Progesterone Micro 200mg Capsules
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, it's essential to take it as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely.
If you're taking this medication once a day, 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 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
- Take this medication at bedtime, as it can cause dizziness or drowsiness.
- Take with food, as this can help with absorption and reduce stomach upset.
- Do not drive or operate machinery until you know how this medication affects you.
- Inform your doctor if you smoke, have high blood pressure, high cholesterol, diabetes, or a family history of blood clots, as these can increase risks associated with hormone use.
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
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
Respiratory symptoms, including:
+ Shortness of breath
+ Sudden weight gain
+ Swelling in the arms or legs
Mobility issues, 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 symptoms, including:
+ Pain when passing urine
+ Frequent urination
Mood changes, such as depression or memory problems
This medication may cause fluid retention, leading to swelling or weight gain. If you experience swelling, weight gain, or trouble breathing, 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Dizziness, drowsiness, tiredness, or weakness
Headache
Gastrointestinal symptoms, 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 list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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:
- Unusual vaginal bleeding or spotting
- Sudden severe headache or migraine
- Sudden vision changes (e.g., partial or complete loss of vision, double vision)
- Numbness or weakness in an arm or leg, especially on one side of the body
- Chest pain, shortness of breath, or coughing up blood (signs of blood clot in lungs)
- Pain, swelling, or warmth in the leg (signs of blood clot in leg)
- Yellowing of the skin or eyes (jaundice), dark urine, or persistent abdominal pain (signs of liver problems)
- Lump in the breast
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. Be sure to describe the allergic reaction 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 may 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 consulting your doctor.
Precautions & Cautions
Until you know how this medication affects you, avoid driving and other activities that require your full attention. 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. Blood clots can manifest as heart attacks, strokes, or clots in the legs, lungs, or eyes. If you have a history of blood clots, inform your doctor. Prolonged periods of immobility, such as during long trips, bed rest after surgery, or illness, may increase your risk of developing blood clots. Discuss this with your doctor.
Certain side effects, including heart attacks, strokes, and breast cancer, have been reported in individuals taking estrogen with progestin. The risk of these side effects may vary depending on factors such as treatment duration, whether estrogen is taken with or without progestin, and other individual factors. Your doctor will help you weigh the benefits and risks of using this medication.
If you are 65 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, discuss them 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
- Vomiting
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
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort) may significantly decrease progesterone plasma concentrations, reducing therapeutic effect.
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, erythromycin) may significantly increase progesterone plasma concentrations, increasing risk of adverse effects.
Moderate Interactions
- Moderate CYP3A4 inducers/inhibitors (monitor for altered efficacy/toxicity).
- Drugs that affect gastrointestinal motility or absorption (e.g., antacids, laxatives) may alter progesterone absorption.
Monitoring
Baseline Monitoring
Rationale: Progesterone is extensively metabolized by the liver; baseline assessment is important, especially in patients with hepatic impairment.
Timing: Prior to initiation of therapy.
Rationale: Hormone therapy can affect lipid metabolism.
Timing: Prior to initiation of therapy, especially if used as part of HRT.
Routine Monitoring
Frequency: Annually or as clinically indicated (for women with intact uterus receiving estrogen therapy)
Target: Normal endometrial thickness, absence of hyperplasia/malignancy
Action Threshold: Abnormal bleeding, endometrial thickening, or signs of hyperplasia/malignancy require further investigation.
Frequency: Periodically
Target: Normal limits
Action Threshold: Significant elevation may require intervention or re-evaluation of therapy.
Frequency: Annually or as per standard screening guidelines
Target: Normal findings
Action Threshold: New lumps, pain, or abnormal mammogram findings require further investigation.
Symptom Monitoring
- Abnormal vaginal bleeding or spotting
- Breast tenderness or lumps
- Mood changes (e.g., depression, irritability)
- Headache or migraine
- Dizziness or drowsiness
- Symptoms of thromboembolic events (e.g., leg pain/swelling, chest pain, shortness of breath, sudden vision changes)
- Symptoms of liver dysfunction (e.g., jaundice, dark urine, abdominal pain)
Special Patient Groups
Pregnancy
Progesterone is Pregnancy Category B. It is sometimes used off-label for luteal phase support in assisted reproductive technologies (ART) or for prevention of preterm birth in specific high-risk cases (though often vaginal or injectable routes are preferred for these indications). Its use should be carefully considered and discussed with a healthcare provider.
Trimester-Specific Risks:
Lactation
Progesterone is excreted in breast milk. While generally considered compatible with breastfeeding (L3), caution is advised. Monitor the infant for any signs of drowsiness or other effects.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Not indicated for use in children.
Geriatric Use
No specific dose adjustments are generally required based on age alone. However, geriatric patients may be more sensitive to the sedative effects of progesterone and may have increased risk factors for cardiovascular events, requiring careful monitoring.
Clinical Information
Clinical Pearls
- Oral micronized progesterone should be taken at bedtime to minimize the impact of common side effects like dizziness and drowsiness.
- Taking progesterone with food, especially a fatty meal, significantly increases its absorption and bioavailability.
- This formulation is distinct from synthetic progestins and has a different pharmacokinetic and pharmacodynamic profile.
- It is crucial to differentiate between oral micronized progesterone and other progestin formulations (e.g., medroxyprogesterone acetate) when discussing indications and side effects.
- For women with an intact uterus receiving estrogen therapy, progesterone is essential to prevent endometrial hyperplasia and reduce the risk of endometrial cancer.
Alternative Therapies
- Other progestins (e.g., medroxyprogesterone acetate, norethindrone acetate)
- Vaginal progesterone (e.g., Crinone, Endometrin, Prometrium vaginal inserts) for luteal phase support or prevention of preterm birth
- Injectable progesterone (e.g., Progesterone in oil) for specific fertility or pregnancy indications
- Intrauterine devices (IUDs) releasing levonorgestrel (e.g., Mirena) for endometrial protection or contraception