Provera 5mg Tablets
WARNING: Hormone therapy (HT):Do not use this drug with an estrogen to prevent heart disease or dementia. A study of women taking an estrogen with a progestin showed a raised chance of heart attack, stroke, breast cancer, a blood clot, and dementia. Use this drug for the shortest time needed at the lowest useful dose. Your doctor will talk with you on a regular basis to see if you need to keep taking this drug. @ COMMON USES: It is used to lower the chance of endometrial changes after menopause in people who are getting estrogen therapy.It is used to treat uterine bleeding due to hormonal imbalance.It is used to treat people who do not have a monthly period cycle.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Progestin
Pharmacologic Class
Progestogen
Pregnancy Category
Category X
FDA Approved
Sep 1959
DEA Schedule
Not Controlled
Overview
What is this medicine?
Medroxyprogesterone is a man-made form of a hormone called progesterone. It's used to treat certain problems with a woman's menstrual cycle, like absent periods or abnormal bleeding. It can also be used with estrogen to help prevent changes in the lining of the uterus in women taking estrogen after menopause.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. To maintain the effectiveness of your treatment, make every effort to take your doses as scheduled and avoid missing any doses.
Storing and Disposing of Your Medication
To ensure the quality and safety of your medication, store it at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so. Instead, consult with your pharmacist for guidance on the proper disposal method. You may also want to inquire about potential drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. To maintain the effectiveness of your treatment, make every effort to take your doses as scheduled and avoid missing any doses.
Storing and Disposing of Your Medication
To ensure the quality and safety of your medication, store it at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so. Instead, consult with your pharmacist for guidance on the proper disposal method. You may also want to inquire about potential drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Do not smoke, especially if you are over 35, as smoking increases the risk of serious cardiovascular side effects.
- Maintain a healthy diet and exercise regularly to help manage weight and cardiovascular health.
- Report any unusual vaginal bleeding, breast lumps, or symptoms of blood clots immediately.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication
Dose Range:
2.5 - 10 mg
Condition-Specific Dosing:
secondaryAmenorrhea:
5-10 mg daily for 5-10 days
abnormalUterineBleeding:
5-10 mg daily for 5-10 days
endometrialHyperplasiaPrevention:
2.5-5 mg daily continuously OR 5-10 mg daily for 10-14 consecutive days of a 28-day cycle (when used with estrogen)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (use in adolescents for specific conditions like secondary amenorrhea may follow adult dosing, but generally not for routine use)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended
Dialysis:
Considerations: Not extensively studied, but unlikely to be significantly removed by dialysis due to high protein binding and metabolism.
Hepatic Impairment:
Mild:
Adjustment may be considered, use with caution
Moderate:
Use with caution, consider dose reduction
Severe:
Contraindicated in severe hepatic dysfunction or disease
Pharmacology
Mechanism of Action
Medroxyprogesterone acetate (MPA) is a synthetic progestin. It acts on the estrogen-primed endometrium, converting it from a proliferative to a secretory state. It also inhibits pituitary gonadotropin secretion (LH and FSH), which in turn inhibits follicular maturation and ovulation. In high doses, it can have anti-estrogenic, anti-androgenic, and glucocorticoid-like effects.
Pharmacokinetics
Absorption:
Bioavailability:
Variable, approximately 10-50%
Tmax:
2-4 hours
FoodEffect:
Food increases bioavailability and peak plasma concentrations.
Distribution:
Vd:
Approximately 20 Âą 3 L
ProteinBinding:
Approximately 90% (primarily to albumin, not SHBG)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 12-17 hours (single dose), 30-50 hours (multiple doses)
Clearance:
Not readily available, but primarily hepatic
ExcretionRoute:
Primarily renal (conjugated metabolites), some fecal
Unchanged:
<1% in urine
Pharmacodynamics
OnsetOfAction:
Within hours (progestational effects)
PeakEffect:
Within days to weeks for therapeutic effects
DurationOfAction:
Depends on dose and formulation; for oral, effects persist as long as drug is present.
Safety & Warnings
BLACK BOX WARNING
PROGESTINS WITH ESTROGENS: The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50-79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. DEMENTIA: The WHI Memory Study (WHIMS), a substudy of WHI, reported an increased risk of probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily oral CE (0.625 mg) combined with MPA (2.5 mg) relative to placebo. It is unknown whether these findings apply to younger postmenopausal women. Other doses of oral CE and MPA, and other combinations and dosage forms of estrogens and progestins, were not studied in the WHI and, in the absence of comparable data, these risks should be assumed to be similar. Therefore, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Change in balance
+ Drooping on one side of the face
+ Blurred eyesight
Eye problems, including:
+ Changes in vision or loss of vision
+ Bulging eyes
+ Changes in how contact lenses feel
Breast-related symptoms, such as:
+ Lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal symptoms, including:
+ Itching or discharge
+ Abnormal vaginal bleeding
Mood changes, such as:
+ Depression
+ Other mood changes
Seizures
Fluid retention, which may cause:
+ Swelling
+ Weight gain
+ Trouble breathing
Signs of a blood clot, including:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in vision
Signs of gallbladder problems, including:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
+ Bloating
+ Severe upset stomach or vomiting
Signs of pancreatitis, such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of low calcium levels, including:
+ Muscle cramps or spasms
+ Numbness and tingling
+ Seizures
Memory problems or loss
Feeling confused
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects, or if they bother you or do not go away, contact your doctor or seek medical help:
Weight gain or loss
Headache
Dizziness
Drowsiness
Fatigue
Weakness
Nervousness
Excitability
Upset stomach or vomiting
Bloating
Changes in sex interest
Acne
Hair loss
Hair growth
Enlarged breasts
Tender breasts
Vaginal bleeding or spotting
Stomach pain
Trouble sleeping
Changes in menstrual cycle or absence of periods
Hormone Therapy (HT) Specific Side Effects
Stomach cramps
Joint pain
* Leg cramps
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Change in balance
+ Drooping on one side of the face
+ Blurred eyesight
Eye problems, including:
+ Changes in vision or loss of vision
+ Bulging eyes
+ Changes in how contact lenses feel
Breast-related symptoms, such as:
+ Lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal symptoms, including:
+ Itching or discharge
+ Abnormal vaginal bleeding
Mood changes, such as:
+ Depression
+ Other mood changes
Seizures
Fluid retention, which may cause:
+ Swelling
+ Weight gain
+ Trouble breathing
Signs of a blood clot, including:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in vision
Signs of gallbladder problems, including:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
+ Bloating
+ Severe upset stomach or vomiting
Signs of pancreatitis, such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of low calcium levels, including:
+ Muscle cramps or spasms
+ Numbness and tingling
+ Seizures
Memory problems or loss
Feeling confused
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects, or if they bother you or do not go away, contact your doctor or seek medical help:
Weight gain or loss
Headache
Dizziness
Drowsiness
Fatigue
Weakness
Nervousness
Excitability
Upset stomach or vomiting
Bloating
Changes in sex interest
Acne
Hair loss
Hair growth
Enlarged breasts
Tender breasts
Vaginal bleeding or spotting
Stomach pain
Trouble sleeping
Changes in menstrual cycle or absence of periods
Hormone Therapy (HT) Specific Side Effects
Stomach cramps
Joint pain
* Leg cramps
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden severe headache, dizziness, or fainting
- Sudden vision changes (e.g., partial or complete loss of vision)
- Sudden numbness or weakness on one side of the body
- Chest pain, shortness of breath, or coughing up blood
- Pain, swelling, or warmth in the leg (especially calf or thigh)
- Yellowing of skin or eyes (jaundice), dark urine, light-colored stools
- Severe mood changes or depression
- New breast lumps or changes
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer or other types of cancer
+ Liver disease
+ Heart attack
+ Stroke
+ Tumors that may be influenced by estrogen or progesterone
Unexplained vaginal bleeding
If you are breastfeeding or plan to breastfeed
* If you are pregnant, think you might be pregnant, or are planning to become pregnant. Note: This medication should not be taken during pregnancy.
Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
A history of certain health conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer or other types of cancer
+ Liver disease
+ Heart attack
+ Stroke
+ Tumors that may be influenced by estrogen or progesterone
Unexplained vaginal bleeding
If you are breastfeeding or plan to breastfeed
* If you are pregnant, think you might be pregnant, or are planning to become pregnant. Note: This medication should not be taken during pregnancy.
Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists. Your doctor may advise you to stop taking this medication before certain surgical procedures, and will instruct you on when to resume taking it after the surgery or procedure.
Blood Clot Risk
This medication may increase the risk of blood clots, which can be life-threatening. Blood clots can occur in the form of heart attack, stroke, or clots in the leg, lung, or eye. If you have a history of blood clots, inform your doctor. Additionally, if you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as it may increase your risk of blood clots.
Diabetes and Triglyceride Monitoring
If you have diabetes, closely monitor your blood sugar levels. This medication may also cause high triglyceride levels. Inform your doctor if you have a history of high triglyceride levels.
Regular Health Checks
Regularly check your blood work and bone density as advised by your doctor. Take calcium and vitamin D supplements as directed by your doctor.
Breast Cancer Risk
There may be an increased risk of breast cancer associated with this medication. Ensure you have regular breast exams and gynecology check-ups, and perform breast self-exams as instructed by your doctor.
Lab Tests and Skin Effects
This medication may affect certain lab tests, so inform all your healthcare providers and lab workers that you are taking this medication. Additionally, this medication may cause dark patches of skin on your face, so avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear.
Age-Related Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Hormone Therapy (HT) Considerations
If you are undergoing hormone therapy, be aware that high blood pressure has been associated with medications like this one. Regularly check your blood pressure as advised by your doctor. Certain side effects, such as heart attack, stroke, breast cancer, and others, have been reported in some individuals taking estrogen with a progestin. Discuss the benefits and risks of using this medication with your doctor, considering factors such as treatment duration, estrogen use with or without a progestin, and other individual factors.
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists. Your doctor may advise you to stop taking this medication before certain surgical procedures, and will instruct you on when to resume taking it after the surgery or procedure.
Blood Clot Risk
This medication may increase the risk of blood clots, which can be life-threatening. Blood clots can occur in the form of heart attack, stroke, or clots in the leg, lung, or eye. If you have a history of blood clots, inform your doctor. Additionally, if you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as it may increase your risk of blood clots.
Diabetes and Triglyceride Monitoring
If you have diabetes, closely monitor your blood sugar levels. This medication may also cause high triglyceride levels. Inform your doctor if you have a history of high triglyceride levels.
Regular Health Checks
Regularly check your blood work and bone density as advised by your doctor. Take calcium and vitamin D supplements as directed by your doctor.
Breast Cancer Risk
There may be an increased risk of breast cancer associated with this medication. Ensure you have regular breast exams and gynecology check-ups, and perform breast self-exams as instructed by your doctor.
Lab Tests and Skin Effects
This medication may affect certain lab tests, so inform all your healthcare providers and lab workers that you are taking this medication. Additionally, this medication may cause dark patches of skin on your face, so avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear.
Age-Related Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Hormone Therapy (HT) Considerations
If you are undergoing hormone therapy, be aware that high blood pressure has been associated with medications like this one. Regularly check your blood pressure as advised by your doctor. Certain side effects, such as heart attack, stroke, breast cancer, and others, have been reported in some individuals taking estrogen with a progestin. Discuss the benefits and risks of using this medication with your doctor, considering factors such as treatment duration, estrogen use with or without a progestin, and other individual factors.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Drowsiness
- Fatigue
- Vaginal bleeding
What to Do:
Seek immediate medical attention. There is no specific antidote; treatment is symptomatic and supportive. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Aminoglutethimide (may significantly decrease MPA plasma concentrations)
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort - may decrease MPA efficacy)
Moderate Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir - may increase MPA plasma concentrations)
- Grapefruit juice (may increase MPA levels)
- Warfarin (potential for altered anticoagulant effect, monitor INR)
Minor Interactions
- Not well-documented for minor interactions with clinical significance.
Monitoring
Baseline Monitoring
Complete medical history and physical examination (including blood pressure, breast and pelvic examination)
Rationale: To assess overall health, identify contraindications, and establish baseline for potential adverse effects.
Timing: Prior to initiation of therapy
Lipid profile
Rationale: Progestins can affect lipid metabolism.
Timing: Prior to initiation, especially if risk factors for cardiovascular disease are present.
Blood glucose (HbA1c or fasting glucose)
Rationale: Progestins may decrease glucose tolerance.
Timing: Prior to initiation, especially in diabetic or pre-diabetic patients.
Routine Monitoring
Blood pressure
Frequency: Annually or as clinically indicated
Target: Normal limits
Action Threshold: Significant elevation requiring intervention
Breast examination
Frequency: Annually
Target: Normal
Action Threshold: New lumps, pain, or discharge
Pelvic examination and Pap test
Frequency: Annually or as clinically indicated
Target: Normal
Action Threshold: Abnormal findings
Signs and symptoms of thromboembolic events
Frequency: Ongoing patient education and monitoring
Target: Absence of symptoms
Action Threshold: New onset of chest pain, shortness of breath, leg pain/swelling, sudden severe headache, vision changes
Symptom Monitoring
- Unusual vaginal bleeding or spotting
- Breast tenderness or lumps
- Mood changes, depression
- Headaches, migraines
- Fluid retention, weight gain
- Symptoms of liver dysfunction (jaundice, dark urine, abdominal pain)
- Symptoms of thromboembolism (leg pain/swelling, chest pain, shortness of breath, sudden severe headache, vision changes)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy (Category X). There is evidence of fetal harm, including genital abnormalities in female and male fetuses, and cardiovascular defects. Should not be used to prevent habitual or threatened abortion.
Trimester-Specific Risks:
First Trimester:
Highest risk for congenital anomalies, particularly genital abnormalities.
Second Trimester:
Risk of adverse effects on fetal development, though less studied than first trimester.
Third Trimester:
Not indicated; potential for adverse effects on fetal development and labor.
Lactation
Medroxyprogesterone is excreted in breast milk. While generally considered compatible with breastfeeding (L3), caution is advised. Observe infant for potential effects (e.g., jaundice, breast enlargement).
Infant Risk:
Low to moderate risk. No adverse effects have been consistently reported in breastfed infants, but long-term effects are not fully established. May affect milk production, especially if initiated early postpartum.
Pediatric Use
Safety and efficacy not established in pediatric patients. Use is generally not recommended, except for specific indications in adolescents under specialist guidance (e.g., secondary amenorrhea).
Geriatric Use
Use with caution in elderly women, especially those over 65 years of age, due to increased risk of probable dementia when used in combination with estrogen, as observed in the WHIMS study. The lowest effective dose for the shortest duration should be used. Increased risk of cardiovascular events and breast cancer also applies.
Clinical Information
Clinical Pearls
- Medroxyprogesterone acetate (MPA) is a progestin, not an estrogen. It is often used to counteract the effects of estrogen on the endometrium.
- For secondary amenorrhea or abnormal uterine bleeding, MPA is typically given for 5-10 days to induce a withdrawal bleed.
- When used with estrogen for hormone therapy, MPA helps reduce the risk of endometrial hyperplasia and cancer associated with unopposed estrogen.
- Patients should be thoroughly counselled on the Black Box Warnings, especially regarding cardiovascular events, breast cancer, and dementia, particularly if used for hormone therapy.
- MPA can cause weight gain, mood changes, and fluid retention. Counsel patients on these potential side effects.
- Ensure a negative pregnancy test before initiating therapy for menstrual disorders.
Alternative Therapies
- Oral contraceptives (for menstrual cycle regulation)
- Levonorgestrel-releasing intrauterine system (Mirena, Kyleena - for abnormal uterine bleeding, endometrial protection)
- GnRH agonists/antagonists (for severe endometriosis or fibroids)
- NSAIDs (for dysmenorrhea)
- Tranexamic acid (for heavy menstrual bleeding)
Cost & Coverage
Average Cost:
Varies, typically $20-$50 per 30 tablets (5mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.