Prometrium Micro 100mg Capsules
WARNING: 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 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 B
FDA Approved
May 1998
DEA Schedule
Not Controlled
Overview
What is this medicine?
Progesterone is a natural female hormone. This medication is used to replace progesterone in women who are not producing enough of it, often in combination with estrogen therapy to protect the lining of the uterus, or for certain fertility treatments.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
If you take this medication once a day, it's best to take it at bedtime.
You can take this medication with or without food. However, if it causes stomach upset, take it with food to help minimize this side effect.
Always take your medication with a full glass of water.
If you have difficulty swallowing, consult your doctor for guidance.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, avoiding refrigeration or freezing.
Keep it in a dry place, away from bathrooms and areas prone to moisture.
Ensure all medications are kept in a secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you forget to take a dose:
Take the missed dose 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 a missed dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
If you take this medication once a day, it's best to take it at bedtime.
You can take this medication with or without food. However, if it causes stomach upset, take it with food to help minimize this side effect.
Always take your medication with a full glass of water.
If you have difficulty swallowing, consult your doctor for guidance.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, avoiding refrigeration or freezing.
Keep it in a dry place, away from bathrooms and areas prone to moisture.
Ensure all medications are kept in a secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you forget to take a dose:
Take the missed dose 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 a missed dose.
Lifestyle & Tips
- Take the capsule at bedtime to minimize dizziness or drowsiness.
- Take with food to improve absorption and reduce stomach upset.
- Avoid driving or operating machinery until you know how this medication affects you.
- Do not share this medication with others.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For prevention of endometrial hyperplasia in postmenopausal women receiving concomitant estrogen: 200 mg daily at bedtime for 12 days sequentially per 28-day cycle. For treatment of secondary amenorrhea: 400 mg daily at bedtime for 10 days.
Dose Range:
100 - 400 mg
Condition-Specific Dosing:
prevention of endometrial hyperplasia:
200 mg daily at bedtime for 12 days sequentially per 28-day cycle
secondary amenorrhea:
400 mg daily at bedtime for 10 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution.
Dialysis:
Not specifically studied; use with caution.
Hepatic Impairment:
Mild:
Use with caution.
Moderate:
Use with caution.
Severe:
Contraindicated in severe hepatic dysfunction or disease.
Pharmacology
Mechanism of Action
Progesterone is a naturally occurring steroid that is secreted by the corpus luteum, placenta, and adrenal cortex. In the presence of adequate estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium. It is necessary to establish and maintain a pregnancy. Progesterone also inhibits pituitary gonadotropin secretion, which in turn prevents follicular maturation and ovulation.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 10% (due to extensive first-pass metabolism)
Tmax:
1.5 to 2 hours
FoodEffect:
Food increases the bioavailability of progesterone.
Distribution:
Vd:
Approximately 2-4 L/kg
ProteinBinding:
96% to 99% (primarily to albumin and corticosteroid-binding globulin)
CnssPenetration:
Yes
Elimination:
HalfLife:
5 to 20 hours (parent drug)
Clearance:
Not readily quantifiable due to extensive first-pass metabolism
ExcretionRoute:
Primarily urine (as metabolites), some feces
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Not precisely defined for hormonal effects; physiological effects begin with receptor binding.
PeakEffect:
Not precisely defined for hormonal effects; peak plasma levels occur at 1.5-2 hours.
DurationOfAction:
Not precisely defined for hormonal effects; related to half-life and sustained receptor binding.
Safety & Warnings
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
Respiratory issues, including:
+ Shortness of breath
+ Sudden weight gain
+ Swelling in the arms or legs
Mobility problems, such as:
+ Trouble walking
Severe dizziness or fainting
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
Urinary problems, including:
+ Pain when passing urine
+ Frequent urination
Mood changes, such as:
+ Depression
+ Memory problems or loss
This medication may cause fluid retention, leading to swelling, weight gain, or breathing difficulties. If you experience any of these symptoms, inform your doctor. Seek immediate medical attention if you notice signs of a blood clot, including:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color change, or pain in a leg or arm
Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Dizziness, drowsiness, tiredness, or weakness
Headache
Gastrointestinal issues, including:
+ Constipation
+ Diarrhea
+ Vomiting
+ Upset stomach
Stomach pain or cramps
Bloating
Breast-related symptoms, such as:
+ Enlarged breasts
+ Tender breasts
Muscle pain
Weight gain
Vaginal bleeding or spotting
Decreased interest in sex
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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
Respiratory issues, including:
+ Shortness of breath
+ Sudden weight gain
+ Swelling in the arms or legs
Mobility problems, such as:
+ Trouble walking
Severe dizziness or fainting
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
Urinary problems, including:
+ Pain when passing urine
+ Frequent urination
Mood changes, such as:
+ Depression
+ Memory problems or loss
This medication may cause fluid retention, leading to swelling, weight gain, or breathing difficulties. If you experience any of these symptoms, inform your doctor. Seek immediate medical attention if you notice signs of a blood clot, including:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color change, or pain in a leg or arm
Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
Dizziness, drowsiness, tiredness, or weakness
Headache
Gastrointestinal issues, including:
+ Constipation
+ Diarrhea
+ Vomiting
+ Upset stomach
Stomach pain or cramps
Bloating
Breast-related symptoms, such as:
+ Enlarged breasts
+ Tender breasts
Muscle pain
Weight gain
Vaginal bleeding or spotting
Decreased interest in sex
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 migraines
- Sudden vision changes (e.g., partial or complete loss of vision, double vision)
- Sudden chest pain, shortness of breath, or coughing up blood (signs of a blood clot in the lungs)
- Pain, swelling, or warmth in the leg (signs of a blood clot in the leg)
- Yellowing of the skin or eyes (jaundice)
- Severe abdominal pain
- Unusual vaginal bleeding or spotting after menopause
- Lump in the breast
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. Be sure to describe the symptoms you experienced.
If you have a peanut allergy, as the capsules contain peanut oil.
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 may be influenced by estrogen or progesterone
Unexplained vaginal bleeding
* If you are pregnant or think you might be pregnant. Do not take this medication during pregnancy unless your doctor advises you to do so.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage 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. Be sure to describe the symptoms you experienced.
If you have a peanut allergy, as the capsules contain peanut oil.
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 may be influenced by estrogen or progesterone
Unexplained vaginal bleeding
* If you are pregnant or think you might be pregnant. Do not take this medication during pregnancy unless your doctor advises you to do so.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and they will instruct you on when to resume taking it after the surgery or procedure.
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. If you have a nut or seed allergy, discuss this with your doctor. Additionally, if you have diabetes (high blood sugar), consult with your doctor, as this medication may increase your blood sugar levels.
Regular breast exams and gynecology check-ups are crucial, and you should also perform breast self-exams as instructed by your healthcare provider. This medication may interfere with certain laboratory tests, so it is vital to inform all your healthcare providers and laboratory personnel that you are taking this drug.
There is a risk of blood clots associated with this medication, which can be life-threatening and may include heart attack, stroke, or clots in the leg, lung, or eye. If you have a history of blood clots, inform your doctor. Prolonged periods of immobility, such as long trips, bedrest after surgery, or illness, may increase your risk of blood clots, so discuss this with your doctor.
Certain side effects, including heart attack, stroke, and breast cancer, 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, whether estrogen is taken with or without a progestin, and other individual factors. Discuss the benefits and risks of using this medication with your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. This medication is not a form of birth control and will not prevent pregnancy. If you have questions or concerns, consult with your doctor.
If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. If you have a nut or seed allergy, discuss this with your doctor. Additionally, if you have diabetes (high blood sugar), consult with your doctor, as this medication may increase your blood sugar levels.
Regular breast exams and gynecology check-ups are crucial, and you should also perform breast self-exams as instructed by your healthcare provider. This medication may interfere with certain laboratory tests, so it is vital to inform all your healthcare providers and laboratory personnel that you are taking this drug.
There is a risk of blood clots associated with this medication, which can be life-threatening and may include heart attack, stroke, or clots in the leg, lung, or eye. If you have a history of blood clots, inform your doctor. Prolonged periods of immobility, such as long trips, bedrest after surgery, or illness, may increase your risk of blood clots, so discuss this with your doctor.
Certain side effects, including heart attack, stroke, and breast cancer, 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, whether estrogen is taken with or without a progestin, and other individual factors. Discuss the benefits and risks of using this medication with your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. This medication is not a form of birth control and will not prevent pregnancy. If you have questions or concerns, consult with your doctor.
If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Dizziness
- Nausea
- Fatigue
What to Do:
In case of suspected overdose, seek immediate medical attention or contact a poison control center (e.g., 1-800-222-1222). Treatment is generally supportive.
Drug Interactions
Major Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort) - may decrease progesterone levels.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, grapefruit juice) - may increase progesterone levels.
Monitoring
Baseline Monitoring
Liver function tests (LFTs)
Rationale: To assess hepatic function, especially in patients with a history of liver disease, as progesterone is extensively metabolized by the liver.
Timing: Prior to initiation of therapy if clinically indicated.
Routine Monitoring
Clinical symptoms (e.g., abnormal vaginal bleeding, breast changes, mood disturbances, signs of thromboembolism)
Frequency: Periodically during therapy
Target: Absence of concerning symptoms
Action Threshold: Report any new or worsening symptoms to healthcare provider immediately.
Endometrial biopsy (for prevention of endometrial hyperplasia)
Frequency: As clinically indicated, typically annually or biennially
Target: Absence of hyperplasia
Action Threshold: Presence of hyperplasia may require dose adjustment or alternative therapy.
Symptom Monitoring
- Abnormal vaginal bleeding or spotting
- Breast tenderness or pain
- Headache
- Dizziness or drowsiness
- Nausea
- Abdominal pain
- Mood changes (e.g., depression, irritability)
- Signs of blood clots (e.g., sudden severe headache, vision changes, chest pain, shortness of breath, pain/swelling in leg)
- Jaundice (yellowing of skin or eyes)
Special Patient Groups
Pregnancy
Prometrium is Pregnancy Category B. It is indicated for use in assisted reproductive technology (ART) to support early pregnancy. It is not indicated for general use during pregnancy.
Trimester-Specific Risks:
First Trimester:
Category B for ART use; generally considered safe for this specific indication.
Second Trimester:
Not indicated for general use; limited data.
Third Trimester:
Not indicated for general use; limited data.
Lactation
Progesterone is excreted in breast milk. While generally considered compatible with breastfeeding (L3), caution is advised. The effects on the breastfed infant are not well-established.
Infant Risk:
Low to moderate risk; monitor infant for any adverse effects.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for use in children.
Geriatric Use
No specific dose adjustment is generally required based on age alone. However, caution is advised due to the potential for increased risk of cardiovascular events and other adverse effects in older women receiving hormone therapy, particularly when combined with estrogen.
Clinical Information
Clinical Pearls
- Advise patients to take Prometrium at bedtime to mitigate common side effects like dizziness and drowsiness.
- Taking the medication with food can enhance absorption and reduce gastrointestinal upset.
- Emphasize the importance of regular follow-up appointments, especially for postmenopausal women on concomitant estrogen therapy, to monitor for endometrial changes.
- Counsel patients on the signs and symptoms of thromboembolic events and instruct them to seek immediate medical attention if these occur.
Alternative Therapies
- Medroxyprogesterone acetate (oral or injectable)
- Norethindrone acetate (oral)
- Levonorgestrel-releasing intrauterine system (IUD) for endometrial protection
- Progesterone vaginal gel or suppositories (for ART or other indications)
Cost & Coverage
Average Cost:
$50 - $100 per 30 capsules (100mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (generic) or Tier 2 (brand) on most commercial and Medicare Part D plans.
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.