Medroxyprogesterone 2.5mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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 effectiveness of your treatment, do not 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 safe place, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the proper disposal method. You may also want to inquire about 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. 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 taking this medication as part of hormone replacement therapy, as smoking significantly increases the risk of serious side effects like blood clots, stroke, and heart attack.
- Maintain a healthy diet and exercise regularly.
- Discuss any concerns about weight gain or fluid retention with your doctor.
- Attend all scheduled follow-up appointments and screenings (e.g., mammograms, blood pressure checks).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
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 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 conjugated estrogens and medroxyprogesterone acetate, 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.
Because of these risks, 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
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 medical attention immediately:
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
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Breast-related symptoms, including:
+ Lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal symptoms, such as:
+ Itching or discharge
+ Abnormal vaginal bleeding
Mood changes, including depression
Seizures
Fluid retention, characterized by swelling, weight gain, or 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 or dizziness
+ Passing out
+ Changes in eyesight
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
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects. If you're concerned about any of these symptoms or if they persist, contact your doctor or seek medical attention:
Weight gain or loss
Headache
Dizziness, sleepiness, tiredness, or weakness
Nervousness and excitability
Upset stomach or vomiting
Bloating
Changes in sex interest
Acne
Hair loss or growth
Enlarged or tender breasts
Vaginal bleeding or spotting
Stomach pain
Trouble sleeping
Changes in menstrual cycle or absence of periods
Hormone Therapy (HT) Specific Side Effects
If you're undergoing hormone therapy, you may experience additional side effects, including:
Stomach cramps
Joint pain
* Leg cramps
Reporting 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
- Sudden severe chest pain, shortness of breath, or coughing up blood
- Pain, swelling, or warmth in the leg (especially the calf or thigh)
- New breast lump or changes in the breast
- Unusual vaginal bleeding or spotting after menopause
- Yellowing of the skin or eyes (jaundice)
- Severe abdominal pain
Before Using This Medicine
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. Describe the allergic reaction and its symptoms.
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 grow in response 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 ensure that it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & 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 need to stop this medication before certain surgeries or procedures, and will advise you on when to resume taking it after the surgery or procedure is complete.
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 extended periods, 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 while taking this medication. High triglyceride levels have been reported with this drug, so inform your doctor if you have a history of elevated triglycerides.
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, so avoid sun exposure, sunlamps, and tanning beds, and use protective measures such as sunscreen, 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
Drugs like this one have been associated with high blood pressure, so have your blood pressure checked regularly as directed by your doctor. Certain side effects, including heart attack, stroke, breast cancer, and others, have been reported in some individuals taking estrogen with a progestin. The risk of these side effects may vary depending on factors such as treatment duration, estrogen use with or without a progestin, and other individual factors. Discuss the benefits and risks of using this medication with your doctor.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Drowsiness
- Dizziness
- Fatigue
- Abnormal vaginal bleeding
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive.
Drug Interactions
Major Interactions
- Aminoglutethimide (may significantly decrease MPA plasma concentrations)
- CYP3A4 inducers (e.g., Carbamazepine, Phenobarbital, Phenytoin, Rifampin, St. John's Wort - may decrease MPA efficacy)
- CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin - may increase MPA concentrations)
Moderate Interactions
- Grapefruit juice (may increase MPA levels)
- Warfarin (potential for altered anticoagulant effect, monitor INR)
- Cyclosporine (MPA may increase cyclosporine levels)
- Theophylline (MPA may increase theophylline levels)
- Oral hypoglycemics/Insulin (MPA may decrease glucose tolerance, requiring dose adjustment)
Minor Interactions
- Laboratory tests (may affect certain endocrine and liver function tests)
Monitoring
Baseline Monitoring
Rationale: To identify contraindications, risk factors, and establish baseline health status.
Timing: Prior to initiation of therapy.
Rationale: Progestins can affect blood pressure.
Timing: Prior to initiation of therapy.
Rationale: To screen for breast cancer, especially important with hormone therapy.
Timing: Prior to initiation of therapy, as appropriate for age and risk factors.
Rationale: Hormone therapy can affect lipid metabolism.
Timing: Prior to initiation of therapy (if used for HRT).
Rationale: MPA is metabolized by the liver; assess baseline function.
Timing: Prior to initiation of therapy, especially if hepatic impairment is suspected.
Routine Monitoring
Frequency: Annually or as clinically indicated.
Target: Normal range for patient.
Action Threshold: Significant increase or sustained hypertension.
Frequency: Annually or as clinically indicated.
Target: No new abnormalities.
Action Threshold: New lumps, pain, or suspicious findings.
Frequency: Annually or as clinically indicated.
Target: Normal findings.
Action Threshold: Abnormal bleeding, pain, or suspicious findings.
Frequency: Periodically (e.g., every 1-2 years) if used for HRT.
Target: Individualized based on cardiovascular risk.
Action Threshold: Significant adverse changes in lipid levels.
Frequency: Periodically, especially in diabetic or pre-diabetic patients.
Target: Individualized.
Action Threshold: Significant increase in blood glucose.
Symptom Monitoring
- Signs and symptoms of thromboembolic events (e.g., sudden chest pain, shortness of breath, sudden severe headache, sudden loss of vision, pain/swelling in leg)
- Signs and symptoms of myocardial infarction (e.g., chest pain, discomfort, shortness of breath, pain in arm/shoulder)
- Signs and symptoms of stroke (e.g., sudden numbness or weakness, confusion, trouble speaking, vision problems, dizziness, loss of balance)
- New breast lumps or changes
- Unusual vaginal bleeding or spotting
- Severe abdominal pain
- Jaundice (yellowing of skin or eyes)
- Mood changes, depression
Special Patient Groups
Pregnancy
Medroxyprogesterone acetate is contraindicated during pregnancy. There is evidence of risk to the fetus based on human experience. It should not be used to prevent miscarriage.
Trimester-Specific Risks:
Lactation
Medroxyprogesterone is excreted in breast milk. While generally considered compatible with breastfeeding at low doses, caution is advised. Monitor the infant for potential effects.
Pediatric Use
Safety and efficacy have not been established in pediatric patients for the indications typically treated with 2.5mg tablets (e.g., HRT). Use in adolescents for specific conditions (e.g., endometriosis, contraception) is typically with different formulations or higher doses and under specialist guidance.
Geriatric Use
Increased risk of stroke, deep vein thrombosis, pulmonary embolism, and probable dementia in women 65 years of age or older when used as part of combined HRT. Use the lowest effective dose for the shortest duration consistent with treatment goals. Close monitoring is essential.
Clinical Information
Clinical Pearls
- Medroxyprogesterone 2.5mg is primarily used in continuous combined HRT to protect the endometrium from estrogen-induced hyperplasia.
- Patients should be thoroughly counseled on the Black Box Warnings, especially regarding cardiovascular risks, stroke, and breast cancer, particularly if used for HRT.
- Regular follow-up, including breast exams and mammograms, is crucial during therapy.
- Report any unusual vaginal bleeding immediately, as it may indicate endometrial issues.
- This medication does not protect against sexually transmitted infections.
- Ensure patients understand the importance of not smoking while on hormone therapy.
Alternative Therapies
- Other progestins (e.g., micronized progesterone, norethindrone acetate, dydrogesterone)
- For abnormal uterine bleeding: Tranexamic acid, NSAIDs, GnRH agonists, endometrial ablation, hysterectomy.
- For secondary amenorrhea: Treatment of underlying cause, other progestins.
- For HRT: Other forms of estrogen (transdermal, vaginal), selective estrogen receptor modulators (SERMs), non-hormonal therapies for menopausal symptoms (e.g., SSRIs/SNRIs, gabapentin, clonidine).