Progesterone Micro 200mg Capsules

Manufacturer BIONPHARMA Active Ingredient Progesterone Capsules(proe JES ter one) Pronunciation proe JES ter one
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.
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Drug Class
Hormone, Progestin
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Pharmacologic Class
Progestin
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Pregnancy Category
Category B
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FDA Approved
May 1998
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Progesterone is a natural female hormone. This medication is used to help prevent the thickening of the lining of the uterus (endometrial hyperplasia) in women taking estrogen after menopause, or to help restart menstrual periods in women who have stopped having them (secondary amenorrhea). It works by replacing the progesterone your body might not be making enough of.
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How to Use This Medicine

Taking Your Medication

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.
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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.

Dosing & Administration

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Adult Dosing

Standard Dose: For prevention of endometrial hyperplasia in postmenopausal women receiving concomitant estrogen: 200 mg orally once daily at bedtime for 12 days sequentially per 28-day cycle. For secondary amenorrhea: 400 mg orally once daily at bedtime for 10 days.
Dose Range: 200 - 400 mg

Condition-Specific Dosing:

endometrial_hyperplasia_prevention: 200 mg orally once daily at bedtime for 12 days sequentially per 28-day cycle.
secondary_amenorrhea: 400 mg orally once daily at bedtime for 10 days.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: Use with caution; no specific dose adjustment recommended but monitor for adverse effects.
Dialysis: Not available

Hepatic Impairment:

Mild: Use with caution.
Moderate: Use with caution; consider dose reduction.
Severe: Contraindicated in severe hepatic dysfunction or disease.

Pharmacology

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Mechanism of Action

Progesterone is a naturally occurring steroid that is secreted by the corpus luteum, placenta, and adrenal cortex. It binds to progesterone receptors in target tissues (e.g., uterus, breast, hypothalamus, pituitary), leading to changes in gene expression. In the endometrium, it induces secretory changes in an estrogen-primed uterus, transforming the proliferative endometrium into a secretory endometrium. It also inhibits gonadotropin secretion and prevents further follicular maturation and ovulation.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 10% (due to extensive first-pass metabolism)
Tmax: 1.5-2 hours
FoodEffect: Increased absorption when taken with food, especially fatty meals.

Distribution:

Vd: Not available (extensively distributed)
ProteinBinding: 96-99% (primarily to albumin and corticosteroid-binding globulin)
CnssPenetration: Yes

Elimination:

HalfLife: 5-20 hours (variable, due to metabolites)
Clearance: Not available
ExcretionRoute: Primarily urine (50-60%) and feces (10%) as metabolites
Unchanged: Less than 1%
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Pharmacodynamics

OnsetOfAction: Not precisely defined for therapeutic effect; hormonal effects begin rapidly after absorption.
PeakEffect: Approximately 1.5-2 hours (corresponds to Tmax)
DurationOfAction: Effects persist for approximately 24 hours, allowing once-daily dosing.

Safety & Warnings

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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
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.
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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
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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 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.
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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 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 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.
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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

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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.
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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

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Baseline Monitoring

Liver function tests (LFTs)

Rationale: Progesterone is extensively metabolized by the liver; baseline assessment is important, especially in patients with hepatic impairment.

Timing: Prior to initiation of therapy.

Lipid profile

Rationale: Hormone therapy can affect lipid metabolism.

Timing: Prior to initiation of therapy, especially if used as part of HRT.

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Routine Monitoring

Endometrial assessment (e.g., biopsy, ultrasound)

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.

Blood pressure

Frequency: Periodically

Target: Normal limits

Action Threshold: Significant elevation may require intervention or re-evaluation of therapy.

Breast examination/mammography

Frequency: Annually or as per standard screening guidelines

Target: Normal findings

Action Threshold: New lumps, pain, or abnormal mammogram findings require further investigation.

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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

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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:

First Trimester: Generally considered safe for specific indications (e.g., luteal phase support).
Second Trimester: No increased risk of congenital anomalies observed with therapeutic use.
Third Trimester: No specific risks identified, but typically not initiated in late pregnancy unless for specific indications.
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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.

Infant Risk: Low to moderate risk. Small amounts are excreted into breast milk. No adverse effects have been consistently reported in breastfed infants, but theoretical concerns exist regarding potential hormonal effects.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Not indicated for use in children.

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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

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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.
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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
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Cost & Coverage

Average Cost: $100 - $250 per 30 capsules (brand)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand), varies by insurance plan
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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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.