrawal bleed or a ‘period’ in women who ovulate or menstruate infrequently,” explains Michele Hakakha, M.D., a board-certified obstetrician and gynecologist based in Los Angeles and co-author of Expecting 411: Clear Answers and Smart Advice for Your Pregnancy. It may also be prescribed for a short period if a woman is trying to conceive, in conjunction with the ovulation-stimulating drug Clomid.
- Can a Woman Become Pregnant During Her Period?
- Ovulation Facts
- Pros and Cons of Ovulation Predictor Kits
Provera and Ovulation Stimulation
When prescribed for women trying to get pregnant, Provera is usually given for 10 days. After that time a woman can expect bleeding from two to 10 days later. “This regimen is often used for women who are trying to conceive, to initiate an artificial period so that the fertility drug Clomid (clomiphene citrate) can be started. Clomid is started on day three, four or five of a menstrual cycle and helps ensure ovulation,” says Dr. Hakakha.
Provera does help regulate the menstrual cycle, but it can also interfere with ovulation, says Dr. Hakakha.
“Typically Provera is used for short periods of time in specific situations (for example, to bring on a period) and is rarely used continuously by women trying to conceive, as it can prevent ovulation and thin the lining of the uterus, making implantation of an embyro very difficult,” Dr. Hakakha continues. Few women take Provera because they’re trying to conceive.
- Can a Woman Become Pregnant During Her Period?
- Ovulation Facts
- Pros and Cons of Ovulation Predictor Kits
Provera and Pregnancy
Not only can Provera interfere with ovulation, it is also not recommended for use during pregnancy. “Provera is a type of progesterone that is used to stop menstrual bleeding and when the drug is stopped, it causes withdrawal bleeding,” says Daniel Roshan, M.D., a board-certified obstetrician and assistant professor at the New York University School of Medicine, who specializes in high-risk fetal medicine. “There is no use for it in pregnancy; however, other kinds of progesterone are used to support and maintain the pregnancy.”
“Provera is for menstrual irregularity, and once a woman is pregnant, should not be taken,” advises Dr. Roshan. “Progestrone suppositories or Prometrium (another type of synthetic progesterone) are okay to take if needed.”
Oddly enough, the side effects of Provera are similar to the side effects of pregnancy: nausea, vomiting, breast tenderness, and headaches. But if you become pregnant or are thinking about becoming pregnant while taking Provera, you should tell your healthcare practitioner right away.
Provera does not cause miscarriage, but some studies have shown that there may be a link between certain birth defects in mothers who are exposed to progestins such as Provera during the first trimester of pregnancy. Provera has been classed as a category X drug by the U.S. Food and Drug Administration, meaning that it can cause birth defects and is contraindicated for use in pregnancy.
Although Provera may affect ovulation and impair fertility, you are not advised to take Provera as a substitute for some other form of contraception because it does not prevent the release of an egg (ovulation). As Dr. Hakakha points out, Provera can prevent ovulation and thin the uterine lining, making it more difficult for an embryo to implant. “It is not, however, a form of birth control,” she adds. Ask your doctor which type of contraception you should use while taking Provera; to avoid any drug interactions, consider a non-hormonal method.
Copyright © 2011 Meredith Corporation.
- Can a Woman Become Pregnant During Her Period?
- Ovulation Facts
- Pros and Cons of Ovulation Predictor Kits
- By Jennifer Barton
PROVERA® (medroxyprogesterone acetate) tablets Information for Patients
What is PROVERA?
PROVERA is a medicine that contains medroxyprogesterone acetate, a progestin hormone.
What is PROVERA used for?
PROVERA is used to:
- Treat menstrual periods that have stopped or to treat abnormal uterine bleeding. Women with a uterus who are not pregnant, who stop having regular menstrual periods or who begin to have irregular menstrual periods may have a drop in their progesterone level. Talk with your healthcare provider about whether PROVERA is right for you.
- Reduce your chances of getting cancer of the uterus (womb). In postmenopausal women with a uterus who use estrogens, taking progestin in combination with estrogen will reduce your chance of getting cancer of the uterus (womb).
Who should not take PROVERA?
Do not start taking PROVERA if you:
- have unusual vaginal bleeding
- currently have or have had certain cancers
Estrogen plus progestin may increase your chance of getting certain types of cancers, including cancer of the breast. If you have or have had cancer, talk with your healthcare provider about whether you should use PROVERA.
- had a stroke or heart attack
- currently have or have had blood clots
- currently have or have had liver problems
- are allergic to PROVERA or any of its ingredients
See the list of ingredients in PROVERA at the end of this leaflet.
- think you may be pregnant
PROVERA is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not use PROVERA if the test is positive and talk to your healthcare provider. There may be an increased risk of minor birth defects in children whose mothers take PROVERA during the first 4 months of pregnancy.
PROVERA should not be used as a test for pregnancy.
What should I tell my healthcare provider before taking PROVERA? Before you take PROVERA, tell your healthcare provider if you:
- have any other medical problems
Your healthcare provider may need to check you more carefully if you have certain conditions such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis (severe pelvic pain), lupus, or problems with your heart, liver, thyroid, kidneys, or have high calcium in your blood.
- are going to have surgery or will be on bed rest
Your healthcare provider will let you know if you need to stop taking PROVERA.
- are breast feeding
The hormone in PROVERA can pass into your breast milk.
Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how PROVERA works. PROVERA may also affect how other medicines work.
How should I take PROVERA?
Start at the lowest dose and talk to your healthcare provider about how well that dose is working for you. The lowest effective dose of PROVERA has not been determined. You and your healthcare provider should talk regularly (every 3 to 6 months) about the dose you are taking and whether you still need treatment with PROVERA.
- Absence of menstrual period: PROVERA may be given in doses ranging from 5 to 10 mg daily for 5 to 10 days.
- Abnormal Uterine Bleeding: PROVERA may be given in doses ranging from 5 to 10 mg daily for 5 to 10 days.
- Overgrowth of the lining of the uterus: When used in combination with oral conjugated estrogens in postmenopausal women with a uterus, PROVERA may be given in doses ranging from 5 or 10 mg daily for 12 to 14 straight days per month.
What are the possible side effects of PROVERA?
The following side effects have been reported with the use of PROVERA alone:
- breast tenderness
- breast milk secretion
- breakthrough bleeding
- spotting (minor vaginal bleeding)
- irregular periods
- amenorrhea (absence of menstrual periods)
- vaginal secretions
- insomnia, sleepiness, fatigue
- premenstrual syndrome-like symptoms
- thrombophlebitis (inflamed veins)
- blood clot
- itching, hives, skin rash
- hair loss, hair growth
- abdominal discomfort
- increase in weight
- changes in vision and sensitivity to contact lenses
Call your healthcare provider right away if you get hives, problems breathing, swelling of the face, mouth, tongue or neck
The following side effects have been reported with the use of PROVERA with an estrogen.
Side effects are grouped by how serious they are and how often they happen when you are treated.
Serious, but less common side effects include:
- heart attack
- blood clots
- breast cancer
- cancer of the uterus
- cancer of the ovary
- high blood pressure
- high blood sugar
- gallbladder disease
- liver problems
- changes in your thyroid hormone levels
- enlargements of benign tumors (“fibroids”)
Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
- new breast lumps
- unusual vaginal bleeding
- changes in vision and speech
- sudden new severe headaches
- severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
- memory loss or confusion
Less serious, but common side effects include:
- breast pain
- irregular vaginal bleeding or spotting
- stomach or abdominal cramps, bloating
- nausea and vomiting
- hair loss
- fluid retention
- vaginal yeast infection
These are not all the possible side effects of PROVERA with or without estrogen. For more information, ask your healthcare provider or pharmacist for advice about side effects. Tell your healthcare provider if you have side effect that bothers you or does not go away. You may report side effects to Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088.
What can I do to lower my chances of a serious side effect with PROVERA?
- Talk with your healthcare provider regularly about whether you should continue taking PROVERA. The addition of a progestin is generally recommended for women with a uterus to reduce the chance of getting cancer of the uterus (womb).
- See your healthcare provider right away if you get vaginal bleeding while taking PROVERA.
- Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
- If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have a higher chance of getting heart disease. Ask your healthcare provider for ways to lower your chance of getting heart disease.
General information about safe and effective use of PROVERA
- Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.
- Do not take PROVERA for conditions for which it was not prescribed.
- Do not give PROVERA to other people, even if they have the same symptoms you have. It may harm them.
Keep PROVERA out of the reach of children.
This leaflet provides a summary of the most important information about PROVERA. If you would like more information, talk with your health care provider or pharmacist. You can ask for information about PROVERA that is written for health professionals. You can get more information by calling the toll-free number, 1-800-438-1985.
What are the ingredients in PROVERA?
Each PROVERA tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate.
This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com