Medroxyprogesterone 10mg 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
Progestin
Pregnancy Category
Category D
FDA Approved
Sep 1959
DEA Schedule
Not Controlled
Overview
What is this medicine?
Medroxyprogesterone is a man-made form of progesterone, a natural hormone in your body. It's used to help regulate menstrual periods, treat abnormal bleeding from the uterus, and manage certain conditions like endometriosis. It works by affecting the lining of the uterus and the hormones that control your menstrual cycle.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to use it as directed by your doctor. Carefully read all the information provided with your medication and follow the instructions closely. To maintain the best results, make every effort not to miss any doses.
Storing and Disposing of Your Medication
Store your medication 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. Dispose of any unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. If you're unsure about the best way to dispose of your medication, consult with your pharmacist. You may also want to check if there are any drug take-back programs available 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. Avoid taking two doses at the same time or taking extra doses.
To get the most benefit from your medication, it's essential to use it as directed by your doctor. Carefully read all the information provided with your medication and follow the instructions closely. To maintain the best results, make every effort not to miss any doses.
Storing and Disposing of Your Medication
Store your medication 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. Dispose of any unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. If you're unsure about the best way to dispose of your medication, consult with your pharmacist. You may also want to check if there are any drug take-back programs available 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. Avoid taking two doses at the same time or taking extra doses.
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 regular exercise.
- Report any unusual vaginal bleeding to your doctor immediately.
- Attend regular check-ups, including breast exams and mammograms as recommended.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For secondary amenorrhea or abnormal uterine bleeding: 5-10 mg orally daily for 5-10 days, starting on day 16 or 21 of the menstrual cycle.
Dose Range:
5 - 10 mg
Condition-Specific Dosing:
secondaryAmenorrhea:
5-10 mg orally daily for 5-10 days
abnormalUterineBleeding:
5-10 mg orally daily for 5-10 days
endometriosis:
Higher doses (e.g., 50 mg daily or 100 mg 3 times weekly) may be used for endometriosis, but 10mg tablets are typically for other indications.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for these indications; use in precocious puberty is off-label and requires specialist guidance.
Adolescent:
Dosing for secondary amenorrhea or abnormal uterine bleeding is similar to adult dosing, but should be guided by a specialist.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended, but use with caution due to potential for fluid retention.
Dialysis:
Not available
Hepatic Impairment:
Mild:
Use with caution.
Moderate:
Use with caution; consider lower doses or extended intervals.
Severe:
Contraindicated in severe liver disease due to extensive hepatic metabolism.
Pharmacology
Mechanism of Action
Medroxyprogesterone acetate (MPA) is a synthetic progestin. It acts by binding to progesterone receptors in target tissues, primarily the uterus, breast, and hypothalamus. It transforms the proliferative endometrium into a secretory endometrium. In sufficient doses, it inhibits the secretion of pituitary gonadotropins (LH and FSH), thereby inhibiting follicular maturation and ovulation. It also increases the viscosity of cervical mucus and thins the endometrium.
Pharmacokinetics
Absorption:
Bioavailability:
10-50% (variable)
Tmax:
2-4 hours
FoodEffect:
Food may increase bioavailability.
Distribution:
Vd:
2000 L
ProteinBinding:
Approximately 90% (primarily to albumin and corticosteroid-binding globulin)
CnssPenetration:
Yes
Elimination:
HalfLife:
12-17 hours (oral)
Clearance:
Not available
ExcretionRoute:
Primarily urine (as conjugated metabolites), some feces
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Within hours (for endometrial effects)
PeakEffect:
Not precisely defined for all effects; hormonal effects are sustained with daily dosing.
DurationOfAction:
Effects persist as long as therapy continues; withdrawal bleeding typically occurs 3-7 days after cessation.
Safety & Warnings
BLACK BOX WARNING
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, DEMENTIA. Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia. 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. 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 CE 0.625 mg combined with MPA 2.5 mg relative to placebo. It is unknown whether these risks 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
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
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 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
Most people experience no side effects or only mild side effects while taking this medication. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Weight gain or loss
Headache
Dizziness
Drowsiness
Fatigue
Weakness
Nervousness or 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) Side Effects
Stomach cramps
Joint pain
Leg cramps
Reporting Side Effects
If you have questions about side effects or experience any side effects not listed here, 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 experience any of the following symptoms, contact your doctor or seek medical attention right away:
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 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
Most people experience no side effects or only mild side effects while taking this medication. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Weight gain or loss
Headache
Dizziness
Drowsiness
Fatigue
Weakness
Nervousness or 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) Side Effects
Stomach cramps
Joint pain
Leg cramps
Reporting Side Effects
If you have questions about side effects or experience any side effects not listed here, 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 or migraine
- Sudden partial or complete loss of vision
- Sudden chest pain, shortness of breath, or coughing up blood (signs of blood clot in lungs)
- Pain, swelling, or warmth in one leg (signs of blood clot in leg)
- Yellowing of the skin or eyes (jaundice)
- Severe abdominal pain
- Lump in the breast
- Symptoms of depression (e.g., persistent sadness, loss of interest in activities)
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 conditions to ensure safe treatment:
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 cancers
+ Liver disease
+ Heart attack
+ Stroke
+ Tumors that are sensitive to estrogen or progesterone
Unexplained vaginal bleeding
Breast-feeding or plans to breast-feed
* Pregnancy or potential pregnancy. 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 identify any potential interactions between this medication and your other health conditions or treatments.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
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 cancers
+ Liver disease
+ Heart attack
+ Stroke
+ Tumors that are sensitive to estrogen or progesterone
Unexplained vaginal bleeding
Breast-feeding or plans to breast-feed
* Pregnancy or potential pregnancy. 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 identify any potential interactions between this medication and your other health conditions or treatments.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
Important Warnings and Cautions
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug. Your doctor may instruct you to stop taking this medication before certain surgical procedures, and will advise you 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, notify 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
Follow your doctor's instructions for regular blood work and bone density tests. 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, 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 drug. Additionally, this medication may cause dark skin patches on your face. Avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when going outside.
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
Drugs like this one may increase the risk of high blood pressure. Monitor your blood pressure as directed by your doctor. Certain side effects, such as heart attack, stroke, breast cancer, and others, have been reported in people 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.
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug. Your doctor may instruct you to stop taking this medication before certain surgical procedures, and will advise you 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, notify 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
Follow your doctor's instructions for regular blood work and bone density tests. 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, 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 drug. Additionally, this medication may cause dark skin patches on your face. Avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear when going outside.
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
Drugs like this one may increase the risk of high blood pressure. Monitor your blood pressure as directed by your doctor. Certain side effects, such as heart attack, stroke, breast cancer, and others, have been reported in people 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
- Dizziness
- Withdrawal bleeding may occur
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. Contact a poison control center or emergency services immediately. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Aminoglutethimide (may significantly decrease MPA plasma concentrations)
Moderate Interactions
- CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's Wort - may decrease MPA levels)
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir - may increase MPA levels)
- Grapefruit juice (may increase MPA levels)
Minor Interactions
- Warfarin (potential for altered anticoagulant effect, monitor INR)
- Cyclosporine (potential for increased cyclosporine levels)
Monitoring
Baseline Monitoring
Pregnancy test
Rationale: To rule out pregnancy before initiation, as it is contraindicated.
Timing: Before starting therapy
Physical examination (including breast and pelvic exam)
Rationale: To assess overall health and rule out contraindications.
Timing: Before starting therapy
Blood pressure
Rationale: To establish baseline and monitor for potential hypertension.
Timing: Before starting therapy
Routine Monitoring
Blood pressure
Frequency: Periodically, especially if long-term use
Target: Normal range for patient
Action Threshold: Significant increase or sustained hypertension
Lipid profile
Frequency: Annually for long-term use
Target: Normal range for patient
Action Threshold: Significant adverse changes
Mammogram
Frequency: As per age-appropriate screening guidelines (e.g., annually for women over 40)
Target: Normal
Action Threshold: Abnormal findings
Annual physical examination
Frequency: Annually
Target: Overall health assessment
Action Threshold: New or worsening conditions
Symptom Monitoring
- Signs of thromboembolic events (e.g., sudden severe headache, vision changes, chest pain, shortness of breath, leg pain/swelling)
- Abnormal vaginal bleeding (spotting, breakthrough bleeding, prolonged bleeding)
- Mood changes or depression
- Jaundice or signs of liver dysfunction
- Severe abdominal pain
- Lump in the breast
Special Patient Groups
Pregnancy
Contraindicated during pregnancy. Medroxyprogesterone acetate is classified as Pregnancy Category D. There is evidence of fetal risk based on human experience, but potential benefits may warrant use of the drug in pregnant women despite potential risks in serious or life-threatening situations.
Trimester-Specific Risks:
First Trimester:
Potential for congenital anomalies, particularly genital abnormalities in female fetuses, if exposure occurs during the first trimester.
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, caution is advised. Observe the infant for any potential adverse effects.
Infant Risk:
Low to moderate risk. No consistent adverse effects on infant growth or development have been reported, but theoretical concerns exist regarding hormonal exposure.
Pediatric Use
Safety and efficacy have not been established in prepubertal children for the indications of secondary amenorrhea or abnormal uterine bleeding. Use in adolescents should be carefully considered and monitored.
Geriatric Use
Use with caution in elderly patients. Increased risk of cardiovascular events, breast cancer, and dementia has been observed in postmenopausal women receiving combined estrogen and progestin therapy. The lowest effective dose for the shortest duration should be used.
Clinical Information
Clinical Pearls
- Medroxyprogesterone acetate is a versatile progestin used for various gynecological conditions, but its use requires careful patient selection and monitoring.
- Always rule out pregnancy before initiating therapy for gynecological indications.
- Patients should be advised about the potential for irregular bleeding patterns, especially during the initial cycles of treatment.
- Long-term use, particularly in combination with estrogen, carries risks of cardiovascular events, breast cancer, and dementia, as highlighted by the WHI study.
- Bone mineral density loss is a concern with long-term, high-dose use, particularly in adolescents, though less pronounced with oral 10mg doses than with injectable Depo-Provera.
Alternative Therapies
- Norethindrone acetate (another oral progestin)
- Oral contraceptives (for menstrual regulation or abnormal bleeding)
- Levonorgestrel-releasing intrauterine system (IUD) (for abnormal uterine bleeding)
- Tranexamic acid or NSAIDs (for heavy menstrual bleeding)
- GnRH agonists (for endometriosis, but with different side effect profile)
Cost & Coverage
Average Cost:
$15 - $50 per 30 tablets (10mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
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 your 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 happened.