Medroxyprogesterone 5mgtablets

Manufacturer TEVA Active Ingredient Medroxyprogesterone Tablets(me DROKS ee proe JES te rone) Pronunciation me DROKS ee proe JES te rone
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.
đŸˇī¸
Drug Class
Progestin
đŸ§Ŧ
Pharmacologic Class
Progestin
🤰
Pregnancy Category
Category X
✅
FDA Approved
Sep 1959
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Medroxyprogesterone is a synthetic hormone similar to progesterone, which is naturally produced by the body. It's used to help regulate menstrual periods, treat abnormal uterine bleeding, and protect the lining of the uterus when estrogen is also being taken.
📋

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 not to miss any doses.

Storing and Disposing of Your Medication

To keep your medication in good condition, 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 medications, do not flush them down the toilet or pour them 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 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. It's crucial to avoid taking two doses at the same time or taking extra doses, as this can increase the risk of adverse effects.
💡

Lifestyle & Tips

  • Do not smoke, especially if you are over 35, as smoking increases the risk of serious cardiovascular side effects.
  • Maintain regular physical activity and a healthy diet.
  • Report any unusual or severe symptoms to your doctor immediately.

Dosing & Administration

đŸ‘¨â€âš•ī¸

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 (with estrogen): 2.5-5 mg daily continuously OR 5-10 mg daily for 10-14 consecutive days of a 28-day cycle
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (unless for specific off-label uses under specialist guidance)
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed
Severe: No specific adjustment needed
Dialysis: Not significantly dialyzable; no specific adjustment needed

Hepatic Impairment:

Mild: Use with caution
Moderate: Use with caution; consider lower dose
Severe: Contraindicated

Pharmacology

đŸ”Ŧ

Mechanism of Action

Medroxyprogesterone acetate (MPA) is a synthetic progestin that acts on progesterone receptors in target tissues such as the uterus, breast, hypothalamus, and pituitary gland. It transforms proliferative endometrium into secretory endometrium, inhibits gonadotropin secretion (LH and FSH), and can inhibit ovulation at higher doses. It also possesses some glucocorticoid and weak androgenic activity.
📊

Pharmacokinetics

Absorption:

Bioavailability: 10-30%
Tmax: 2-4 hours
FoodEffect: Food may increase bioavailability

Distribution:

Vd: 20 Âą 3 L
ProteinBinding: Approximately 88% (primarily to albumin)
CnssPenetration: Yes

Elimination:

HalfLife: 17-30 hours (variable)
Clearance: Not available
ExcretionRoute: Primarily urine (conjugated metabolites), some feces
Unchanged: <1%
âąī¸

Pharmacodynamics

OnsetOfAction: Within hours (progestational effects)
PeakEffect: Varies by indication and regimen
DurationOfAction: Depends on dose and regimen; progestational effects persist for several days after discontinuation of daily dosing.

Safety & Warnings

âš ī¸

BLACK BOX WARNING

Medroxyprogesterone acetate (MPA) should not be used during pregnancy. 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 receiving daily conjugated equine estrogens (CEE) combined with MPA compared to placebo. The WHI Memory Study (WHIMS) reported an increased risk of probable dementia in postmenopausal women 65 years of age or older receiving CEE plus MPA compared to placebo. These risks should be weighed against the benefits of therapy.
âš ī¸

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 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
Eye problems, including:
+ Changes in eyesight or loss of vision
+ Bulging eyes
+ Changes in how contact lenses feel
Breast changes, such as:
+ A 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 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

Most people do not experience serious side effects, and many have no side effects or only mild ones. However, if you notice 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
Feeling sleepy, tired, or weak
Feeling nervous and excitable
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 no period
Hormone therapy (HT) side effects:
+ Stomach cramps
+ Joint pain
+ Leg cramps

Reporting Side Effects

This is not a comprehensive list of all 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 or migraine
  • Sudden vision changes (e.g., partial or complete loss of vision, double vision)
  • Sudden chest pain, shortness of breath, or coughing up blood
  • Pain, swelling, or warmth in the leg (especially calf)
  • Weakness or numbness in an arm or leg, or one side of the body
  • Slurred speech
  • Yellowing of the skin or eyes (jaundice)
  • Severe abdominal pain
  • New breast lump
  • Unusual or heavy vaginal bleeding after menopause
📋

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 are sensitive to estrogen or progesterone
Unexplained vaginal bleeding
If you are breast-feeding or plan to breast-feed
* If you are pregnant or think you may be 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 medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
âš ī¸

Precautions & Cautions

Important Warnings and Cautions

When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment. Your doctor may advise you to stop taking this medication before certain surgical procedures, and will provide guidance on when to resume treatment 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 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. This medication may also cause high triglyceride levels; 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; inform all your healthcare providers and lab workers about your treatment. Additionally, this medication may cause dark skin patches on your face; 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) Specific Warnings
When taking this medication as part of hormone therapy, be aware of the following risks:

High blood pressure: Monitor your blood pressure regularly, as directed by your doctor.
Cardiovascular risks: Certain side effects, such as heart attack, stroke, and breast cancer, have been reported in some individuals taking estrogen with a progestin. Discuss the benefits and risks of this medication with your doctor, considering factors such as treatment duration, estrogen use with or without a progestin, and individual risk factors.
🆘

Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Drowsiness
  • Dizziness
  • Breast tenderness
  • Abdominal pain
  • Fatigue

What to Do:

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Treatment is generally supportive.

Drug Interactions

🔴

Major Interactions

  • Aminoglutethimide (may significantly decrease MPA plasma concentrations)
🟡

Moderate Interactions

  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort - may decrease MPA levels)
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin - may increase MPA levels)
  • Bosentan (may decrease MPA levels)
đŸŸĸ

Minor Interactions

  • May affect glucose tolerance (monitor in diabetics)
  • May affect thyroid function tests (decrease T3/T4, increase TSH binding capacity)

Monitoring

đŸ”Ŧ

Baseline Monitoring

Complete medical history and physical examination (including blood pressure, breast and pelvic exam)

Rationale: To identify contraindications, risk factors, and establish baseline health status.

Timing: Prior to initiation of therapy

Liver function tests

Rationale: MPA is metabolized in the liver; severe hepatic impairment is a contraindication.

Timing: Prior to initiation, especially if history of liver disease

📊

Routine Monitoring

Blood pressure

Frequency: Annually or as clinically indicated

Target: Normal limits

Action Threshold: Significant elevation requires evaluation

Breast examination

Frequency: Annually

Target: Normal

Action Threshold: New lumps or changes require further investigation

Pelvic examination

Frequency: Annually

Target: Normal

Action Threshold: Abnormal findings require further investigation

Blood glucose (for diabetic patients)

Frequency: Periodically

Target: Individualized

Action Threshold: Significant hyperglycemia requires adjustment of antidiabetic therapy

đŸ‘ī¸

Symptom Monitoring

  • Signs of thromboembolic disorders (e.g., sudden severe headache, sudden partial or complete loss of vision, sudden onset of proptosis, diplopia, papilledema, sudden chest pain, shortness of breath, pain/swelling in calf)
  • Signs of liver dysfunction (e.g., jaundice, severe abdominal pain)
  • New breast lumps or changes
  • Unusual vaginal bleeding
  • Severe mood changes or depression
  • Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)

Special Patient Groups

🤰

Pregnancy

Contraindicated in pregnancy (Category X). There is evidence of fetal harm, including genital abnormalities in female and male fetuses, when progestins are given during the first trimester of pregnancy.

Trimester-Specific Risks:

First Trimester: High risk of fetal abnormalities (e.g., clitoral enlargement, labial-scrotal fusion in female fetuses; hypospadias in male fetuses).
Second Trimester: Not indicated; potential for adverse effects on fetal development.
Third Trimester: Not indicated; potential for adverse effects on fetal development.
🤱

Lactation

Use with caution. Medroxyprogesterone is excreted in breast milk. While no adverse effects have been reported in breastfed infants, long-term effects are unknown. Consider the benefits of breastfeeding versus the potential risks to the infant.

Infant Risk: L3 (Moderately safe; small amounts excreted, potential for minor effects, but generally considered compatible with breastfeeding by some sources).
đŸ‘ļ

Pediatric Use

Safety and efficacy have not been established in pediatric patients for the indications of secondary amenorrhea or abnormal uterine bleeding. Not generally recommended for use in children.

👴

Geriatric Use

Increased risk of cardiovascular events, breast cancer, and probable dementia when used in combination with estrogen in postmenopausal women. Use the lowest effective dose for the shortest duration consistent with treatment goals and risks. Close monitoring is advised.

Clinical Information

💎

Clinical Pearls

  • Medroxyprogesterone acetate is not indicated for use as a diagnostic test for pregnancy.
  • Before initiating therapy for abnormal uterine bleeding, organic pathology (e.g., fibroids, polyps, cancer) should be ruled out.
  • Patients should be advised to report any signs or symptoms of thromboembolic events immediately.
  • For prevention of endometrial hyperplasia in postmenopausal women receiving estrogen, MPA can be given continuously or cyclically.
  • Long-term use of progestins alone or with estrogens in postmenopausal women has been associated with increased risks, as outlined in the Black Box Warning.
🔄

Alternative Therapies

  • Other progestins (e.g., norethindrone, oral micronized progesterone)
  • Combined oral contraceptives (for abnormal uterine bleeding or amenorrhea)
  • GnRH agonists/antagonists (for severe endometriosis or fibroids, not direct substitutes for MPA's primary indications)
  • Levonorgestrel-releasing intrauterine system (for abnormal uterine bleeding or endometrial protection)
💰

Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (5mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (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 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.